DETAILED ACTION
The preliminary amendment submitted on August 4, 2023 has been entered. Claims 1-9 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 AIA . 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 Objections
Claim 1 is objected to because of the following informality: The phrase “in need thereof” should be inserted after the word “subject.” Appropriate correction is required.
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 1-2 and 4-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2012/0142776 A1 by Leinwand et al.
Leinwand (cited in applicant’s IDS1) discloses “methods for inducing physiologic hyper-trophy in cardiac cells of a patient comprising administering to the cardiac cells an effective amount of a pharmaceutical composition comprising an isolated or purified fatty acid composi-tion” (para. 0011). According to this method, “physiologic hypertrophy is induced in cardiac cells or cardiomyocytes” (para. 0008), i.e. heart muscle cells, so the examiner concludes that the reference discloses “muscle enhancement” and “enlarging muscle fiber” within the meaning of the instant claims. The composition that is administered to the patient (para. 0011) comprises myristic acid, also known as tetradecanoic acid or C14:0, as well as tridecanoic acid (C13:0) or pentadecanoic acid (C15:0), among other fatty acids (para. 0117), which meets the limitations of instant claim 2. The compositions “should contain at least 0.1% of active compound … preferably between 25-60%” (para. 0265), which meets the limitations of claim 4. Food product containing the fatty acids can be in the form of “vegetable oil based products (spreads, salad oils, mayon-naise etc.)” (para. 0271), “beverages (alcoholic or non-alcoholic drinks, juices and juice-type mixed drinks, and dietary supplement and meal replacement drinks etc. as well as concentrates or premixes for beverages” (para. 0271), and food compositions for “humans or animals” (para. 0213), which meets the limitations of claims 6-9.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2013/ 0338114 A1by de Ferra et al.
De Ferra discloses “compositions and methods for the administration of therapeutically effective amounts of naturally occurring, isolated compounds that are biologically active in increasing muscle mass and strength” (para. 0009). The reference also discloses “a method for increasing skeletal muscle hypertrophy comprising orally administering to a subject an effective amount of … lysophosphatidic acid (LPA)” (para. 0011). The LPA is a glycerol ester of “tridecanoic acid (13:0), myristic acid (14:0), myristoleic acid (cis-9-tetradecenoic acid, 14:1), pentadecanoic acid (15:0),” or other fatty acids (para. 0068), which meets the limitations of claims 2-3. The compositions taught by the reference “typically contain at least 1% of active compound,” for example, “from about 2% to about 90% of the weight of a given unit dosage form,” and are “incorporated directly into the food of a patient’s diet” (para. 0089), which meets the limitations of claims 4 and 7. De Ferra also discloses compositions in the form of dispersions in pharmaceu-tically acceptable oils (para. 0091), which meets the limitation of claim 6. The compositions may be in the form of a nutritional supplement or a powder that can be added to water or a sports drink (para. 0020), which meets the limitations of claims 7-8. Finally, the method may be used to “enhancement of muscle mass and strength in mammals such as humans, equines and canines” (para. 0009), i.e., as animal feed additives within the meaning of claim 9.
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 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 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 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of copending Application No. 19/130,853 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. See the claims submitted on May 16, 2025 in the ‘853 Application. They are directed to methods of administering the same fatty acids as recited in the instant claims. There is no specific manipulative difference between the claims of the ‘853 Application and the instant claims, so the examiner concludes that the outcome would be the same, i.e., muscle enhance-ment. That is, by practicing the methods claimed in the ‘853 Application, one would necessarily also cause muscle enhancement within the meaning of the instant claims. See MPEP 2112 (rejection based on inherency). Claim 3 of the ‘853 Application is directed to glycerin fatty acid esters, which is substantially the same subject matter of instant claim 3. Claim 6 of the ‘853 Application is directed to oil or fat compositions, which suggests instant claim 6. Claim 5 of the ‘853 Application is drawn to food or beverage compositions, such suggests instant claim 7. Claim 7 of the ‘853 Application is drawn to supplements, which suggest instant claim 8. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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, 7:00 am - 6:00 pm (Eastern Time).
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/ Primary Examiner, Art Unit 1628
November 25, 2025 (revised December 17, 2025)
1 See the information disclosure statement (IDS) submitted on August 4, 2023.