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
19556549 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 7-26 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 recite the composition of claim 1, comprising “beetroot, spinach, carrot…”, however, claim 1 doesn’t recite these components. There is insufficient antecedent basis for these limitations, and the claims are indefinite.
Claim 9 recites the composition of claim 1, comprising “at least one component that is ion-exchange resin-based”. Claim 1 doesn’t recite this component. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claim 10 recites the composition of claim 1, comprising “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 recites the composition of claim 1, comprising “citric acid”. However, claim 1 doesn’t recite this component. There is insufficient antecedent basis for this limitation, and the claim is indefinite.
Claims 12-14 recite the composition of claim 1, comprising “beetroot, spinach, rocket..”. However, claim 1 doesn’t recite these limitations. There is insufficient antecedent basis for these limitations, and the claims are indefinite.
Claim 15 recites the composition of claim 1, comprising “a botanical nitrate source, a vegetable nitrate source..”. However, claim 1 doesn’t recite these components. There is insufficient antecedent basis for these limitations, and the claims are indefinite.
Claim 16 recites the composition of claim 1, comprising “beetroot and an antioxidant”. However, claim 1 doesn’t recite these components. There is insufficient antecedent basis for these limitations, and the claims are indefinite.
Claims 17-24 and 30 recite the composition of claim 1, comprising amino acids selected from “aspartic acid, proline, glycine, ….”. However, claim 1 doesn’t recite these components. There is insufficient antecedent basis for these limitations, and the claims are indefinite.
Claims 25-26 recite the composition of claim 1, comprising glycine. However, claim 1 doesn’t recite glycine, therefore the claims are indefinite as there is no antecedent basis for this limitation.
Claim 30 recites the composition of claim 1, comprising “beetroot, spinach, and broccoli”. However, claim 1 doesn’t recite these components. There is insufficient antecedent basis for these limitations, and the claim is indefinite.
To overcome these rejections, it is suggested that “further” be added before “comprises” or “comprising” in the claims.
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 1-30 of copending Application No. 19558385 (reference application); over claims 1-30 of 19558184; over claims 1-30 of 19556470; over claims 1-30 of 19558364; over claims 1-30 of 19558063; over claims 1-30 of 19559247; over claims 1-30 of 19558396; over claims 1-30 of 19559196; over claims 1-30 of 19557927; over claims 1-30 of 19556905; and over claims 1-30 of 19558139. Although the claims at issue are not identical, they are not patentably distinct from each other because they encompass supplement compositions comprising agmatine and a separate non-ester nitrate compound, wherein the amount of nitrate compound is either the same or overlapping (see instant claim 1; claims 1 & 17 of ‘139; claims 1 & 18 of ‘905; claims 1 & 17 of ‘927; claims 1 & 17 of ‘196; claims 1 & 17 of ‘396; claims 1 & 17 of ‘247; claims 1 & 17 of ‘063; claims 1 & 17 of ‘364; claims 1 & 17 of ‘470, ‘385, ‘184). The instant and copending claims additionally recite the composition in powder or gel forms (see instant claims 2-3 and claims 2-3 of copending appl.); further comprising beetroot, spinach, broccoli (see instant claim 7 and claim 7 of copending appl.); wherein the composition further includes an ion-exchange resin (see instant claim 9 and claim 9 of copending appl.); and further comprising an antioxidant (see instant claim 10 and claim 10 of copending app.). As such, the instant and copending claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, 10-12, and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19559853 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to supplement compositions comprising agmatine and a separate non-ester nitrate compound, wherein the amount of nitrate ion present is at least 0.05625 mg. Additionally, both sets of claims further recite the composition in powder or gel dosage forms (see instant claims 2-3, & copending claims 13-14); further including a vegetable and botanical nitrate source (instant claim 15, & copending claims 27-28); and further comprising the antioxidant, citric acid (instant claims 10-11, & copending claim 30). As such, the instant and copending claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6 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 Wallace, WO 2006085127 A1, publ. 8/17/2006. 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 supplements comprising agmatine and a separate non-ester nitrate compound, wherein the amount of nitrate ion is overlapping. The patented claims recite the amount of nitrate ion as at least 30.7 mg., which overlaps with the amount recited in the instant claims. While the patented claims don’t explicitly recite the solid supplement composition in the form of a powder or gel, these dosage forms would have been prima facie obvious in view of Wallace. Wallace teaches topical dosage forms comprising agmatine (abstract; p. 9, lines 10-16), wherein suitable dosage forms include gels and powders (p. 13, line 24-p. 14, line 3). As such, it would have been prima facie obvious to have formulated the agmatine composition of the patented claims in the form or powders or gels, since Wallace teaches these dosage forms for agmatine, and have had a reasonable expectation of success. The instant and patented claims are therefore not patentably distinct.
Claims 1-8, 12-14, and 17-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-24 of U.S. Patent No. 8952045 C1. 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 supplements comprising agmatine and a separate non-ester nitrate compound, wherein the amount of nitrate ion is overlapping. The patented claims recite the amount of nitrate ion as at least 30 mg., which overlaps with the amount recited in the instant claims. Furthermore, both sets of claims include gels and powders (instant claims 2-3 and patented claim 22); and further comprising beetroot, spinach, carrot, broccoli, and mushroom (instant claim 7 & patented claims 23-24). As such, the instant and patented claims are therefore not patentably distinct.
Claims 1-6 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 Wallace, WO 2006085127 A1, publ. 8/17/2006. 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 supplements comprising agmatine and a separate non-ester nitrate compound, wherein the amount of nitrate ion is overlapping. The patented claims recite the amount of nitrate ion as at least 30.7 mg., which overlaps with the amount recited in the instant claims. While the patented claims don’t explicitly recite the solid supplement composition in the form of a powder or gel, these dosage forms would have been prima facie obvious in view of Wallace. Wallace teaches topical dosage forms comprising agmatine (abstract; p. 9, lines 10-16), wherein suitable dosage forms include gels and powders (p. 13, line 24-p. 14, line 3). As such, it would have been prima facie obvious to have formulated the agmatine composition of the patented claims in the form or powders or gels, since Wallace teaches these dosage forms for agmatine, and have had a reasonable expectation of success. The instant and patented claims are therefore not patentably distinct.
Information Disclosure Statements
The IDS filed on 4/27/26 have been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
