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 .
Priority
This application, filed 03/04/2026 is a Continuation of 19030516, filed 01/17/2025, now U.S. Patent # 12577210.
19030516 is a Continuation of 17522680, filed 11/09/2021, now U.S. Patent # 12227483.
17522680 is a Divisional of 14621738, filed 02/13/2015, now U.S. Patent # 11166979.
14621738 is a Continuation of 13920066, filed 06/17/2013, now U.S. Patent # 8957100.
13920066 is a Continuation of 13038615, filed 03/02/2011, now U.S. Patent # 8466187.
13038615 is a Continuation in Part of 12336938, filed 12/17/2008, now U.S. Patent # 8034836.
12336938 is a Continuation of 11950273, filed 12/04/2007, now U.S. Patent # 7777074.
11950273 Claims Priority from Provisional Application 60973229, filed 09/18/2007. As noted in the office action mailed on 9/17/25 for 19030516, Applicants have submitted the
subject matter of the claims is supported by US 8466187 (formerly 13038615), which is in direct
continuity with this application. Additionally, during prosecution of 19030516 Applicants had
outlined how the claimed subject matter is supported by 13038615, referring specifically to
composition 10 in the specification, as well as tablet and capsule sizes that are well known to
one of ordinary skill in the art. However, 12336938 does not appear to provide support to the
claimed amount of nitrate ion. Therefore, the effective filing and priority date of the claims is
3/2/2011.
Status of Claims
Claims 1-30 are currently pending. A track one status has been granted.
Claims 1-30 were examined and are rejected.
Claim Rejections-35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-26 and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7-8 depend from claim 1 and recites “solid supplement composition comprises beetroot, ….”, however, claim 1 doesn’t recite the inclusion of beetroot and the other vegetable recited in the claims. There is insufficient antecedent basis for this limitation, and the claims are indefinite.
Claim 9 depends from claim 1 and recites “solid supplement composition comprises at least one component that is ion-exchange resin-based”, however, claim 1 doesn’t recite this component. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claim 10 depends from claim 1 and recites “solid supplement composition comprises an antioxidant”, however, claim 1 doesn’t recite this component. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claim 11 depends from claim 1 and recites “solid supplement composition comprises citric acid”, however, claim 1 doesn’t recite this component. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claim 12 depends from claim 1 and recites “the solid supplement composition comprises three or more of the following: beetroot, ….”, however, claim 1 doesn’t recite these ingredients. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claim 13 depends from claim 1 and recites “the solid supplement composition comprises four or more of the following: beetroot, ….”, however, claim 1 doesn’t recite these ingredients. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claim 14 depends from claim 1 and recites “the solid supplement composition comprises five or more of the following: beetroot, ….”, however, claim 1 doesn’t recite these ingredients. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claim 15 depends from claim 1 and recites “the solid supplement composition comprises a botanical nitrate source ….”, however, claim 1 doesn’t recite these ingredients. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claim 16 depends from claim 1 and recites “the solid supplement composition comprises beetroot ….”, however, claim 1 doesn’t recite these ingredients. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claims 17-18 depend from claim 1 and recites “the solid supplement composition comprises at least one isolated amino acid compound selected from: aspartic acid ….”, however, claim 1 doesn’t recite these ingredients. There is insufficient antecedent basis for this limitation, and the claims are indefinite.
Claims 19-20 depend from claim 1 and recites “the solid supplement composition comprises at least two isolated amino acid compounds selected from: aspartic acid ….”, however, claim 1 doesn’t recite these ingredients. There is insufficient antecedent basis for this limitation, and the claims are indefinite.
Claims 21-22 depend from claim 1 and recites “the solid supplement composition comprises at least three isolated amino acid compounds selected from: aspartic acid ….”, however, claim 1 doesn’t recite these ingredients. There is insufficient antecedent basis for this limitation, and the claims are indefinite.
Claims 23-24 depend from claim 1 and recites “the solid supplement composition comprises at least four isolated amino acid compounds selected from: aspartic acid ….”, however, claim 1 doesn’t recite these ingredients. There is insufficient antecedent basis for this limitation, and the claims are indefinite.
Claims 25-26 depend from claim 1 and recite “the solid supplement composition comprises an isolated amino acid compound that is glycine”, however, claim 1 doesn’t recite this limitation. There is insufficient antecedent basis for this limitation, and the claims are indefinite.
Claim 30 depends from claim 1 and recites the composition to comprise “beetroot, spinach, and broccoli, and comprises isolated amino acid compounds that are aspartic acid,…”, however, claim 1 doesn’t recite these limitations. There is insufficient antecedent basis for these limitations, and the claim is indefinite.
To overcome these rejections, it is suggested “further” be added before “comprises”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slaga et. al., US 6451341 B1, patented 9/17/2002.
Slaga teaches a formulation comprising vitamins, minerals, and other beneficial supplements, wherein the formulation is protective against cardiovascular disease, cancer, and facilitates immunological integrity (title & abstract; col. 3, lines 50-65). Slaga teaches the formulation to include preferred amino acids, such as glutamine (col. 4, lines 19-33; col. 9, lines 10-34). Slaga teaches the formulation to further comprise a vitamin B1 compound, such as thiamine mononitrate, in an amount from about 1-2 mg. (col. 13, lines 43-55); potassium in the form of a salt, such as potassium nitrate, in a preferred amount of 10-1000 mg (col. 15, lines 50-65). Slaga teaches the formulation is preferably in the form of a sustained release tablet (col. 24, lines 1-15). In addition to vitamins, minerals, and glutamine, the formulation also comprises antioxidants such as vitamin E (abstract; col. 8, lines 6-23).
The claimed solid supplement comprising at least one isolated and separate non-ester nitrate compound, and at least one isolated amino acid, glutamine, wherein the amount of nitrate ion present is at least about 0.05625 mg. would have been prima facie obvious in view of Slaga. As discussed above, Slaga teaches a supplement formulation, preferably as an oral sustained release tablet comprising glutamine, and vitamins and minerals such as thiamine mononitrate and potassium nitrate, wherein the amount of thiamine mononitrate is about 1-2 mg. (corresponding to about 0.5-1 mg nitrate ion), and the amount of potassium nitrate is from 10-1000 mg (corresponding to about 5-500 mg. nitrate ion). Therefore, one of ordinary skill in the art would have arrived at the claimed solid supplement based on the teachings of Slaga, and have had a reasonable expectation of success.
Claim(s) 2-6, 9-11, and 17-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Slaga et. al., US 6451341 B1 as applied to claim 1 above, and further in view of Scheele, WO 2007070454 A2, publ. 6/21/2007, intl. filing date 12/8/2006.
The disclosure of Slaga as discussed previously is incorporated herein. However, Slaga doesn’t explicitly teach the supplement composition in the form of a powder or gel; to comprising an ion-exchange resin, or the additional claimed components.
Scheele teaches a high protein dietary supplement composition, beneficial for the treatment of various conditions, and for improving the health of consumers (title & abstract; para [0001]). Scheele teaches the supplement composition to comprise lysine, arginine (para [0003-0004]), and additional amino acids such as glutamine (para [0047], [0099]), valine, aspartic acid, 400 mg. glycine, and proline (para [0098]). Scheele teaches the supplement composition can comprise additional excipients or additives such as citric acid (para [0037]). The supplement composition is in the form of powders, tablets, pellets, capsules (para [0059]), and sustained release forms comprising ion-exchange resins or polymeric gels (para [0083]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have incorporated the supplement composition of Slaga in the solid forms of powders or gels in view of the teachings of Scheele. Both Slaga and Scheele teach supplement compositions that provide health improving benefits, and while Slaga teaches sustained release oral tablets are preferred, Scheele teaches powders and polymeric gels also as acceptable dosage forms for supplement compositions. Therefore, one of ordinary skill in the art would have formulated the supplement compositions of Slaga as powders or polymeric gels, and have had a reasonable expectation of success. Scheele further teaches the supplement compositions to comprise glutamine and additional amino acids such as lysine, arginine, valine, aspartic acid, 400 mg. glycine, and proline, and citric acid as an excipient; and an ion-exchange resin. Since Slaga also teaches a supplement composition, it would have been prima facie obvious to have added these additional components into the composition, and have had a reasonable expectation of success.
Claim Rejections-Nonstatutory 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 1-6, 9-11, and 17-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 124-130 of U.S. Patent No. 8455531 C2 in view of Slaga et. al., US 6451341 B1, further in view of Scheele, WO 2007070454 A2, publ. 6/21/2007, intl. filing date 12/8/2006. Although the instant and patented claims are not identical, they are not patentably distinct from each other because both sets of claims encompass solid supplement compositions comprising at least one non-ester nitrate compound, and at least one isolated amino acid compound, glutamine, wherein the nitrate and amino acid compounds are separate compounds, and the amount of nitrate ion is overlapping. The amount of nitrate ion in the patented claims is at least 30.7 mg., which overlaps with the claimed amount. Additionally, both sets of claims recite the inclusion of additional amino acids agmatine, norvaline, ornithine, valine, aspartic acid, glycine, and proline (see patented claim 124, & instant claims 18-19). Although the patented claims don’t recite the compositions in the form of a powder or gel; the inclusion of an antioxidant or citric acid; or an ion-exchange resin, these components would have been prima facie obvious in view of Slaga and Scheele.
Slaga teaches a formulation comprising vitamins, minerals, and other beneficial supplements, wherein the formulation is protective against cardiovascular disease, cancer, and facilitates immunological integrity (title & abstract; col. 3, lines 50-65). Slaga teaches the formulation to include preferred amino acids, such as glutamine (col. 4, lines 19-33; col. 9, lines 10-34). Slaga teaches the formulation to further comprise a vitamin B1 compound, such as thiamine mononitrate, in an amount from about 1-2 mg. (col. 13, lines 43-55); potassium in the form of a salt, such as potassium nitrate, in a preferred amount of 10-1000 mg (col. 15, lines 50-65). Slaga teaches the formulation is preferably in the form of a sustained release tablet (col. 24, lines 1-15). In addition to vitamins, minerals, and glutamine, the formulation also comprises antioxidants such as vitamin E (abstract; col. 8, lines 6-23).
Scheele teaches a high protein dietary supplement composition, beneficial for the treatment of various conditions, and for improving the health of consumers (title & abstract; para [0001]). Scheele teaches the supplement composition to comprise lysine, arginine (para [0003-0004]), and additional amino acids such as glutamine (para [0047]), valine, aspartic acid, 400 mg. glycine, and proline (para [0098]). Scheele teaches the supplement composition can comprise additional excipients or additives such as citric acid (para [0037]). The supplement composition is in the form of powders, tablets, pellets, capsules (para [0059]), and sustained release forms comprising ion-exchange resins or polymeric gels (para [0083]).
Since Scheele teaches powders and polymeric gels as suitable dosage forms for supplement compositions, as well as citric acid as an excipient and an ion-exchange resin, it would have been prima facie obvious to have formulated the solid supplement composition of the patented claims with these components and characteristics, and have had a reasonable expectation of success. Furthermore, as Slaga teaches supplement compositions comprising glutamine and a separate, non-ester nitrate compound to further comprise an antioxidant, one of ordinary skill in the art would have been motivated to have incorporated an antioxidant into the composition of the patented claims, for improved stability. For these reasons, the instant and patented claims are not patentably distinct.
Claims 1-6, 9-11, and 17-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-57 of U.S. Patent No. 8952046 C2 in view of Slaga et. al., US 6451341 B1, further in view of Scheele, WO 2007070454 A2, publ. 6/21/2007, intl. filing date 12/8/2006. Although the instant and patented claims are not identical, they are not patentably distinct from each other because both sets of claims encompass solid supplement compositions comprising at least one non-ester nitrate compound, and at least one isolated amino acid compound, glutamine, wherein the nitrate and amino acid compounds are separate compounds, and the amount of nitrate ion is overlapping. The amount of nitrate ion in the patented claims is at least 30.7 mg., which overlaps with the claimed amount. Additionally, both sets of claims recite the inclusion of additional amino acids agmatine, norvaline, ornithine, valine, aspartic acid, glycine, and proline (see patented claim 55, & instant claims 18-19). Although the patented claims don’t recite the compositions in the form of a powder or gel; the inclusion of an antioxidant or citric acid; or an ion-exchange resin, these components would have been prima facie obvious in view of Slaga and Scheele.
Slaga teaches a formulation comprising vitamins, minerals, and other beneficial supplements, wherein the formulation is protective against cardiovascular disease, cancer, and facilitates immunological integrity (title & abstract; col. 3, lines 50-65). Slaga teaches the formulation to include preferred amino acids, such as glutamine (col. 4, lines 19-33; col. 9, lines 10-34). Slaga teaches the formulation to further comprise a vitamin B1 compound, such as thiamine mononitrate, in an amount from about 1-2 mg. (col. 13, lines 43-55); potassium in the form of a salt, such as potassium nitrate, in a preferred amount of 10-1000 mg (col. 15, lines 50-65). Slaga teaches the formulation is preferably in the form of a sustained release tablet (col. 24, lines 1-15). In addition to vitamins, minerals, and glutamine, the formulation also comprises antioxidants such as vitamin E (abstract; col. 8, lines 6-23).
Scheele teaches a high protein dietary supplement composition, beneficial for the treatment of various conditions, and for improving the health of consumers (title & abstract; para [0001]). Scheele teaches the supplement composition to comprise lysine, arginine (para [0003-0004]), and additional amino acids such as glutamine (para [0047]), valine, aspartic acid, 400 mg. glycine, and proline (para [0098]). Scheele teaches the supplement composition can comprise additional excipients or additives such as citric acid (para [0037]). The supplement composition is in the form of powders, tablets, pellets, capsules (para [0059]), and sustained release forms comprising ion-exchange resins or polymeric gels (para [0083]).
Since Scheele teaches powders and polymeric gels as suitable dosage forms for supplement compositions, as well as citric acid as an excipient and an ion-exchange resin, it would have been prima facie obvious to have formulated the solid supplement composition of the patented claims with these components and characteristics, and have had a reasonable expectation of success. Furthermore, as Slaga teaches supplement compositions comprising glutamine and a separate, non-ester nitrate compound to further comprise an antioxidant, one of ordinary skill in the art would have been motivated to have incorporated an antioxidant into the composition of the patented claims, for improved stability. For these reasons, the instant and patented claims are not patentably distinct.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24 of U.S. Patent No. 8952045 C1 in view of Slaga et. al., US 6451341 B1, further in view of Scheele, WO 2007070454 A2, publ. 6/21/2007, intl. filing date 12/8/2006. Although the instant and patented claims are not identical, they are not patentably distinct from each other because both sets of claims encompass solid supplement compositions comprising at least one non-ester nitrate compound, and at least one isolated amino acid compound, glutamine, wherein the nitrate and amino acid compounds are separate compounds, and the amount of nitrate ion is overlapping. The amount of nitrate ion in the patented claims is at least 30 mg., which overlaps with the claimed amount. Additionally, both sets of claims recite the inclusion of additional amino acids agmatine, norvaline, ornithine, valine, aspartic acid, glycine, and proline (see patented claim 55, & instant claims 18-19); a vegetable nitrate source selected from beetroot, spinach, rocket, carrot, broccoli, cabbage, and mushroom (instant claim 14 & patented claim 23); and the formulation as a powder or gel (patented claim 22 & instant claims 2-3). Although the patented claims don’t recite the inclusion of an antioxidant or citric acid; or an ion-exchange resin, these components would have been prima facie obvious in view of Slaga and Scheele.
Slaga teaches a formulation comprising vitamins, minerals, and other beneficial supplements, wherein the formulation is protective against cardiovascular disease, cancer, and facilitates immunological integrity (title & abstract; col. 3, lines 50-65). Slaga teaches the formulation to include preferred amino acids, such as glutamine (col. 4, lines 19-33; col. 9, lines 10-34). Slaga teaches the formulation to further comprise a vitamin B1 compound, such as thiamine mononitrate, in an amount from about 1-2 mg. (col. 13, lines 43-55); potassium in the form of a salt, such as potassium nitrate, in a preferred amount of 10-1000 mg (col. 15, lines 50-65). Slaga teaches the formulation is preferably in the form of a sustained release tablet (col. 24, lines 1-15). In addition to vitamins, minerals, and glutamine, the formulation also comprises antioxidants such as vitamin E (abstract; col. 8, lines 6-23).
Scheele teaches a high protein dietary supplement composition, beneficial for the treatment of various conditions, and for improving the health of consumers (title & abstract; para [0001]). Scheele teaches the supplement composition to comprise lysine, arginine (para [0003-0004]), and additional amino acids such as glutamine (para [0047]), valine, aspartic acid, 400 mg. glycine, and proline (para [0098]). Scheele teaches the supplement composition can comprise additional excipients or additives such as citric acid (para [0037]). The supplement composition is in the form of powders, tablets, pellets, capsules (para [0059]), and sustained release forms comprising ion-exchange resins or polymeric gels (para [0083]).
Since Scheele teaches powders and polymeric gels as suitable dosage forms for supplement compositions, as well as citric acid as an excipient and an ion-exchange resin, it would have been prima facie obvious to have formulated the solid supplement composition of the patented claims with these components and characteristics, and have had a reasonable expectation of success. Furthermore, as Slaga teaches supplement compositions comprising glutamine and a separate, non-ester nitrate compound to further comprise an antioxidant, one of ordinary skill in the art would have been motivated to have incorporated an antioxidant into the composition of the patented claims, for improved stability. For these reasons, the instant and patented claims are not patentably distinct.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, and 29-30 of US 12741941 B2 in view of Slaga et. al., US 6451341 B1; further in view of Scheele, WO 2007070454 A2, publ. 6/21/2007, intl. filing date 12/8/2006. The patented and instant claims are drawn to a solid supplement composition comprising at least one non-ester nitrate compound; at least one isolated amino acid compound; wherein the amount of nitrate ion is overlapping (for instance at least 0.05625 mg for the instance claims, compared to at least 1 mg. recited by the patented claims). The difference between the instant and patented claims is that the instant claims recite the inclusion of glutamine; gel or powder dosage forms; an antioxidant; citric acid; an ion-exchange resin; and additional amino acids including aspartic acid, proline, glycine, valine, agmatine, ornithine, and arginine which are not explicitly recited by the patented claims. However, the addition of glutamine to the solid supplement composition of the patented claims would have been prima facie obvious. Slaga teaches a formulation comprising vitamins, minerals, and other beneficial supplements, wherein the formulation is protective against cardiovascular disease, cancer, and facilitates immunological integrity (title & abstract; col. 3, lines 50-65). Slaga teaches the formulation to include preferred amino acids, such as glutamine (col. 4, lines 19-33; col. 9, lines 10-34). Slaga teaches the formulation to further comprise a vitamin B1 compound, such as thiamine mononitrate, in an amount from about 1-2 mg. (col. 13, lines 43-55); potassium in the form of a salt, such as potassium nitrate, in a preferred amount of 10-1000 mg (col. 15, lines 50-65). Slaga teaches the formulation is preferably in the form of a sustained release tablet (col. 24, lines 1-15). In addition to vitamins, minerals, and glutamine, the formulation also comprises antioxidants such as vitamin E (abstract; col. 8, lines 6-23). Therefore, it would have been prima facie obvious to have modified the solid formulations of the copending claims by incorporating glutamine, since Slaga teaches this amino acid as beneficial for supplement compositions, and have had a reasonable expectation of success. Scheele teaches a high protein dietary supplement composition, beneficial for the treatment of various conditions, and for improving the health of consumers (title & abstract; para [0001]). Scheele teaches the supplement composition to comprise lysine, arginine (para [0003-0004]), and additional amino acids such as glutamine (para [0047]), valine, aspartic acid, 400 mg. glycine, and proline (para [0098]). Scheele teaches the supplement composition can comprise additional excipients or additives such as citric acid (para [0037]). The supplement composition is in the form of powders, tablets, pellets, capsules (para [0059]), and sustained release forms comprising ion-exchange resins or polymeric gels (para [0083]).
Since Scheele teaches powders and polymeric gels as suitable dosage forms for supplement compositions, as well as citric acid as an excipient and an ion-exchange resin, it would have been prima facie obvious to have formulated the solid supplement composition of the patented claims with these components and characteristics, and have had a reasonable expectation of success. Furthermore, as Slaga teaches supplement compositions comprising glutamine and a separate, non-ester nitrate compound to further comprise an antioxidant, one of ordinary skill in the art would have been motivated to have incorporated an antioxidant into the composition of the patented claims, for improved stability. For these reasons, the instant and patented claims are not patentably distinct.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19556905; over claim 1-30 of 19557927; over claims 1-30 of 19558063; over claims 1-30 of 19558139; over claims 1-30 of 19558184; over claims 1-30 of 19558364; over claims 1-30 of 19556549; over claims 1-30 of 19558364; over claims 1-30 of 19560948; over claims 1-30 of 19561310; over claims 1-30 of 19561265; over claims 1-30 of 19558139; over claims 1-30 of 19559811; over claims 1-30 of 19559853; over claims 1-30 of 19556470; over claims 1-30 of 19561329; over claims 1-30 of 19561394; over claims 1-30 of 19561346; and over claims 1-30 of 19562179 in view of Slaga et. al., US 6451341 B1. The copending and instant claims are drawn to a solid supplement composition comprising at least one non-ester nitrate compound; at least one isolated amino acid compound; wherein the amount of nitrate ion is overlapping (for instance at least 0.05625 mg for the instance claims, compared to either 0.05625 mg. or at least 1 mg. recited by the copending claims). Additionally, both sets of claims recite the compositions in gels or powders (claims 2-3); comprising beetroot, spinach, carrot, broccoli, and mushroom (claim 7); further comprising an ion-exchange resin (claim 9); an antioxidant (claim 10); citric acid (claim 11); and additional amino acids including aspartic acid, proline, glycine, valine, agmatine, ornithine, and arginine (claim 19). The difference between the instant and copending claims is that the instant claims recite the inclusion of glutamine, which is not explicitly recited by the copending claims. However, the addition of glutamine to the solid supplement composition of the copending claims would have been prima facie obvious. Slaga teaches a formulation comprising vitamins, minerals, and other beneficial supplements, wherein the formulation is protective against cardiovascular disease, cancer, and facilitates immunological integrity (title & abstract; col. 3, lines 50-65). Slaga teaches the formulation to include preferred amino acids, such as glutamine (col. 4, lines 19-33; col. 9, lines 10-34). Slaga teaches the formulation to further comprise a vitamin B1 compound, such as thiamine mononitrate, in an amount from about 1-2 mg. (col. 13, lines 43-55); potassium in the form of a salt, such as potassium nitrate, in a preferred amount of 10-1000 mg (col. 15, lines 50-65). Slaga teaches the formulation is preferably in the form of a sustained release tablet (col. 24, lines 1-15). In addition to vitamins, minerals, and glutamine, the formulation also comprises antioxidants such as vitamin E (abstract; col. 8, lines 6-23). Therefore, it would have been prima facie obvious to have modified the solid formulations of the copending claims by incorporating glutamine, since Slaga teaches this amino acid as beneficial for supplement compositions, and have had a reasonable expectation of success.
These are provisional nonstatutory double patenting rejections.
Information Disclosure Statements
The IDS filed on 4/27/26 have been considered.
Correspondence
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627
