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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27 March 2026 has been entered.
Applicant’s amendment of 27 March 2026, in which claims 1, 7, 10, 13 have been amended, is acknowledged.
Claims 1-17 are pending in the instant application.
Claims 1-17 are being examined on their merits herein.
Response to arguments of 27 March 2027
On 27 March 2026, Applicant has amended independent claims 1, 7, 10, 13 to recite that the C5 ketone body is administered in a dosage amount of approx. 10 g per administration; Applicant has further amended independent claim 1, 10 to recite taurine being administered in combination with C5 ketone bodies.
In view of Applicant’s amendment of 27 March 2026, the rejection of claims 7, 8, 13, 14 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Roe, is herein withdrawn.
In view of Applicant’s amendment of 27 March 2026, modified rejections are being made below.
Applicant has presented no arguments against the rejection of the instant claims on the ground of nonstatutory double patenting over claims of U.S. Patent No. 11,337,945; over claims of copending Application No. 18/157,788; over claims of copending Application No. 18/319,334; and over claims of copending Application No. 18/225,093. As a result, these rejections are herein maintained.
Modified rejections are made below, based on Applicant’s amendment of 27 March 2026.
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.
Claims 7-9, 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Roe, C. (US 2013/0005818, cited in PTO-892 of 31 March 2025), in view of Schiffmann et al. (US 2011/0306663, cited in IDS), in further view of D’Agostino (US 2014/0350105, cited in PTO-892).
Roe teaches [0089] a method of administering to a subject 5 carbon ketone bodies
3-hydroxypentanoate (BHP) and/or 3-ketopentanoate (BKP) in the form of free ketone bodies, which provides the free ketones in vivo after administration [0089], which is consistent with a method for increasing blood ketone levels in a subject, as in instant claims 7, 8.
3-hydroxypentanoate (BHP) is a C5-ketone body of instant claim 8.
3-ketopentanoate (BKP) is a C5-ketone body of instant claims 14.
Roe teaches [0090] that the C5 ketone bodies BHP and BKP can be used directly for therapy.
Roe teaches that the odd carbon fatty acid compositions of the invention are ketogenic [0017], i.e. increase blood ketone levels, as in instant claims 7, 8, and ameliorate the effects of physical exertion ([0018], lines 1-9), which is consistent with lowering exertion during exercise in a subject, as in instant claims 13, 14.
Roe teaches [0089] administering odd carbon fatty acids that are converted or metabolized to the 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and 3-ketopentanoate (BKP). Administration of the 5 carbon ketone bodies BHP and/or BKP in the form of either free ketone bodies or in other forms capable of providing the free ketones in vivo after administration; such forms of BHP and/or BKP as a triglyceride form/ester, or a salt form, can be used [0089].
Thus, Roe teaches that odd carbon fatty acids can be administered interchangeably with 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and 3-ketopentanoate (BKP), to provide free ketones in vivo after administration.
Roe teaches that odd chain fatty acids C5, C7 or C15 [0057] are ketogenic [0058].
Roe exemplifies C7 as the source of odd fatty acids, provided as triheptanoin [0059], and teaches [0124] that after initiating the triheptanoin diet, the subject (unable to walk before administration of diet) was running; thus, Roe teaches lowering exertion during exercise which is running, as in instant claim 15.
Roe exemplifies [0084] formulations comprising odd chain fatty acid C5, which is a short chain fatty acid of instant claims 9, 17, and odd chain fatty acid C7, which is a medium chain fatty acid of instant claims 9, 17.
Roe does not teach that the C5 ketone body is administered in a dosage amount of 10g per administration, as in the instant claims.
Roe does not teach lowering exertion during sprinting, as in instant claim 16, upon administration of C5 ketone bodies.
Roe does not teach administering an additional compound, such as a short or medium fatty acid, or an ester of a medium chain fatty acid, to the individual, in addition of the C5 ketone body, to increase blood ketone levels and lower exertion during exercise, as in instant claims 9, 17.
Schiffmann et al. (US 2011/0306663) teach ketogenic [0047] pharmaceutical compositions comprising odd-chain fatty acids C5, C7, C9, C11, C13 and/or C15 [0046].
Schiffmann teaches [0072], [0074] combinations of odd chain fatty acids C5, C7, C9, C11, C13 and/or C15 in a formulation, such as odd-chain fatty acid C7 and odd-chain fatty acid C15, which are medium and long chain fatty acids, as in instant claims 9, 17.
Schiffmann also teaches [0077] that the compositions of the invention contain stearic acid, which is a long chain fatty acid.
When using C7 as the source of odd fatty acids, these can be provided as triglyceride triheptanoin [0048]. Schiffmann teaches [0089] that after ingestion of triheptanoin, peripheral tissues receive heptanoate and C5 ketone bodies.
Schiffmann teaches that triheptanoin supplementation improved motor performance /physical performance, which includes lowering exertion during exercise.
D’Agostino (US 2014/0350105, cited in PTO-892) teaches a method of increasing blood ketone levels [0032]-[0033] in a subject (relevant to claims 7-9) by administering to the subject beta-hydroxybutyrate, which is a direct homolog of the C5-ketone body 3-hydroxypentanoate of the instant claims, in an amount of between 5 g to 30 g, or between 10 g to 20 g, or 10 g [0033], in combination with at least one medium chain fatty acid or ester thereof.
D’Agostino teaches (Abstract) that the combination of beta-hydroxybutyrate and medium chain fatty acid or ester thereof was used to induce ketosis, achieving blood ketone levels of 2-7 mmol/l.
D’Agostino teaches that ketone supplementation has beneficial effects on physical performance [0032], and is used to enhance athletic performance, which is relevant to instant claim 13.
It would have been obvious to combine the teachings of Roe and Schiffmann to arrive at the instant invention.
The person of ordinary skill in the art would have administered C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) taught by Roe, to an individual, and would have measured exertion during exercise which is running or sprinting, before and after administration, because Schiffmann teaches that ketogenic compositions capable of providing the free ketones in vivo after administration improve motor performance/physical performance, and Roe teaches that ketogenic compositions of the invention, such as 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and 3-ketopentanoate (BKP), or odd carbon fatty acid C5, C7 or C15 which are converted or metabolized to the 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and 3-ketopentanoate (BKP) in vivo upon administration, ameliorate the effects of physical exertion. Thus, a person of ordinary skill in the art would have administered C5 ketone body to an individual, with a reasonable expectation that said administration will lower exertion during exercise such as running or sprinting in the individual.
Further, regarding claims 9, 17, a person of ordinary skill in the art would have co-administered to an individual C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) taught by Roe, and a medium chain fatty acid C7 or ester thereof, because Roe and Schiffmann teach that C7 fatty acid or esters such as triheptanoin provide C5 ketone bodies upon in vivo after administration. Thus, the person of ordinary skill in the art would have co-administered to a subject C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) and a medium chain fatty acid C7 or ester thereof, with the expectation that the combination increases physical performance levels/motor performance, lowers exertion during exercise in the individual, and increases blood ketone levels in the individual. Since all compounds for co-administration herein are known to be useful to increase blood ketone levels, increase motor performance, and lower exertion during exercise in the individual, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Since Schiffmann teaches that C7 fatty acid or esters such as triheptanoin provide C5 ketone bodies upon in vivo after administration, the person of ordinary skill in the art would have co-administered to a subject C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP), and a medium chain fatty acid C7 or ester thereof, with the expectation that the combination is effective to increase blood ketone levels, and ketone body supplementation results in increased physical performance/ lower exertion during exercise in the subject.
Further, it would have been obvious to combine the teachings of Roe and D’Agostino to arrive at the instant invention. The person of ordinary skill in the art would have replaced beta-hydroxybutyrate with its direct homolog C5 keto body 3-hydroxypentanoate (BHP), in a combination with medium fatty acids or ester thereof taught by D’Agostino, with the expectation that the resulting combination is effective to increase blood ketone levels and to increase physical performance/ lower exertion during exercise in the subject.
In the absence of unexpected results, stereoisomers are considered obvious variants of each other. "Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties". In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
With respect to the amount of C5 keto body 3-hydroxypentanoate (BHP) to be administered, the person of ordinary skill in the art would have determined the therapeutic dose of BHP to be administered orally, starting with the amounts of ketone source disclosed by D’Agostino [0033], so that a state of ketosis is achieved corresponding to blood ketone levels of 2-7 mmol, as taught by D’Agostino.
As such, claims 7-9, 13-17 are rejected as prima facie obvious.
Claims 1-6, 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Roe, C. (US 2013/0005818, cited in PTO-892 of 31 March 2025), in view of Martin et al. (US 6,380,244, cited in IDS), Schiffmann et al. (US 2011/0306663, cited in IDS), D’Agostino (US 2014/0350105, cited in PTO-892), in further view of Luckose et al. (Critical Reviews in Food Science and Nutrition 2015, 55 (13), 1793-1807, cited in PTO-892) and Carneiro et al. (Journal of Nutritional Biochemistry 2009, 20, 503-511, cited in PTO-892).
Roe teaches [0089] a method of administering to a subject 5 carbon ketone bodies
3-hydroxypentanoate (BHP) or 3-ketopentanoate (BKP), which are C5-ketone bodies of instant claims 1, 2, 10, 11, in the form of free ketone bodies, which provides the free ketones in vivo after administration [0089], which is consistent with a method for increasing blood ketone levels in a subject.
3-ketopentanoate (BKP) is a C5-ketone body of instant claims 2, 11.
Roe teaches [0090] that the C5 ketone bodies BHP and BKP can be used directly for therapy.
Roe teaches that the odd carbon fatty acid compositions of the invention are ketogenic [0017], i.e. increase blood ketone levels, and increase energy [0014, last five lines], as in instant claim 4, and ameliorate the effects of physical exertion ([0018], lines 1-9), which is consistent with increasing physical performance, as in instant claims 1, 2.
Roe teaches [0089] administering odd carbon fatty acids that are converted or metabolized to the 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and 3-ketopentanoate (BKP). Administration of the 5 carbon ketone bodies BHP and/or BKP in the form of either free ketone bodies or in other forms capable of providing the free ketones in vivo after administration; such forms of BHP and/or BKP as a triglyceride form, or a salt form, can be used [0089].
Thus, Roe teaches that active agent odd carbon fatty acids can be administered interchangeably with 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and 3-ketopentanoate (BKP), to provide free ketones in vivo after administration.
Roe teaches that odd chain fatty acids C5, C7 or C15 [0057] are ketogenic [0058].
Roe exemplifies [0084] formulations comprising odd chain fatty acid C5, which is a short chain fatty acid of instant claims 6, 12, and odd chain fatty acid C7, which is a medium chain fatty acid of instant claims 6, 12.
Roe teaches [0016] that the odd-chain fatty acid or ketone is administered in a composition that further includes a nutritionally effective amount of branched amino acids. The genus of branched amino acids encompasses leucine.
Roe does not teach a method of increasing mental performance, as in instant claim 1, as a measure of well-being, as in instant claim 3, or increasing focus, as in instant claim 5, with 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and/or 3-ketopentanoate (BKP).
Roe does not teach that the C5 ketone body is administered in a dosage amount of 10g per administration, as in the instant claims.
Roe does not teach that administering C5 ketone body to an individual decreases blood glucose levels in the individual, as in instant claims 10-11.
Roe does not teach administering an additional compound, such as an ester of a medium chain fatty acid, to the individual, in addition of the C5 ketone body, as in instant claims 6, 12.
Roe does not teach taurine being administered in combination with the C5 ketone body, as in the instant claims.
Martin (US 6,380,244) teaches that administering 3-hydroxyacid esters or oligomers to a subject elevates the ketone bodies concentration in the blood, and decreases the blood glucose concentration in the subject (Example 2), as in instant claims 10, 11.
Martin teaches (column 4, lines 19-26) nutritional compositions comprising 3-hydroxyacids, esters of 3-hydroxyacids [0042], or oligomers of 3-hydroxyacids; preferred 3-hydroxyacids include, for example, 3-hydroxyvaleric acid, which is a C5 keto body of the instant claims. Martin teaches that increasing blood ketone levels is useful for example, for treatment of diabetes and insulin resistant states (column 3, lines 58-63).
Schiffmann et al. (US 2011/0306663) teach ketogenic [0047] pharmaceutical compositions comprising odd-chain fatty acids C5, C7, C9, C11, C13 and/or C15 [0046].
Schiffmann teaches [0072], [0074] combinations of odd chain fatty acids C5, C7, C9, C11, C13 and/or C15 in a formulation, such as odd-chain fatty acid C7 and odd-chain fatty acid C15, which are medium and long chain fatty acids, as in instant claims 6, 12.
Schiffmann also teaches [0077] that the compositions of the invention contain stearic acid, which is a long chain fatty acid.
When using C7 as the source of odd fatty acids, these can be provided as triglyceride triheptanoin [0048]. Schiffmann teaches [0089] that after ingestion of triheptanoin, peripheral tissues receive heptanoate and C5 ketone bodies; brain uptake of ketone bodies has been demonstrated in humans [0089].
Schiffmann teaches that triheptanoin supplementation improved motor performance (physical performance mas in instant claim 1) and quality of life (well-being as in instant claim 3).
Schiffmann teaches that the dietary off chain fatty acids of the invention increase mental focus, as in instant claim 5.
D’Agostino (US 2014/0350105, cited in PTO-892) teaches a method of increasing blood ketone levels [0032]-[0033] in a subject by administering to the subject beta-hydroxybutyrate, which is a direct homolog of the C5-ketone body 3-hydroxypentanoate of the instant claims, in an amount of between 5 g to 30 g, or between 10 g to 20 g, or 10 g [0033], in combination with at least one medium chain fatty acid or ester thereof.
D’Agostino teaches (Abstract) that the combination of beta-hydroxybutyrate and medium chain fatty acid or ester thereof was used to induce ketosis, achieving blood ketone levels of 2-7 mmol/l.
D’Agostino teaches that ketone supplementation has beneficial effects on cognitive and physical performance [0011], which is relevant to instant claim 1, and reduction of blood glucose levels (Abstract), which is relevant to claim 10.
Luckose et al. (Critical Reviews in Food Science and Nutrition 2015, 55 (13), 1793-1807, cited in PTO-892) teach that taurine is ergogenic (Table 1), thus increases the capacity of the body or mind to perform a task, which is relevant to claim 1. Luckose teaches that taurine is used as a performance enhancing ingredient (page 1795, right column, first paragraph; also page 17907, left column, under Taurine and exercise performance; also page 1800, right column, last paragraph, page 1801, first paragraph).
Carneiro et al. (Journal of Nutritional Biochemistry 2009, 20, 503-511, cited in PTO-892) teach that taurine supplementation modulates glucose homeostasis, which is relevant to claim 10.
It would have been obvious to combine the teachings of Roe, Martin, Schiffmann, D’Agostino, Luckose and Carneiro to arrive at the instant invention.
The person of ordinary skill in the art would have administered C5 keto bodies 3-hydroxypentanoate (BHP) or 3-ketopentanoate (BKP) taught by Roe, to an individual, and would have measured mental performance levels, including well-being, or focus, before and after administration, because Schiffmann teaches that ketogenic compositions capable of providing the free ketones in vivo after administration improve not only motor performance (physical performance as in instant claim 1) but also quality of life (well-being as in instant claim 3), and increase mental focus, as in instant claim 5. Thus, a person of ordinary skill in the art would have administered C5 ketone body to an individual, with a reasonable expectation that said administration will improve quality of life/ well-being, and increase mental focus, thus increasing mental performance in the individual.
Further, the person of ordinary skill in the art would have administered C5 keto bodies 3-hydroxypentanoate (BHP) or 3-ketopentanoate (BKP) taught by Roe, to an individual, and would have measured blood glucose levels in the individual before and after administration, because Martin teaches that administering 3-hydroxyacid esters to a subject elevates the ketone bodies concentration in the blood and decreases the blood glucose concentration in the subject (Example 2), as in instant claims 10, 11. Thus, a person of ordinary skill in the art would have administered C5 ketone body to an individual, with a reasonable expectation that said administration will decrease blood glucose levels in the individual, as in instant claims 10, 11.
Further, regarding claims 6, 12, a person of ordinary skill in the art would have co-administered to an individual C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) taught by Roe, and a medium chain fatty acid C7 or ester thereof, because Roe and Schiffmann teach that C7 fatty acid or esters such as triheptanoin provide C5 ketone bodies upon in vivo after administration. Thus, the person of ordinary skill in the art would have co-administered to a subject C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) and a medium chain fatty acid C7 or ester thereof, with the expectation that the combination increases mental performance levels/focus, or increases physical performance levels/motor performance, decreases blood glucose levels in the individual, and increases blood ketone levels in the individual. Since all compounds for co-administration herein are known to be useful to increase blood ketone levels, increase mental performance, increase motor performance, decrease blood glucose levels, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Since Schiffmann teaches that C7 fatty acid or esters such as triheptanoin provide C5 ketone bodies upon in vivo after administration, the person of ordinary skill in the art would have co-administered to a subject C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP), and a medium chain fatty acid C7 or ester thereof, with the expectation that the combination is effective to increase blood ketone levels, and ketone body supplementation results in greater mental clarity, improvement in cognitive performance, increasing physical performance in the subject.
Further, it would have been obvious to combine the teachings of Roe and D’Agostino to arrive at the instant invention. The person of ordinary skill in the art would have replaced beta-hydroxybutyrate with its direct homolog C5 keto body 3-hydroxypentanoate (BHP), in a combination with medium fatty acids or ester thereof taught by D’Agostino, with the expectation that the resulting combination is effective to increase blood ketone levels, to increase cognitive and physical performance, as in instant claim 1, and to reduce blood glucose levels, as in instant claim 10.
In the absence of unexpected results, stereoisomers are considered obvious variants of each other. "Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties". In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
With respect to the amount of C5 keto body 3-hydroxypentanoate (BHP) to be administered, the person of ordinary skill in the art would have determined the therapeutic dose of BHP to be administered orally, starting with the amounts of ketone source disclosed by D’Agostino [0033], so that a state of ketosis is achieved corresponding to blood ketone levels of 2-7 mmol, as taught by D’Agostino.
Further, regarding claim 1, a person of ordinary skill in the art would have co-administered to an individual C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) taught by Roe, and taurine, because Luckose teaches that taurine is ergogenic, thus increases the capacity of the body or mind to perform a task. Thus, the person of ordinary skill in the art would have co-administered to a subject C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) and taurine, with the expectation that the combination increases physical performance levels/motor performance. Since all compounds for co-administration herein are known/expected to be useful to increase blood ketone levels and increase physical performance, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Regarding claim 10, a person of ordinary skill in the art would have co-administered to an individual C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) taught by Roe, and taurine, because Carneiro teaches that taurine supplementation modules glucose homeostasis. Thus, the person of ordinary skill in the art would have co-administered to a subject C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) and taurine, with the expectation that the combination decreases blood glucose levels in the subject. Since all compounds for co-administration herein are known/expected to be useful to increase blood ketone levels and decrease blood glucose levels/modulated glucose homeostasis, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
As such, claims 1-6, 10-12 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 1-17 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 of 31 March 2025), in view of Schiffmann et al. (US 2011/0306663, cited in IDS). 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 is drawn to a method for increasing blood ketone levels in an individual, by 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; wherein the composition is administered orally to increase blood ketone levels in the subject. Claims 10 and dependent claims 11, 18-20 of U.S. Patent No. 11,337,945 are drawn to a composition for […] increasing blood ketone levels in an individual, the composition consisting essentially of: about 1 g to about 20 g of a C5-ketone or salt thereof, wherein the C5 ketone or salt thereof comprises at least one of β-hydroxypentanoate or β-ketopentanoate. There is substantial overlap between claim 8 and claims 10-11, 18-20 of U.S. Patent No. 11,337,945, and instant claims 7-8, which are drawn to a method of increasing blood ketone levels in a subject by administering to the subject a C5 ketone body (claim 7) which is β-hydroxypentanoate (claim 8).
Claim 12 of U.S. Patent No. 11,337,945 depends on claim 1 and teaches that administering a composition comprising 1 to 50 g of β-hydroxypentanoate or salt thereof, to an individual to aid in fat loss or weight loss (claim 1), increases mental performance levels, or increases physical performance levels as in instant claim 1, or lowers exertion during exercise in the individual, as in instant claim 13; claim 6 of U.S. Patent No. 11,337,945 teaches that administering a composition comprising 1 to 50 g of β-hydroxypentanoate or salt thereof, to aid in fat loss or weight loss (claim 1), decreases blood glucose levels in the individual, as in instant claim 10. Claim 2 of U.S. Patent No. 11,337,945 teaches that the composition comprising 1 to 50 g of β-hydroxypentanoate or salt thereof, used in the method of claim 1, further comprises β-ketopentanoate, as in instant claims 2, 10, 14.
It would have been obvious to use the teachings of claims 1-8, 10-14, 18-20 of U.S. Patent No. 11,337,945 to arrive at the instant invention. The person of ordinary skill in the art would have administered to an individual a composition comprising 1 to 50 g of β-hydroxypentanoate or salt thereof, the composition further comprising β-ketopentanoate, with the expectation that said administration increases mental performance levels, or increases physical performance levels as in instant claim 1, lowers exertion during exercise in the individual, as in instant claim 13, decreases blood glucose levels in the individual, as in instant claim 10, and increases blood ketone levels in an individual, as in instant claim 7.
Regarding instant claims 6, 9, 12, 17, Schiffmann et al. (US 2011/0306663) teach ketogenic [0047] pharmaceutical compositions comprising odd-chain fatty acids C5, C7, C9, C11, C13 and/or C15 [0046].
Schiffmann teaches [0072], [0074] combinations of odd chain fatty acids C5, C7, C9, C11, C13 and/or C15 in a formulation, such as odd-chain fatty acid C7 and odd-chain fatty acid C15, which are medium and long chain fatty acids, as in instant claims 6, 9, 12, 17.
Schiffmann also teaches that, when using C7 as the source of odd fatty acids, these can be provided as triglyceride triheptanoin [0048]. Schiffmann teaches [0089] that after ingestion of triheptanoin, peripheral tissues receive heptanoate and C5 ketone bodies; brain uptake of ketone bodies has been demonstrated in humans [0089].
Schiffmann teaches that triheptanoin supplementation improved motor performance (physical performance mas in instant claim 1) and quality of life (well-being as in instant claim 3).
Schiffmann teaches that the dietary off chain fatty acids of the invention increase mental focus, as in instant claim 5.
Regarding instant claims 6, 9, 12, 17, it would have been obvious to combine the teachings of claims of U.S. Patent No. 11,337,945 and Schiffmann to arrive at the instant invention. The person of ordinary skill in the art would have added a medium chain fatty acid C7 or ester thereof, to a composition comprising 1 to 50 g of β-hydroxypentanoate or salt thereof, the composition further comprising β-ketopentanoate, and would have administered said composition to an individual, with the expectation that said administration increases mental performance levels/focus, or increases physical performance levels/motor performance, lowers exertion during exercise in the individual, decreases blood glucose levels in the individual, and increases blood ketone levels in the individual. Since all compounds for co-administration herein are known to be useful to increase blood ketone levels, increase mental performance, increase motor performance, decrease blood glucose levels, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Since Schiffmann teaches that C7 fatty acid or esters such as triheptanoin provide C5 ketone bodies upon in vivo after administration, which is consistent with a method for increasing blood ketone levels in a subject, the person of ordinary skill in the art would have co-administered to a subject β-hydroxypentanoate or salt thereof, β-ketopentanoate, and a medium chain fatty acid C7 or ester thereof, with the expectation that the combination is effective to increase blood ketone levels, and ketone body supplementation results in greater mental clarity, improvement in cognitive performance, increasing physical performance in the subject.
As such, the instant claims are rendered obvious by claims of U.S. Patent No. 11,337,945.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-3, 13-21, 25-30 of copending Application No. 18/157,788 (reference application) in view of Schiffmann et al. (US 2011/0306663, cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3, 13-21, 25-30 of copending Application No. 18/157,788 render obvious the instant claims.
Claims 1-3, 13-21 of copending Application No. 18/157,788 are drawn to a composition comprising more than 0% and less than 100% wt. of at least one C5 ketone body and a carrier; claim 2 recites that the C5 ketone body is selected from β-hydroxypentanoate or a salt thereof, β-ketopentanoate or a salt thereof; claim 3 recites enantiomers of β-hydroxypentanoate, β-ketopentanoate, which are inherently present in β-hydroxypentanoate, β-ketopentanoate, respectively; claims 13-21 recite that the ketone body is one or more salt of the C5 ketone body, or one or more acid of the C5 ketone body, where the acid of the C5 ketone body is selected from β-hydroxypentanoic acid, β-ketopentanoic acid, or combinations thereof (claim 20). The Specification of copending Application No. 18/157,788 teaches [0038] that administration of a composition of the invention increases blood ketone levels (as in instant claims 7, 8), improves mental acuity (as in instant claim 1); improves focus (as in instant claims 5); improves energy (as in instant claim 4); improves cognitive function; decrease blood glucose levels (as in instant claims 10-11); improve performance and strength (which lead to lowering exertion during exercise, as in instant claims 13-16); improves mood and/or well-being (as in instant claim 3).
Claims 25-27 of copending Application No. 18/157,788 are drawn to a method for increasing blood ketone levels (as in instant claims 7-8) in an individual with a composition comprising more than 0% and less than 100% wt. of at least one C5 ketone body and a carrier; claim 26, 27 recite that the C5 ketone body comprises a non-racemic mixture of β-hydroxypentanoate enantiomers (claim 26), or a non-racemic mixture of β-ketopentanoate enantiomers (claim 27).
Claims 28-30 of copending Application No. 18/157,788 are drawn to a method of restoring cognitive function, which could be read as a method of increasing mental performance (as in instant claim 1), in an individual with a composition comprising more than 0% and less than 100% wt. of at least one C5 ketone body and a carrier; claim 29, 30 recite that the C5 ketone body comprises a non-racemic mixture of β-hydroxypentanoate enantiomers (claim 29), or a non-racemic mixture of β-ketopentanoate enantiomers (claim 30).
It would have been obvious to use the teachings of claims 1-3, 13-21, 25-30 of copending Application No. 18/157,788 to arrive at the instant invention. The person of ordinary skill in the art would have administered to an individual a composition comprising more than 0% and less than 100% wt. of at least one C5 ketone body and a carrier, where the C5 ketone body is selected from β-hydroxypentanoate or a salt thereof, β-ketopentanoate or a salt thereof, or enantiomers, with the expectation that said administration increases mental performance levels, or increases physical performance levels as in instant claim 1, lowers exertion during exercise in the individual, as in instant claim 13, decreases blood glucose levels in the individual, as in instant claim 10, and increases blood ketone levels in an individual, as in instant claim 7.
Regarding instant claims 6, 9, 12, 17, Schiffmann et al. (US 2011/0306663) is as above.
Regarding instant claims 6, 9, 12, 17, it would have been obvious to combine the teachings of claims 1-3, 13-21, 25-30 of copending Application No. 18/157,788 and Schiffmann to arrive at the instant invention. The person of ordinary skill in the art would have added a medium chain fatty acid C7 or ester thereof (taught by Schiffmann), to a composition comprising more than 0% and less than 100% wt. of at least one C5 ketone body selected from β-hydroxypentanoate or salt thereof, β-ketopentanoate or salt thereof, and would have administered said composition to an individual, with the expectation that said administration increases mental performance levels/focus, or increases physical performance levels/motor performance, lowers exertion during exercise in the individual, decreases blood glucose levels in the individual, and increases blood ketone levels in the individual. Since all compounds for co-administration herein are known to be useful to increase blood ketone levels, increase mental performance, increase motor performance, decrease blood glucose levels, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Since Schiffmann teaches that C7 fatty acid or esters such as triheptanoin provide C5 ketone bodies upon in vivo after administration, which is consistent with a method for increasing blood ketone levels in a subject, the person of ordinary skill in the art would have co-administered to a subject β-hydroxypentanoate or salt thereof, β-ketopentanoate, and a medium chain fatty acid C7 or ester thereof, with the expectation that the combination is effective to increase blood ketone levels, and ketone body supplementation results in greater mental clarity, improvement in cognitive performance, increasing physical performance in the subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-20 of copending Application No. 18/319,334 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 of copending Application No. 18/319,334 render obvious the instant claims.
Claims 1-20 of copending Application No. 18/319,334 are drawn to a method of treating cognitive impairment in an individual with a composition comprising more than 0% and less than 100% wt. of at least one C5 ketone body and a carrier; claims 3, 4 recite that the C5 ketone body is selected from β-hydroxypentanoate or a salt thereof, β-ketopentanoate or a salt thereof; claim 5 recites that the ketone body is one or more salt of the C5 ketone body, or one or more acid of the C5 ketone body, where the acid of the C5 ketone body is selected from β-hydroxypentanoic acid, β-ketopentanoic acid, or combinations thereof (claim 9); claims 10-11 recite that the composition further comprises one or more lipids as one or more medium chain fatty acid having from 6 to 12 C atoms or a mono, di or triglyceride derivative thereof (as in instant claim 6).
It would have been obvious to use the teachings of claims 1-20 of copending Application No. 18/319,334 to arrive at the instant invention. The person of ordinary skill in the art would have administered to an individual a composition comprising more than 0% and less than 100% wt. of at least one C5 ketone body and a carrier, where the C5 ketone body is selected from β-hydroxypentanoate or a salt thereof, β-ketopentanoate or a salt thereof, with the expectation that said administration, which is taught by claims 1-20 of copending Application No. 18/319,334 to be effective to increase cognitive function, will be effective to increase mental performance levels, including focus and well-being, in the individual.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-12, 16 of copending Application No. 18/225,093 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12, 16 of copending Application No. 18/225,093 render obvious the instant claims.
Claims 1-12, 16 of copending Application No. 18/225,093 are drawn to a method of treating metabolic dysfunction, by treating symptoms of metabolic impairment in an individual having type 2 diabetes, including hyperglycemia (claim 16), with a composition comprising more than 0% and less than 100% wt. of at least one C5 ketone body and a carrier; claims 3, 4 recite that the C5 ketone body is selected from β-hydroxypentanoate or a salt thereof, β-ketopentanoate or a salt thereof; claim 5 recites that the ketone body is one or more salt of the C5 ketone body, or one or more acid of the C5 ketone body, where the acid of the C5 ketone body is selected from β-hydroxypentanoic acid, β-ketopentanoic acid, or combinations thereof (claim 9); claims 10-11 recite that the composition further comprises one or more lipids as one or more medium chain fatty acid having from 6 to 12 C atoms or a mono, di or triglyceride derivative thereof (as in instant claim 12).
It would have been obvious to use the teachings of claims 1-12, 16 of copending Application No. 18/225,093 to arrive at the instant invention. The person of ordinary skill in the art would have administered to an individual a composition comprising more than 0% and less than 100% wt. of at least one C5 ketone body and a carrier, where the C5 ketone body is selected from β-hydroxypentanoate or a salt thereof, β-ketopentanoate or a salt thereof, with the expectation that said administration, which is taught by claims 1-12, 16 of copending Application No. 18/225,093 to be effective to treat hyperglycemia, will be effective to decrease blood glucose levels in the individual.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-17 are rejected.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629