DETAILED ACTION
Claims 1-7, submitted on August 6, 2024, are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-7 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particu-larly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The claims (especially claim 1) are replete with indefinite language, and the identity of the “subject in need” is unclear. The claims include numerous recitations of functional properties that do not appear to require the artisan to do anything in particular. For example, it is unclear what a person must actually do in order to “enhance[] mitochondrial ATP production” or “reduce[] excessive radical oxygen species formation from OXPHOS” or “increase cellular capacity to adjust cytosolic NAD+/NADH- ratio in timely manner when needed.” These outcomes appear to be inherent properties of the compounds that are administered, and it is unclear what additional steps one must perform in order to effectuate these outcomes. See MPEP 2173.05(g) for a discussion of functional claim limitations. Furthermore, the claims include language suggesting that certain steps are optional. For example, they are drawn to treating an “animal, such as a mammal, poultry, and fish.” In this context, the use of “such as” is indefinite for the reasons discussed in MPEP 2173.05(d). It is unclear whether the claims are actually limited to “a mammal, poultry, and fish.” The claims also require that the method “can” be performed in a “timely manner” and “when needed.” Whether the method “can” be performed suggests that the claim is drawn to optional subject matter. It would also be a matter of opinion, which would necessarily vary from person to person, whether the method is performed in a “timely” manner or “when needed.” Finally, it appears that essentially everyone would benefit from “sharpening the control of unfolded protein response” and other outcomes recited in the claims, so it is unclear who is intended to be within the meaning of “subject in need.”
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trimbo (US 6,306,828 B1).
Trimbo (cited in applicant’s IDS1) discloses “new and improved energy substrates” for administering to a patient having a “nutritional deficit or depletion such as experienced after prolonged exercise such as marathon running (col. 3, l. 66 – col. 4, l. 5). This “enantiomerically-enriched energy substrate” is, for example, an ester of glyceric acid (col. 5, ll. 5-11). The refer-ence is silent regarding the stereochemistry of the glyceric acid, but it must be at least one of d-glyceric acid, l-glyceric acid, or dl-glyceric acid inasmuch as these are the only possible stereo-isomers of this compound, and the instant claims are directed to all of them. They may be provided in the form of a solution (col. 7, ll. 1-15), which are “administered parenterally, enterally, intraperitoneally or topically” (col. 3, ll. 60-65), and are described as nutritional formu-lations or supplements (col. 1, ll. 12-15), which meets the limitations of claims 2-5.
The recitation of “wherein the composition enhances mitochondrial ATP production and simultaneously reduces excessive radical oxygen species formation from OXPHOS, and further-more can increase cellular capacity to adjust cytosolic NAD+/NADH- ratio in timely manner when needed” in claim 1 does not implicate any specific difference from the method taught by the prior art. See MPEP 2111.02. Instead, it appears to represent applicant’s discovery of a mecha-nism of action whereby the treatment discussed in the cited reference operates. The discovery, however, of a previously unappreciated property of the prior art, or of a scientific explanation for its functioning, does not render it patentably new to the discoverer. The claiming of a new use, new function, or unknown property, which is inherently present in the prior art although not specifically disclosed therein, does not make the instant claims patentable. Trimbo discloses a method comprising the same active step (administering to a subject) the same drug (glyceric acid), so it is a reasonable conclusion that the mechanism of action applicant recites in the instant claim would necessarily occur even though it may not be specifically disclosed in the reference. For similar reasons, it is Office policy that a “wherein” clause in a method claim “is not given weight when it simply expresses the intended result of a process step positively recited.” See MPEP 2111.04. The “wherein” clause that comprises the last three lines of text in claim 1 has therefore not been accorded patentable weight.
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 explained in MPEP 2141 et seq. They 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Trimbo as applied above.
The disclosure of Trimbo is relied upon as set forth above. The difference between the prior art and the claims at issue is that this reference does not specifically disclose the claimed dosage amounts. Trimbo, however, discloses that the energy or caloric density can be calculated (see, e.g., col. 3, ll. 18-60). It appears that the subject matter of claims 6-7 is just such a calcu-lation, arrived at by routine experimentation. See MPEP 2144.05(II)(A) (optimization within prior art conditions or through routine experimentation). The examiner therefore finds the claims to be prima facie obvious when the teachings of Trimbo are considered as a whole.
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 possi-ble 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 provi-sions 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 accompa-nied 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 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,500,176 B2; claims 1-13 of U.S. Patent No. 11,357,746 B2;2 and claims 1-10 of U.S. Patent No. 12,083,084 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
The claims of the ‘176 Patent are drawn to a method of treating any of a variety of differ-ent non-communicable diseases or disorders, the method comprising administering a composi-tion comprising glyceric acid, salt or esters thereof, to a subject in need thereof, wherein the composition enhances mitochondrial ATP production and simultaneously reduces excessive radical oxygen species formation from oxidative phosphorylation (OXPHOS), and wherein the non-communicable disease or disorder is selected from a defined list of such conditions. As explained above, it appears that essentially everyone, including the “subject” referred to in the claims of the ‘176 Patent, is within the meaning of the instant claims. The examiner therefore concludes that the instant claims are anticipated by the claims of the ‘176 Patent. The instant claims are also rejected for double patenting over the ‘746 Patent and the ‘084 Patent for substantially the same reasons.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
October 13, 2026
1 See the information disclosure statement (IDS) submitted on August 6, 2026.
2 Also cited in applicant’s IDS.
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