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
Claims 1-42 are pending in the instant application.
Claims 1-16, 23-26, 36-39 are withdrawn, as being drawn to a non-elected invention or to a non-elected species.
Claims 17-22, 27-35, 40-42 are examined herein.
Priority
This application is a Continuation of U.S. Patent Application 18/329,539, filed on 5 June 2023.
Information Disclosure Statement
No information disclosure statement (IDS) has been submitted.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 17-42, drawn to a composition comprising: a plurality of medium-chain triglycerides; a plurality of amino acids; a plurality of forms of beta-hydroxybutyrate, in the reply filed on 22 January 2026, is acknowledged. Claims 1-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Applicant’s election without traverse of a mixture of sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, and magnesium beta-hydroxybutyrate, as the specific mixture/plurality of beta-hydroxybutyrate forms; the election of caprylic acid as the medium chain triglyceride; and the election of L-carnitine fumarate as the amino acid, in the reply filed on 22 January 2026, is acknowledged. Claims 17-22, 27-35, 40-42 read on the elected species. Claims 23-26, 36-39 are withdrawn, as being drawn to a non-elected species.
Since the Applicant did not put forth any arguments against the requirement for restriction/election, the election is treated as an election without traverse and the restriction requirement is herein made FINAL.
Claims 17-22, 27-35, 40-42 have been examined to the extent they read on the elected species, and the following objections and rejections are made below.
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 22, 35 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 22 is drawn to “the composition of claim 21, wherein the salt cation”; yet, claim 21 does not recite a salt cation. As such, there is insufficient antecedent basis for the term “the salt cation” of claim 22, in claim 21.
Similar analysis applies to claim 35.
Appropriate correction is required.
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.
Claim interpretation: the term “a plurality” in the claims is interpreted to be two or more.
Claims 17-19, 21-22, 27-32, 34-35, 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. (US 2014/0350105, cited in PTO-892) and Henderson (US 2008/0287372, cited in PTO-892), in view of Jaffe (US 2007/0243211, cited in PTO-892).
D’Agostino teaches a composition comprising ([0033], claim 1)
at least one beta-hydroxybutyrate compound, wherein the beta-hydroxybutyrate compound comprises one or more of: a beta-hydroxybutyrate salt comprising, for example, sodium beta-hydroxybutyrate, potassium beta- hydroxybutyrate, calcium beta- hydroxybutyrate, magnesium beta-hydroxybutyrate, as in instant claims 21, 22, 34, 35; or a salt mixture further comprising beta-hydroxy butyrate sodium salt, beta- hydroxy butyrate potassium salt, beta-hydroxy butyrate calcium salt, beta- hydroxy butyrate magnesium salt or combination thereof; and
at least one medium chain fatty acid or ester thereof [0033], such as medium chain triglyceride [0037], including caprylic acid, as in instant claims 18, 31.
The ketone precursor beta-hydroxybutyrate compounds are administered at between 2 g and 50 g, or between 10 grams and 20 grams [0033].
The at least one medium chain triglyceride is administered at between 5 g and 50 g [0037].
D’Agostino teaches [0039] that the ketone precursors are preferably ingested along with nutritional substrates such as, for example, amino acids such as branched amino acids (leucine, isoleucine, valine) and carnitine that assists in mitochondrial function.
D’Agostino teaches (claim 15) a composition comprising
at least one beta-hydroxybutyrate (BHB) compound which is sodium salt of beta-hydroxybutyrate and potassium salt of beta-hydroxybutyrate, as in instant claims 21, 22, 34, 35, and
at least one medium chain triglyceride (MCT),
wherein the at least one MCT and BHB salt mixture is present at a ratio of 1:1.
D’Agostino teaches [0040] that the BHB/MCT composition is used as brain tonic, or anti-aging supplement. A combination BHB/MCT is administered in a range 1:1 to 1:2 mixture to elevate blood ketone to a level that would be considered nutritional ketosis.
D’Agostino teaches [0041] that the preferred route of administration of the mixture of beta-hydroxybutyrate salts and MCT oil is oral, delivered for example as a tablet/ingestible pill, as in instant claim 17.
D’Agostino teaches that the compositions of the invention can be used as an adjunct to a ketogenic diet [0040]; further, ketone supplementation results in greater mental clarity, improvement in cognitive performance [0010].
D’Agostino does not teach that the medium chain triglycerides are present in the composition at 0.1 to 2 grams, as in instant claim 27, 40, that the amino acids are at 0.1 to 1 grams, as in instant claims 28, 41, and that the beta-hydroxybutyrate forms are at a concentration of 10-40% of the composition, as in instant claims 29, 42.
D’Agostino does not teach that carnitine is provided in the form of L-carnitine fumarate, as in instant claims 20, 33.
Henderson (US 2008/0287372, cited in PTO-892) teaches a composition for oral administration capable of elevating ketone body concentrations in a mammal (ketogenic), comprising medium chain triglycerides (MCT) for treatment of age-associated memory impairment/cognitive decline [0015].
Henderson teaches [0034] that the MCT contains greater than 95% C8 at R1, R2, R3 in chemical formula [0033], which is consistent with the medium chain triglycerides comprising caprylic acid, as in instant claims 18, 31.
Henderson teaches [0050] co-administration of a composition comprising at least one compound capable of elevating ketone body concentrations, such as MCT and L-carnitine or a derivative of L-carnitine.
Henderson teaches that MCT is combined with L-carnitine at doses required to increase the utilization of MCT.
Henderson exemplifies a composition for oral supplementation comprising [0119] MCT 0.1-50 g, L-carnitine 250-500 mg, where the amounts overlap with the ranges in instant claims 27, 28, 40, 41.
Henderson exemplifies [0121] a composition for oral supplementation as tablet/ingestible pill (as in instant claim 17) comprising MCT 0.1-1000 mg tablet, L-carnitine 250-500 mg, where the amounts overlap with the ranges in instant claims 27, 28, 40, 41.
Henderson further teaches [0056] that ketone body precursor compounds appropriate for the present invention include any compound capable of directly elevating ketone body concentration, such as, for example, D-beta-hydroxybutyrate.
Henderson teaches that compositions of the invention are in the form of, for example, ingestible tablet/pill, or parenteral solution (claim 24).
Henderson does not specifically teach that the composition is for transdermal supplementation, as in instant claims 30-35, 40-42.
Henderson does not exemplify a composition comprising a plurality of forms of beta-hydroxybutyrate, added to a plurality of MCT and a plurality of amino acids, as in the instant claims.
Henderson does not specifically teach that carnitine is provided in the composition in the form of L-carnitine fumarate, as in instant claims 20, 33.
D’Agostino and Henderson do not teach that the composition is for transdermal supplementation, as in instant claims 30-35, 40-42.
Jaffe (US 2007/0243211) teaches a composition comprising one or more medium chain triglycerides and L-carnitine (claims 1, 2), wherein the composition of the invention is administered orally, or transdermally, or topically to the skin [0166], [0168], as gels [0104]; the composition comprises MCTs, which are ketogenic [0113]; the metabolism of MCT in hepatocytes produces ketone body beta-hydroxybutyrate.
It would have been obvious to combine the teachings of D’Agostino and Henderson to arrive at the instant invention. The person of ordinary skill in the art would have co-administered beta-hydroxybutyrate salts as plurality of forms of beta-hydroxybutyrate, together with medium chain triglycerides and a plurality of amino acids including carnitine, because
D’Agostino teaches a composition used as brain tonic, or anti-aging supplement, comprising ketone precursors as a mixture/combination of sodium beta-hydroxybutyrate, potassium hydroxybutyrate, calcium beta-hydroxybutyrate, or/and magnesium hydroxybutyrate, and at least one medium chain triglyceride, including caprylic acid,
where the ketone precursors are ingested along with amino acids such as branched amino acids (leucine, isoleucine, valine) and carnitine,
and Henderson teaches a ketogenic composition for treatment of age-associated memory impairment/cognitive decline, comprising medium chain triglycerides comprising caprylic acid,
and L-carnitine or a derivative of L-carnitine, where the composition may further include any compound capable of directly elevating ketone body concentration, such as, for example, D-beta-hydroxybutyrate.
Thus, the person of ordinary skill in the art would have co-administered in a composition the salts of beta-hydroxybutyrate taught by D’Agostino with the MCT comprising caprylic acid and amino acids such as carnitine taught by Henderson to a subject in need of a brain tonic/anti-aging supplement to treat age-related cognitive decline, with the expectation that said co-administration/composition is ketogenic and is therapeutically effective to treat age-related cognitive decline.
Regarding claims 27-29, 40-42, the person of ordinary skill in the art would have prepared a ketogenic composition by combining BHB/MCT in a range 1:1 to 1:2, as taught by D’Agostino, and would have used the relative amounts/ratio of MCT and L-carnitine or derivative thereof in the composition taught by Henderson, MCT 0.1-1000 mg, L-carnitine 250-500 mg, with the expectation that the resulting composition maintains ketogenic properties and is effective to treat age-related cognitive decline.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). MPEP 2144.05.
It is well within the skill of the art to determine the effective amount within a range through routine experimentation. It is noted that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.)
Regarding claims 30-35, 40-42, the person of ordinary skill in the art would have prepared the composition as an ingestible pill to be taken orally, or, alternatively, as a composition for transdermal supplementation, because Jaffe teaches ketogenic compositions comprising one or more medium chain triglycerides and L-carnitine administered orally, or transdermally, as gels. Thus, the person of ordinary skill in the art would have prepared a composition for transdermal administration containing the ingredients above, with a reasonable expectation of success.
As such, claims 17-19, 21-22, 27-32, 34-35, 40-42 are rejected as prima facie obvious.
Claims 17, 20, 30, 33 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino et al. (US 2014/0350105, cited in PTO-892) and Henderson (US 2008/0287372, cited in PTO-892) in view of Jaffe (US 2007/0243211, cited in PTO-892), as applied to claims 17, 30 above, in further view of Buononato (US 2003/0171417, cited in PTO-892).
D’Agostino and Henderson and Jaffe are as above.
Buononato (US 2003/0171417) teaches the advantages of using L-carnitine fumarate as a form of L-carnitine in pharmaceutical compositions.
Buononato teaches [0008] that l-carnitine fumarate is very stable and non-hygroscopic, without provoking gastrointestinal side effects. It was developed to overcome complex problems of storage and processing due to L-carnitine inner salt hygroscopicity.
Regarding claims 20, 33, the person of ordinary skill in the art would have used L-carnitine fumarate as a form of carnitine in the composition, because Buononato teaches the advantages of using L-carnitine fumarate as a form of L-carnitine in pharmaceutical compositions, namely L-carnitine fumarate is very stable and non-hygroscopic, without provoking gastrointestinal side effects. Thus, the person of ordinary skill in the art would have used L-carnitine fumarate as a form of carnitine in the composition, with the expectation of better stability and better humidity resistance over other forms of L-carnitine salts.
As such, claims 17, 20, 30, 33 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 17-22, 27-35, 40-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-4, 10-11, 16-17, 19-21, 23-26, 32-33, 38-39, 41-45, 51-52, 57-58, 60 of co-pending U.S. Patent Application No. 18/329,539 (cited in PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4, 10-11, 16-17, 19-21, 23-26, 32-33, 38-39, 41-45, 51-52, 57-58, 60 of co-pending U.S. Patent Application No. 18/329,539 render obvious the instant claims.
Claims 1-4, 10-11, 16-17, 19-21, 23-26, 32-33, 38-39, 41-45, 51-52, 57-58, 60 of co-pending U.S. Patent Application No. 18/329,539 recite a formulation comprising, among others, a plurality of medium-chain triglycerides; a plurality of amino acids; and a plurality of forms of beta-hydroxybutyrate, which are the very components in the instant composition. Claims 3-4, 25, 26, 44, 45 recite that the plurality of amino acids comprises carnitine, in the form of L-carnitine fumarate, as in instant claims 19, 20, 32, 33. Claims 10, 11, 32, 33, 51, 52 recite that the plurality of forms of beta-hydroxybutyrate comprises an ionic salt, wherein the salt cation comprises at least one of sodium, potassium, calcium, or magnesium, as in instant claims 21, 22, 34, 35. Claims 19, 41, 60 recite that at least one of the plurality of forms of beta- hydroxybutrate is present in a concentration between 10-40%, as in instant claims 29, 42. Claim 20 recites oral administration, and claim 23 recites an ingestible pill, as in instant claim 17; claim 21 recites transdermal administration, and claim 22 recites a composition for transdermal supplementation, comprising an aqueous gel, as in instant claim 30. Claims 17, 39, 58 recite that plurality of amino acids is between 0.1 and 1 grams, as in instant claims 28, 41.
Thus, there is considerable overlap between the composition in claims of co-pending U.S. Patent Application No. 18/329,539 and the composition in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 17-22, 27-35, 40-42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12-16, 18-21, 26-28, 30-33, 38-39 of U.S. Patent Application No. 18/338, 310 (cited in PTO-892) in view of Henderson (US 2008/0287372, cited in PTO-892).
Claims 1-6, 12-16, 18-21, 26-28, 30-33, 38-39 of U.S. Patent Application No.
18/338,310 recite a supplement formulation comprising therapeutically-effective amounts of:a plurality of amino acids;a plurality of forms of beta-hydroxybutyrate; claims 3-4, 18, 19 recite that the plurality of amino acids comprises carnitine, in the form of L-carnitine fumarate, as in instant claims 19, 20, 32, 33. Claims 5, 6, 20, 21 recite that the plurality of forms of beta-hydroxybutyrate comprises an ionic salt, wherein the salt cation comprises at least one of sodium, potassium, calcium, or magnesium, as in instant claims 21, 22, 34, 35. Claim 12 recites that at least one of the plurality of forms of beta- hydroxybutrate is present in a concentration between 10-40%, as in instant claims 29, 42. Claim 13 recites oral administration, and claim 16 recites an ingestible pill, as in instant claim 17; claim 14 recites transdermal administration, and claim 28 recites a composition for transdermal supplementation, comprising an aqueous gel, as in instant claim 30. Claim 26 recites that plurality of amino acids is between 0.1 and 1 grams, as in instant claims 28, 41.
Claims 1-6, 12-16, 18-21, 26-28, 30-33, 38-39 of U.S. Patent Application No. 18/338,310 do not recite a plurality of medium-chain triglycerides in the composition, as in the instant claims.
Henderson exemplifies a composition for oral supplementation comprising [0119] MCT 0.1-50 g, L-carnitine 250-500 mg, where the amounts overlap with the ranges in instant claims 27, 28, 40, 41.
Henderson exemplifies [0121] a composition for oral supplementation as tablet/ingestible pill (as in instant claim 17) comprising MCT 0.1-1000 mg tablet, L-carnitine 250-500 mg, where the amounts overlap with the ranges in instant claims 27, 28, 40, 41.
Henderson further teaches [0056] that ketone body precursor compounds appropriate for the present invention include any compound capable of directly elevating ketone body concentration, such as, for example, beta-hydroxybutyrate.
Henderson teaches that compositions of the invention are in the form of, for example, ingestible tablet/pill, or parenteral solution (claim 24).
It would have been obvious to combine the teachings of claims 1-6, 12-16, 18-21, 26-28, 30-33, 38-39 of U.S. Patent Application No. 18/338, 310 and Henderson to arrive at the instant invention. The person of ordinary skill in the art would have co-administered beta-hydroxybutyrate salts as plurality of forms of beta-hydroxybutyrate, together with medium chain triglycerides and a plurality of amino acids including carnitine, because
claims 1-6, 12-16, 18-21, 26-28, 30-33, 38-39 of U.S. Patent Application No. 18/338, 310 teach a composition comprising a plurality of amino acids, such as carnitine, or its form L-carnitine fumarate, and a plurality of forms of beta-hydroxybutyrate; present in the amounts in the instant claims, and
Henderson teaches a composition comprising medium chain triglycerides comprising caprylic acid, and L-carnitine or a derivative of L-carnitine, where the composition may further include any compound capable of directly elevating ketone body concentration, such as, for example, beta-hydroxybutyrate.
Thus, the person of ordinary skill in the art would have added MCT to the composition of claims 1-6, 12-16, 18-21, 26-28, 30-33, 38-39 of U.S. Patent Application No. 18/338, 310, using the relative amounts of MCT and carnitine taught by Henderson, with the expectation that the resulting composition is ketogenic.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 17-22, 27-35, 40-42 are rejected.
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/IRINA NEAGU/ Primary Examiner, Art Unit 1629
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