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 Piper betle (Paan) leaf in combination with one or more of the extracts or fractions derived from Dolichos biflorus (Kulathi), Commiphora mukul (Guggulu), Boerhaavia diffusa (punarnava), Tribulus terrestris (caltrop) and Zingiber officinale (ginger) for the treatment of obesity and as anti-oxidant, anti-inflammatory and anti diabetic agent from the books – Vaidyamanorama by Kali Dasa (Ayurveda, Exhibit 1), Yogaratnakara - Commentary by Lakshmipatisastri, Edited by Brahmasankara Sastri (Ayurveda, Exhibit 2), Sodhalanighantau by Sodhala (Ayurveda, Exhibit 3), Bharata Bhaisajya Ratnakara vol II- Compiled by Naginadasa Chaganalala Saha (Ayurveda, Exhibit 4), The Ayurvedic Pharmacopoeia of India - Part I, Vol. I- Govt. of India (Ayurveda, Exhibit 5), Bharata Bhaisajya Ratnakara vol III- Compiled by Naginadasa Chaganalala Saha (Ayurveda, Exhibit 6) and Rasatantrasarah Evam Siddhaprayogasamgrahah;- part I by Krishan Gopal Ayurveda Bhawan (Ayurveda, Exhibit 7).

2. Relevant Extract of USPTO Examination Report

USPTO Patent Examiner(s) took cognizance of TKDL references. Extract of examination report are reproduced below:

“Claims 23-27, 30-36, 40, 41, 46, 48, 49, 57, 59, 60 and 61 are rejected under 35 U.S.C. 103(a) as being unpatentable over H’drogepathya (V) (newly as necessitated by amendment).

         H’drogepathya teaches a therapeutic formulation (dietary formulation) for treating heart disease (which reads on treating a condition associated with adjpogenesis) consisting of Dolichos biflours, piper betie, rain water, buttermilk (which reads on a milk containing beverage and biologically acceptable excipient), Allium sativum (which) reads on a bio-protectant) and Zingiber officinale (which reads on anti-inflammatory agent). Please not that combining water with Dolichos biflorus and Piper betle in a composition would provide a water extract of Dolichos biflorus and Piper betle.

         Although H’drogepathya does not teach that the composition is an anti-adipogenic composition, the claimed functional properties are intrinsic to the preparation bought by H’drogepathya because the ingredients taught by H’drogepathya are one and the same as disclosed in the instantly claimed invention of Applicant. Thus, the composition taught by H’drogepathya is intrinsically an anti-adipogenic composition.

         It would have been obvious to modify the composition taught by H’drogepathya by modifying the amounts of each of the ingredients because at the time the invention was made, it was known that Dolichos biflorus, Piper betle, rain water, buttermilk, Allium sativum and Zingiber officinale are all useful ingredients for treating heart disease as clearly taught by H’drogepathya.

         Based upon the beneficial teachings of the cited references, the skill of one of ordinary skill in the art, and absent evidence to the contrary, there would have been a reasonable expectation of success to result in the claimed invention.

         Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.

         Claims 23-36, 39-41, 45-49, 57 and 59-60 are rejected under 35 U.S.C. 103(a) as being unpatentable over H’drogepathya (V).

         Based upon the beneficial teachings of the cited references, the skill of one of ordinary skill in the art, and absent evidence to the contrary, there would have been a reasonable expectation of success to result in the claimed invention.

         Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.

         Claims 23-36, 39-41, 45-49, 57 and 59-61 are rejected under 35 U.S.C. 103(a) as being unpatentable over H’drogepathya (V), in view of “WorldHealth.net Tribulus

         Based upon the beneficial teachings of the cited references, the skill of one of ordinary skill in the art, and absent evidence to the contrary, there would have been a reasonable expectation of success to result in the claimed invention.

         Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.

         Claims 23-26, 40, 41, 46, 49, 57, 59 and 61-63 are rejected under 35 U.P.C. 103(a) as being unpatentable over Arambewela et al. (W1), in view of Dawa E-Kulthi Barae Ziuabitus (X1)

         Dawa E-Kulthi Barae Ziyablitus teaches a decoction of the whole plant of Dolichos biflorus (which reads on an aqueous extract of Dolichos biflorus leaves, since the extract would contain an extract of leaves) for treating diabetes.

         Based upon the beneficial teachings of the cited references, the skill of one of ordinary skill in the art, and absent evidence to the contrary, there would have been a reasonable expectation of success to result in the claimed invention.

         Accordingly the claimed invention was prima facie obvious to one of ordinary skill in the art at the time the invention was made, especially in the absence of evidence to the contrary.”

Full examination report can be referred at 20100203117-II.pdf

3. Outcomes of Third Party Submission & Examination Report

As the outcome of TKDL third party and other documents cited in examination report, Applicant KRAMER & AMADO, P.C., ALEXANDRIA, US, decided to amend the claims on 02.07.2012.