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.
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, 17-26, 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, 12-14, and 30 are recites the limitation that the solid supplement "comprises beetroot, spinach, carrot….". 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.
Claim 16 recites the solid supplement composition of claim 1, “comprises beetroot and an antioxidant”. However, these ingredients are not recited in claim 1, therefore 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 and 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, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petrus, US 20030215430 A1, publ. 11/20/2003.
Petrus teaches a composition for the treatment or prevention of endothelial dysfunction which comprises anti-inflammatory agents and dietary supplements (title & abstract; para [0002], [0006]). Petrus teaches the composition preferably contains a zinc salt in a dosage between 10-60 mg. per day, with zinc nitrate included as a suitable zinc salt (para [0040]; p. 7, claims 1 & 3); this would correspond to an amount of nitrate ion between 5-30 mg. Petrus further teaches the composition includes dietary supplement compounds that have been associated with improving endothelial dysfunction and generation of nitric oxide, such as L-arginine (para [0043], [0045], [0049]). Petrus teaches the composition in solid dosage forms such as powders and tablets (p. 7, claims 5 & 6).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art, before the effective filing date of the claims to have arrived at the solid supplement composition of the instant claims, comprising at least one non-ester nitrate compound, zinc nitrate; arginine; wherein the zinc nitrate is a separate compound than arginine; and wherein the composition comprises an amount of nitrate ion that is at least 1 mg, e.g., between 5-30 mg., in consideration of Petrus. Petrus teaches a composition for the treatment or prevention of endothelial dysfunction which comprises anti-inflammatory agents and dietary supplements, with zinc salts, inclusive of zinc nitrate taught, and L-arginine taught as an agent to improve endothelial function. Additionally, Petrus teaches the dose of zinc salt to range from about 10-60 mg. per day, as well as solid dosage forms such as tablets and powders. As such, one of ordinary skill in the art would have arrived at the claimed solid supplement composition of the instant claims, and have had a reasonable expectation of success.
Claim(s) 3, 9, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petrus, US 20030215430 A1, publ. 11/20/2003 as applied to claims 1-2, 4, and 10 above, and further in view of Kuhrts, WO 0006151, publ. 2/10/2000.
The disclosure of Petrus as discussed previously is incorporated herein. However, Petrus doesn’t teach or suggest a gel dosage form, an ion-exchange resin, or an additional amino acid as recited in claims 17-18.
Kuhrts teaches sustained release pharmaceutical compositions comprising an agent that enhances or modulates the endogenous production of nitric oxide in a mammal, with L-arginine exemplified (title & abstract). In addition, L-ornithine is included as an active agent (p. 1, 1st para). Oral dosage forms are exemplified (p. 5, 1st para under Summary). Kuhrts teaches the inclusion of an ion-exchange resin in the sustained release composition (p. 12, 1st full para). Suitable dosage forms include tablets, capsules, powders (p. 11, 1st para; p. 26, claim 9); and hydrogels (p. 21, Ex. 4; p. 26, claim 10).
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 an additional amino acid, L-ornithine; and an ion-exchange resin into the composition taught by Petrus, in consideration of the teachings of Kuhrts. Petrus teaches compositions for the treatment or prevention of endothelial dysfunction and enhancing nitric oxide production which comprises anti-inflammatory agents and dietary supplements comprising L-arginine and a zinc salt such as zinc nitrate, in solid dosage form. Kurhts teaches sustained release compositions comprising L-arginine for enhancing nitric oxide production, and teaches suitable oral dosage forms to include tablets, powders, and gels, with ion-exchange resins as suitable excipients. Since both Petrus and Kuhrts teach compositions comprising L-arginine for enhancing nitric oxide production, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated the types of dosage forms and excipients taught by Kuhrts into the composition of Petrus, and have had a reasonable expectation of success. Kuhrts further teaches L-ornithine to enhance nitric oxide production, therefore one of ordinary skill in the art would have been motivated to have incorporated L-citrulline into the composition taught by Petrus, with the reasonable expectation nitric oxide production would have been enhanced.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petrus, US 20030215430 A1, publ. 11/20/2003 as applied to claims 1-2, 4, and 10 above, and further in view of Froelich et. al., DE 19800812 A1, pub. 7/15/1999. English translation of Froelich referred to for the rejection.
The disclosure of Petrus as discussed previously is incorporated herein. However, Petrus doesn’t teach or suggest the inclusion of citric acid in the composition.
Froelich teaches oral compositions comprising L-arginine as an active agent (para [0001]). Froelich teaches oral compositions must include L-arginine in large amounts, e.g., grams, which can cause issues with absorption (para [0006-0007]). Froelich teaches L-arginine is available in powder compositions for oral administration, however, there are issues with taste and dissolution (para [0008]). Froelich teaches oral compositions comprising L-arginine, an effervescent agent, and an acid, of which citric acid is exemplified, increase the dissolution of the powder oral dosage form and have improved taste (para [0011-0013], [0022], [0028]).
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 citric acid as an additive into the L-arginine composition of Petrus, in view of Froelich. Both Petrus and Froelich teach oral dosage forms comprising L-arginine, including powders, while Froelich teaches the inclusion of citric acid and an effervescent aid in improvement of taste and increases dissolution. As such, one of ordinary skill in the art would have been motivated to have added such excipients into the composition of Petrus, for the advantages taught by Froelich, 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 1-18 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 U.S. Patent No. 12577209 B2 in view of Kuhrts, WO 0006151, publ. 2/10/2000; and Froelich et. al., DE 19800812 A1, pub. 7/15/1999. The instant and patented claims are both drawn to supplement compositions comprising arginine, and a separate, non-ester nitrate compound, wherein the amount of the nitrate ion is at least about 1 mg. Both sets of claims recite the inclusion of a vegetable nitrate source (see patented claim 29 & instant claim 15), as well as beetroot, spinach, and rocket (instant claim 12 & patented claim 19). The difference between the claims is that the patented claims are drawn to a semisolid rather than a solid composition; additionally, the instant claims recite the inclusion of citric acid; the inclusion of an ion-exchange resin; and the inclusion of L-ornithine, none of which are recited in the patented claims. However, the incorporation of such ingredients would have been prima facie obvious in view of Kuhrts and Froelich.
Kuhrts teaches sustained release pharmaceutical compositions comprising an agent that enhances or modulates the endogenous production of nitric oxide in a mammal, with L-arginine exemplified (title & abstract). In addition, L-ornithine is included as an active agent (p. 1, 1st para). Oral dosage forms are exemplified (p. 5, 1st para under Summary). Kuhrts teaches the inclusion of an ion-exchange resin in the sustained release composition (p. 12, 1st full para). Suitable dosage forms include tablets, capsules, powders (p. 11, 1st para; p. 26, claim 9); and hydrogels (p. 21, Ex. 4; p. 26, claim 10).
Froelich teaches oral compositions comprising L-arginine as an active agent (para [0001]). Froelich teaches oral compositions must include L-arginine in large amounts, e.g., grams, which can cause issues with absorption (para [0006-0007]). Froelich teaches L-arginine is available in powder compositions for oral administration, however, there are issues with taste and dissolution (para [0008]). Froelich teaches oral compositions comprising L-arginine, an effervescent agent, and an acid, of which citric acid is exemplified, increase the dissolution of the powder oral dosage form and have improved taste (para [0011-0013], [0022], [0028]).
As such, it would have been prima facie obvious to have modified the composition of the patented claims as a solid dosage form such as powders, tablets, or gels as such dosage forms are taught by Kuhrts to be suitable for L-arginine, along with an ion-exchange resin as an excipient. Furthermore, as L-ornithine is taught to share utility with L-arginine as a nitric oxide enhancer, it would have been obvious to have added this amino acid to the composition of the patented claims. As Froelich teaches an effervescent agent and citric acid improve taste and increase dissolution of L-arginine oral dosage forms, it would have been further obvious to have added such excipients to the composition of the patented claims. For these reasons, the instant and patented claims are obvious variants of each other and 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 Kuhrts, WO 0006151, publ. 2/10/2000; and Froelich et. al., DE 19800812 A1, pub. 7/15/1999. The instant and patented claims are both drawn to solid supplement compositions comprising arginine, and a separate, non-ester nitrate compound, wherein the amount of the nitrate ion is overlapping. The patented claims recite the amount of nitrate ion as at least 30.7 mg., which overlaps with the claimed amount of at least 1 mg. Both sets of claims recite the inclusion of another amino acid such as glycine, aspartic acid, proline, valine, agmatine, norvaline, and ornithine (see instant claim 18 & patented claim 55). The difference between the claims is that the instant claims recite the inclusion of citric acid; gel or powder dosage forms; and the inclusion of an ion-exchange resin, none of which are recited in the patented claims. However, the incorporation of such ingredients would have been prima facie obvious in view of Kuhrts and Froelich.
Kuhrts teaches sustained release pharmaceutical compositions comprising an agent that enhances or modulates the endogenous production of nitric oxide in a mammal, with L-arginine exemplified (title & abstract). In addition, L-ornithine is included as an active agent (p. 1, 1st para). Oral dosage forms are exemplified (p. 5, 1st para under Summary). Kuhrts teaches the inclusion of an ion-exchange resin in the sustained release composition (p. 12, 1st full para). Suitable dosage forms include tablets, capsules, powders (p. 11, 1st para; p. 26, claim 9); and hydrogels (p. 21, Ex. 4; p. 26, claim 10).
Froelich teaches oral compositions comprising L-arginine as an active agent (para [0001]). Froelich teaches oral compositions must include L-arginine in large amounts, e.g., grams, which can cause issues with absorption (para [0006-0007]). Froelich teaches L-arginine is available in powder compositions for oral administration, however, there are issues with taste and dissolution (para [0008]). Froelich teaches oral compositions comprising L-arginine, an effervescent agent, and an acid, of which citric acid is exemplified, increase the dissolution of the powder oral dosage form and have improved taste (para [0011-0013], [0022], [0028]).
As such, it would have been prima facie obvious to have modified the composition of the patented claims as dosage forms such as as powders or gels as such dosage forms are taught by Kuhrts to be suitable for L-arginine, along with an ion-exchange resin as an excipient. As Froelich teaches an effervescent agent and citric acid improve taste and increase dissolution of L-arginine oral dosage forms, it would have been further obvious to have added such excipients to the composition of the patented claims. For these reasons, the instant and patented claims are obvious variants of each other and 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 Kuhrts, WO 0006151, publ. 2/10/2000; and Froelich et. al., DE 19800812 A1, pub. 7/15/1999. The instant and patented claims are both drawn to solid supplement compositions comprising arginine, and a separate, non-ester nitrate compound, wherein the amount of the nitrate ion is overlapping. The patented claims recite the amount of nitrate ion as at least 30 mg., which overlaps with the claimed amount of at least 1 mg. Both sets of claims recite the inclusion of another amino acid such as glycine, aspartic acid, proline, valine, agmatine, norvaline, and ornithine (see instant claim 18 & patented claim 20); gel or powder dosage forms (patented claim 22 & instant claims 2-3); and further comprising beetroot, spinach, carrot, broccoli, and mushroom (instant claim 7 & patented claim 23). The difference between the claims is that the instant claims recite the inclusion of citric acid, and the inclusion of an ion-exchange resin, none of which are recited in the patented claims. However, the incorporation of such ingredients would have been prima facie obvious in view of Kuhrts and Froelich.
Kuhrts teaches sustained release pharmaceutical compositions comprising an agent that enhances or modulates the endogenous production of nitric oxide in a mammal, with L-arginine exemplified (title & abstract). In addition, L-ornithine is included as an active agent (p. 1, 1st para). Oral dosage forms are exemplified (p. 5, 1st para under Summary). Kuhrts teaches the inclusion of an ion-exchange resin in the sustained release composition (p. 12, 1st full para). Suitable dosage forms include tablets, capsules, powders (p. 11, 1st para; p. 26, claim 9); and hydrogels (p. 21, Ex. 4; p. 26, claim 10).
Froelich teaches oral compositions comprising L-arginine as an active agent (para [0001]). Froelich teaches oral compositions must include L-arginine in large amounts, e.g., grams, which can cause issues with absorption (para [0006-0007]). Froelich teaches L-arginine is available in powder compositions for oral administration, however, there are issues with taste and dissolution (para [0008]). Froelich teaches oral compositions comprising L-arginine, an effervescent agent, and an acid, of which citric acid is exemplified, increase the dissolution of the powder oral dosage form and have improved taste (para [0011-0013], [0022], [0028]).
As such, it would have been prima facie obvious to have modified the composition of the patented claims by incorporating an ion-exchange resin as an excipient, as Kuhrts teaches this excipient as acceptable for oral L-arginine compositions. As Froelich teaches an effervescent agent and citric acid improve taste and increase dissolution of L-arginine oral dosage forms, it would have been further obvious to have added such excipients to the composition of the patented claims. For these reasons, the instant and patented claims are obvious variants of each other and are not patentably distinct.
Claims 1-6, 9-11, and 17-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19559811 (reference application) in view of Kuhrts, WO 0006151, publ. 2/10/2000; and Froelich et. al., DE 19800812 A1, pub. 7/15/1999. 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 arginine; at least one non-ester nitrate compound; wherein the non-ester nitrate compound and arginine are separate compounds; and wherein the amount of nitrate ion in the composition is at least 1 mg. The difference between the claims is that the copending claims don’t recite gel or powder dosage forms; additionally, the instant claims recite the inclusion of citric acid; the inclusion of an ion-exchange resin; and the inclusion of L-ornithine, none of which are recited in the copending claims. However, the incorporation of such ingredients would have been prima facie obvious in view of Kuhrts and Froelich.
Kuhrts teaches sustained release pharmaceutical compositions comprising an agent that enhances or modulates the endogenous production of nitric oxide in a mammal, with L-arginine exemplified (title & abstract). In addition, L-ornithine is included as an active agent (p. 1, 1st para). Oral dosage forms are exemplified (p. 5, 1st para under Summary). Kuhrts teaches the inclusion of an ion-exchange resin in the sustained release composition (p. 12, 1st full para). Suitable dosage forms include tablets, capsules, powders (p. 11, 1st para; p. 26, claim 9); and hydrogels (p. 21, Ex. 4; p. 26, claim 10).
Froelich teaches oral compositions comprising L-arginine as an active agent (para [0001]). Froelich teaches oral compositions must include L-arginine in large amounts, e.g., grams, which can cause issues with absorption (para [0006-0007]). Froelich teaches L-arginine is available in powder compositions for oral administration, however, there are issues with taste and dissolution (para [0008]). Froelich teaches oral compositions comprising L-arginine, an effervescent agent, and an acid, of which citric acid is exemplified, increase the dissolution of the powder oral dosage form and have improved taste (para [0011-0013], [0022], [0028]).
As such, it would have been prima facie obvious to have modified the composition of the copending claims as a solid dosage form such as powders or gels as such dosage forms are taught by Kuhrts to be suitable for L-arginine, along with an ion-exchange resin as an excipient. Furthermore, as L-ornithine is taught to share utility with L-arginine as a nitric oxide enhancer, it would have been obvious to have added this amino acid to the composition of the copending claims. As Froelich teaches an effervescent agent and citric acid improve taste and increase dissolution of L-arginine oral dosage forms, it would have been further obvious to have added such excipients to the composition of the copending claims. For these reasons, the instant and copending claims are obvious variants of each other and are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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
Prosecution Insights