1. Third Party Submission under Art 37 CFR 1.99

TKDL third party submission under Art 37 CFR 1.99 brought to the notice of examination division the prior art references on the use of Holoptelea integrifolia (Putikaranja) for the treatment of Obesity from the books – Gadanigrahah by Sodhala (Ayurveda, Exhibit 1), Bharata Bhaisajya Ratnakara - Compiled by Naginadasa Chaganalala Saha (Ayurveda, Exhibit 2) and Sushruta Samhita, Edited & translated by P.V Sharma, Vol.-II (Ayurveda, Exhibit 3).

2. Relevant Extract of USPTO Examination Report

USPTO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report are reproduced below:
“Claims 1, 3-4, 16, 18-19, and 25-26 are rejected under 35 U.S.C. 102(b) as being Anticipated by Sodhala et al. (1999) (English Translion) with evidence provided by Anwikar et al. (2010).

Sodhala et al. teach a therapeutic composition which is made by powdering plant material including the fruit of Holoptelea integrifolia and the fruit or Solanum xanthocarpum, boiling the powdered plant material with water, wherein a specific quantity of water is retained after boiling and then filtering the composition to obtain the decoction (Kvatha) (see e.g. pages 5-6 of 15). Therefore, Sodhala et al. Teach a Decoction (which is a water extract) of herbs, including Holotelea integrifolia and Solanum xanthocarpum. Since the composition contains water, the composition contains a biologically acceptable excipient and therefore is formulated as a nutraceutical or pharmaceutical dosage form, as instantly claimed. In addition, nothing would preclude the parenteral administration of the decoction disclosed by Sodhlala et al. and the composition could be injected or used in drop form since it is a liquid containing water as an excipient. Furthermore, Sodhala et al. teach that the composition is orally administered and is a therapeutic composition and is useful in the treatment of, among other conditions, obesity (see page 6 of 15) therefore, the composition reads on a food for specified health uses, as instantly claimed.

Therefore, the reference is deemed to anticipate the instant claims above.

The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:

Claims 1, 3-4, 16, 18-20 and 25-26 are rejected under 35 U.S.C. 102(b) as anticipated by or, in the alternative, under 35 U.S.C 103(a) as obvious over by Sodhala et al. (1999) (English Translation) with evidence provided by Anwikar et al. (2010).

Sodhala et al. teach a therapeutic composition which is made by powdering plant material including the fruit of Holotelea integrifolia, boiling the powdered plant material with water, wherein a specific quantity of water is retained after boiling and then filtering the composition to obtain the decoction (Kvatha) (see e.g. pages 5-6 of 15) and is relied upon for the reason set forth above.  While Sodhala et al. do not explicitly teach that the filtration step is performed with fine filters, that the filtrate is evaporated after filtration step and then purified, it should be noted that the extract of instant claim 20 is part of a Composition which may comprise additional ingredients.  Therefore, although the solvent (which may be water) has been evaporated, when adding the concentrated extract to an herbal composition which may comprise additional ingredients, including water, the extract would not be expected to differ from an extract from which water had not been evaporated.  In addition, while instant claim 20 recites the steps of using fine filter and of purifying, it is not explicitly disclosed how fine the filters are or how the purification takes place or to what degree the extract is purified.  Therefore, absent evidence to the contrary, the extract disclosed by Sodhala, which has also been filtered, would be expected to be substantially the same as the instantly claimed extract.

            The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:

Claims, 1, 3-4, 16-20. 25-26 and 30 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sodhala et al. (1999) (English Translation) with evidence provided by Anwikar et al.  (2010) Jacobs et al. (US 2005/0130933 A1).

            Sodhala et al. teach a therapeutic composition which comprises a water extract of the fruit of Holoptelea integrifolia and a biologically acceptable excipient (i.e. water) which reads on an anti-adipogenic and pro-lipolytic herbal supplement, as instantly claimed, and are relied upon for the reasons set forth above.  As discussed above, Sodhala et al. teach that the composition is orally administered and is a therapeutic composition and is useful in the treatment of, among other conditions, obesity (see page 6 of 15).

            Claims 1, 3-4, 16, 18-21 and 25-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over by Sodhala et al. (1999) (English Translation) with evidence provided by Anwikar et al (2010) in view of Mason (1999).

            Sodhala et al. teach a therapeutic composition which comprises a filtered decoction of the fruit of Holoptelea integrifolia and a biologically acceptable excipient (i.e. water) which would be expected to be substantially the same as the instantly claimed composition although it was made in a slightly different manner and are relied upon for the reasons set forth above.

            Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.           

Claims 1, 3-4, 16, 18-20, 22, and 25-26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Sodhala et al. (1999) (English Translation) with evidence provided by Anwikar et al (2010) in view of Watanabe (1999).

            Sodhala et al. teach a therapeutic composition which comprises a water extract of the fruit of Holoptelea integrifolia and a biologically acceptable excipient (i.e water) which reads on an anti-adipogenic and pro-lipolytic herbal supplement, as instantly claimed, and are relied upon for the reasons set forth above.  As discussed above, Sodhala et al. Teach that the composition is orally administered and is a therapeutic composition and is useful in the treatment of, among other conditions, obesity.”

Full examination report can be referred at 20100203078.pdf

3. Outcomes of Third Party Submission & Examination Report

As the outcome of TKDL third party and other documents cited in examination report Applicant M/s LAILA NUTRACEUTICALS, Vijayawada, India, decided to amend the claims on 18.11. 11. and 18.04.2012.

Analysis of amendment of claims

The Applicant originally claimed the usefulness of an Anti-adipogenic and pro-lipolytic herbal supplements, comprising an extract or purified fraction derived from Holoptelea integrifolia for inhibiting or preventing or controlling adipogenesis and lipolysis involved diseases wherein said adipogenesis and lipolysis involved diseases comprise obesity, overweight, hyperlipedemia, type 2 diabetes, cardiovascular disease and atherosclerosis and the the source of extract or fraction is a Holoptelea integrifolia plant part selected from the group, of leaf, seed, trunk, root, and mixtures thereof, to be novel. TKDL submitted its prior art evidences stating the use of Holoptelea integrifolia (Putikaranja) for the treatment of Obesity and Diabetes mellitus. Based on the TKDL evidences and Examiner’s report the Applicant amended the claims specifying that the extract being obtained from leaves of Holoptelea integrifolia and being present in an amount which is effective for inhibiting or controlling obesity, overweight, or hyperlipidemia.