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 .
DETAILED ACTION
Claims 1-10 are pending and examined on the merits.
Election/Restrictions
Applicant’s election without traverse of the species ginger in the reply filed on 1/14/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/17/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a “written description” rejection, rather than an enablement rejection under 35 U.S.C. 112, first paragraph. Applicant us directed to the Guidelines for the Examination of Patent Applications under the 354 U.S.C. 112, 1 “Written Description” Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
The claims are drawn to a composition. However, the specification only discloses ginger, Muira puama, Paullinia cupana, L-arginine and/or L-citrulline . In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been sufficiently described. In this case, only the composition, ginger, Muira puama, Paullinia cupana, L-arginine and/or L-citrulline, has been described while the claims potentially encompass thousands of other plant extracts, element, compounds, ingredients, etc. Applicant has not demonstrated what the active compounds of “the composition” are and what other plants might potentially have these compounds. This limited information is not deemed sufficient to reasonably convey to one skilled in the art that Applicant was in possession of active compounds extracted from all types of plants at the time the application was filed. Thus, it is concluded that the written description requirement is not satisfied for the claimed genus.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for ginger, Muira puama, Paullinia cupana, L-arginine and/or L-citrulline does not reasonably provide enablement for all compositions. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and the breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Limited amount of guidance and limited number of working examples in the specification
While the Specification recited compositions comprising ginger, Muira puama, Paullinia cupana, L-arginine and/or L-citrulline for stimulating Nos (page 5). No other types of ingredients are cited.
Nature of the invention
There are many compounds from plants. Plants species are about 380,000 last known (see https://en.wikipedia.org/wiki/Plant#:~:text=A%20definition%20based%20on%20genomes%20includes%20the,from%20single%20cells%20to%20the%20tallest%20trees). Thus it would be impossible to test all plants and its compounds for NO activity.
State of the prior art
There are many compounds in many species of plants. Medicinal plants are a primary source of organic compounds, both for their medicinal and physiological effects, and for the industrial synthesis of a vast array of organic chemicals. It would be difficult to test all plants for NO activity.
Relative skill level of those in the art
Those in the art would have a difficult time to test for all plants because of the many sources of compounds from different plants. Therefore, the relative skill level required would be high.
Predictability or unpredictability in the art
Because of the many plant species, the unpredictability in the art would be high.
The breadth of the claims
The breadth of the claims is broad, particularly for any composition.
Applicant’s claims are broadly drawn to a composition that is able to protect human arterial endothelial cells from endothelial cell dysfunction. In order to be enabled for all compositions, applicant must demonstrate that the invention is able to practice the invention. Applicant’s specification does not set forth any evidence that the claimed product is able to identify all compositions for its NO activity. Because applicant’s specification does not show other compositions and the art acknowledges that identifying all plants with NO activity would be difficult, a person of ordinary skill in the art would be forced to experiment unduly in order to determine if applicant’s invention actually functions as claimed. Therefore, the claims are not considered enabled for the all compositions.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rajfer (US 20120121740 A1).
Rajfer teaches a method of treating or preventing erectile dysfunction or age related erectile dysfunction, comprising the steps of administering to a patient having or at risk of having the dysfunction ginger or a ginger derivative and an additional compound selected from the group consisting of L-arginine, L-citrulline, and mixtures of L-arginine and L-citrulline, said administration step comprising administering of from about 250 mg up to 2 g of ginger or ginger derivative (meets Claim 3) and from about 500 mg to 3 g of the additional compound on substantially a daily basis over a period of at least one month for treatment of erectile dysfunction or age related erectile dysfunction (Claim 1), further comprising muira puama and paulinia cupana (Claim 15). The patient is given on a substantially daily basis at least about 400 mg L-argininie, L-citrulline or a mixture thereof (Claim 12). The preferred formulations for use at least once a day for the treatment of ED comprise from about 100 mg, preferably at least about 250 mg, to about 2 grams ginger, preferably, about 1 g to about 3 g L-arginine or L-citrulline sufficient to produce the same effect on NO production in vivo as said amount of L-arginine. Preferably, a composition of the present inventions comprises about 250 mg to 2 grams L-arginine or 250 mg to 2 grams L-citrulline (or a mixture of L-arginine and L-citrulline) (meets Claim 4 and 5), about 500 mg Paullinia cupana (meets Claim 9), and about 100 mg to about 3 g Muira Puama (meets Claims 6 and 7 limitation), preferably about 500 mg to about 1.5 g Muira Puama. The forgoing formulation above may additionally or in place of ginger contain about 20 mg to about 1000 mg 6-gingerol, preferably about 220 mg 6-gingerol, although the present inventor has found it preferable to use ginger or ginger root extract [0060].
Therefore, the reference anticipates the claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10973866 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because he amounts are not the same.
U.S. Patent No. 10973866 B2 teaches
1. A method for treatment of erectile dysfunction or age related erectile dysfunction, comprising: administering a pharmaceutically effective amount of a composition over a sufficient period of time that results in an increase in erectile function, wherein the composition consists essentially of 10 mg to 2 g ginger or a ginger derivative, an effective amount of Muira puama, an effective amount of Paullinia cupana, and an effective amount of at least one of the group consisting of L-arginine and L-citrulline that stimulates the production of iNOS resulting in slowing, stopping or reversing smooth muscle cell deterioration, wherein smooth muscle deterioration is associated with erectile dysfunction and age related erectile dysfunction.
2. The method according to claim 1, wherein the amount of L-arginine, L-citrulline, or a mixture of L-arginine and L-citrulline in the composition is 10 mg to 3 g.
3. The method according to claim 1, wherein the amount of Muira puama in the composition is 500 mg to 1.5 g.
4. The method according to claim 1, wherein the amount of Paullinia cupana in the composition is 500 mg.
5. The method according to claim 1, wherein the composition consists essentially of 500 mg of ginger or ginger derivative, 1,600 g of L-arginine, L-citrulline, or mixture of L-arginine and L-citrulline, 500 mg to 1.5 g of Muira puama, and 500 mg of Paullinia cupana.
However, the amounts are not the same.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising 250 mg to 2 g ginger, 10 mg to 3 g L-arginine, L-citrulline, 100 mg to 3 g Muira puama, at least 250 mg Paulinia cupana of the active agent combination for the following reasons. The reference does teach the composition for stimulating the production of iNOS. U.S. Patent No. 10973866 B2 teaches 10 mg to 2 g ginger (Claim 1), 10 mg to 3 g L-arginine, L-citrulline (Claim 2), Muira puama 500 mg to 1.5 g (Claim 3), 500 mg Paullinia cupana (Claim 4). Thus, it would have been obvious to make a concentrated composition containing ginger, L-arginine, L-citrulline, Puira puama and Paullinia cupana for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Conclusion
No claim is allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached on Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655