1. Relevant Extract of USPTO Examination Report

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

“Claims 1 and 11 are rejected under 35 U.S.C.103(a) as being unpatentable over Uccatadyamodakah (In Vangasena; Shankar et al., Eds.; Bombay, India, 1996; p. 236; cited as Exhibit 1 in the IDS of 29 March 2013), Nilakamala Kanda Gunah (Kaiyadeva, Nilakamala Kanda Gunah. In Kaiyadevanighantu; Sharma et al., Eds.; Varanasi, India, 1979; p. 268-269; cited as Exhibit 3 in the IDS of29 March 2013

Uccatadyamodakah teaches a method of stimulating in a subject a feeling of satiation with a therapeutic formulation comprising Mucuna pruriens. Uccatadyamodakah teaches the administration is oral, in the evening, on empty stomach (before the subject eats a meal, as in claims 1, 11).

Uccatadyamodakah does not teach a method of stimulating a feeling of having already eaten with a combination of an extract from Mucuna pruriens and Nelumbo nucifera.

Uccatadyamodakah does not specifically teach administration of the composition 45 minutes before the subject eats a meal, as in instant claim 11.

Even though Uccatadyamodakah does not specifically teach that an extract of Mucuna pruriens contains L-Dopa, the L-Dopa content is an inherent property of the seeds of Mucuna pruriens, known at the time the invention was made, as evidenced by Van Der Glcssen et al. (US 2006/0165822, published 27 July 2006, cited in the IDS of 14 October 2011, see Abstract, [0016]. Mucuna pruriens used either as seed powder or as extract, also [0022]).

Nilakamala Kanda Gunah teaches a method of stimulating in a subject a feeling of satiation with a therapeutic formulation comprising Nelumbo Nucifera.

Even though Nilakamala Kanda Gunah and Ono do not specifically teach that an extract of Nelumbo nucifera contains an aporphine alkaloid such as nuciferine, the nuciferine content is an inherent property of the Nelumbo nucifera seed extract, known at the time the invention was made, as evidenced by shamma et al. (Chem. Rev. 1964, 64(1), 59-79, cited in PTO-892).

It would have been obvious to a person of ordinary skill in the art at the time the invention was made to combine an extract of Mucuna pruriens and an extract of Nelumbo nucifera, in a therapeutic formulation, wherein the amount of L-Dopa is 50 mg to 500 mg and the amount of nuciferine alkaloid is 2 mg to 50 mg, and use the formulation to stimulate a feeling of having already eaten.

The person of ordinary skill in the art at the time the invention was made would have been motivated to combine an extract of Mucuna pruriens and an extract of Nelumbo nucifera, because Mucuna pruriens (seeds or extract) was known to induce satiation, as taught by Uccatadyamodakah, and was known to be used (in doses/ sachets of seeds containing 250 mg L-Dopa) to treat metabolic and nutritional disorders, as taught by Van Der Glessen.

Furthermore, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to administer the combination of extracts of Mucuna pruriens and Nelumbo nucifera 45 minutes before the subject cats a meal. The person of ordinary skill in the art would have been motivated to administer the composition before the subject eats a meal, because compositions comprising Mucuna pruriens were known to be administered orally on an empty stomach, as taught by Uccatadyamodakah. Varying the time before the composition is administered to the subject with the aim of improving the therapeutic effect of the composition is considered routine for the skilled artisan.

Claims 12 and 13 are rejected under 35 U .S.C. 1 03(a) as being unpatentable over Uccatadyamodakah, Van Der Glessen, Nilakamala Kanda Gunah. Ono and Shamma, as applied to claims 1 and 11 above.”

Full examination report can be referred at 20120115891-IV.pdf

2. Outcomes of Examination Report.

As the outcome of TKDL references and other documents cited in examination report, the Examiner again rejected the claims 1 and 11-13 on 03-Oct-14.