1. Third Party Submission under Art 37 CFR 1.290

TKDL third party submission under Art 37 CFR 1.290 brought to the notice of examination division the prior art references on the use of Piper betle (Paan), tribulus terrestris(caltrop), sulphur, Dolichos biflorus, commiphora mukul, piper nigrum (Black Pepper), ziniber officinale (ginger), boerhaavia diffusa and honey for the treatment of obesity and Urinary disorders and as anti-oxidant, anti-inflammatory 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 23-36, 39-41, 45-49, 57-60, 62 and 64 are rejected under pre- AIA 35 U.S.C. 103(a) as being unpatentable over laksmivilasarasa (X1), in view of Medoroge Pathya (U2), Punarnavadikwatha (V2) and Vanga Shodhana (W2) (newly applied as necessitated by amendment).

         Laksmivilasarasa teaches a composition for treating obesity comprising Piper betle leaves, Tribulus terrestris and Sulphur (which reads o n an extract of each plant in claim 60), wherein the composition can be orally administered and can be in the form of an alcoholic extract, alcoholic preparation of sweet expressed juice and in the form of a pill or bolus.

         Laksmivilasarasa does not expressly teach Piper betle leaves obtained by extraction with 40-60% ethanol and the product-by-process steps as claimed. However, it should be noted that in Product-by-Process type claims, the process of producing the product is given no patentable weight since it does not impart novelty to a product when the product is taught by the prior art.

         Medoroge Pathya teaches a dietary composition for treating obesity comprising Dolichos biflorus, Commiphora mukul, Piper nigrum and Zingiber officinale, fermented drug distillate containing alcohol and water Pathya further teaches that the composition further comprises honey (which reads on at least one biologically acceptable excipient).

         Punarnavadikwatha teaches a therapeutic compound formula consisting of Boerhaavia diffusa for treating obesity.

         Vanga Shodhana teaches a therapeutic single/compound formulation consisting of Dolichos biflorus leaf for use in various formulations.

         It would have been obvious to modify the composition taught by Lak3/4____sarasa by combining an alcohol extract of Piper betle leaves, Tribulus terrestris and sulphur, with an extract of Dolichos biflorus plant (including leaves), commi[hora mukul extract, Boerhaavia diffusa extract, Tribulus terrestris extract, Piper nigrum extract and Zingiber officinale extract and honey because at the time the invention was made, it was known that Piper betle leaf alcohol extract, sulphur, Dolichos biflorus plant (including leaves) alcohol and aqueous extract, Commiphora mukul extract, Boerhaavia diffusa extract, Tribulus terrestris extract, Piper nigrum, Zingiber officinale extract and honey are effective ingredients for treating obesity that could be combined with food and orally consumed and could also be administered as a bolus, as clearly taught by the above references.

         It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. Based on the disclosure by these references that Piper betle leaf alcohol extract, sulphur, Dolichos biflorus plant (including leaves) alcohol and aqueous extract, Commiphora mukul extract, Boerhaavia diffusa extract, Tribulus terrestris extract, Piper nigrum, Zingiber officinale extract and honey could be orally consumed and provided as a bolus for treating obesity, the artisan would have been motivated to combine and provided as a bolus for treating obesity, the artisan invention resides in combining old ingredients of known properties where the result obtained thereby are no more than the additive effect of the ingredients.”

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

3. Outcomes of Third Party Submission & Examination Report

As the outcome of TKDL third party and other documents cited in examination report, decided to reject the claims 23-36, 39-41, 45-49, 57-60, 62 and 64 on 05.05.2015.