Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application is a CON of 19/030,516 (01/17/2025 now US12577210)
19/030,516 is a CON of 17/522,680 (11/09/2021 now US12227483)
17/522,680 is a DIV of 14/621,738 (02/13/2015 now US11166979)
14/621,738 is a CON of 13/920,066 (06/17/2013 now US8957100)
13/920,066 is a CON of 13/038,615 (03/02/2011 now US8466187)
13/038,615 is a CIP of 12/336,938 1(2/17/2008 now US8034836)
12/336,938 is a CON of 11/950,273 (12/04/2007 now US7777074)
11/950,273 has PRO 60/973,229 (09/18/2007).
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, including Application No. 60/973,229, 11/950,273, 13/038,615, and 13/920,066, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, at least the claim language “nitrate” and “amino acid” being a “separate compound”; and “nitrate ion (NO3-) that is at least about 0.05626 mg” do not have support in the prior-filed application and on of skill in the art would not recognize Applicant possessed such a scope. Accordingly, Claims 1-30 are not entitled to the benefit of the prior application
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: For example, the prior filed applications do not provide support for the new matter of at least: “nitrate” and “amino acid” being a “separate compound”; “at least one non-ester nitrate compound”; and “nitrate ion (NO3-) that is at least about 0.05626 mg”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim language of “nitrate” and “amino acid” being a “separate compound”; and “nitrate ion (NO3-) that is at least about 0.05626 mg” do not have support in the prior-filed application and on of skill in the art would not recognize Applicant possessed such a scope and is considered new claim language. As per MPEP 2163.04, Applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the new (or amended) claim limitations in the application as filed thus the claims prima facie do not comply with the written description requirement. See Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007) (holding that “[MPEP] § 2163.04 [subsection] (I)(B) as written is a lawful formulation of the prima facie standard for a lack of written description 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.
Claims 1-30 are rejected under 35 U.S.C. 103 as being unpatentable over Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679).
Gilad teaches agmatine containing dietary supplements and foods in combination with additional health promoting ingredients (Title, Abstract), including studies demonstrating efficacy (pages 6-10). Gilad teaches the formulation of the supplement in well known forms including powders, tablets, chewables, and edible supporting matrix, for example ([0017]). Gilad teaches agmatine is derived from plants ([0004]).
Gilad does not teach a nitrate compound.
Larsen teaches nitrate supplementation has a beneficial effects, including more efficient energy production from a study of the administration of sodium nitrate at 0.1 mmol/kg/day or ~310 mg nitrate ion in human subjects (subjects approx. 50kg; nitrate ion is 62mg/mmol) (Abstract; [0003]; [0006]-[0024]). Larsen teaches dosage forms including solid and semi-solid and various routes of administration ([0041]). Larsen teaches the supplement comprises beetroot ([0051]).
Ashmead teaches a solid composition for administration to animals comprising amino acids specifically recited and a second compound including a nitrate to increase metabolic activity (Abstract, claims 1, 5, 27, 32). Ashmead teaches formulation as a powder, gel, and paste ([0047]). Ashmead teaches use of nitrogen-containing botanical extracts ([0030]). Ashmead teaches examples including citric acid as part of the composition ([0050]-[0057]).
One of ordinary skill in the art following the teaching of Gilad would have considered formulating the agmatine supplement with additional health promoting ingredients including nitrates based on the teaching of Larsen. As demonstrated by Larsen nitrate was known to be a results effective variables that would impact the utility of the composition, specifically having more energy production. The level of skill in the art is high as evidenced by the teaching of the cited art such that one of ordinary skill in the art would consider routine the optimization of the amount of active ingredients to maximize therapeutic effect. In view of the results of Larsen’s human study, one of ordinary skill in the art would have had reasonable expectation of success in optimization of the amount of essential nitrates including in amounts corresponding to 20-120 mg nitrate ion and arrive at the claimed invention including as a solid, gel, and semisolid supplement composition. One of ordinary skill in the art would have also considered the teaching of Ashmead in combination to include citric acid, as a gel, and botanical extracts. Thus, the claims are prima facie obvious. MPEP 2144.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12612370. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 12448357. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12240819. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11155524. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-46 of U.S. Patent No. 10736916. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-59 of U.S. Patent No. 10736917. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 10646508. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-131 of U.S. Patent No. 10555921. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 10485777. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10472322. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10435356. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10426750. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 8957101. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 8952045 C1 (Reexam). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-11, 13-58 of U.S. Patent No. 8952046 C2 (Reexam). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-69 of U.S. Patent No. 8466187 C1 (Reexam). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 8455531 C1 (Reexam). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 8183288 C1 (Reexam). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 8178572 C1 (Reexam). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 7777074 C1 (Reexam). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of the following copending Application Nos. (reference applications). Although the claims at issue are not identical, they are not patentably distinct from each other because they are not patentably distinct from each other because the reference application claims a supplement/composition and/or use comprising a nitrate and the same amino acid such that would anticipate and render obvious the instant claims in view of the teaching of Gilad et al. (US20100172890, EFD 2008-09-11) in view of Larsen et al. (US20100092441) and Ashmead et al. (US20080194679) as deatailed above. Reference applications listed below:
19/556549
19/030189
18/824840
17/693191
19/558385
19/558396
19/559853
19/556348
19/556374
19/556424
19/556454
19/556470
19/556505
19/556587
19/556645
19/556872
19/556905
19/557927
19/558063
19/558139
19/558166
19/558184
19/558202
19/558355
19/558364
19/559166
19/559196
19/559247
19/559287.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
