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”.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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 § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-3, 10-13, 15-16, 18-20, 24-29 are rejected under 35 U.S.C. 102(a),(b),(e) as being anticipated by Hill et al. (WO2008028951).
Hill teaches a solid supplement composition comprising thiamin mononitrate (1.2mg) and threonine (p. 14-16, Example 3) which anticipates the claims.
Claims 1-7, 10-13, 15-16, 18-22, 24-29 are rejected under 35 U.S.C. 102(b) as being anticipated by Harrison et al. (“General techniques of cell culture”, Cambridge Press 1997, 162 pages).
Harrison teaches powdered cell culture media formulation including Ca(NO3)2 (100mg) and threonine (p. 31-35, RPMI) which anticipates the claims.
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 Ashmead et al. (US20080194679).
Ashmead teaches a solid composition for administration to animals comprising amino acids and a second compound including a nitrate to increase metabolic activity (Abstract, claims 1, 5, 27, 32). Ashmead teaches formulation as a powder and gel ([0047]). Ashmead teaches use of nitrogen-containing botanical extracts ([0030]). Ashmead teaches examples including citric acid as part of the composition ([0050]-[0057]).
Ashmead does not specifically teach the claimed amounts of nitrate.
One of ordinary skill in the art following the teaching of Ashmead would have known that the active ingredient components of amino acid and nitrate were results effective variables that would impact the utility of the composition. The level of skill in the art is high as evidenced by the teaching of Ashmead 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 examples in the prior art, one of ordinary skill in the art would have had reasonable expectation of success in optimization of the amount of nitrate and arrive at the claimed invention. 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 1-33 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 method of use of a composition comprising a nitrate and amino acid that would anticipate and render obvious the instant claims in view of the teaching of Ashmead et al. (US20080194679) as detailed above.
Claims 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19562667 (reference application). 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 comprising a nitrate and amino acid that would anticipate and render obvious the instant claims in view of the teaching of Ashmead et al. (US20080194679) as detailed above.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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