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 7-8, 10-15, 17-25, 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, 12-14, and 30 are recites the limitation that the solid supplement "comprises beetroot, spinach, ….". However, these claims depend directly from claim 1, and claim 1 doesn’t recite this limitation. There is insufficient antecedent basis for this limitation in the claim. It is suggested “further” be added in these claims before “comprises” to overcome this rejection.
Claim 10 recites the solid supplement composition of claim 1, “comprises an antioxidant”. However, claim 1 doesn’t recite this limitation. There is insufficient antecedent basis for this limitation in the claim. It is suggested “further” be added in these claims before “comprises” to overcome this rejection.
Claim 11 recites the solid supplement composition of claim 1, “comprises citric acid”. However, claim 1 doesn’t recite this limitation. There is insufficient antecedent basis for this limitation in the claim. It is suggested “further” be added in these claims before “comprises” to overcome this rejection.
Claim 15 recites the solid supplement composition of claim 1, “comprises a botanical nitrate source, a vegetable nitrate source, ….”. However, claim 1 doesn’t recite this limitation. There is insufficient antecedent basis for this limitation in the claim. It is suggested “further” be added in these claims before “comprises” to overcome this rejection.
Claims 25-26 recite “the composition of claim 1, “comprises an isolated amino acid compound that is glycine”. However, claim 1 doesn’t recite glycine. There is insufficient antecedent basis for this limitation in the claims. It is suggested “further” be added in the claims before “comprises” to overcome this rejection.
Claims 17-24 and 30 recite the solid supplement composition of claim 1, “comprises at least one isolated amino acid compound selected from: aspartic acid, proline, glycine, ….”. However, claim 1 doesn’t recite this limitation. There is insufficient antecedent basis for this limitation in the claims. It is suggested “further” be added in these claims before “comprises” to overcome this rejection.
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) 1-2, 4, 6, 10-11, 17-26, and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amato, US 20110064712 A1, publ. 3/17/2011, filed on 9/16/2010, cited in an IDS.
Amato teaches dietary supplement compositions (title & abstract; para [0002]). The amino acid L-tyrosine is included in an exemplary dietary supplement (para [0037], Table 1; para [0042-0043]). Particularly, Amato teaches an exemplary composition to contain 105 mg. of L-tyrosine (para [0096], table 2). Amato discloses the following exemplary supplement composition (para [0100-0101], Table 4):
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. Thus, Amato teaches a powder supplement composition comprising glutamine nitrate as a completely separate compound in an amount up to 500 mg, corresponding to up to 250 mg. nitrate ion. The above composition further comprises resveratrol, a well-known antioxidant; citric acid; 2500 mg. L-leucine; 500 mg. L-isoleucine; 1200 mg. L-valine; 1200 mg. L-lysine; 1200 mg. L-phenylalanine; 800 mg. threonine; 650 mg. L-histidine; 450 mg. L-methionine; 250 mg. L-proline; 50 mg. glycine; and 250 mg. L-tryptophan. Additionally, Amato teaches the supplement compositions can further include additional amino acids such as aspartic acid and arginine (para [0030-0031], [0090]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to have arrived at the claimed solid supplement composition comprising at least one non-ester nitrate compound, glutamine nitrate, in an amount up to 500 mg., which corresponds to up to 250 mg. of nitrate ion; L-tyrosine as a separate compound; resveratrol as an antioxidant; citric acid; 500 mg. L-leucine; 500 mg. L-isoleucine; 1200 mg. L-valine; 1200 mg. L-lysine; 1200 mg. L-phenylalanine; 800 mg. threonine; 650 mg. L-histidine; 450 mg. L-methionine; 250 mg. L-proline; 50 mg. glycine; 250 mg. L-tryptophan; aspartic acid; and arginine, in consideration of Amato, and have had a reasonable expectation of success.
Claim(s) 3, 5, 9, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Amato, US 20110064712 A1, publ. 3/17/2011, filed on 9/16/2010 as applied to claims 1-2, 4, 6, 10-11, 17-26, and 28-29 above, and further in view of Scheele, US 20090018072 A1, publ. 1/15/2009.
The disclosure of Amato as discussed previously is incorporated herein. However, Amato doesn’t explicitly teach or suggest gel dosage forms, an ion-exchange resin, or at least about 200 mg. glycine.
Scheele teaches dietary supplement compositions that are high in protein and contain essential as well as semi-essential amino acids (title & abstract; para [0002]). Scheele includes tyrosine as an amino acid in the composition (para [0103], [0124] & table 3, [0185] & table 5), as well as glycine in an amount of 400 mg. (para [0103]). Scheele teaches suitable carriers and dosage forms to include ion-exchange resins and gel dosage forms (para [0088], [0272]).
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 modified the composition taught by Amato by arriving at a gel dosage form, incorporated an ion-exchange resin, and incorporated glycine in an amount of at least about 200 mg. in view of the teachings of Scheele. Similar to Amato, Scheele teaches dietary supplement compositions comprising amino acids such as tyrosine. Additionally, Scheele teaches gel dosage forms as suitable for dietary supplements as well as ion-exchange resins, and the presence of the amino acid glycine in an amount of greater than 200 mg., e.g., 400 mg. As both Amato and Scheele teach dietary supplement compositions containing amino acids such as tyrosine, it would have been prima facie obvious to have incorporated the gel dosage forms, ion-exchange resin, and glycine in an amount of 400 mg. into the dietary supplement composition taught by Amato, 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 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19559685 (reference application) in view of Amato, US 20110064712 A1; and Scheele, US 20090018072 A1. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to solid supplement compositions comprising at least one non-ester nitrate compound; tyrosine; and wherein the amount of nitrate ion overlaps. For instance, the amount of nitrate ion in the copending claims is at least 0.05625 mg, which overlaps with the amount of nitrate ion recited in the instant claims, at least 0.33125 mg. Both sets of claims recite the composition as a powder or gel (see instant claims 2-3, & copending claims 8-9); and wherein the composition further includes beetroot, rocket, & spinach (copending claims 10-11 & instant claim 13). The copending claims don’t recite the inclusion of additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, however, it would have been prima facie obvious to have added these components in view of Amato and Scheele. Amato discloses dietary supplement compositions (title & abstract; para [0002]). The amino acid L-tyrosine is included in an exemplary dietary supplement (para [0037], Table 1; para [0043]). Particularly, Amato teaches an exemplary composition to contain 105 mg. of L-tyrosine (para [0096], table 2). Amato discloses the following exemplary supplement composition (para [0100-0101], Table 4):
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. Thus, Amato discloses a powder supplement composition comprising glutamine nitrate as a completely separate compound in an amount up to 500 mg. The above composition further comprises resveratrol, a well-known antioxidant; citric acid; 2500 mg. L-leucine; 500 mg. L-isoleucine; 1200 mg. L-valine; 1200 mg. L-lysine; 1200 mg. L-phenylalanine; 800 mg. threonine; 650 mg. L-histidine; 450 mg. L-methionine; 250 mg. L-proline; 50 mg. glycine; and 250 mg. L-tryptophan. Additionally, Amato teaches the supplement compositions can further include additional amino acids such as aspartic acid and arginine (para [0030-0031], [0090]). Scheele teaches dietary supplement compositions that are high in protein and contain essential as well as semi-essential amino acids (title & abstract; para [0002]). Scheele includes tyrosine as an amino acid in the composition (para [0103], [0124] & table 3, [0185] & table 5), as well as glycine in an amount of 400 mg. (para [0103]). Scheele teaches suitable carriers and dosage forms to include ion-exchange resins and gel dosage forms (para [0088], [0272]). Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 Amato, US 20110064712 A1; and Scheele, US 20090018072 A1. Although the claims at issue 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; tyrosine; and wherein the amount of nitrate ion overlaps. For instance, the amount of nitrate ion in the patented claims is at least 30.7 mg, which overlaps with the amount of nitrate ion recited in the instant claims, at least 0.33125 mg. The patented claims don’t recite the inclusion of a powder or gel dosage form; ion-exchange resin; additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; and further comprising an antioxidant as recited by the instant claims, however, it would have been prima facie obvious to have added these components in view of Amato and Scheele. Amato discloses dietary supplement compositions (title & abstract; para [0002]). The amino acid L-tyrosine is included in an exemplary dietary supplement (para [0037], Table 1; para [0043]). Particularly, Amato teaches an exemplary composition to contain 105 mg. of L-tyrosine (para [0096], table 2). Amato discloses the following exemplary supplement composition (para [0100-0101], Table 4):
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. Thus, Amato discloses a powder supplement composition comprising glutamine nitrate as a completely separate compound in an amount up to 500 mg. The above composition further comprises resveratrol, a well-known antioxidant; citric acid; 2500 mg. L-leucine; 500 mg. L-isoleucine; 1200 mg. L-valine; 1200 mg. L-lysine; 1200 mg. L-phenylalanine; 800 mg. threonine; 650 mg. L-histidine; 450 mg. L-methionine; 250 mg. L-proline; 50 mg. glycine; and 250 mg. L-tryptophan. Additionally, Amato teaches the supplement compositions can further include additional amino acids such as aspartic acid and arginine (para [0030-0031], [0090]). Scheele teaches dietary supplement compositions that are high in protein and contain essential as well as semi-essential amino acids (title & abstract; para [0002]). Scheele includes tyrosine as an amino acid in the composition (para [0103], [0124] & table 3, [0185] & table 5), as well as glycine in an amount of 400 mg. (para [0103]). Scheele teaches suitable carriers and dosage forms to include ion-exchange resins and gel dosage forms (para [0088], [0272]). Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; a powder or gel dosage form; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. The instant and patented claims are therefore 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 Amato, US 20110064712 A1; and Scheele, US 20090018072 A1. Although the claims at issue 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; tyrosine; and wherein the amount of nitrate ion overlaps. For instance, the amount of nitrate ion in the patented claims is at least 30 mg, which overlaps with the amount of nitrate ion recited in the instant claims, at least 0.33125 mg. Additionally, both sets of claims recite the composition in the form of a powder or gel (patented claim 22 & instant claims 2-3); further comprising cabbage, spinach, beetroot, mushrooms, and rocket (patented claims 23-24 & instant claim 12).The patented claims don’t recite the inclusion of an ion-exchange resin; additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; and further comprising an antioxidant as recited by the instant claims, however, it would have been prima facie obvious to have added these components in view of Amato and Scheele. Amato discloses dietary supplement compositions (title & abstract; para [0002]). The amino acid L-tyrosine is included in an exemplary dietary supplement (para [0037], Table 1; para [0043]). Particularly, Amato teaches an exemplary composition to contain 105 mg. of L-tyrosine (para [0096], table 2). Amato discloses the following exemplary supplement composition (para [0100-0101], Table 4):
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. Thus, Amato discloses a powder supplement composition comprising glutamine nitrate as a completely separate compound in an amount up to 500 mg. The above composition further comprises resveratrol, a well-known antioxidant; citric acid; 2500 mg. L-leucine; 500 mg. L-isoleucine; 1200 mg. L-valine; 1200 mg. L-lysine; 1200 mg. L-phenylalanine; 800 mg. threonine; 650 mg. L-histidine; 450 mg. L-methionine; 250 mg. L-proline; 50 mg. glycine; and 250 mg. L-tryptophan. Additionally, Amato teaches the supplement compositions can further include additional amino acids such as aspartic acid and arginine (para [0030-0031], [0090]). Scheele teaches dietary supplement compositions that are high in protein and contain essential as well as semi-essential amino acids (title & abstract; para [0002]). Scheele includes tyrosine as an amino acid in the composition (para [0103], [0124] & table 3, [0185] & table 5), as well as glycine in an amount of 400 mg. (para [0103]). Scheele teaches suitable carriers and dosage forms to include ion-exchange resins and gel dosage forms (para [0088], [0272]). Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. The instant and patented claims are therefore 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 Amato, US 20110064712 A1; and Scheele, US 20090018072 A1. Although the claims at issue 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; tyrosine; and wherein the amount of nitrate ion overlaps. For instance, the amount of nitrate ion in the patented claims is at least 30.7 mg, which overlaps with the amount of nitrate ion recited in the instant claims, at least 0.33125 mg. The patented claims don’t recite the inclusion of a powder or gel dosage form; ion-exchange resin; additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; and further comprising an antioxidant as recited by the instant claims, however, it would have been prima facie obvious to have added these components in view of Amato and Scheele. Amato discloses dietary supplement compositions (title & abstract; para [0002]). The amino acid L-tyrosine is included in an exemplary dietary supplement (para [0037], Table 1; para [0043]). Particularly, Amato teaches an exemplary composition to contain 105 mg. of L-tyrosine (para [0096], table 2). Amato discloses the following exemplary supplement composition (para [0100-0101], Table 4):
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. Thus, Amato discloses a powder supplement composition comprising glutamine nitrate as a completely separate compound in an amount up to 500 mg. The above composition further comprises resveratrol, a well-known antioxidant; citric acid; 2500 mg. L-leucine; 500 mg. L-isoleucine; 1200 mg. L-valine; 1200 mg. L-lysine; 1200 mg. L-phenylalanine; 800 mg. threonine; 650 mg. L-histidine; 450 mg. L-methionine; 250 mg. L-proline; 50 mg. glycine; and 250 mg. L-tryptophan. Additionally, Amato teaches the supplement compositions can further include additional amino acids such as aspartic acid and arginine (para [0030-0031], [0090]). Scheele teaches dietary supplement compositions that are high in protein and contain essential as well as semi-essential amino acids (title & abstract; para [0002]). Scheele includes tyrosine as an amino acid in the composition (para [0103], [0124] & table 3, [0185] & table 5), as well as glycine in an amount of 400 mg. (para [0103]). Scheele teaches suitable carriers and dosage forms to include ion-exchange resins and gel dosage forms (para [0088], [0272]). Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; a powder or gel dosage form; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. The instant and patented claims are therefore not patentably distinct.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12577210 B2 in view of Amato, US 20110064712 A1; and Scheele, US 20090018072 A1. Although the claims at issue 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; tyrosine; and wherein the amount of nitrate ion overlaps. For instance, the amount of nitrate ion in the patented claims is at least 0.05625 mg, which overlaps with the amount of nitrate ion recited in the instant claims, at least 0.33125 mg. Additionally, both sets of claims recite the composition further comprising spinach, beetroot, and rocket (patented claim 10 & instant claim 12).The patented claims don’t recite the inclusion of an ion-exchange resin; powder or gel dosage forms; additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; and further comprising an antioxidant as recited by the instant claims, however, it would have been prima facie obvious to have added these components in view of Amato and Scheele. Amato discloses dietary supplement compositions (title & abstract; para [0002]). The amino acid L-tyrosine is included in an exemplary dietary supplement (para [0037], Table 1; para [0043]). Particularly, Amato teaches an exemplary composition to contain 105 mg. of L-tyrosine (para [0096], table 2). Amato discloses the following exemplary supplement composition (para [0100-0101], Table 4):
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. Thus, Amato discloses a powder supplement composition comprising glutamine nitrate as a completely separate compound in an amount up to 500 mg. The above composition further comprises resveratrol, a well-known antioxidant; citric acid; 2500 mg. L-leucine; 500 mg. L-isoleucine; 1200 mg. L-valine; 1200 mg. L-lysine; 1200 mg. L-phenylalanine; 800 mg. threonine; 650 mg. L-histidine; 450 mg. L-methionine; 250 mg. L-proline; 50 mg. glycine; and 250 mg. L-tryptophan. Additionally, Amato teaches the supplement compositions can further include additional amino acids such as aspartic acid and arginine (para [0030-0031], [0090]). Scheele teaches dietary supplement compositions that are high in protein and contain essential as well as semi-essential amino acids (title & abstract; para [0002]). Scheele includes tyrosine as an amino acid in the composition (para [0103], [0124] & table 3, [0185] & table 5), as well as glycine in an amount of 400 mg. (para [0103]). Scheele teaches suitable carriers and dosage forms to include ion-exchange resins and gel dosage forms (para [0088], [0272]). Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. The instant and patented claims are therefore not patentably distinct.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, and 30 of U.S. Patent No. 12540119 B2 in view of Amato, US 20110064712 A1; and Scheele, US 20090018072 A1. Although the claims at issue 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; tyrosine; and wherein the amount of nitrate ion overlaps. For instance, the amount of nitrate ion in the patented claims is at least 0.05625 mg, which overlaps with the amount of nitrate ion recited in the instant claims, at least 0.33125 mg. Additionally, both sets of claims recite the composition further comprising spinach, beetroot, and rocket (patented claim 18 & instant claim 12). The patented claims don’t recite the inclusion of an ion-exchange resin; powder or gel dosage forms; additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; and further comprising an antioxidant as recited by the instant claims, however, it would have been prima facie obvious to have added these components in view of Amato and Scheele. Amato discloses dietary supplement compositions (title & abstract; para [0002]). The amino acid L-tyrosine is included in an exemplary dietary supplement (para [0037], Table 1; para [0043]). Particularly, Amato teaches an exemplary composition to contain 105 mg. of L-tyrosine (para [0096], table 2). Amato discloses the following exemplary supplement composition (para [0100-0101], Table 4):
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. Thus, Amato discloses a powder supplement composition comprising glutamine nitrate as a completely separate compound in an amount up to 500 mg. The above composition further comprises resveratrol, a well-known antioxidant; citric acid; 2500 mg. L-leucine; 500 mg. L-isoleucine; 1200 mg. L-valine; 1200 mg. L-lysine; 1200 mg. L-phenylalanine; 800 mg. threonine; 650 mg. L-histidine; 450 mg. L-methionine; 250 mg. L-proline; 50 mg. glycine; and 250 mg. L-tryptophan. Additionally, Amato teaches the supplement compositions can further include additional amino acids such as aspartic acid and arginine (para [0030-0031], [0090]). Scheele teaches dietary supplement compositions that are high in protein and contain essential as well as semi-essential amino acids (title & abstract; para [0002]). Scheele includes tyrosine as an amino acid in the composition (para [0103], [0124] & table 3, [0185] & table 5), as well as glycine in an amount of 400 mg. (para [0103]). Scheele teaches suitable carriers and dosage forms to include ion-exchange resins and gel dosage forms (para [0088], [0272]). Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. Therefore, it would have been prima facie obvious to have incorporated additional amino acids such as aspartic acid, glycine, proline, valine, agmatine, norvaline, ornithine, or arginine; further comprising an antioxidant; and an ion-exchange resin as recited by the instant claims, as Amato and Scheele teach these components as suitable for supplement compositions. The instant and patented claims are therefore not patentably distinct.
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
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