DETAILED ACTION
Claims 1-20, submitted on September 4, 2025, 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.
Priority
This application is a continuation in part of prior-filed application no. 19/221,260, which, in turn, is a continuing application of several other prior-filed applications. A continuation-in-part application may include matter not disclosed in a prior-filed application. Only the claims of the continuation-in-part application that are disclosed in the manner provided by 35 U.S.C. 112(a) in the prior-filed application are entitled to the benefit of the filing date of the prior-filed application. If there is a continuous chain of copending nonprovisional applications, such as in the present situation, each copending application must disclose the claimed invention of the later-filed application in the manner provided by 35 U.S.C. 112(a) in order for the later-filed application to be entitled to the benefit of the earliest filing date. To be entitled to the benefits provided by 35 U.S.C. 120, the invention disclosed in the previously filed application must be described therein in such a manner as to satisfy all the requirements of the first paragraph of 35 U.S.C. 112.
If a claim in a continuation-in-part application recites a feature that was not disclosed or adequately supported by a proper disclosure under 35 U.S.C. 112 in the parent nonprovisional application but was first introduced or adequately supported in the continuation-in-part appli-cation, such a claim is entitled only to the filing date of the continuation-in-part application. By way of further illustration, if the claims of a continuation-in-part application that are only entitled to the continuation-in-part filing date read on published or patented subject matter, a rejection under 35 U.S.C. 102 would be proper. See MPEP 211.05 (Sufficiency of Disclosure in Prior-Filed Application).
The instant claims are drawn to a “method for improving heart function.” There is no written support within the meaning of § 112(a) in any prior-filed application for “improving heart function.” The instant claims are therefore not entitled to the benefit of any prior-filed applica-tions to which priority is claimed (see the “Domestic Applications for which benefit is claimed” in the Filing Receipt mailed on September 24, 2025). Instead, all of the pending claims are only entitled to the actual filing date of this continuation-in-part application, namely, September 4, 2025. This is the critical date for assessing prior art, and anything that qualifies as prior art under 35 U.S.C. 102 as of SEPTEMBER 4, 2025 is citable against the instant claims.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2024/ 0197668 A1 by Millet.
Millet specifically discloses all of the limitations of the instant claims, except that the “composition improves heart function” (see claims 1, 12, and 17), that it “provides energy to the heart” (claims 8, 14, and 19), and that the “S-beta-hydroxybutyrate provides antiglycation and signaling effects” (claims 9, 15, and 20). The outcomes, however, are inherent in the methods taught by the reference.
Specifically, Millet discloses a method of administering (para. 0048) to a human (para. 0038) a composition that comprises “optically pure (100%) S-beta-hydroxybutyrate or a non-racemic mixture of S-beta-hydroxybutyrate enriched with the S-enantiomer (i.e., more than 50% and less than 100% by enantiomeric equivalents of S-beta-hydroxybutyrate and less than 50% and more than 0% by enantiomeric equivalents of R-beta-hydroxybutyrate)” (para. 0049), which is the same composition referred to in claims 1 and 12. The “S-beta-hydroxybutyrate … can be provided in various forms, such as salts and/or esters and/or free acid form(s)” (para. 0055), which meets the limitations of claims 2, 13, and 18. “[T]he non-racemic mixture can include both salt and ester forms of S-beta-hydroxybutyrate” (para. 0062), which meets the limitations of claim 3. Millet also discloses “optically pure S-beta-hydroxybutyrate or non-racemic mixture enriched with S-beta-hydroxybutyrate, wherein the compositions contain from about 50.5% to 100% by enantiomeric equivalents of S-beta-hydroxybutyrate and from about 49.5% to 0% by enantiomeric equivalents of R-beta-hydroxybutyrate” (see abstract), which meets the limitations of claims 4 and 16. In some embodiments, “S-1,3-butanediol or non-racemic mixture enriched with the S-enantiomer” is also administered (para. 0068), which meets the limitations of claim 5. The reference also discloses administering short- and medium-chain triglycerides (para. 0045-46 and 0063-64) within the meaning of claims 6-7. The composition is provided in the form of a kit that contains a measuring device and a container, such as a carton or box (para. 0040-41), which meets the limitations of claims 10-11. Millet further discloses tablets, capsules, beverages, and so forth (para. 0056), which are within the meaning of claims 12 and 17.
Millet discloses a method of administering to a human the exact same compositions of the instant claims. The mechanism of action or therapeutic outcomes recited in the instant claims would therefore be inherent in the teaching of the reference, including the following: that the “composition improves heart function” (see claims 1, 12, and 17), that it “provides energy to the heart” (claims 8, 14, and 19), and that the “S-beta-hydroxybutyrate provides antiglycation and signaling effects” (claims 9, 15, and 20). The examiner appreciates that these limitations are not specifically disclosed by the reference, but there is no requirement of law that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is, in fact, inherent in the prior art reference. The fact that a characteristic is a necessary feature or result of the prior art is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention. The discovery of a previously unappreciated properties 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 that is inherently present in the prior art—although not necessarily disclosed therein—does not necessarily make the instant claims patentable. See MPEP 2112. Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in the prior art. The fact that applicant has evidently recognized another advantage that would flow naturally from following the teachings of the prior art cannot be the basis for patentability. See MPEP 2145(II).
The examiner therefore concludes that claims 1-20 are anticipated by Millet based upon the principle of inherency.
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 1-3, 5-9, 12-15, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,245,243 B1. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘243 Patent claims composition for administering ketone bodies and ketone body precursors to a subject, comprising a non-racemic mixture of S-beta-hydroxybutyrate and R-beta-hydroxybutyr-ate, wherein the non-racemic mixture comprises from 52% to 85% by enantiomeric equivalents of the S-beta-hydroxybutyrate and 48% to 15% by enantiomeric equivalents of the R-beta-hydroxybutyrate. See claim 1 of the ‘243 Patent. The accompanying specification discloses that this composition is used in a method of administering to a human (col. 3, ll. 12-27 and col. 4, ll. 46-50). It is co-administered with S-1,3-butanediol (col. 6, ll. 60-67) and short- or medium-chain triglycerides (col. 7, ll. 15-40). It also discloses tablets, capsules, and food compositions (col. 6, ll. 42-49). As explained in detail above, the mechanism of action or therapeutic outcomes recited in the instant claims would therefore be inherent in the teaching of the reference, including the following: that the “composition improves heart function” (see claims 1, 12, and 17), that it “provides energy to the heart” (claims 8, 14, and 19), and that the “S-beta-hydroxybutyrate provides antiglycation and signaling effects” (claims 9, 15, and 20).
Claims 1-9 and 12-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,596,128 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘128 Patent is directed to a method of administering a ketone body composition to a subject, the ketone body composition comprising a non-racemic mixture of S-beta-hydroxybutyrate and R-beta-hydroxybutyrate that is enriched with the S-beta-hydroxybutyrate relative to the R-beta-hydroxybutyrate, wherein the non-racemic mixture comprises less than 100% by enantiomeric equivalents of the S-beta-hydroxybutyrate and greater than 0% by enantiomeric equivalents of the R-beta-hydroxybutyrate. Dependent claim 2 requires that the non-racemic mixture contains from 52% to 99% by enantiomeric equivalents of the S-beta-hydroxybutyrate and 48% to 1% by enantiomeric equivalents of the R-beta-hydroxybutyrate, which meets the limitations of instant claims 4 and 16. The ‘128 Patent also discloses using 1,3-butanediol (col. 6, ll. 60-67), as well as short- and medium-chain fatty acids (col. 7, ll. 17-57), which meets the limitations of instant claims 5-7. The ‘128 Patent also discloses tablets, capsules, and food compositions (col. 6, ll. 42-47). As explained above, the limitations of the instant claims that are drawn to a mechanism or action or therapeutic outcome pertaining to heart physiology are inherent in the subject matter of the ‘128 Patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,596,130 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘130 Patent is drawn to a composition for administering ketone bodies and/or ketone body precursors to a subject, the ketone body composition comprising a non-racemic mixture of S-beta-hydroxybutyr-ate salt and R-beta-hydroxybutyrate salt enriched with the S-beta-hydroxybutyrate salt relative to the R-beta-hydroxybutyrate salt, with the proviso that the S-beta-hydroxybutyrate salt is not calcium S-beta-hydroxybutyrate, wherein the non-racemic mixture comprises from less than 100% by enantiomeric equivalents of the S-beta-hydroxybutyrate salt and greater than 0% by enantiomeric equivalents of the R-beta-hydroxybutyrate salt. Dependent claim 2 requires that the non-racemic mixture contains from 52% to 99% by enantiomeric equivalents of the S-beta-hydroxybutyrate salt and 48% to 1% by enantiomeric equivalents of the R-beta-hydroxybutyrate salt. Claim 13 is drawn to a kit, and dependent claims 14-19 are drawn to cartons, boxes, meas-uring devices, short- and medium-chain triglycerides, butanediol, and so forth. As explained above, “improving heart function” and the subject matter of instant claims 8-9, 14-15, and 19-20 is inherent in the disclosure of the ‘130 Patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,185,518 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘518 Patent is a continu-ation in part of the ‘130 Patent discussed above. The instant claims are not patentably distinct from the invention claimed in the ‘518 for substantially the same reasons discussed above.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,944,598 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘598 Patent is a continu-ation in part of the ‘518 Patent, discussed above, and the instant claims are not patentably distinct from the claims of the ‘598 Patent for substantially the same reasons discussed above.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,329,734 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-22 of copending Application No. 18/105,030 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 17 of the ‘030 Application is drawn toa composition for use in making a beverage or food product comprising beta-hydroxybutyric acid that is pure S-beta-hydroxy-butyric acid or enriched with S-beta-hydroxybutyric acid relative to R-beta-hydroxybutyric acid so as to contain at least 60% by enantiomeric equivalents of S-beta-hydroxybutyric acid and no greater than 40% by enantiomeric equivalents of R-beta-hydroxybutyric acid; and a beta-hydroxybutyrate salt component that is pure S-beta-hydroxybutyrate salt or enriched with S-beta-hydroxybutyrate salt relative to R-beta-hydroxybutyrate salt so as to contain at least 60% by enantiomeric equivalents of S-beta-hydroxybutyrate salt and no greater than 40% by enanti-omeric equivalents of R-beta-hydroxybutyrate salt. The accompanying specification describes this composition as having utility in treating humans (see, e.g., pp. 17-18). As explained in detail above, the mechanism of action or therapeutic outcomes recited in the instant claims would therefore be inherent in the teaching of the reference, including the following: that the “compo-sition improves heart function” (see claims 1, 12, and 17), that it “provides energy to the heart” (claims 8, 14, and 19), and that the “S-beta-hydroxybutyrate provides antiglycation and signaling effects” (claims 9, 15, and 20). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of copending Application No. 18/217,111 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 10 of the ‘111 Application is drawn to a method for exogenously increasing ketone body level in a subject, comprising administering an exogenous beta-hydroxybutyric acid that is enantiomerically pure S-beta-hydroxybutyric acid or a non-racemic mixture enriched with S-beta-hydroxybutyric acid that contains greater than 50% and less than 100% by enantiomeric equivalents of S-beta-hydroxybutyric acid and less than 50% and greater than 0% by enantio-meric equivalents of R-beta-hydroxybutyric acid. As explained in detail above, the limitations of the instant claims that relate to “improving heart function” are inherent in the method of the ‘111 Application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/907,258 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘258 Application is directed to an aqueous beta-hydroxybutyric acid composition formulated as a nutritional supplement, or for addition to water, beverage, or food product, for ingestion by oral delivery to provide exogenous ketone bodies that exogenously increase blood ketone level in a mammal, the composition comprising: water; and 0.4% w/v to 55% w/v of exogenous beta-hydroxybutyric acid in monomeric form at least partially dissolved in the water, wherein the exogenous beta-hydroxybutyric acid is enantiomerically pure S-beta- hydroxybutyric acid or a non-racemic mixture enriched with S-beta-hydroxybutyric acid relative to R-beta-hydroxybutyric acid so as to include at least 60% by enantiomeric equivalents of S- beta-hydroxybutyric acid and no more than 40% by enantiomeric equivalents of R-beta- hydroxy-butyric acid. As explained in detail above, the limitations of the instant claims that relate to “improving heart function” are inherent. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/221,260 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 15 of copending Application No. 19/303,084 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/315,079 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. 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
December 11, 2025(revised December 30, 2025)