Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Instant claims 1-25 is pending. Instant claims 1-25 is now evaluated on its merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-8, 19 and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 6-8, 19 and 25 recites the limitation of the composition further comprising creatine hydrocholoride. The above claims are dependent of claims 1, 12 and 21 which are directed to increasing arginine and nitric oxide physiological levels in which creatine is known in the art to be related to muscle gain, endurance and high-intensity work; it does not relate to increasing arginine and nitric oxide physiological levels as they are of different pathways. Applicants’ specification nor the claims iterate the usage of creatine hydrochloride in increasing arginine and nitric oxide physiological levels. Thus, the additive of creatine hydrochloride is not enabled to increasing arginine and nitric oxide physiological levels.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 9-18, 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Ochiai et al. (JP 6255079 B2).
Regrading claims 1-4, 9-18, 20-24, Ochiai teaches an oral preparation for increasing blood arginine concentration and the concentration of blood nitric oxide metabolites in an animal comprising administration of a composition of citrulline or a salt thereof and arginine or a salt thereof (relevant to claims 1, 9, 12, 15 and 21-22) (abstract, claim 3). The salt of citrulline comprises hydrochloride (relevant to claims 2-3, 13-14, 24). Of the above composition Ochiai teaches the addition of extra additives which comprises antioxidants (relevant to claims 4 and 18), wherein the composition is administered at dosage amount of 100mg to 10g in a form selected from the group consisting of tablets, powders, granules and capsules (relevant to claims 10-11, 16-17, 23) (claims 7, 9).
In terms of aqueous solubility about 120 mg/ml to about 200 mg/ml in water at 62°F, it is known in the art the aqueous solubility of citrulline hydrochloride at room temperature (68°F) is 200 mg/ml.
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have administered the composition taught by Ochiai wherein the aqueous solubility of the citrulline hydrochloride is about 120 mg/ml to about 200 mg/ml in water at 62°F and ACEplasma is within the claimed range. One would have been motivated to do so as Ochiai teaches the same composition with the same active ingredient of citrulline hydrochloride within the same claimed dosage range. Thus, the composition of Ochiai would possess the same properties as claimed invention as per MPEP 2112.01 (II): Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Additionally, per applicants’ specification the aqueous solubility of citrulline hydrochloride is about 120 mg/ml to about 200 mg/ml in water at 62°F negligent of dosage amounts.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ochiai et al. (JP 6255079 B2) in view of Montenegro et al. Betalain-rich concentrate supplementation improves exercise performance and recovery in competitive triathletes, Applied Physiology, Nutrition, and Metabolism, October 2016, Pgs. 1-7.
The teachings of Ochiai for the above 103 rejection of claims 1-4, 9-18, 20-24 are incorporated herein by reference.
Ochiai fails to teach the taught antioxidant consisting of betalain.
Montenegro teaches betalain, a natural, water-soluble pigments found in beetroots is an antioxidant that neutralize superoxide radicals that leads to an increase in nitric oxide availability in the blood, and subsequently increased blood flow and oxygen delivery (Pg 167, 2nd para.).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have administered the oral composition taught by Ochiai for increasing blood arginine concentration and the concentration of blood nitric oxide metabolites wherein the antioxidant is betalain. One would have been motivated to do so because Ochiai teaches the above composition comprising an antioxidant and Montenegro teaches betalain is an antioxidant that promotes the increase in nitric oxide in the blood. There is a reasonable expectation of using the antioxidant of betalain in the composition taught by Ochiai to increase the concentration of blood nitric oxide metabolites.
Conclusion
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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