Saturday, 25 July 2015

An Analysis of TKDL at the EPO

Following my recent post on the IPKat here about (at least partly) false claims made by the Indian government regarding the relevance of the Traditional Knowledge Digital Library (TKDL), I thought I would have a good look at a bigger sample of the recent claims that have been made. These are listed on the TKDL website here as 'major milestones'. Another list is available here on the TKDL website indicating all instances where the TKDL has been used in third party observations, but without any claims to the relevance of the observations.

The major milestones page claims that things have happened, such as applications being refused or withdrawn, "based on the TKDL evidences". Based on the cases I have seen so far, these claims have turned out not to be true. The recent announcement by the Indian government to have "foiled an attempt by consumer goods giant Colgate-Palmolive to patent a mouthwash formula containing herb extract by citing ancient texts that show it was traditionally used in ancient medicinal practices" was just one recent example, as I showed in my recent post.

I wondered whether there had been any cases where the TKDL had been actually relevant in determining the outcome of an application. The only way to find out was to look at each of the cases and see what actually happened. The table below, which is derived from the TKDL's own list, shows for each European application in the list a summary of what happened, and whether the claim is true or false (or perhaps somewhere inbetween). You don't need to take my word for it though, as links are provided in each case for verification if needed.

Where I have indicated that the TKDL claim is false, this is based on there being no objections raised by the examiner in relation to the TKDL documents or, in some cases, that the examiner has specifically stated that the references were not as relevant as those already cited, and therefore could not possibly have made any difference. Where I have indicated that the claim is true, this is where either the examiner has specifically raised objections and/or the applicant has responded to the references by amendment. Whether any subsequent deemed withdrawal has anything to do with the TKDL citations is, of course, unknown, but I have given the TKDL the benefit of any doubt where any objections have been raised during prosecution.

TKDL Claim
Evidence from EP Register
True or False?
BASF Beauty Care Solutions France SAS, France has amended the claims of the application no. EP2157966 for "MC-1R, MC-2R, and/or [mu] opioid receptors simulation" based on the TKDL evidences.
No mention of TKDL evidence in summons to oral proceedings dated 9 Jan 2015. Applicant responded to TKDL evidence with no amendments.
FALSE
Based on TKDL evidences, MORINAGA MILK INDUSTRY CO., LTD. 33-1, Shiba 5-chome Minato-ku, Tokyo 108-8384 / Japan has amended the claims of application no. EP1941899 for "Agent for promoting glucagon-like peptide 1 secretion, food or drink for promoting glucagon-like peptide 1 secretion, agent for inhibiting postprandial increase in blood sugar level and food or drink for inhibiting postprandial increase in blood sugar level" and then the application was deemed to be withdrawn.
Last examination report dated 8 Jan 2015 cites two documents, neither from TKDL. No response filed, application deemed withdrawn.
FALSE
Based on TKDL evidences, Phenolics, LLC, P.O. Box 2439, 846 San Carlos Avenue, El Granada, CA 94108-2439 / United States has amended the claims of application no. EP1572219 for "Efficient method for producing compositions enriched in total phenols" and then the application was deemed to be withdrawn.
TKDL observations mentioned in examination report dated 13 Jan 2011, but documents already cited by examiner used in novelty/inventive step objections.
FALSE
Based on the TKDL evidences, Application no. EP2328598 (Phenolics, LLC United States) for "Novel compositions containing isolated tetrameric type a proanthocyanadin and methods of use and manufacture", is deemed to be withdrawn.
Inventive step objection based on document D1 cited by examiner in last examination report dated 7 March 2014. TKDL observations also mentioned. Application subsequently deemed withdrawn due to no renewal fee payment.
TRUE (partially)
Based on the TKDL evidences, application no. EP2464363 (M/S Medasani, Munisekhar / India) for "Natural extract from whole banana fruit (Musa Spp.)", is refused.
Decision to refuse dated 20 March 2015 based on objections in examination report dated 17 March 2015, cites document D8 (WO 2004/069143) as main reference for novelty & inventive step, D10-12 & D18 used in inventive step. None of cited documents from TKDL.
FALSE
Based on the TKDL evidences, Application no. EP2689806 (Colgate-Palmolive Company/ United States of America) for "Oral compositions containing extracts of myristica fragrans and related methods", is deemed to be withdrawn.
Last examination report dated 6 October 2014 cites document not from TKDL as main reference.
FALSE
Avon Products / U.S. has amended the claims of the application no. EP1827362 for "Compositions and methods of their use for improving the condition and appearance of skin" based on the TKDL evidences.
Examination report dated 7 Aug 2014 cites TKDL observations in novelty & inventive step arguments. Applicant subsequently amends claims.
TRUE
Based on the TKDL evidences, Nestec S.A. / Switzerland have withdrawn their Application No. EP2243383 for "A method and composition for nutritionally improving glucose control and insulin action."
Summons to oral proceedings dated 1 Aug 2014 specifically mentions third party observations not being more relevant than documents already on file.
FALSE
Based on the TKDL evidences, Application no. EP2266586 (Lifeline Nutraceuticals Corporation 6400 South Fiddler's Green Circle, Suite 1970 Englewood, CO 80111 / United States) for "Compositions and method for alleviating inflammation and oxidative stress in a mammal", is deemed to be withdrawn.

Application was closed on 18-Mar-15.
TKDL evidence mentioned in last examination report dated 30 April 2014, but examiner cited documents used in novelty & inventive step objections.
FALSE
Nestec S.A. Avenue Nestlé 55 1800 Vevey / Switzerland has amended the description of the application no. EP1750651 for "Composition for improving skin, hair and coat health containing flavanones" based on the TKDL evidences.
Novelty objections raised in last examination report based on examiner cited documents and TKDL evidence. Examiner also raises novelty objection citing orange juice with pulp as prior art.
 TRUE (partially)
M/S Indena S.p.A. / Italy has amended the claims of the application no. EP2046324 for "Treatment and prevention mucositis by anthocyanidin derivatives.
Novelty & inventive step objections raised in last examination report based on 35 documents cited by examiner. TKDL evidence not used.
N/A (no claim made)
Based on the TKDL evidences, Application no. EP1558271 (Metaproteomics, LLC / United States) for "Compositions that treat or inhibit pathological conditions associated with inflammatory response", is deemed to be withdrawn.

Application was closed on 09-Jan-15.
Examiner considered claims to be new and inventive over cited documents and TKDL documents in examination report dated 3 March 2014. Minor clarity objections raised. No response filed, application deemed withdrawn.
FALSE 
Based on the TKDL evidences, Application no. EP2419508 (Somalabs, Inc., 40 Allen Road, South Burlington, VT 05403 / United States) for "Method for the induction of a reward response by modulation of dopaminergic systems in the central nervous system", is deemed to be withdrawn.

Application was closed on 12-Nov-14.
TKDL observations used in examination report dated 7 March 2014 for inventive step argument. Application then deemed withdrawn due to missing renewal fee.
TRUE
Unitika, Ltd./ Japan has amended the claims of the application no. EP2226071 for "Composition for oral administration" based on the TKDL evidences.
Novelty objection in examination report dated 20 Feb 2015 based on document cited by international examiner. TKDL evidence not mentioned.
FALSE
Based on the TKDL evidences, Unigen, Inc. / US, have amended the claims of application no. EP1881839 for "Compositions of Bakuchiol and methods of making the same" and then the application was withdrawn.

Application was closed on 12-Nov-2014.
Intention to grant issued 17 Feb 2014. No response filed, application deemed withdrawn. TKDL references stated to be not relevant in examination report dated 11 March 2010.
FALSE
Laboratoires Expanscience / France has amended the claims of the application no. EP2506724 for "Vigna unguiculata seed extract and compositions containing the same" based on the TKDL evidences.
Inventive step objections in examination report dated 12 March 2014 based on TKDL evidence. Claims amended in response.
TRUE
New Chapter, Inc. / US has amended the claims of the application no. EP2435057 for "Compositions and methods for modulating lipid composition" based on the TKDL evidences. Application was refused on 17-Jun-2015.
Amendments made in response to documents cited by examiner. Examination report dated 7 March 2014 indicates that "third-party observations has been taken into account", but novelty & inventive step objections based only on examiner cited documents. Reasons for refusal in summons to oral proceedings dated 10 March 2015 made no mention of TKDL references.
FALSE
Mimozax Co., Ltd. , 4291-1, Miyauchi Hatsukaichi-shi, Hiroshima 738-0034 / Japan has amended the description of the application no. EP2052731 for "Composition for preventing and/or treating itching containing component originating in the bark of tree belonging to the genusacacia." based on the TKDL references.
No third party observations have been filed.
FALSE
Nanyang Polytechnic/ Singapore has amended the claims of the application no. EP2416793 for "A plant extract comprising statins and preparation techniques and uses thereof" based on the TKDL evidences.
Search opinion dated 25 July 2013 invited applicant to comment on TKDL references. Applicant responded on 6 June 2014 with amendments.
TRUE
Based on the TKDL evidences, Application no. EP1901701 (Ott, David M., 777 Panoramic Way, Berkeley, CA 94704 / US) for "Personal care and medicinal products incorporating bound Organosulfur groups", is deemed to be withdrawn.

Application was closed on 14-Aug-14.
Examination report dated 9 October 2013 raised novelty objections relating to examiner cited documents. Third party observations mentioned, but no specific objections raised. No response filed, application deemed withdrawn.
FALSE
Based on the TKDL evidences, Application no. EP2293689 (Mars, Incorporated / US) for "Food product", is deemed to be withdrawn.

Application was closed on 04-Aug-14.
Examination report dated 22 November 2013 considered third party observations to be relevant for inventive step. No response filed, application deemed withdrawn.
TRUE
Based on the TKDL evidences, Application no. EP2269598 (Metaproteomics, LLC/ United States) for "Curcuminoid compositions exhibiting synergistic inhibition of the expression and/or activity of cyclooxygenase-2", is deemed to be withdrawn.

Application was closed on 18-Jul-14.
Search opinion dated 23 May 2011 cited TKDL references mentioned in third party observations, raising novelty objections based on these. Subsequent deemed withdrawal due to non-payment of renewal fee.
TRUE
Based on the TKDL evidences, Application no. EP1993522 (Kao Corporation 14-10, Nihonbashi-Kayabacho, 1-chome Chuo-ku Tokyo 103-8210 / Japan) for "Resveratrol and/or grape leaf extract as i.a. endurance improver, anti-aging agent, muscle strength improver", is deemed to be withdrawn.

Application was closed on 23-May-14.
Examination report dated 29 March 2011 mentioned third party observations, but considered documents already cited by examiner to be more relevant. 
FALSE
Universiti Putra Malaysia, UPM Serdang, 43400 Selangor Darul Ehsan / Malaysia has amended the claims of the application no. EP2349302 for "Cardioprotective effects of nutraceuticals isolated from nigella sativa seeds" based on the TKDL evidences.
Search opinion dated 10 July 2012 indicated that TKDL references were not considered to be as relevant as examiner cited documents. 
FALSE

Out of a total of 23 cases where a claim has been made that something happened "based on the TKDL evidences", 15 turn out to be completely false. There are no cases where an application has been refused based on TKDL evidence, but several where an application has lapsed for one reason or another after TKDL evidence has been submitted. It looks to me like the TKDL is a potentially useful source of prior art in limited circumstances, but is nowhere near as significant as it is made out to be. Perhaps the Indian government could be a little more honest and make claims where they are actually justified.

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