The Patent (Amended) Act And The Patent Rules , 2003 as amended b y The Patent (amended ) Rules
In the matter of t h e p r o v i s i o n s under The Section 25(1) of The Patents (Amendment) Act 2 0 0 5 a n d T h e Patents Rules (Amendment) 2006 And In the matter of Patent application no.359/KOL/2007dtd. 13/04/2006 filed by M/ s Tata Tea Limited[now known as Tata Global Beverages Limited](Applicant) And
In the matter of Pre grant by way of representation u/s 25(1) of the Act by M/s HindusthanUnilever Ltd. Hearing Held on 24/08/2015 at 11.30a.m before Dr. S. Chattopadhyay, Astt. Controller, Patents & Designs Present: 1.
Shri S. Majumdar and Dr. S.Ganguly and others ,agent for opposition
2. Shri V.D. Gulwani, Agent for applicant
DECISION
A representation u/s.25(1) of the Patent Act, 1970, against the Patent application as in the reference above has been filed by M/s S.Majumdar & Co.,Ko;kata on behalf of M/s Hindustan Unilever Ltd., Mumbai on 17/04/2008 on the following grounds:a) that the applicant for the patent or the person under or through whom he claims, wrongfully obtained the invention or any part thereof from him or from a person under or through whom he claims: b) that the invention so far as claimed in any claim of the complete specification has been published before the priority date of the claimi) in any specification filed in pursuance of an application for a patent made in India on or after the 1st day of January ,1912; or ii) in India or elsewhere, in any other document:
c) that the invention so far as claimed in any claim of the complete specification is claimed in a claim of a complete specification published on or after the priority date of the applicant’s claim and filed in pursuance of an application for a patent in India, being a claim of which the priority date is earlier than that of the applicant’s claim; d) that the invention so far as claimed in any claim of the complete specification was publicly known or publicly used in India before the priority date of that claim, e) that the invention so far as claimed in any claim of the complete specification is obvious and clearly does not involve any inventive step, having regard to the matter published as mentioned in clause(b) or having regard to what was used in India before the priority date of the applicant’s claim; f) that the subject of any claim of the complete specification not an invention with in the meaning of this Act, or is not patentable under this Act. g) that the complete specification does not sufficiently and clearly describe the invention or the method by which it is to be performed h) that the applicant has failed to disclose to the Controller the information required by Section 8 or has furnished the information which in any material particular was false to his knowledge. i) that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used for the invention; j) that the invention so far as claimed in any claim of the complete specification is anticipated having regard to the knowledge, oral or otherwise, available within any local or indigenous community in India or elsewhere.
After completion of the procedure prescribed u/s 25(1) to read with Rule 55 under prevailing Rules a hearing has been scheduled on 24/08/2015 at 11.30a.m to dispose the above mentioned pre grant representation u/s 25(1) against the subject application 359/Kol/2007.
The hearing has taken place as scheduled and written submission of the opponent along with applicant have been taken on record and annexed as A and B respectively along with subject decision. Upon consideration of the grounds of opposition raised by opponent vis a vis the arguments placed by the agent of the applicant under the provision of section 25(1) of the Act and prevailing Rules followed by written note of arguments I shall turn my eyes to the grounds of opposition submitted by opponent for pregnant opposition and subsequent submission thereby from the applicant.
It has been clarified during the hearing by undersigned on query of opponent of the proceedings that the arguments and counter arguments shall be done on the basis of initially filed claims . In the later proceedings u/s 15 of the Act relying on WPC332/2010(UCB Vs CIPLA)wherein the Hon’ble justice had held that pre grant oppositions process is nothing but an extension of examination process under chapter IV of the Patent Act. In the said hearing the applicant has been clarified the reason for non allowability of form 13 which has been explained where said amendments violates prescribed Rules and section 57(2) to read with section 59 the Act. First of all I would like to mention that subject application is related to flavoured herbal tea composition and process of manufacturing the same having four herbal formulations, each of the formulations comprising plurality of herbs and wherein each herb is taken within specific weight percentage range and provides a definite flavour when this flavour composition is used for preparation of herbal flavoured tea composition as per the process of the present invention wherein in the final product is made in two main steps comprising first step of making of flavored concentrate and the second step of dilution/blending with tea or tea components to get the end product. At this junction the opponent argued that with the background of invention ordinary person skilled in the art expects that the invention focuses to a process for preparation of herbal tea composition which process does away with the disadvantages of the prior art processes as the opponent thinks that alleged invention resides in the process and not in the product. The applicant defends that there is definite mention of product also in the object of invention and stated that the main object was to provide a flavored herbal tea composition with do-good ingredients having distinct flavor but the end product has taste like a regular tea . It was clarified further by the applicant several times during proceedings u/s 25(1) and u/s 15 of the Act that the flavored herbal tea of the present invention was not a medicinal formulation but has the organoleptic properties of regular tea. In appearance it would 100k like a normal but during consumption, the consumer would feel the difference of flavoring tea. It would be consumed by the tea consumers as a preferred option in lieu of regular tea. With regard to the composition as claimed in the subject application , the opponent pointed out anomaly in the composition and stated that the claim 1 where the composition has been claimed is absurd and cannot be practiced. The applicant denied the allegation by stating that interpretation of claims has not been done in a correct way. While practicing an invention, the physical quantities of the constituents have to be taken which should to total to the required batch size of the composition to be prepared. For this purpose, the constituents have to be taken within the overall ranges of the constituents provided in the specification and at the same time the constituents have to be taken so that the weight percentages make100% of the batch size of the composition to be prepared. This has been very well explained in the specification with the help of four working examples illustrating how the invention is practiced.
With this introduction the opponent argued on the basis of following grounds of opposition 1. Obviousness / lack of inventive step[Section 25(1)(e) 2. Not an invention/ Not patentable[Section 25(1)(f) 3. Insufficiency 25(1)(g) It is to be mentioned that that issue related to novelty ground u/s 25(1)(d) is not argued during the hearing . So the discussion related to the same does not have any meaningful contribution to the present context. Upon considering the arguments u/s 25(1) [and later u/s 15 of the Act ] I have gone through the contentions of the opponent that the said composition as claimed in claim 1 is unable to establish the grounds on lack of obviousness / inventive step issue. The subject application deals with four flavour concentrate with specific ingredients in the specific range of constituents , but the herbs used to form the specific flavour concentrate are well in public domain since ages. Apart from flavouring agent they do have pronounced medicinal activity which is traditionally known but the same has been denied several times by the applicant stating repeatedly that its contribution is to flavour only. In the arguments u/s 15 proceedings also the matter has been mentioned and it has been stated by undersigned that said medicinal activity of well known herbs in the end product depends upon consumer choice which is not denied by the applicant. On query during proceedings u/s 15 of the Act the applicant stated firmly that the invention is in addition of herbs as flavour concentrate which ultimately arrived at the end product by different processes , but it retains the flavour of normal tea. Though the end product is superior one but it does not have any medicinal benefit. At this point I need to mention one pertinent issue that sample of the subject tea composition has been requested by undersigned during the proceedings verbally in hearing u/s 25(1) as well as section 15 of the Act and same sample has been submitted officially and after consuming the same as consumer undersigned is unable to understand the distinct/ unique flavour as claimed by the applicant and found it as normal tea and not superior in flavour in any respect. Further I am in agreement with the contention of the opponent that the flavour parse does not have any technical advancement until and unless it has some do good issue in real sense. The clarification / counter argument submitted by the applicant does not have concrete logic to address the issue related to inventive step as alleged by opponent during procedure. Moreover, I am in opinion that the herbs used in the composition have explicitly some beneficial effect with regard to medicinal aspect known since ages traditionally but it has been denied by the applicant that the same results in flavour per se which eventually makes flavour of the tea composition an distinct and unique one .But there is no trial from the applicant side to prove upon with clarity the superiority of the superior products as claimed in absence of any demonstration in the specification through any concrete data except some colour and inconclusive taste results. During proceeding u/s 15 of the Act though it has been stated by the applicant that market survey for the subject composition may be furnished in the specification if it is required by the office. Hence , the repetitive claim by the applicant for unique test of tea composition without any medicinal effect is not admissible by undersigned as
the applicant does not take any pain to substantiate the query raised again and again during proceedings u/s 15 of the Act for clarification of unique test of the tea composition as claimed . For the issue regarding National Biodiversity Act, it has not been addressed by the applicant as on date and unable to submit the required document during hearing or subsequent submission of written note of arguments except proposal of introduction of one paragraph which is in bracket(The herbs have been sourced from synthetic industries, Cochin, Kerala and Natural Remedies, Bangalore. These herbs are endemic to India and are grown commercially in several region of India , including Kerala, Tamilnadu and Karnataka. These are common herbs and no region can claim exclusively. There are no imported herbal ingredients).With this submission of the applicant without appropriate clarification for the unique taste for the tea composition , I am unable to find out the technical advancement of the application as compared to the existing knowledge having economic significance or both as the herbs used as flavouring agent are well known in public domain since ages and use of choosing few herbs in specific ranges as flavour concentrate and preparing the end product through different processes resulting a normal tea with distinct taste does not allow the composition per se to overcome the issue related to same as the same end product is unable to establish the technical advancement through desired submission for the superior flavour as alleged in the ground of 25(1)(e) of the Act.
Finally , I conclude that the applicant does not take effort to prove upon the issue related to inventive step without any substantial document with supportive data as raised in the petition and eventually , I am unable to find the reason for overcoming the ground 25(1)(e) as raised by opponent in the said petition.
While going through the next allegation of opponent u/s 25(1)(f) that the said application is not invention and not patentable due to the ground that it results an admixture leaving apart synergistic effect and squarely falls u/s 3( e) of the Act having four compositions A to D being admixture and do not have benefits to the consumer of the flavoured herbal tea . The said compositions comprise a number of herbs in specific amount without any supporting data of activity of individual herb or combination of herbs leading the composition as mere admixture. In this context I am in the opinion that though the applicant has argued that the result of the composition provide a unique and distinct flavour, but the same claim is not substantiated with any supporting data in the description of the complete specification, hence the invention with regard to unique test of tea composition is neither described nor enabled. Moreover, after consuming the same as consumer undersigned is not convinced with the claim of the applicant regarding unique test of end product or consumer’s preference for the subject superior tea composition over the regular tea. Besides, a person skilled in the art even by performing the undue experiments can not perform the invention as there is no guidance in the complete specification to understand the teaching of the inventor with regard to distinct flavour of the end product . Moreover , it has been admitted by the applicant during proceedings u/s 15 of the Act that the market survey may be provided if required which in my opinion is a self admission by the applicant that
there is no data in the specification as on date supporting the claim of unique and distinct herbal flavoured tea composition which is claimed as superior product but practically unable to find out the distinct/unique flavour of the end product when consumed the sample as provided by the applicant. Hence , I am in opinion that the applicant failed to address the invention as claimed and unable to substantiate the invention in context of unique flavour and superior tea composition with supportive documents and eventually failed to address section 25(1)(f) of the pre grant proceeding and unable to overcome the same as alleged by the opponent.
Regarding the insufficiency issue as raised by the opponent I am in agreement that the invention is not described in appropriate manner and wording like do good ingredients is not appropriate as mentioned in the specification. When questioned u/s 25(1) and u/s 15 of the proceedings the same is claimed as unique and distinct flavour for the tea composition all along which is not adequate for defining the invention leading to the claimed composition which is not definitive without any experimental data . The insufficiency of invention particularly with regard to distinct flavour of tea composition lacks in technical support in the specification and there is no trial by the applicant to clarify the same with regard to flavour and denial of beneficial activity of the herbs though their medicinal/ nutritional effect of the tea composition added further the non definitive feature of the claimed invention as required in description of the specification . It is pertinent to mention that during assessment of the sufficiency of disclosure the complete specification shall fully and particularly describe the invention and its operation or use and the method by which it is to be performed and it should also disclose the best method of performing the invention which is known to the applicant and for which he is entitled to claim protection and there should not be any grey zone in the specification.As a result of the same the whole subject-matter that is claimed in the claims, and not only a part of it, must be capable of being carried out by a skilled person in the relevant art without the burden of an undue amount of experimentation .In the light of the above mentioned argument the subject application as submitted lacks in disclosure in full proof way and I consider it is the afterthought of the applicant where further market survey are proposed to be carried out in order to address objections raised during proceedings. In the proceedings u/s 15 there is a trial from the applicant to amend the claim in prescribed manner, but the above mentioned insufficiency is not addressed therein also where the same insufficiency in disclosure still persists regarding the flavor of the product as claimed. Hence , I am in opinion that the issue of insufficiency ground as raised by the opponent in the pre grant proceedings has been pointed out appropriately and applicant was unable to address the same which eventually failed to overcome the ground u/s 25(1)(g) of the Act as raised by the opponent.
So in view of the facts and circumstances of the application as above against the pre grant opposition u/s 25(1) of the Act I hereby accept the representation filed by opponent under section 25(1) to read with rule 55(1) and refuse the patent application no. 359/KOl/2007 u/s
25(1) to read with Rule 55(6) under prevailing Rules under the provision of Patent Act, 1970 (as amended).
Dtd. 05/11/2015
(Dr. S. Chattopadhyay)) ASST. CONTROLLER OF PATENTS AND DESIGNS
Enclosed : Annexure A and B Copy: 1.Shri S.Majumdar, C/o. M/s S. Majumdar & Co., 5, Harish Mukherjee Road, Kolkata700025 2.Shri V.D. Gulwani, C/o. M/s Dua Associates , Tolstoy House, 15, Tolstoy Marg, New Delhi-110001
BEFORE THE CONTROLLER OF PATENTS,KOLKATA
Hearing held on August 24, 2015 in the matter of a representation for pre-grant opposition under section 25(1) of the Act and Rule 55 of the Rules to Indian Patent Application No. 359/KOL/2007 dated March 12,2007
M/s Hindustan Unilever Limited (represented by S. Majumdar & Co.,Kolkata) ...........................OPPONENT; And Tata Tea Limited (now known as "Tata Global Beverages Limited) (represented by VD Gulwani, Senior Patent Attorney, Dua Associates)............... APPLICANT
WRITTEN SUBMISSION Pursuant to the hearing for pre-grant opposition to patent application no. 359/KOL/2007 held at the Patents Office, Kolkata on August 24, 2015 with Dr. Sukanya Chattopdhyay, Learned Controller of Patents & Designs, chairing the proceedings, the applicant hereby makes the written submission on the arguments held during the hearing:
1. GROUNDS OF OPPOSITION The opponent stated at the outset that he wanted to oppose the patent application on the following grounds: (a) Lack of inventive Step/Obviousness(S. 25(1)(e)) (b) Lack of Novelty(S.25(1)(d)) (c) Insufficiency of information (25(1)(g)) (d) Not an invention (section 25(1)(f))
The opponent alleged that the invention lacks novelty and inventive step in view of the citations of prior art: REP-2: 1251/MUM/2004; REP-1; US
6,210,738;
EV-1 WO 98/23164 (PCT/EP97/06072); EV-2: 970/CHE/2004
(pages 41 to 48 of representation); and EV-3: 00381/KOL/2004 (pages 49 to 58) attached to their representations.
2. APPLICANT'S SUBMISSION REGARDING THE ALLEGATION OF LACK OF NOVELTY 2.1 In regard to novelty, the applicant wishes to draw attention to the citations, particularly the following citations, made in IPAB order 224/2010:
>-
Lord Westbury in Hills v. Evans (1862) 4 De G.F. & l. 288 at 301 (Cited in IPAB order 224/2010) has well-known statement that for proving lack of novelty; 'The information given by the prior publication musfor the purposes of practical utili be equal to that given by the subsequent patent "
>-
The judgment of the Sachs Ll with the classic statement in General Tire, [1972] RPC 457 at p.485 (Cited in IPAB order 224/2010):it was held that: ''To determine whether a patentee's claim has been anticipated by an earlier publication it is necessary to compare the earlier publication with the patentee's claim. The earlier publication musfor this purpose, be interpreted as at the date of its publication, having regard to the surrounding circumstances which then existed, and without regard to subsequent events. ... If the earlier publication, so construed, discloses the same device as the device which the patentee by his claim, so construed, asserts that he has invented, the patentee's claim has been anticipated, but not otherwise. "
>-
In Flour Oxidising v Carr (1908) 25 RPC 428 at 457, line 34,approved in BTH v Metropolitan Vickers (1928) 45 RPC 1 at 24, line 1); (General Tire & Rubber Co v Firestone
Tyre & Rubber Co Ltd (1972) RPC 457 at 486)" (Cited in IPAB Order 224/2010) It was held that to prove anticipation ''A signposhowever clear, upon the road to the patentee's invention
will not suffice. The prior inventor must be clearly to have shown to have planted his flag at the precise destination before the patentee."
>-
L l Sachs in General Tyre & Rubber Co. Vs. Firestone Tyre Co. (1972) RPC 4567 at page 485, held: ''for anticipation to
occur the antecedent document must contain clear and unmistakable directions to do what the patentee has claimed in the claim under consideration.''
2.2 It may kindly be noted from the above citations that for proving lack of
novelty, the teachings of prior art citations must be equal to that of the present patent application. In the present matter, the applicant submits that the allegations of lack of novelty by the opponents on the basis of prior art are baseless as none of the cited prior art teaches the essential integers of the product or process of the present patent application. The teachings of the citations of prior art are substantially different from that of the present invention of the Applicant. In view of above, none of the prior art citation anticipates the invention and as such the present invention satisfies the criterion of novelty.
2.3
The attention of the opponent was drawn to the para 6.3 of their representation (page-13) where the opponent have candidly admitted that the claimed process has multiple steps and process parameters which in combination may not be found in any single literature.
3. INVENTIVE STEPS IN PRODUCT 3.1 COMPARISON
of
PRODUCT OF PRESENT INVENTION WITH
PRODUCT OF CITED PATENT REP-2: 1251/MUM/2004
>-
Opponent's Product is a medicinal formulation whereas the applicant's product is a herbal flavoured tea composition: -3.
The description, abstract, title and claims of the invention of cited opponent's patent application no. 1251/MUM/2004 do not use the word "flavoured". The first object of the invention as stated on page-32 of the opponent's representation (page 39) states that the object of their invention is to provide the benefits of Withania somnifera without affecting the organoleptic properties of tea. It is worthwhile to note that when preferred quantity of 50 to 90% of Withania somnifera is used in tea, it is highly unlikely that the organoleptic properties of tea are not lost. It would neither have the appearance of tea nor taste like a regular tea and may not be acceptable to tea consumers as a regular tea. In the next object on page-32 of representation it is stated that object of the invention is to provide benefits of Withania somnifera and other herbs like licorice, ginger, tulsi and elaichi. Thus providing of a ""flavoured tea composition" is not the object of the invention. Further, it may kindly be noted flavour is not the known characteristic of ginger when used alone. Ginger is used to provide relief for throat and cold. Similarly, tulsi alone as such or licorice alone as such, is not used for flavouring tea but for health benefits. The present invention teaches four herbal formulations, each of the formulations comprising plurality of herbs and wherein each herb is taken within specific weight percentage range. Further on page45 of opponent's representation, the opponent has stated that their product provides enhanced protection against common colds and cough. It is thus evident from the facts brought out above that the opponent's product is primarily a medicinal formulation whereas the applicant's product is a herbal flavoured product which could become the preferred option of tea. ':» Opponent's Product preferablY contains 50 to 90% of Withania
somnifera (ashwagandhal whereas applicant's product does not contain any amount of Withania somnifera The opponent's product of the above cited patent application, as per description on page 12 of the specification of patent application no. -4
1251/MUM/2004 (page 39 of the opponent's representation) preferably
contains 50 to 90% by weight of Withania somnifera and as per claim-1, contains 0.1% to
15% by weight of Withania somnifera.
WHEREAS the applicant's product does not contain Withania somnifera at all. The applicant's product is an herbal flavoured tea composition which would become preferred option of tea as against regular tea presently taken by the consumers. Whereas the opponent's product, preferably containing 50 to 90% of Withania somnifera, would hardly have the organoleptic properties of tea and is certainly not going to be the preferred option of tea by tea consumers whereas the applicant's product being an herbal flavoured tea would certainly become preferred option for tea.
Opponent's product does not teach use of Darieeling Brokens whereas Applicant's Product contains 1 to 8% of Darieeling Brokens: The opponent's product nowhere mentions the use of Darjeeling Brokens whereas the applicant's product contains 1 to 8% of Darjeeling Brokens. Darjeeling Brokens is a grade of tea of Darjeeling origin using the orthodox process of manufacture.
The
opponent's product has
large
quantity of
one
herb
CWithania somnifera) to the extent of preferably 50 to 90% as per description WHERAS in the present invention. the plurality of natural herbal flavours constitutesonly0.5 to 5% of the weight of the composition.
The cited patent application as per claim-1, single herb Withania somnifera can go up to 15% as per claim-1 and up to 90% as per preferred embodiment described on page-39. Whereas,in the applicant's process, the total quantity of the plurality of herbs in any of the four formulations, can go up to 5% only, of the weight of composition.
-5
l>- Opponent's product may optionally have one or more of
licorice,
ginger.
or
cardamom
in
any
unspecified
quantities either alone or in any combination whereas applicant's
product
has
four
distinct
and
novel
formulations of herbal flavour. each having plurality of herbs within specified weight percentage ranges :
The essential component of the opponent's product is ashwagandha (Withania somnifera), the other herbal components are optional and could be taken alone or in any combination in any arbitrary quantity as a person skilled in the art may like for practicing the invention. The ginger, as used in the opponent's product, is primarily to support the medicinal value of ashwagandha (Withania somnifera) to provide relief from cough and cold. Similarly, Licorice is used for throat, cough, and bronchitis. Thus these herbs taken in the opponent's product are primarily intended to have medicinal value for cough and cold and are not intended to make a herbal flavoured tea. Whereas the product of the applicant has four distinct formulations of herbal flavours, each formulation is novel having a plurality of herbs wherein each herb is taken within the specified range of weight percentages as already explained above. Some of the herbs used in these herbal formulations are not taught by any of the citations made by the opponent. The allegation by the Opponent that the present invention uses known characteristics of elaichi, ginger and tulsi is not correct. In this regard, the applicant explained that firstly; except for cardamom, neither ginger nor tulsi as stand-alone herb is used for flavour but for medicinal purposes to give relief from cold and throat congestion and other relief. Secondly, in the present invention, none of these herbs is taken in a
-6
traditional manner and none of these herbs is taken as a stand-alone herb. In composition-A of herbal flavours of the present invention, a blend of herbal flavours includes 0.1 - 0.5% of Bacopa monniert, 0.3 - 0.7 % of Ocimum sanctum, 0.05 - 0.3% of Mentha piperita, 0.05 - 0.3% of Zingiber officina/is and 0.1 - 0.3% of Elettaria cardamom. Thus composition-A includes Bacopa monnieri and Mentha piperita besides ginger, tulsi and cardamom. Further, each of the herbs is not taken in any arbitrary quantities but it is taken within specified range of weight percentage. Further/ it has been determined after extensive evaluations that when these herbs are taken in the definite percentage ranges as above, then blend of these herbs provides a definite flavour to the tea. Thus it is neither traditional use of the herbs nor use of the known characteristic of these herbs. Further such a blend of herbs as above, for use as a flavour for tea, is not taught by any of the cited prior art and is also not known in the art. Composition-S of herbal flavours of the present invention includes herbal flavours 0.05 - 0.15% of Salvia officina/is, 0.5- 0.11% of G/ycyrrhiza glabra, 0.01- 0.09% of Mentha piperita andO.l- 0.3% of Zingiber officina/is. Thus composition- B also does not use ginger in stand-alone mode and also does not use its known characteristics, but uses its blend with three other herbs Salvia officinalis, Glycyrrhiza glabra and Mentha piperita, each taken within definite range of weight percentage. The blend of said herbs, with each herb within specified range of weight percentages, gives a definite flavour when this flavour composition is used for preparation of herbal flavoured tea composition as per the process of the present invention. Thus it is not the traditional use of the known characteristics of the herbs as alleged by the opponent.
-7
Composition-( of herbal flavours includes 0.1 - 0.55 of Bacopa monnier0.05 - 0.15% of
Cente//a asiatica, 0.3 - 0.7% of
Ocimum sanctum, 0.1 ·- 0.3% of Zingiber officina/is, andO.OS 0.15 of Foenicu/um vulgare. Out of these herbs, Centel/a asiatica, tulsi and ginger are used for medicinal value and not for their
flavour value. Further, Centel/a asiatica, tulsi and ginger are not being used as such in any arbitrary quantities but the blend of these herbs is used with another herb Foenicu/um vulgare, where each is taken within the specified range of weight percentages and the blend provides a definite flavour when tea composition is prepared by the process of the present invention.
Further, composition-D of herbal flavours includes 0.005 0.013% of Trachispermum amm10.1 - 0.2% of Mentha piperita, and 0.05 - 0.35% of Elettaria cardamom. Trachispermum amm is not a taught by the cited patent and is traditionally not used as such in tea preparation. Such a blend of these herbs is not taught by the opponent's Indian Patent Application No. 1251/MUM/2004.
Opponent's
product
includes food
binder
selected
from
polysaccharide. gum. polymer or mixture thereof WHEREAS Applicant's product includes a specific encapsulant which is a modified starch derived from waxv maize which is admitted by the opponent's expert (Dr.
Prakash Dattatraya
Virkarl
on
affidavit to have abilitv to form stable dispersions/emulsions
As per claim-S (page-46) of opponent's patent application, the food grade binder used in the cited opponent's process is polysaccharide, gum, polymer or mixture thereof whereas applicant's product and process includes a specific encapsulant which is a modified starch derived from waY0f maize which has been found to have ability to form very stable oil
-8
1 solid -in-water
emulsions/ dispersions. Thus the encapsulant used in the applicant's product/process is different from the food grade binder used in the opponent's Indian Patent Application No. 1251/MUM/2004. In this regard the following lines (lines 2-3 on page-S of affidavit, first para) from the affidavit of Dr. Prakash Dattatraya Virkar, Beverages R&D Programme
Director
in Hindustan Unilever
Limited
are
reproduced below wherein referring to the modified starch used by the applicant, he has stated: "It is not disputed that modified starch of the type stated does
help to retain the emulsion stability..............."
Thus the expert of Hindustan Unilver Limited, who are opponents in this case, have themselves admitted that the use of modified starch derived from waxy maze as used in the applicant's product/process is superior
in
performance as it enables
retraining of the emulsion stability.
As regards the use of oil component, the attention is drawn to the following lines on page 15, first paragraph of the original specification:
"In addition to the use of powdered natural flavours, liquid flavours oil/oleoresins could be used"
Attention is also drawn to the Table-6, page 22-23of the original specification which provides specification of natural herbal flavours used in the present invention, which is reproduced below for ready reference, wherein the oil components are highlighted: ""Table-6: Specification of Natural herbal flavours used in the present invention [ Natural Flavours . ._ l_[_s_pe_c_ifi-lc_a_tio_n_s
_ -9
] Analytical]
Method Bacopa monnieri
Total bacosides :LO%
HPTLC
Ocimum sanctum
Rosmarinic acid 0.33
HPTLC
Mentha piperita
Volatile oil 55ml/100g
GC
Zingiber officina/is
Oleoresing ginger/ginger oil 42.86%,
HPLC
57.14% Elettaria cardamom
Volatile oil >30%
GC
Salvia officina/is
45.1 ml/100g
GC
G/ycyrrhiza g/abra
Glycyrrhizin >5%
HPLC
Centel/a asiatica
Total triterpenes>2%
HPLC
Foeniculum vulgare
Volatile oil 4%
GC
Trachispermum ammi Volatile oil 5-6%
GC
-
3.2
COMPARISON of PRODUCT OF PRESENT INVENTION WITH
PRODUCT OF CITATION OF REP-1: US 6.210,738 }- The cited patent relates to '"Freeze-dried
Ginseng Berry Tea"
wherein ginseng berries are derived from Panax ginseng plant WHEREAS the present invention uses tea selected from black tea, green tea or oolong tea or a combination thereof, wherein tea is based on plant Camellia sinensis var. sinensis or Camellia sinensis
var.
Assamica, rooibos tea obtained from Aspalathus linearis.
}- The beverage composition of the cited patent comprises fine powder of freeze-dried ginseng berries which is combined with any one or more of over 100 herbs listed in the col.6 (page-23 of representation), in any unspecified quantities. Incidentally, except for cardamom, it does not include any other herb of the applicant. On the other hand, it includes ashwagandha and licorice of the opponent's product. - 10
;;.. The preferred embodiment given in col.8 of cited document REP-2 (page -44 of the representation) includes ginseng berry, fruit juice,
royal jelly and preservative. The applicant wonders how this can be treated as anticipatory prior art for the tea composition of the applicant's herbal flavoured tea composition.
;;.. Another preferred embodiment of cited patent shows ginseng berry with wild honey and royal jelly. The example -1 given in col.8, page 24 shows freeze dried ginseng berry mixed with cactus juice extract,
wild honey and royal jelly. Example-2 shows freeze dried ginseng berry mixed with passion fruit extract, honey, sodium benzoate, etc. Example 3 teaches freeze dried ginseng berry mixed
with
American ginseng root extract, strawberry extract, Ginseng leaf and dehydrated mint leaf. Example 4 teaches freeze dried ginseng berry mixed with ginseng berry extract, Rasberry extract, Ginseng root extract and dehydrated mint leaf.
Example 5 teaches freeze dried
ginseng berry mixed with ground ginseng root, ground freeze
dried apple and dehydrated mint leaf. None of the preferred embodiments and the Examples teach preparation of herbal flavoured tea but relate to a beverage using variety of juices/extract, jelly, honey, preservative, etc. ;;.. It is not understood how any of the above compositions, illustrated in working examples of the cited patent, can be construed as anticipatory prior art for the herbal flavoured tea of the present invention when even basic component of tea based on Camellia sinensis plant namely black tea, green tea or oolong tea or any combination thereof, which forms a major component of the product, in the applicant's invention is NOT used in the composition of the cited patent
- 11
3.3 COMPARISON of PRODUCT OF PRESENT INVENTION WITH PRODUCT OF CITATION OF • EV-1: WO 98/23164 (pages 12 to 37 of representation)
>-
The product of the cited patent comprises a blend of a first fermented tea and an unfermented tea so that the blend contains catechins and phenols in the ratio of 0.15 to 0.4 preferably between 0.2 to 0.3, wherein the fermented tea is low grown black tea and the green tea is from Assam jat.
>-
Thus the product of the cited patent is just a blend of black tea and green tea which is entirely different from the product of the present invention.
3.4 COMPARISON of PRODUCT OF PRESENT INVENTION WITH PRODUCT OF CITATION OF • EV-2: 970/CHE/2004 (pages 41to 48 of representation)
>-
The product of the cited patent is a medicinal beverage having health benefits for diabetics and obesity.
>-
The main constituent (70%) is Camellia
thea whereas the main
constituent in the composition of the present invention is black tea, green or oolong tea or any combination thereof.
>-
The product is a beverage prepared from thirteen herbs which includes herbs like neem (Azadirachta indica), brahmi (Centellaasiatica), ginger, licorice, and several other herbs listed on page 47 of the representation. A beverage containing neem as one of the constituents cannot be compared with an herbal flavoured beverage of the present invention.
- 12
3.5 COMPARISON of PRODUCT OF PRESENT INVENTION WITH PRODUCT OF CITATION OF EV-3: 00381/KOL/2004 {pages 49 to 58 of Representation) )>
The product of the cited patent is an anti-oxidant enriched functionally active herbal beverage.
)>
The herbal beverage of cited patent contains sugar, lemon, mint leaves, tulsi leaves, black pepper, black salt, saffron, honey, ginger, herbal premix/natural colours, tea extract and water. It is not understood how such a composition including black pepper, black salt,lemon,saffron, honey can be compared with the herbal flavoured tea of the present invention. Moreover,the composition here
is water based
beverage, while the
applicant's product is a dry tea product, which needs to be brewed to get a beverage.
4.INVENTIVE STEPS IN PROCESS 4.1 COMPARISON of
PROCESS OF PRESENT INVENTION WITH
PROCESS OF CITED PATENT REP-2: 1251/MUM/2004 PROCESS of OPPONENT )>
The Process of cited patent is either dry blending or a combination of dry blending and wet blending. In dry blending, the dried powder of Withania somnifera (ashwagandha) powder is just blended with tea. To the mixture thus obtained, optionally, dry powders of one or more herbs selected from tulsi, cardamom, ginger and licorice, in any arbitrary quantities are added and mixed. (Comments: In the use of dry herbs in the dry blending, there is a risk of deblending. The present invention does not use the step of dry blending at all for the inclusion of herbalextracts).
- 13
;.. In the combination of dry blending with wet blending, firstly a dry blend is prepared as above. When preparing the tea with ashwagandha (Withania somnifera) (Comments: no herbs and no herbal oil at this stage), an aqueous solution/dispersion/emulsion of the food grade binder is sprayed on to above mix. (Comments: IT IS TO BE NOTED THAT
THE
OPPONET
HAS
THEMSELVES
USED
TERM
dispersion/emulsion, EVEN WHEN NO OIL IS USED AT THIS STAGE). Then it is stated (para- 3, page- 40 of representation) that an aqueous
solution/dispersion/emulsion
of
the
food
grade
binder
(Comments: The opponent again has used the term "emulsion"
even before mixing of oil) is mixed with oil of one or more herbs tulsi, licorice, cardamom and ginger and sprayed over this dry blend under mixing in a planetary mixer to obtain a pre-mix. (COMMENTS:
Claims do claim preparation of pre-mix but claims just mixing of herbs and aqueous food grade binder) ;.. In the final stage, the pre-mix is blended (COMMENTS: Claims do not
claim blending of pre-mix with tea) with green/black/oolong tea in a ratio varying from 2:1 to 1:100 (page-39) (Comments: This is such
an extra-ordinary wide range of ratio for mixing of pre-mix with tea varying from 2:1 to 1:100 which is incapable of being practiced by a person skilled in the art). The claims neither claim mixing of pre mix with tea nor the ratio in which pre-mix is to be mixed with bulk tea. It is worthwhile to note that if one part of pre-mix containing herbs is mixed with 100 parts of green/blackjoolong tea, there would hardly be any flavour effect of stand-alone herb Cardamom (the only flavour herb that too if at all used (being optional) in the tea composition) and it cannot therefore be compared with the herbal flavoured tea of the present invention.
COMPARISON WITH THE APPLICANT'S PROCESS ., 14-
>-
In this regard
attention of the Learned Controller is drawn
firstly to the para 6.3 (page-13) of the representation wherein the opponent
has been candid enough to admit that
the
applicant's process has multiple steps and process parameters which
in
combination may
not
be found
in any
single
literature.... The applicant has therefore admitted the novelty of the process.
>-
In the opponent's process, it may be noted that the herbs are used in two stages. Firstly, the dry herbs have to be taken at the stage of preparing dry blend. Then at the stage of wet blending,herbs need to be taken in the form of oils and mixed into the aqueous solution of binder for spraying over the dry blend. WHERAS In the applicant's process, an encapsulant is mixed with hot water from 60°C to 80°C in Silverson emulsifier for 5 minutes. At this stage itself one of the flavour composition (out of four flavour compositions described under para 3.1) is added. The
opponent's process does not teach incorporation of herbs at the stage of aqueous solution of encapsulant. This incorporation of herbal flavours at the stage of aqueous solution of encapsulant further necessitates special gentle and rapid drying process to prevent oxidative thermal damage
of added flavours. After
addition of a flavour composition either in powder form or in oil/oleoresin form, the solution is subjected to high speed rotation > 1000 rpm giving a uniformly homogenised dispersion/emulsion, depending upon whether herbs are taken in powder form or in oil form.
>-
The dispersion/emulsion thus obtained is coated on tea particles using a special mixer having Forberg design. Further the wet mass thus obtained having herbal formulation requires gentle and rapid drying
to prevent any adverse effect on the flavours and taste. This is · done in the present invention by Fluidised Bed Dryer using - 15
optimised drving conditions of inlet temperature of 90-110°C and residence time
of 6-10 minutes to reduce the moisture
content to 2 to 3% obtaining flavour concentrate. The flavours here refers to one of the four herbal formulations
J;>
(Composition-A, Composition-S, Composition-(,
and Composition-D)
(see under para 3.1 above) and not stand alone herbs. The herbal formulation could be dried powder or in the form of oils or oleoresins. When herbs are taken in the form of dry powder, the solution may be referred to dispersion and when oil is used the solution may be referred to as emulsion. The term dispersion also includes emulsion and therefore in both the cases whether dry powder of herbs is taken or when herbs are taken in the form of oils, the technically correct term to use would be "dispersion". :.. The flavour concentrate thus prepared is blended, using a rotary blender, with 1 to 8% of Darjeeling Brokens and the required quantity of green tea/black teajoolong tea to prepare the desired batch size of the composition. Thus it may be noted that the process of the present invention is substantially different from the process of the cited patent.
>
To facilitate comprehension of the inventive feature of the process, the comparative features of the process are tabulated below for the convenience of the Learned Controller: COMPARISON OF PROCESS OF 1251/MUM/2004 WITH
THE PROCESS OF THE
PRESENT INVENTION Process as per Present
Process as per
Invention
1251/MUM/2004
An encapsulant is mixed with
The Process of cited patent
(l)Process
hot water from 60°C to 80°C in
is either dry blending or a
1251[MUM[2004 claims only
combination
mixing of tea, ashwagandha,
Silverson
emulsifier
for
5
- 16
of
Comments
dry
Claim
12
of
minutes. At this stage itself a
blending and wet blending.
aqueous binder and at least
flavour
In dry blending, the dried
one herb. It does not claim
one
herbal
composition, out of the four formulations
herbal
powder
of
Withania
combination of dry blending
somnifera
(ashwagandha)
and wet blending comprising
(Composition-A, Composition-
powder is just mixed with
two
and
tea. To the mixture thus
blending followed by second
Composition-D) is added.
obtained, optionally, one
step of wet blending. Further,
The solution is subjected to
or more of the dry powders
Wet blending step essentially
high
speed
of
requires
rpm
giving a
Composition-(,
B,
rotation
>1000
homogenised
dispersion/emulsion, depending herbs
upon
whether
are taken
in powder
form or in oil form. Encapsulant
is
a
modified
herbs
selected
tulsi,
cardamom,
and
licorice,
from
process
first
dry
spraying
of
ginger
dispersion/emulsion over tea
any
particles which is not claimed
are
in any of the claims. Claim 12
in
quantities
arbitrary
step
added and mixed.
claims
P refe ra b ly
grade binder and it does not
50
to
Withania
90%
only
aqueous
food
claim an emulsion of food
somnifera
grade binder which further
maize.
10 to 50% of tea,
establishes
0.3 to 0.7% of encapsulant;
Up to
starch
10
derived
to
waxy
from
SO%
(green/black/oolong
30% food
grade
oil
that
component is not claimed by the opponent is any of the
of Claim-1
claims.
combination thereof) at the
85 to 99.9% tea
2. None of the claims claim
time of preparation of flavour
0.1
concentrate;
somnifera;
How this can be emulsion?
0.05 to 5 % of food grade
3. There
composition,
binder;
preparing of pre-mix and no
( 1 to 8% Darjeeling brokens
At least
and Rest of the quantity of
!!.lic,o"'r-"ic""e, __,g"'i'-'ng,.,e,r_,_,---'t"'u,ls,i.
0.5
to
5%
herbal
or
any
flavour
To
15%
one
Withania
herb
from
use of any herb in oil form.
is no claim about
claim as to in what ratio premix
is
blended
with
tea, to prepare the batch size cardamom,
black/green/oolong
tea.
In
taken
description
39},
an
at the final stages of quantity/weight
blending discussed below)
percentage not specified
(page
extra-ordinary wide range of ratio varying from 2:1to 1:100 is given for mixing of pre-mix with
tea
is
given.
The
invention cannot be practiced
- 17
in
this
manner
confuse the
as
it
will
person skilled in
the art as to in what ratio the premix is to
be mixed with
tea. (4) Hindustan Unilever Expert, Dr. Prakash Dattatraya Virkar, on affidavit, has admitted on page-S
that
""It is
not
disputed that modified starch of the type stated does help to
retain
the
emulsion
stability"". Thus the encapsulant used in the
present
invention
has
been admitted even by the expert of the opponents on affidavit that it is superior in emulsion
stability
as
compared to the food grade binder used by the opponent. (S)Stand-alone
herbs,
in
arbitrary quantities are taken
in
process
the
herbs
applicant's
but
formulation
not
a
of
definite
plurality
(compositions
of
given
above),wherein each herb is taken
in specified
weight
percentages. (6) In the opponent's process of
combination
blending process,
with
wet
of
dry
blending
herbs are taken in
L----------------- ---------------.-L-----------------.18.
two
stages,
firstly, the
dry
herbs are taken at the stage of preparing dry blend and then in the second step
again the
herbs are taken in the form of oils and sprayed over the dry blend. (7)As against the use of herbs twice, firstly at the dry blend stage then again at the wet blending over
stage dry
applicant's
for spraying
blend,
In the
process, a herbal
formulation is incorporated at the stage of aqueous solution of encapsulant in hot water at 60
to
80'C.
This
offers
following advantages: (i) As there are plurality of herbs in a herbal composition and that too either in solid form or in oil form, the incorporation of these herbs at
the
stage
of aqueous
solution of encapsulant and then subjecting the solution to mixing by high speed rotation at rotational rpm
speeds
>1000 uniform
ensures
homogenisation
of
the
plurality of the herbs in the aqueous
solution
encapsulant. thoroughly
- 19
of
the
When such homogenous
solution herbs
of the
plurality of
is sprayed
particles,
over tea
it
consistency
ensures
in coating of the
composition of the plurality of flavour herbs throughout the bulk tea during preparation of flavour concentrate. (ii) Taking of plurality of herbs first at the stage of dry blend and then again at the stage of wet
blend as done by the
opponent,
would
substantially
larger quantities
of
require
herbs.
incorporating
Whereas
of plurality of
herbs only once at the stage of the
aqueous
encapsulant the
quantity
solution
of
economises
on
of plurality of
herbs and makes the product cost-effective. (8) As in Applicant's process, herbal
composition
is
incorporated at the stage of hot
aqueous
solution
of
encapsulant; the
applicant's
process
therefore
necessitates gentle but rapid drying to prevent oxidative thermal
damage
to
added
flavours. This is done by using a fluidized bed dryer with inlet air temperature of 70-
- 20
11o•c preferably between 80go•c and residence time of 610 minutes, till the moisture content is reduced to 2 to 3%.
The dispersion/emulsion thus
In the combination of dry
((9) The step-1of dry blending
prepared is then coated on tea
blending
wet
is of herbs is not required in
particles using a special mixer
blending, firstly a dry blend
the applicant's process. The
having Forberg design. The
is prepared as above. Then
herbal
emulsion/dispersion
is an
with
aqueous
sprayed using Flow Distortion
dispersion/
Bar (FDB) which is a rotor with
the
radial
pins.
The
solution/
emulsion
food
special optionally
of
grade
binder,
mixed
with
arrangement ensures uniform
herbal oils, is sprayed on to
coating
of
particles
above mix.
without
breaking
of
Food
tea
tea
particles.
(powder/oil) out of the four herbal
compositions,
is
incorporated only once in the hot aqueous solution at 60°C to so•cof encapsulant. (10) In applicant's process, the
grade
binder
polysaccharide, polymer
composition
or
thereof.
a
is
dispersion/emulsion is coated
gum,
on to the part of the quantity
mixture
(10 to 50% by weight) of tea particles using a special mixer having Forberg design using Flow Distortion Bar having rotor with radial fins.
The coated tea particles are
•
(11)
subjected to optimised drying
minutes
time to
of
gentle
6-10
reduce
the
against
requirement of
necessary
conditions of 90 to 11o•c and residence
As
and rapid
drying in
the applicant's process to
the avoid
oxidative
thermal
moisture content to 2 to 3%. damage
For dying, fluidised bed dryer is used which
flavours
has special
to
the
(as flavours
features of aerodynamic steel
added
fabricated plenum chamber,
aqueous
variable
encapsulant), there
speed
drive,
a
specially designed hot air fan
added
at
the
stage
solution
are of of
is no
such step required in the
- 21
with impeller blades to deliver
opponent's process.
the required quantum of hot air,
and specially designed
cyclone dust extraction system to pick up only fibre, fluff and leaving
the
behind
the
tea
particles
chamber
(see
specification). In the opponent's process,
In the opponent's process,
In the applicant's process, the
pre-mix is blended with
Darjeeling brokens, which is a
flavour concentrate is blended
black/green/oolong tea in
grade of Darjeeling orthodox
with 1 to 8% by weight of
the ratio from 2:1 to 1:100
tea, is not used.
Darjeeling brokens, which is a
(page 40).
grade of Darjeeling Orthodox tea and with the required quantity
of
black/green/
oolong tea. L
L
4.2
i
COMPARISON of PROCESS OF PRESENT INVENTION WITH
PROCESS OF CITED PATENT REP-1: US 6.210,738
In the cited patent ginseng berries are freeze-dried at (-) 25°F by which the water in the berries sublimates directly into vapour. Such dried ginseng berries are ground to a fine powder and mixed with any one or more out of more than 100 herbs listed on col.6, page-23; and col.7 on page 24 of the representation.
Natural fruit flavourings such as strawberry, pineapple, apple, lemon, orange are added.
Thus it may be noted that the process of the cited patent is entirely different from the process of the present invention - 22
4.3 COMPARISON of PROCESS OF PRESENT INVENTION WITH PROCESS
OF
CITED
PATENT
·EV-1
WO
98/23164
(PCT /EP97/06072) (Page 12 to 36 of representation)
>-
The process involves blending of a carefully selected green tea and black tea so that the combination has catechines and phenols in the ratio between 0.15 to 0.4%. Such combination has 10% higher anti-oxidant properties. The black tea selected is a low grown black tea and green tea is from an Assam jat.
>-
The process of the cited patent is not comparable to the process of the present invention,as the process of the cited patent just involves mixing of green and black tea in specific ratio to get the desired catechin/ phenols
4.4 COMPARISON of PROCESS OF PRESENT INVENTION WITH PROCESS OF CITED PATENT ·EV-2: 970/CHE/2004 (pages 41 to
48 of representation)
>-
The process involves blending of 13 herbs in weight percentages: Syzigium jambolanum (5%), Hibiscus roasasinensis (2.5%); Centella asiatica (2%)1 Tinospora cordifolia (2.5%) 1 Hemidismus indicus (5%), Cassia auriculata (5%), Glycyrrhiza) glabra (licorice) (2%), Terminalia arjuna(2.5%)1
Azadirachta indica (neem) (1%), Coeus vettiroroids
(0.5%), Coriandrum sativum (0.5%)
1
Zingiber officinale (Ginger) (1%),
and Camellia thea (70%).
>-
Whereas the applicant's process uses only specific combination of herbs and contains tea as a major components and involves coating of a solution of herbal extract on tea and further incremental mixing with tea
- 23
in specific weight percentages and hence the applicant's process is different from the cited process which is just a blending of 13 herbs.
4.5 COMPARISON of PROCESS OF PRESENT INVENTION WITH
PROCESS OF CITED PATENT EV-3: 00381/KOL/2004 (pages 49 to 58 of Representation)
>-
The process involves subjecting tea leaves to aqueous extraction, spray drying the tea liquor to powder form, washing the powder with chloroform and separating the layers, extracting the aqueous layer with a suitable organic non-polar solvent; concentrating in rotary vacuum evaporator; freeze drying to obtain crude tea extract; purifying by reverse phase extraction using chloroform, butanol and di-ethyl ether, mixing the other ingredients in a mechanical mixer and packing.
>-
Thus the process involves mechanical mixing of tea extract with sugar, lemon, mint leaves, tulsi leaves, black pepper, black salt,saffron, honey, ginger, herbal pre-mix/concentrate/natural colours and water.
>-
Thus it can be seen that the process is different from the process of the present invention described above.
5. ALLEGATION OF OBVIOUSNESS Allegations
>-
The opponent alleged that the invention is obvious in view of the combination of the prior art.
>-
In this regard, the opponent cited EPO Board of Appeal decision dated July 05, 2000 (case no. T0355/97)
Applicant's Submission - 24
• The opponent has made a general baseless statement that the invention is rendered obvious without pointing out which combination of
the prior art renders the present invention obvious. An invention is rendered obvious when one essential integer of an invention is taught by one prior art document, the other essential integer of the invention is taught by other prior art document, and so on. In the present case, the opponent has failed to cite prior art documents which teach different essential integers of the present invention. The opponent has also not cited any prior art which teaches preparation of even a single herbal formulation comprising plurality of herbs to be taken in specific weight percentages and which together exhibit a distinct flavour, as compared to four such herbal formulations taught by the present invention, which have been determined after extensive evaluations. It may kindly be
noted that the
opponent's process claims
11 and 12 in
1251/MUM/2004 claim only the mixing of Withania somnifera with tea,aqueous binder and optionally comprising other herbs selected from licorice,ginger,cardamom and tulsi and drying to a moisture content less than 10%. None of the claims claim a two step process with first step of dry blending and second step of spraying an emulsion over the dry blend. The claim 12 uses the expression "aqueous food grade finder"" which solution of binder in water. Thus claim
means
12 does not claim
emulsion. None of the claims claim use of oil components or herbs in oil form. None of the claims claim spraying of emulsion over the dry blend.
The opponent has also not cited any prior art
which teaches the incorporation of herbal flavours in the hot aqueous solution of an encapsulant in hot water at certain temperature, subjecting the solution to high speed emulsification/dispersion at > 1000 rpm so that the flavours get consistently/uniformly distributed in the aqueous solution of encapsulant (this is not taught in the cited process); coating the emulsion/dispersion on part of the quantity of tea using a mixer having Forberg design and later subjecting to rapid but gentle - 25
drying to a moisture content of 2-3% under specific processing parameters of time and temperature in a fluidized bed dryer so that there is no oxidative thermal damage caused to added flavour formulation and also to the taste of tea (because flavour formulation is incorporated at the stage of aqueous solution of
encapsulant), and
finally blending with Darjeeling brokens in specified weight percentage and the remaining quantity of tea. The applicant fails to understand under the above circumstances how the present invention is rendered obvious. • This citation of EPO Board of Appeal decision dated July 05, 2000 (case no. T0355/97) relates to an appeal against the decision of opposition division rejecting the opposition filed against EP 0289 297.The invention related to process for preparing of 4-aminophenol from nitrobenzene in a sulphuric acid pre-treated with hydrogen peroxide.
The patentee
claimed that improving the performance index (increasing rate of reaction) without losing selectivity was due to his invention of pre treatment of sulphuric acid with hydrogen peroxide. A prior art patent taught the use of sulphuric acid as a suitable reaction medium for preparing 4-aminophenoi.The board held that pre-treatment of sulphuric acid with hydrogen peroxide was just to improve the purity of sulphuric acid by destruction of the catalyst poisoning agent in the sulphuric acid. This was considered obvious by the Board of Appeal. This is not relevant for the present application which has no such prior art which renders the present invention as obvious, as explained in the preceding paragraph.
6. ALLEGATION OF INADEQUACY OF INFORMATION Allegations Opponent alleged that the specification suffers from inadequacy of information due to following reasons: :1> The phrase "do-good ingredients"" was vague
- 26.
Applicant's process is not clear, at some places, it appears to be dry blending and at other places there is reference to emulsification which refers to wet blending. There is no experimental data relating to mixing Technical advance is not clear
Applicant's Submissions •
As regards the phrase "do-good ingredients" is concerned, it is used only in one of the objects and not in the description of invention. The do-good ingredients are four herbal formulations, the detailed composition of which is given on pages-7-8 above. For obvious reasons the detailed composition of these do-good herbal formulation cannot be provided in the objects of the invention. The detailed composition
of
each
of
the
four
herbal
formulations is provided in the description. It is to be
noted that the insufficiency of the information is not to be adjudged on the basis of the objects of an invention but on the basis of the description of the invention. In the description, the various ingredients taken are well described with weight percentages and also illustrated with working examples. • As regards that it is not clear whether it is dry blending or wet blending or a combination thereof, following lines on page 15, first
1
the attention is drawn to the paragraph of the original
specification:
"In
addition to the
use of powdered natural
flavours, liquid flavours oil/oleoresins could be used"
- 27
Attention is also drawn to the Table-6, page 22-23 of the original specification which provides specification of natural herbal flavours used in the present invention, which is reproduced below for ready reference, wherein the oil components are
highlighted: ""Table-6: Specification of Natural herbal flavours used in the present invention Natural Flavours
Specifications
Bacopa monnieri
Total bacosides 10%
Ocimum sanctum
Rosmarinic acid 0.33
HPTLC
Mentha piperita
Volatile oil 55ml/100g
GC
Oleoresing ginger/ginger oil 42.86%,
HPLC
--
Zingiber officina/is
Analytical Method
-
HPTLC
57.14%
Elettaria cardamom
Volatile oil >30%
GC
Salvia officina/is
45.1 ml/100g
GC
G/ycyrrhiza glabra
Glycyrrhizin >5%
HPLC
Centella asiatica
Total triterpenes>2%
HPLC
Foenicu/um vulgare
Volatile oil 4%
GC
Trachispermum ammi Volatile oil 5-6%
GC
When the herbs are taken in powder form, it becomes dispersion and when the herbs are taken in oil form, the emulsion is formed. The term dispersion covers both emulsion and dispersion. As regards whether it is dry blending or wet blending process, as may be seen from the comparative table given on page-16-22, the process of the present invention is a different process. The opponent's process is either dry blending or a combination of dry blending with wet blending. The combination of dry - 28
blending and wet blending requires firstly the preparation of dry blend, and then spraying aqueous solution of binder over the dry blend to prepare pre-mix followed by final blending (COMMENT: Please note that the opponents claim's in 1251/MUM/2004: (a) These do not claim use of herbal oil, (b) These claims claim (claim 11 and 12) claim m1x1ng of tea, Withania somnifera, aqueous food grade binder, optionally herbs selected from licorice, ginger, cardamom, and tulsi, and drying to a moisture content less than 10%. Thus the expression used is "aqueous food grade
binder" and NOT emulsion. Thus the claims do not claim emulsion. (c) These claims do not claim spraying of emulsion over tea, (d) These claims do not claim preparation of pre-mix; and (e) These claims do not claim the ratio in which finally the pre-mix is blended with tea. WHEREAS. there is no combination of drv lending and wet blending process in the present application. It is not dry blending. It is not the wet blending of the opponent's process wherein aqueous solution of binder is sprayed over a dry blend already containing dry herbs. In the applicant's process an aqueous
solution of encapsulant is prepared in hot water to which one of the four herbal compositions is incorporated, followed by mixing at >100rpm resulting in uniform distribution of herbs in the encapsulant. Then part of the quantity of tea particles are coated with such dispersion/emulsion (depending upon whether herbs are in solid form or in oil form) in a special mixer having Forberg design. Further details are given in the comparative chart and need not be repeated here. The preparation of aqueous solution of encapsulant in hot water at 60 to 80°C and incorporation of a herbal formulation having plurality of herbs in specified weight percentages. at this stage is not taught by the opponent's process, The aqueous encapsulant solution containing herbal formulation, requires gentle and rapid drving to prevent oxidative
- 29
thermal damage to flavours and otherwise the taste and other attributes of tea composition may be adversely affected. • Experimental data is provided on page 18 to 22 of the specification. The data relating to the various herbs is also provided in Table-6 on page-22-23 of the specification. Further experimental data are provided in the four working examples.
• As regards technical advance, it is submitted that the technical advance is brought out above under "Inventive steps in Process" and particularly in the comparative table provided there under. The technical advance of the product has also been brought out under "Inventive Steps in Product". For the sake of brevity, these are not repeated here. • The effect of the technical advance is that it provides an herbal flavoured tea which would become the preferred option for tea for the tea consumers. The plurality of herbs in constituting a herbal formulation in powder form or in the form of oils are incorporated at the stage of aqueous solution of the encapsulant and subjected to high speed rotation > 1000 rpm so that the herbal flavour is uniformly distributed throughout the entire volume of the solution of encapsulant. The homogenous dispersion/emulsion thus obtained is coated on a part of the quantity of tea particles in a mixer of Forberg design and finally blended with remaining quantity of tea. The tea composition thus obtained is consistent in flavour. Each cup of tea prepared from this composition would consistently have the same taste, flavour, and visual appearance (i.e. texture) unlike the opponent's product any one or more of the herbs could be selected from licorice, elaichi, cardamom, and tulsi for health benefits.
Applicant submits that the description of invention is adequate enough to enable a person skilled in the art to independently perform the invention. The
- 30
description is supported with four working examples to illustrate the working of the invention. The allegation of inadequacy of information in the specification of the present invention is therefore baseless. 7.
ALLEGATION
THAT
THE
PRESENT INVENTION IS
NOT AN
INVENTION
:»
Opponent made an allegation that the invention falls within the purview of section 3(e) as it is a mere admixture resulting only in aggregation of properties of the substances and the four compositions of flavours are also mere admixture.
:»
The comparative data to prove enhanced efficacy is not given
APPLICANT'S SUBMISSION • Section 3(e) is applicable when substance is obtained by mere admixture resulting only in the aggregation of the properties of the components thereof. It is not understood how this section 3(e) is applicable to the present invention where the process as explained above is not a mere admixture, but involves specific processing steps at specific processing parameters, in various steps. • Applicant wishes to draw the attention of the Controller hearing proceedings under section 15 in respect of 1003/DEL/2006 held on March 05, 2009 wherein on page-S, para-6, Dr. Kardam had opined as under: "The clinical study provided on page-6 of the specification as well as in the submission, first of all nowhere talks
percentage/ ratio composition which
about
the
of the constituents of the claimed leads to
the
conclusion that
the
alleged composition is mere admixture."
From the above ruling of the Dy. Controller of Patents, it is evident that a composition is an admixture only and only when the constituents are merely added in any ratio/percentage. 31
When the constituents are taken in specified weight percentage ranges, it is not an admixture.
• In the applicant's process, as already described above, an aqueous solution of an encapsulant taken in weight percentage of 0.3 to 0.7%, is prepared in hot water from 60°C to 80°C and of the four herbal formulations (Composition-A, Composition-S, Composition-C, and Composition-D) is incorporated at this stage and the solution thus obtained is subjected to high speed rotation >1000 rpm for 10 minutes. The dispersion/emulsion thus prepared is then coated on tea particles using a special mixer having Forberg design. The coated tea particles need gentle and rapid drying to avoid any adverse effect on flavour and taste. This is done by using fluidised bed dryer under optimised drying conditions of 90 to 110°C and residence time of 6-10 minutes to reduce the moisture content to 2 to 3%. The flavour concentrate thus prepared is blended, using a rotary blender, with 1 to 8% of Darjeeling Brokens and the required quantity of green tea/black teajoolong tea to prepare the desired batch size of the composition. Thus in the case of the present invention, the constituents are not merely admixed but require processing steps to be carried out under specified processing parameters and the constituents have to be taken within the specified range of weight percentages. It cannot be therefore termed as admixture and hence section 3(e) is not applicable to the present invention.
• Similarly, each of the flavour composition (composition A, B, C, D) is not prepared by admixing but by taking each of the herb within the specified range of weight percentages. The plurality of herbs taken in this manner in each composition of the flavour exhibit together a distinct flavour. Hence it is not an admixture as alleged by the opponent. • Citing the proceedings under section 15 in respect of 1003/DEL/2006 held on March 05, 2009, the opponent alleged that the enhanced - 32
efficacy of the composition is not given. The opponent is citing a case which is not relevant to the
present application. It related to a
pharmaceutical composition for which therapeutic enhanced efficacy was required under section 3(d) of the Patents Act. Under section 3(d), where the composition is a new form of known substance, it is not patentable under section 3(d) of the Act unless the applicant proves that it results in the enhancement of the known efficacy of that substance. Thus proving of enhanced therapeutic efficacy is required in case of pharmaceutical compositions to prevent evergreening of patents on such compositions and is not relevant to the present invention. The case relates to determination of the patentability of the following claim: " Pharmaceutical composition for the treatment of bipolar disorders of type- I comprising agomelatine or one of its hydrates, crystalline forms and addition salts with
a
pharmaceutically
acceptable acid or base, on its own or in combination with one or more
pharmaceutically
acceptable
excipients
and
a
thymoregulatory agent." In this matter the Controller of Patents determined that the agomelatine and its hydrate are already known for the treatment of bipolar disorder of type-I and its use for Type-II was a mere discoverv of new use of the known substance. Further, the composition disclosed in the specification was also disclosed in EP1564202 and therefore there was no novelty in the invention. Further, it was determined that percentage/ratio of the constituents were not given in the specification which lead to the conclusion that the claimed composition was a mere admixture. Further the combination of agomelatine and thymoregulatory required data to show enhanced therapeutic efficacy, which was not provided by the applicant. Due to these reasons, the application was refused for grant of
- 33
patent. Thus the invention related to a pharma composition relating to the discovery of the new form/use of the known substance and therefore came under purview of section 3(d). The present invention does not relate to discovery of new form/new use of the known substance and therefore section 3(d) is not applicable to the present invention. It is evident from above that the process of the present invention is not a mere admixture and also is not a mere discovery of new application, therefore does not come under the purview of section 3(d) or section 3(e) of the Patents Act. 8. APPLICANT'S COMMENTS ON THE AFFIDAVIT OF Dr. Prakash Dattatraya Virkar The opponent cited affidavit of Dr. Prakash Dattatraya Virkar, Beverages R&D Programme Director. The para-S of the affidavit cites the patent application WO 98/23164 stating that this patent application discloses several blends. The applicant has brought out above in para 3.3 and para 4.3 how the applicant's product and process are different from the product/process of WO 98/23164. Further, the affidavit has deliberately ignored the fact that use of flavour formulations A to D that use plurality of herbs, each taken in definite percentages with each blend showing a distinct flavour which is different from the individual constituents, is not taught by any of the processes taught in the cited prior art REP-1 or REP-2 or Evidence-1 or Evidence-2. It is pertinent to mention that the composite flavour of the herbal formulation is different from the flavour characteristics of the individual herbal components used in the composition.
Further, the affidavit refers to the various objects of the invention mainly relating to the process alleging that the process is not different from REP-2.Dr. Prakash Dattatraya Virkar, being an employee of opponent has deliberately ignored the inventive feature of the product and steps of the process as compared to REP-2, which have been
. 34-
brought out above and need not be repeated here. The wording of objects is not a ground for opposition and therefore irrelevant for the present proceedings. In many specifications, objects of inventions are not given as objects are not the essential part of the specification. The novelty, inventiveness of an invention is determined on the basis of description of the invention and not on the basis of the objects of the invention.
The issue of emulsion and dispersion brought out in the
affidavit, has been already addressed above and need not be repeated here.
9. Other Allegations by the Opponent The opponent raised following further allegations: (a) Allegation that invention lies in process and not in product: The opponent read out from the prior art and pointed out that most of the drawbacks related to process. Further, only two objects of the invention related to product and stated that the object was to provide a novel herbal tea composition with do-good ingredients in the form of natural flavours and orthodox tea from Darjeeling referred to as 'Darjeeling Brokens'. The other objects related to process. The opponent jumped to the erroneous conclusion that the invention of the present application lies in the process and not in the product just because of the reason that the prior art discusses most of the drawbacks of the processes and not of product and also just because most of the objects relate to process.
(b) Allegation that the original claim-1 by the applicant relates to product by way of the process claim (c) In case the claims are amended, the opponent be given another hearing in view of the citation of Neon Laboratories Pvt. Ltd. Vs. Troikas Pharma limited and others (2012)(2)BomCR54]
(d)
The opponent objected the use of word "normal" tea saying that after adding ingredients of flavour, the tea still tastes like normal tea then what was the use of adding herbal flavours.
- 35
(e)
The patent application 1251/MUM/2004 was not cited as prior art in the specification.
(f) Allegation of use of incorrect weight percentages APPLICANT SUBMISSIONS IN RESPECT OF ABOVE ALLEGATIONS (a). Regarding the allegation that the invention relates to process and not to product just because prior art does not specify the drawbacks of the product and most of the objects relating to the process1 the applicant clarified that firstly the wording of the objects of the invention was not a ground for opposition provided in the section 25 of the Patents Act. Section 25 provides the specific grounds for the pre-grant oppositions and at the end of section 25(1) 1 legislature has provided "but no other ground"
Secondly1 applicant clarified that the products of the prior art are in the field of medicinal herbal beverages and none related to herbal flavoured tea composition and therefore were not comparable to the product of the present invention. The drawbacks can be given for the comparable products but not for WIDELY dissimilar products. The product of the present invention is a unique novel product. The product of the present invention is also different from the product of the opponent's patent application 1251/MUM/2004 and also different from the products reported in patent applications cited in the pre-grant representation. The product of the present invention therefore did not intend to overcome any drawbacks of the products of known art but intended to provide a novel herbal flavoured product different from the known products. (b) Regarding the allegation that that the original claim was product by process claim. The original claim 1 was as under: ""1.
A flavoured herbal tea composition comprising, as weight percentages
of composition: 10-50% of flavour concentrate, 50-90% by weight of plain bulk tea, 1 to 8% by weight of Datjeeling Brokens, which is orthodox smaller or broken - 36
leaf grade of Darjeeling tea, wherein further flavour concentrate comprises 0.5 5% by weight of natural herbal flavours, 0.3 to 0.7 % by weight of an encapsulant and rest as tea particles and wherein further said flavour concentrate is obtained by the steps of: (a)preparing an emulsion by adding slowly 0.3 to 0.7% by weight of an . encapsulant to hot water at temperature between 60°C and 80°C with mixing in an emulsifier for about 5 minutes till a homogenous solution is obtained; cooling the solution to 40-60°C; adding a combination of different natural herbal flavours selected from Composition-A, Composition-S, Composition-C and Composition-D as hereinafter described, so that the emulsion has a solid content in the range of 40 to 80% mixing the solution again at rotational speed higher than 1000rpm for about 10 minutes, obtaining thereby an emulsion, wherein - said composition-A of herbal flavours includes 0.1 - 0.5% of Bacopa monniert, 0.3 - 0.7 % of Ocimum sanctum, 0.05 - 0.3%
of Mentha piperita, 0.05 - 0.3% of Zingiber officina/is and 0.1 0.3% of Elettaria cardamom; -said composition-S of herbal flavours includes 0.05 - 0.15% of Salvia officina/is, 0.5- 0.11% of Glycyrrhiza glabra, 0.01- 0.09%
of Mentha piperita and 0.1- 0.3% of Zingiber officina/is; -said composition-C of herbal flavours includes 0.1 - 0.55% of Bacopa monnierl 0.05- 0.15% of Centella asiatica, 0.3- 0.7% of
Ocimum sanctum, 0.1 - 0.3% of Zingiber officina/is, and 0.05 ·0.15% of Foeniculum vulgare; and -said composition-D of herbal flavours includes 0.005 - 0.013% of Trachispermum amml 0.1 - 0.2% of Mentha piperita, and 0.05 -
0.35% of Elettaria cardamom; (b) wet blending the tea particles with the emulsion as obtained by the step (a) by spraying the said emulsion slowly on to the 10-50% of the tea with mixing in a Forsberg mixer for 5 to 20, preferably 12 to 15 minutes for uniform coating thereby obtaining wet tea agglomerate of tea particles with
- 37
moisture content between 15 and 30% and homogenously coated with the said emulsion; and (c) drying the wet tea agglomerate obtained by step (b) above gently but rapidly in a fluidized bed dryer with inlet air temperature of 70-l10°C preferably between 80-90°C and residence time of 6-10 minutes, till the moisture content is reduced to 2 to 3%, obtaining thereby flavour concentrate. ""
It may kindly be noted:
• that a product by process claim would commence with word like ""A herbal tea composition manufactured by the process of.............".
• Whereas in the present case,claims 1 commences with words :
""A flavoured herbal tea composition comprising, as weight percentages of composition: 10-50% of flavour concentrate .....................""
• The reason why the process steps for the preparation of flavour concentrate were given in the product claim 1 is that the term flavour concentrate used in opening lines of claim-1 had no
antecedent
and
therefore
claim
1 would
have
been
incomprehensible and could not have been allowable if the expression 'flavour concentrate"" used in the claim 1 was not defined in claim 1itself.
• It is to noted the process steps given in the product claim-1 are limited only to what "flavour concentrate" is and how it is prepared. Kindly note that the process steps are NOT given for preparation of complete herbal flavoured product, But only to define the term ""flavour concentrate"" used in the claim L
- 38
•
Process claim
15 is independent process which provides
complete processing steps for the preparation of final herbal flavoured product. The preparation of flavour concentrate is the main and important part of the process of the applicant's product.
The only difference in the final product and the flavour concentrate
is
that
in
the
final
product,
flavour
concentrate is blended with black/green/oolong tea. This final step of the process is claimed in claim-15 and NOT in claim-1. THEREFORE when looked in casual manner it appears that entire processing step have been repeated in claim 1 and claim-15 but it is not so. Hence it is a product claim and not a product by process claim as alleged by the opponent.
(c)Regarding the opponent's contention that in view of judgement of Neon Laboratories Pvt. Ltd. Vs. Troikas Pharma limited and others, the opponent be provided opportunity of hearing if claims are amended. A judgment needs to be viewed in the backdrop of the facts. However, the opponent has not narrated the facts of the case. In the cited case, during the hearing proceedings held on 9.7.2008, the applicant's agent pointed out that they intended to file amended claims. Both sides had agreed that the hearing would be held after the amended claims are filed. The amended claims were filed by the applicant on 11.09.2008 which were forwarded by the controller to the opponent. The opponent filed the response on 7.10.2008 and requested for hearing. However, without opportunity of hearing to the opponent, the patent was granted. Thus opponent was denied opportunity of hearing before amendment of claims and also after amendment of claims.
In the case of the present application, the amended claims were filed on December 13, 2010 long before the hearing held on August 24, 2015 and the amended claims are available in public - 39
domain on the official website of the Indian Patents Office. Further, in the present case/ the amendments are by way of corrections primarily to remove ambiguity in percentages brought out in the First Examination Report and for the compliance of official requirements as per FER. Instead of giving specific weight percentage range of
"50 to 90 % of plain bulk tea", the words "rest being tea particles" have been substituted. It is not understood how this correction requires another opportunity of hearing. The scope of the
invention has neither been narrowed nor enhanced. The above case law is therefore not relevant to this matter.
(d)Regarding the opponenfs objection to the use of word "normal tea// it was clarified that the herbal flavoured tea of the present invention was not a medicinal formulation but has the organoleptic properties of regular tea. In appearance it would look like a normal but during consumption/ the consumer would feel the difference of flavour in tea. It would be consumed by the tea consumers as a preferred option in lieu of regular tea. The opponent is trying to play around the words because he has no grounds on the basis of novelty and inventive steps.
(e)
Regarding the allegation1 that the opponent's patent application no. 1251/MUM/2004 was not cited as prior art in the specification of the present invention1 the applicant clarified that the specification, including · abstract1 title of the patent application no. 1251/MUM/2004 does not even use the word "flavour". The product of the this patent application did not use Darjeeling brokens, which is a grade of tea of Darjeeling origin using the orthodox process of manufacture/ which is one of the essential features of the present invention. The product of this cited opponent's patent
application primarily
related to a
formulation preferably containing 50 to 90%
medicinal
Withania somnifera
(ashwagandha) (with 10 to 50% by weight of tea) (page-39 of representation) to provide enhanced protection against common cold - 40
and cough. The use of herbs licorice, ginger, tulsi and ellaichi is optional and that too for providing a medicinal supplement to the formulation and NOT to provide flavours to tea. The licorice, ginger, tulsi are known as health beneficial herbs in tea. In the present invention, none of these herbs is used in stand-alone mode but is blended with plurality of other herbs in specified weight percentages. In view of above, opponent's patent application could not be identified as prior art for the present patent applications the Indian patent search system was not so well developed at the time of filing of patent application .
(f) As regards the opponent allegation of the incorrect weight percentage the opponent pointed out to original Claim-1 (and not to amended claim 1 filed with Form-13 as early as in December, 2010) which claimed 1050% of flavour concentrate, 50 to 90% of plain bulk tea and 1 to 8% of Darjeeling Brokens. The opponent stated that if one chooses 50% of flavour concentrate and take minimum of 50% of bulk tea then it leaves no room for addition of Darjeeling Brokens.
In this regard, it was clarified that this was not the correct way of interpreting the claims. While practicing an invention, the physical quantities of the constituents have to be taken which should to total to the required batch size of the composition to be prepared. For this purpose, the constituents have to be taken within the overall ranges of the constituents provided in the specification and at the same time the constituents have to be taken so that the weight percentages make 100% of the batch size of the composition to be prepared. This has been very well explained in the specification with the help of four working
examples illustrating how the invention is practiced.
The attention of the opponent was drawn to
page 12 of their
specification of cited patent application No. 1251/MUM/2004 (on which .41.
patent has already been granted) which states that the present invention preferably comprises from 10 to 50% by weight of tea; from 50 to 90% by weight of Withania somnifera and up to 30% by weight of food grade binder. Going by the same arguments as given above by the opponent/ taking 50% of tea and minimum of 50% of Withania somnifera would constitute 100% leaving no room for addition of any food grade binder (required up to 30% in the description and up to 5% in claim4 ) without which the wet blending process cannot be practiced at all. Further, this will also leave no room for the addition of any of the herbs claimed in claim 7.
Even going by the claims1 the claim-1 of the cited opponenfs Indian Patent Application No. 1251/MUM/2004 (on which patent has already been granted) claim 85 to 99.9% of weight of tea and 0.1 to 15% weight of Withania somnifera (or 0.1 to 10% of Withania somnifera in claim 12). When the same logic is applied to the aforesaid cited Indian application as has been applied to the present application/ if maximum
99.9% of tea is taken and minimum of 0.1% of Withania somnifera is taken, there is no scope for addition of the food grade binder required to be taken 0.05 to 5.0% of food grade binder without which the process cannot be practiced. Further there is no scope for addition of any of the herbal flavours (claimed in claim-7). The opponent defended their patent specification by saying that when the herbal flavours are to be added/ the quantities of tea and Withania somnifera have to be altered so as to accommodate the herbal flavours and the food grade binder. The applicant pointed out what about the binder up to 5% claimed in claim-4 without which the wet blending step of the invention cannot be practiced. The applicant submits that similar arguments of adjusting the quantities as given by the opponent for their patent application1 hold good for the claim-1 of -42
the
applicant's patent application for
the
present invention. The
opponent apply different interpretations to the specification and claims of their own patent application 1251/MUM/2004 while apply different interpretations to the applicant's specification and claims, such a dual interpretation which is different for own application and different for the applicant's application should not be permitted. The rep of the applicant clarified that this was not the correct way of interpreting the claims. The individual ingredients need to be taken in quantities within the specified ranges so as to prepare the desired batch size. This has been very well explained in the working examples provided in the specification.
10. Briefs on Legal Citations for ready reference by Learned Controller During the opposition proceedings, the opponent presented legal citations which were not the evidence on record but fresh evidence submitted by the opponent during the proceedings. The opponent did not present the facts in proper perspective and made distorted presentation of facts. The factual position regarding these citations is given below:
>-
Clevent Corporation Patent -Appeal to the Patents Appeal Tribunal- 25th October and 16th November, 1965. The opponent cited the proceeding of the above matter and stated that when an application for leave to amendment is made the applicant shall state the nature of the propose amendment and shall give full particulars of the reason for which the application is made. The cited case is not relevant for the present application as explained below. (i)
In the cited case the application, the reason for amendment as given by the applicant originally was:' 'We wish to limit the claims to machines in which the boring bar is supported at both ends to prevent whipping movement thereof". The reason was later amended as " We wish to limit the claims by disclaimer so that they will distinguish more clearly from what is disclosed in United States of America patent specification no. 2,645,162.
-43
(ii)
The Tribunal noted that the word "reason" required the grounds to be given justifying the making of the application for leave to amend. In the cited case, the Tribunal noted that there was some prior art which the applicant apprehended would adversely affect the validity of this specification unless the claims were restricted (by way of limitation in the claims). The Tribunal noted that it was inconceivable that such knowledge played no part in the decision by the applicant to amend the specification.
Thus it may be noted that the appeal for amendment was dismissed because the applicant deliberately had given the false reason for
amendment to claims saying that they wish to limit the claims so that they will distinguish
more clearly from what was disclosed in
US2,645,162 whereas Tribunal noted that actual reason which
motivated the applicant to file application to amend the claims was the existence of a prior art, which if the claims were not amended, would have adversely affected the validity of the specification. The above cited legal proceedings have no relevance to the present invention.
The applicant in the present invention has not given any false grounds for amendment of claims. The amendment was motivated by removal of the ambiguity in percentages to comply with the official requirements as per FER and by no other considerations but the applicant of the cited patent failed to disclose the true reason of the amendment. Further there is neither any
limitation introduced in the claims nor any enhancement in the scope of the claims. All the essential ingredients of the composition remain un-amended and the process also remains un-amended. The original specification of the present invention provided that in the flavour concentrate, flavour powders, oils or oleoresin could be used. When oil or oleoresins are added to the aqueous solution of encapsulant, the result is emulsion when flavour in powder form is used the result is dispersion. Thus in the case of the present invention either dispersion or emulsion is used. It was later realised .44.
that dispersion includes emulsion and hence instead of using expression "emulsion of dispersion", the term "dispersion" has been used. It is a correction of technical error/defect in the specification to use the term emulsion when either solid or oil could be used..The opponent themselves have used the
expression "'solution/dispersion/emulsion'
in the specification of
their application on page-40 of their representation at the dry blending stage when there is no addition of oils. It is technically correct to use the term "dispersion" when either solid could be used or oils could be used. '.
>-
Citation ofT 0378/86 (change of Category) of 21.10.1987 The proceedings relate to where the claims were converted from process patent into an apparatus patent, after patent granted and the opposition division in an interlocutory decision had maintained the patent in the amended form and changing the claim category. This interlocutory decision of maintaining the patent with amendment in claims from the process to apparatus was contested by the appellant Attention of the Learned Controller is drawn to para 3.1.10 where the Appellate
Board held that
the change of category
made during the
opposition proceedings is compatible with the article 123(3) and is therefore admissible. (Note: Article 123(3) of EPC provides that the claims may not be amended during opposition in such a way to extend the protection concerned). In para 3.3, the Appellate Board
has further held that the protection afforded (as per amended claims) has not been extended by the amendments t:o the claim-1 as granted. In para 3.6, the Board has held that the claims 1 to 6 therefore satisfy the requirements of article 123 EPC. The order was passed based upon the procedural point mentioned in para-12. However, the applicant submits that the above legal
citation is not relevant to the present pre-grant proceedings as the applicant is not making any change in the category of the present application. The patent application originally claimed composition as well
as process for
- 45
the
composition and
amended claims also claim the composition and its process. There is no change in category in the case of the present invention.
>-
Citation of hearing proceedings for 1003/DEL/2006 This hearing under section 15 relates to determination of patentability of the following claim (given in para-S, page 4 of the proceedings): "Pharmaceutical composition for the treatment of bipolar disorders of type-Icomprising agomelatine or one of its hydrates, crystalline forms and addition salts with a pharmaceutically acceptable acid or base, on its own or in combination with one or more pharmaceutically acceptable excipients and a thymoregulatory agent."
The Controller of Patents determined that the agomelatine and its hydrate are already known for the treatment of bipolar disorder of type-! and its use for Type-II was a mere discovery of new use of the known substance. Further, the composition disclosed in the specification was also disclosed in EP1564202 and therefore there was no novelty in the invention. Further, it was determined that percentage/ratio of the constituents were not given in the specification which lead to the conclusion that the claimed composition is a mere admixture. Further the combination of agomelatine and thymoregulatory required data to show enhanced therapeutic efficacy, which was not provided by the applicant. Due to these reasons, the application was refused for grant of patent.
Thus the facts of the above proceedings are entirely different from the present invention. It was a pharmaceutical composition which required data to prove enhanced therapeutic efficacy required under section 3(d) of the Patents Act. This is not relevant in the present invention.
>-
Citation ofsection-15 proceedings for 733/MUMNP/2005
This main reason for rejection of this application was that it was abandoned on specific request of the applicant and even the hearing was not attended by the - 46
applicant. The explanations form the applicant side is therefore missing in the proceedings.. The only objection raised by the Controller was that there was no marking/highlighting to show corrections in the specifications. This is not relevant in the present case, as the corrections were duly highlighted in the specification and 2-3 pages explanation was provided in the response filed with FER,along with Form-13.
>-
CITATION OFT 0355/97 -EP 88303825.9
This relates to an appeal against the decision of opposition division rejecting the opposition filed against EP 0289 297.The invention related to process for preparing of 4-aminophenol from nitrobenzene in a sulphuric acid pre-treated with hydrogen peroxide.
The patentee claimed that the improving the
performance index (increasing rate of reaction) without losing selectivity was due to his invention of pre-treatment of sulphuric acid with hydrogen peroxide. A prior art patent taught the use of sulphuric acid as a suitable reaction medium for preparing 4-aminophenol and the board held that pre-treatment of sulphuric acid with hydrogen peroxide was just to improve the purity of sulphuric acid by destruction of the catalyst poisoning agent in the sulphuric acid. This step of increasing the purity of sulphuric acid by pre-treating of sulphuric acid with hydrogen peroxide to improve the performance index was considered obvious by the Board of Appeal. This is not relevant for the present application which has no such prior art which renders the present invention as obvious.
>
CITATION OF IPAB. REVOCATION PROCEEDINGS FOR PATENT NO. 219504 COrder No. 173 of 20130
The patent no. 219504 related to a combination of "Brimonidine and Timolol' for topical ophthalmic use. The applicant for revocation cited three patents 01, 02, 03, wherein 01 taught in patients with open angle glaucoma, intra ocular pressure (lOP) was reduced by brimonidine and timolol treatment when two
- 47
drugs were administered serially. D2 taught that effects on the intra ocular pressure (IOP) of both the drugs separately were comparable and when both the drugs were applied in combination, a further reduction of IOP was seen. D3 which related to ophthalmic pharmaceutical composition taught that significant number of glaucoma patients required combination of more than one drug in order to achieve therapeutic control of IOP. In view of the teachings of three prior art, IPAB held that the invention of the impugned patent is obvious. In para 26, the attorney of the patent owner contended that the invention did not fall under section 3(d) that the combination of two drugs showed improved efficacy as compared to immunotherapy. However the comparative data of administration of a combination formulation with sequential administration of the two drugs was not provided before IPAB. However, as per para 103, IPAB did not go into section 3(e) issue but revoked the patent on the ground of obviousness as stated above. This is not applicable to the present invention as none of the prior art citations render the present invention as obvious.
>-
Citation of IPAB Revocation proceedings for IP 201910 COrder No.224/2010l
In this case,IPAB observed that the patentee had filed amendments in claims after the counsel for revocation had completed the proceedings and the patentee had not shown any reasonable grounds of his delay and the IPAB therefore did not allow amendment to claims. Further IPAB observed that claim-1 and number of other claims of the impugned patent were anticipated by US 5,289,041 (referred to as US'041 patent) and the two patents US'041 and US 5,798,631 (US'631) made the invention obvious. In view of above, the above proceedings are not relevant to the present case. 11. REQUEST FOR TAKING OF FQRM-13 ON RECORD - 48
The learned presiding controller disclosed at the commencement of the proceeding in reply to the query of the opponent that she has disposed off the Form-13 for the amendment of the specification and has not taken it on record. The applicant requested the leaned Controller to kindly review the decision and take the form-13 filed in the year 2010 on record considering the following submissions.
Rule 55(5) of the Patents Rules provides that the specification be amended to the satisfaction of the Controller before the patent is granted.
In regard to the above, the applicant submits that Form-13 filed in December 2010 was for correction of obvious errors and for
complying with the official requirements raised in FER. The corrections were within the ambit of the provisions under section57 and section 59 of the Patents Act. The section 57 (2) of the Patents Act requires reasons to be given for the amendment in the claims and the amendment in specification. The reason for the corrections were given in detail in the response to FER filed in December, 2010 The section 59 of the Act requires that the amendment in specification should fall within the scope of the invention as described in the specification before amendment. It is submitted in this regard that the corrections were within the scope of the invention and were obvious. These were made to bring clarity in the wording of the claims and to make corresponding corrections in the specification; this is explained in the succeeding paragraphs.
Obvious Corrections made in specification Objection raised in FER The corrections in the claims and the corresponding correction in the specification were necessitated by the Objection at Sr. No. 1 of First Examination Report (FER).The objection raised was that in the herbal - 49
tea composition, the percentage range of individual constituents creates confusion. If one chose to take 50% of flavour concentrate, then 50% plain bulk tea will have to be selected. In that case there is no scope for adding Darjeeling Brokens. The applicant was required to clarify this ambiguity in the claims. To remove this ambiguity, the claim-1 was reworded as under:
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Original Claim-1
A flavoured herbal tea composition comprising, as weight percentages of composition: 10-50% of flavour concentrate, 50-90% by weight .of plain bulk tea, 1 to 8% by weight of Darjeeling Brokens,.......
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Reworded claim as filed with From-13 in December, 2010
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flavoured herbal tea composition comprising 1 to 8% of
Darjeeling Brokens, 10-50% of flavour concentrate and rest being tea
particles,.. Such rewording of claims in compliance of the official requirements raised in FER need to be allowed for compliance of FER requirements. It can be easily seen that the reworded claim as filed with Form-
1does not go beyond the scope of the invention. It is just to remove the ambiguity of weight percentage brought out in the objection at sr. No. 1of FER.
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The words "'50-90% by weight of bulk tea"
have been
substituted with the words "the rest being tea particles", All
the
ingredients
of
the
composition,
their
weight
percentages remaining unchanged. The object is bring clarity depending upon the
weight percentages of Darjeeling
brokens and the flavour concentrate, the remaining weight percentage of the bulk tea particles needs to be taken so that total equals to 100% of the desired batch size. This is further in
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consonance with the four working examples given in the original specification, which are brought out as below.
);>
The working example-1 illustrates that in case a batch of 2
kilograms of the composition of the present invention is required to be prepared,
24 grams (1.2% by weight of
composition) of plurality of herbal flavours as per composition-A is taken, 10 grams (0.5% of the weight of composition) of encapsulant is taken, and 60 grams (3% of the weight of composition) of
Darjeeling Brokens are taken then
the
remaining quantity i.e. 2000 grams- (24+10+60) =1906 grams of bulk tea is taken. A part of the 1906 grams of the bulk tea is used in the preparation of flavour concentrate as per the process of the present invention which constitutes 10 to 50% of the overall weight of the composition. The remaining part of plain bulk tea is blended with flavour concentrate thus prepared to prepare the composition in quantity of required batch
size. );>
Example-4 illustrates when 7.18 grams of flavour, 10 grams of encapsulant is taken and 60 gram of Darjeeling brokens is taken, the remaining 1922.88 grams of black tea is taken for preparing a batch of 2 kilograms. The part of the quantity of tea is taken at the stage for preparation of flavour concentrate i.e. coating of tea particles with the aqueous dispersion/emulsion, and the remaining quantity of tea particles is taken at the final stage of blending the flavour concentrate with the remaining quantity of tea particles.
(g) Obvious Corrections in the claims 20 to 27
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The claims 16 to 27 are dependent process claims with dependency on
independent process
claim
15.
But by oversight, instead of
commencing these claims with the wording as" A process as claimed in claimed 15", these dependent process claims commenced with words "A
flavoured herbal tea composition as claimed in claim 15111 • Evidently this is a typographical error. Obvious correction for changing term 'emulsion" to "dispersion" In this regard, kind attention of the Learned Controller is drawn to page13 of specification of patent application no. 1251/MUM/2004 (page-40 of the representation), wherein the opponent has used the following
phrase for preparation of pre-mix without the herbs: "An aqueous solution/dispersion/emulsion of the food grade binder is sprayed on the mixture obtained by dry blending" At this stage, no herbal oil is used still the opponent has used the
term
"emulsion". In fact he has used all the three
terms
solution/dispersion/emulsion. The specification (para-3 on page 13 and page 40 of representation) states
"For
incorporating
herbs,
an
aqueous
solution/dispersion/emulsion of the food grade is mixed with the oil from any one or more of the herbs. Thus the opponent themselves have used the term "emulsion" even before mixing of oil in the aqueous solution of the binder. As regards applicant's process, attention is drawn to the following opening paragraph on page 15 of the original specification that herbs could be in dry powder forms as well as in herbal oils/oleoresins:
"In addition to the use of powdered natural flavours, liquid flavours (oils)/oleoresins are also be used in the above-mentioned process of making emulsion"
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Further attention is drawn to the Table-6 on page 22-23 of the specification,which has been reproduced above wherein the oil components
used
in
the
present
invention
have
been
highlighted . Thus it is provided in the original specification that in the step of preparing a solution of encapsulant in hot water followed by mixing of herbal flavours at >100rpm for 10 minutes, the herbs taken could be
in dry powder form or could be in the form of herbal oils or oleoresins. It is known in the art that when herbal powder is used the mixture thus formed is referred to as "dispersion" and when the herbal oils are used the mixture thus formed is referred to as "emulsion". Thus in the present invention, dispersion or emulsion is formed depending upon whether herbs are used in dry powder form or whether herbal oil is used .It was later noted that dispersion includes emulsion. Hence instead of saying everywhere in the specification "dispersion or emulsion"', one word "dispersion" was used in the specification filed with Form-13.Hence, the use of word 'dispersion"
is technically more appropriate to cover use of herbal powders (forming dispersion) as well
as use of herbal oils (forming
emulsion) which are both provided in the description as given in the original specification. It is thus correction of an obvious technical error. Dropping of the process steps for flavour concentrate in claim-1 In the independent claim 1 there was reference to 'flavour concentrate"' which had no antecedent. Hence the steps how flavour concentrate is obtained were claimed in claim
1 to
qualify the term "flavour
concentrate". This was dropped in the amended claim 1 filed with Form13. Applicant has no problem if the steps of
preparing flavour
concentrate used in the flavour herbal tea composition are not allowed to be dropped and are retained in claim 1 besides claim-15.
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Thus it may be noted that all the above corrections made in Claims and in the specification filed with Form-13 in December 2010,are obvious corrections which do not go beyond the scope of the invention and which are permissible under section 57, section 59 and section 78(2) of the Patents Act. In view of above, it is humbly requested that the learned controller may kindly review her decision and take Form-13 with amended claims and specification on record. The rewording/amending of claims done in compliance with the official requirements, is a normal patent practice.
Not taking of the Form-13 for making
obvious corrections in claims and corresponding corrections in specification would be denial of right given to the inventors to amend the specification as per provisions under section 57, 59 and 78(2) of the Patents Act. 12. ECONOMIC SIGNIFICANCE OF INVENTION It is submitted that the invention of the present patent application is of huge economic significance to the country, besides offering a unique product not available anywhere in the world. It is expected to be a preferred tea option for tea for the tea consumers the world over. In this regard, your kind attention is drawn to section 2(1)(ja) which provides that an inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.
Thus economic
significance can be construed as inventive step and along with novelty can be considered to be meeting patentability criterion for grant of patent. The present invention has both technical advance as well as huge economic significance.
13. INORDINATE DELAY IN CALLING FOR HEARING Lastly, the applicant wishes to put on record the inordinate delay in calling for the hearing for pre-grant representation. The notice for pre-grant opposition was served by the opponent on October 01, 2010 and reply-statement was filed - 54
by us on behalf of the applicant on December 31, 2010. However, the hearing has been called on August 24, 2015 i.e. after a gap of more than four years. The pre-grant opposition needs to be decided as expeditiously as possible. It is to be noted that the applicant has never asked for adjournment of hearing for the pre-grant opposition. The opponent by citing patent/patent applications which are substantially different from the applicant's invention and by putting forth irrelevant grounds had the malafide intention of achieving the delay in grant of patent to the applicant which he has been able to achieve.
In view of above, the applicant prays for the following reliefs:
1. Rejection of pre-grant representation in toto 2. Acceptance of the patent application no. 359/KOL/2007 for grant of patent 3. Awarding of cost to the applicant
•
2_ ..-..\
Dated: th1s .............day of September, 2015
(VD Gulwani) Applicant's Patent Attorney Dua Associates.
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