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 .
DETAILED ACTION
Applicant’s amendment of 30 January 2026, in which claims 1, 2, 4, 6, 13, 17-20 have been amended, claims 3, 5, 7-12, 22-30 have been cancelled, and new claims 31-43 have been added, is acknowledged.
Claims 1-2, 4, 6, 13-21, 31-43 are pending in the instant application.
Claims 1-2, 4, 6, 13-21, 31-43 are being examined on their merits herein.
Response to arguments of 30 January 2026
In view of Applicant’s amendment of 30 January 2026, all the rejections and objections to claims 3, 5, 7-12, 22-30 are herein withdrawn. Claims 3, 5, 7-12, 22-30 have been cancelled.
In view of Applicant’s amendment of 30 January 2026, the objection to claims 22-30, 2, 6, 8, 12, 3 are herein withdrawn. Claims 22-30, 3, 8, 12 have been cancelled. Applicant has clarified claims 2, 6.
On 30 January 2026, in response to an objection to the Specification, Applicant has submitted an amendment to the Specification with incorrect numbering for the paragraphs amended. Specifically, what is presented in the amendment of 30 January 2026 as paragraph [0050] corresponds actually to [0052] in the original Specification; [0051] corresponds to original [0053]; and the same is the case for all paragraphs, including [0064] in the amended Specification of 01/30/2026, which corresponds to [0066] in the original Specification.
Importantly, not all paragraphs have been amended- for example, [0050] in the original Specification is not amended, even though it contains reference to at least one stereoisomer selected from (R)-b-ketopentanoate, and (S)-b-ketopentanoate (which do not exist, because beta-ketopentanoate does not have a chiral center).
Further, some of the paragraphs are deleted, without re-numbering the remaining paragraphs. Applicant is required to submit a replacement Specification, marked and clean-up version, indicating all the changes, with correct numbers for all paragraphs.
The objection to the Specification is herein maintained.
In view of Applicant’s amendment of 30 January 2026, the rejection of claims 3-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is herein withdrawn. Claim 3, 9-12 have been cancelled. Applicant has deleted from claim 4 recitations related to enantiomers of b-ketopentanoate, which is a compound that does not have a chiral center. New rejections are made below, based on Applicant’s amendment of 30 January 2026.
In view of Applicant’s amendment of 30 January 2026, the rejection of claims 1, 2 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Roe, C. (US 2006/0004099) is herein withdrawn. New rejections are made below, based on Applicant’s amendment of 30 January 2026.
In view of Applicant’s amendment of 30 January 2026, the rejection of claims 1-4, 13, 20 under 35 U.S.C. 103 over Seebach is herein withdrawn.
New rejections are made below, based on Applicant’s amendment of 30 January 2026.
On 30 January 2026, Applicant has filed a terminal disclaimer over US patent 11,337,945. The terminal disclaimer has been disapproved (see reasons of 28 February 2026). The rejection of the claims on the ground of nonstatutory double patenting over claims of U.S. Patent No. 11,337,945 is herein maintained.
Applicant’s amendment of 30 January 2026 necessitated the following new and modified objections and rejections.
Objection to the Specification
The Specification is objected to because it recites [0050] A composition containing b-ketopentanoate may comprises at least one stereoisomer selected from (R)-b-ketopentanoate, and (S)-b-ketopentanoate. See also [0052], [0054], [0057], [0058], [0059], [0060], [0063], [0064], [0066]. This is incorrect, because there is no chiral center in b-ketopentanoate.
Applicant is required to correct the Specification by identifying and deleting all recitations of (R)-b-ketopentanoate, and (S)-b-ketopentanoate, or non-racemic b-ketopentanoate.
Applicant is required to correct all instances in the Specification that recite enantiomers or racemic b-ketopentanoate, and, when entire paragraphs are deleted, Applicant is required to make appropriate changes to the numbering of paragraphs in the Specification.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 is unclear because it recites “increased endogenous production of
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”. It is unclear how the increase is to be measured, as the claim fails to establish a standard or threshold level. It is unclear what biological sample is used for the measurement. It is unclear what the reference sample, used in the comparison, is. In other words, it appears that claim 4 refers to measuring levels of biological molecules in two different biological samples and comparing said levels between the two different biological samples; however, the claim fails to clearly establish the origins of the two different biological samples, or the reference or standard by which one would make a comparison of levels of the one or more biological molecules. One wishing to practice the instantly claimed invention would thus not recognize the metes and bounds for which Applicant seeks protection.
Further, in claim 4, it is unclear what fatty acids and sterols result from the endogenous conversion of S-b-hydroxypentanoate.
The same analysis applies to claim 33.
Appropriate clarification is required.
Claims 1, 2, 4, 6, 13-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation combinations of (R)-b-hydroxypentanoate, and (S)-b-hydroxypentanoate (in any relative ratio, thus including racemic or non-racemic b-hydroxypentanoate), and the claim also recites a non-racemic mixture of b-hydroxypentanoate, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is required.
Claim 1 is unclear because it recites that the composition further comprises a non-racemic mixture of b-hydroxypentanoate. Yet, claim 1 already contains at least one C5 ketone body selected from R- or S- b-hydroxypentanoate, and combinations thereof. It is unclear whether the non-racemic mixture of b-hydroxypentanoate in claim 1 is in addition (“further comprises”) to the already present R- or S- b-hydroxypentanoate.
Claim 1 is further confusing with respect to the amounts of C5 ketone bodies and other ingredients present in the composition. Claim 1 recites that the composition comprises more than 0% and less than 100% wt. of at least one C5 ketone body; and a pharmaceutical carrier; and the composition further comprises non-racemic b-hydroxypentanoate. Since the at least one C5 ketone body is present at less than 100% wt. of the composition, say 99.99%, it is unclear what % wt. is left for the carrier, let alone for the non-racemic b-hydroxypentanoate.
Appropriate clarification is required.
Claims 13-20 are indefinite for a number of reasons. Claim 13 and dependent claims 14-20 are unclear because they depend on claim 1 and recite that the C5 ketone body is further selected from the group consisting of:
one or more salt of the C5 ketone body;
one or more amino acid salt of the C5 ketone body;
one or more ester of the C5 ketone body;
one or more acid of the C5 ketone body;
one or more polymer of the C5 ketone body; and combinations thereof.
Yet, claim 1 does not recite salts, esters, acids or polymers of a C5 keto body. As such, there is insufficient antecedent basis for the recitation salt, amino acid salt, ester, acid, or polymer of C5 ketone body of claim 13, in claim 1.
Furthermore, it is unclear what is meant by “further selected” in claim 13.
Appropriate clarification/correction of the claim language is required.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation “salt of C5 ketone body”, and the claim also recites “amino acid salt of C5 ketone body”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is required.
Claims 31-43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 31 recites the broad recitation combinations of (R)-b-hydroxypentanoate, and (S)-b-hydroxypentanoate (in any relative ratio, thus including racemic or non-racemic b-hydroxypentanoate), and the claim also recites a non-racemic mixture of b-hydroxypentanoate, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is required.
Claim 31 is unclear because it recites that the composition further comprises a non-racemic mixture of b-hydroxypentanoate. Yet, claim 31 already contains at least one C5 ketone body selected from R- or S- b-hydroxypentanoate, and combinations thereof. It is unclear whether the non-racemic mixture of b-hydroxypentanoate in claim 31 is in addition (“further comprises”) to the already present R- or S- b-hydroxypentanoate.
Claim 31 is further confusing with respect to the amounts of C5 ketone bodies and other ingredients present in the composition. Claim 31 recites that the composition comprises more than 0% and less than 100% wt. of at least one C5 ketone body; and a pharmaceutical carrier; and the composition further comprises non-racemic b-hydroxypentanoate. Since the at least one C5 ketone body is present at less than 100% wt. of the composition, say 99.99%, it is unclear what % wt. is left for the carrier, let alone for the non-racemic b-hydroxypentanoate.
Appropriate clarification is required.
Claims 35-42 are indefinite for a number of reasons. Claim 35 and dependent claims 36-42 are unclear because they depend on claim 31 and recite that the C5 ketone body is further selected from the group consisting of:
one or more salt of the C5 ketone body;
one or more amino acid salt of the C5 ketone body;
one or more ester of the C5 ketone body;
one or more acid of the C5 ketone body;
one or more polymer of the C5 ketone body; and combinations thereof.
Yet, claim 31 does not recite salts, esters, acids or polymers of a C5 keto body. As such, there is insufficient antecedent basis for the recitation salt, amino acid salt, ester, acid, or polymer of C5 ketone body of claim 35, in claim 31.
Furthermore, it is unclear what is meant by “further selected” in claim 35.
Appropriate clarification/correction of the claim language is required.
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 35 recites the broad recitation “salt of C5 ketone body”, and the claim also recites “amino acid salt of C5 ketone body”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is required.
Claim Rejections- 35 USC 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Roe, C. (US 2006/0004099, cited in PTO-892).
Roe teaches (claims 1, 2, 9) a composition comprising an odd carbon fatty acid and a carrier, wherein the odd carbon fatty acid comprises 3-hydroxypentanoate (BHP), 3-ketopentanoate (BKP) and mixtures and combinations thereof.
3-hydroxypentanoate (BHP) is a C5-ketone body of instant claims 1, 2.
3-ketopentanoate (BKP) is a C5-ketone body of instant claims 1, 2.
Roe teaches [0091] that the C5 ketone bodies BHP and BKP can be administered in the form of either free ketone bodies (as acids, X = H in instant claim 2) or in other forms, namely as a triglyceride (ester) form (X is alkyl in instant claim 2), a polymeric form or a salt form (X is a metal ion), capable of providing the free ketone in vivo after administration.
As such, instant claims 1, 2 are anticipated by Roe.
Claim Rejections- 35 USC 103
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 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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 6, 13-21, 31-43 are rejected under 35 U.S.C. 103 as being unpatentable over Roe, C. (US 2006/0004099, cited in PTO-892 of 27 August 2025) and Seebach et al. (Helv. Chim. Acta 1994, 77, 2007-2034, cited in PTO-892 of 27 August 2025).
Roe teaches (claims 1, 2, 9) a composition comprising an odd carbon fatty acid and a carrier, wherein the odd carbon fatty acid comprises 3-hydroxypentanoate (BHP), 3-ketopentanoate (BKP) and mixtures and combinations thereof.
3-hydroxypentanoate (BHP) is a 1:1 mixture/combination of R- and S- b-hydroxypentanoate as C5 ketone bodies of instant claims 1, 2, 31, 32.
3-ketopentanoate (BKP) is a C5-ketone body of instant claims 1, 2, 31, 32.
Roe teaches [0091] that the C5 ketone bodies BHP and BKP can be administered in the form of either free ketone bodies (as acids, X = H in instant claim 2, 32, acid in claims 13, 35, 20, 42) or in other forms, namely as a triglyceride (ester) form (X is alkyl in instant claim 2, 32, ester in claims 13, 35), a polymeric form (as in claims 13, 35) or a salt form (X is a metal ion in claims 2, 32, salt in claims 13, 35), capable of providing the free ketone in vivo after administration.
Roe does not teach non-racemic mixtures of R- and S- b-hydroxypentanoate in the composition added to 3-hydroxypentanoate (BHP) or to 3-ketopentanoate (BKP), as in the instant claims.
Seebach (Helv. Chim. Acta 1994, 77, 2007-2034) teaches preparation of enantiomerically pure (R)-3-hydroxypentanoic acid (13)
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(page 2009, under point 2.2, Scheme 1), which is a C5 ketone body of instant claims 1, 2, 13, 31, 32, 35, and is a C5 ketone body of instant claims 2, 32 wherein X = H.
Seebach also teaches (Scheme 2) polymers of (R)-3-hydroxypentanoic acid
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, which are polymers of instant claim 13.
It would have been obvious to add water as a pharmaceutical or dietetically acceptable carrier to compounds (13), (3), or to the polymers of (R)-3-hydroxypentanoic acid disclosed by Seebach, to arrive at the instantly claimed composition.
As such, claims 1-4, 13, 20 are rejected as prima facie obvious.
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 1-21 are rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-8, 10-14, 18-20 of U.S. Patent No. 11,337,945 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-8, 10-14, 18-20 of U.S. Patent No. 11,337,945 anticipate or render obvious the instant claims.
Claim 8 of U.S. Patent No. 11,337,945 teaches orally administering a composition comprising about 1 g to about 50 g of at least one of: β-hydroxypentanoate, β-hydroxypentanoate salt, β-ketopentanoate, or β-ketopentanoate salt.
As such, the instant claims are rendered obvious by claims of U.S. Patent No. 11,337,945.
Conclusion
Claims 1-2, 4, 6, 13-21, 31-43 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S. LUNDGREN can be reached on (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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