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 7 April 2026, in which claims 1-3, 5 have been amended, and claims 8-9, 17-20 have been cancelled, is acknowledged.
Claims 1-7, 10-16 are pending in the instant application.
Claims 1-7, 10-16 are being examined on their merits herein.
Response to arguments of 7 April 2026
In view of Applicant’s amendment of 7 April 2026, all the objections and rejections to claims 8-9, 17-20 are herein withdrawn. Claims 8-9, 17-20 have been cancelled.
On 7 April 2026, Applicant has submitted an amendment to the Specification containing the incorrect number of the paragraphs amended. Applicant states that the amended paragraphs are [0050]-[0063]. This is incorrect. The Objection to the Specification is herein maintained.
On 7 April 2026, Applicant has amended independent claim 1 to recite a method for treating cognitive impairment in an individual, the method comprising: orally administering to the individual at least once per day a unit dose of a composition comprising about 100 mg to about 25 g of at least one five carbon (c5) ketone body, wherein the c5 ketone body is selected from combinations of b-hydroxypentanoate and b-ketopentanoate; and a pharmaceutically or dietetically acceptable carrier;
wherein administration of the composition aids in at least one of restoring cognitive function, increasing cognitive function and/or slowing cognitive decline in an individual.
New rejections are made below, based on Applicant’s amendment of 7 April 2026.
Applicant has not amended the claims in response to the rejections of claims 5-7, 6, 13, 5, 13, 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite. As a result, these rejections are herein maintained.
Applicant’s arguments (Remarks of 7 April 2026, pages 11-14) against the rejection of claims 1-16 under 35 U.S.C. 103 over Henderson, Martin, Roe and Schiffmann, have been considered.
Applicant argues (page 12, second paragraph under point 4) that amended claim 1 now requires that the composition contain both b-hydroxypentanoate and b-ketopentanoate, and it further limits the actives to free acid or salt forms, not the broad esters, oligomers, triglycerides or metabolic precursors.
In response, claim 4 recites that the C5 ketone body is either b-hydroxypentanoate, or b-ketopentanoate, or combinations thereof. Further, the structures in claim 4 include not only acids X = H, or salts, but also esters (X is alkyl, alkenyl, aryl).
The triglycerides such as triheptanoin are relevant for claim 11. Furthermore, triheptanoin is known to convert in vivo to C5 ketone bodies, which treat cognitive impairment.
Applicant argues (page 12, last paragraph) that neither Henderson nor Martin disclose a dual active composition comprising both b-hydroxypentanoate and b-ketopentanoate, Applicant argues (page 13, first paragraph) that Roe and Schiffmann teach odd-chain fatty acids and triheptanoin, which are precursors to C5 ketone bodies, but not C5 ketone bodies as free acid or salt, as in the instant claims. Applicant argues (page 13) that the present amendment to the claims removes esters, oligomers, polymers and odd-chain triglyceride precursors from the actives and instead requires a combination of b-hydroxypentanoate and b-ketopentanoate.
In response, the point of the rejection is that diseases that are treated by administration of odd carbon fatty acids C5, C7, C15, or triheptanoin, that are converted or metabolized to the C5 ketone bodies 3-hydroxypentanoate (BHP) and 3-ketopentanoate (BKP), can alternatively be treated by administration of the C5 ketone bodies BHP and BKP in the form of free ketone bodies or in other forms such as salts or esters, capable of providing the free ketone bodies in vivo after administration (see [0089] Roe, C. (US 2013/0005818)). Prior art teaches administration of odd carbon fatty acids C5, C7, C15, or triheptanoin, as precursors or prodrugs of C5 ketone bodies, to treat cognitive impairment. It would be obvious to administer directly the C5 ketone bodies BHP and BKP in the form of free ketone bodies or in other forms such as salts or esters, capable of providing the free ketone bodies in vivo after administration, to treat cognitive impairment.
A new rejection is made below, based on Applicant’s amendment of 7 April 2026.
On 7 April 2026, Applicant has submitted terminal disclaimers against US patent 11,337,945, and against co-pending US patent applications 18/157,788 and 17/732,482. The terminal disclaimers have been disapproved, with a comment that Applicant is invited to file a power of attorney, along with another copy of the terminal disclaimer form. On 23 June 2026, Applicant has filed a power of attorney, but failed to file another copy of the terminal disclaimer form. As a result, the rejections of the instant claims on the ground of nonstatutory double patenting over claims of US patent 11,337,945, and over claims of co-pending US patent applications 17/732,482 and 18/157,788 are herein maintained.
New and modified rejections are made below, based on Applicant’s amendment of 7 April 2026.
Objection to the Specification
The Specification is objected to because it recites [0058] A composition containing b-ketopentanoate may comprises at least one stereoisomer selected from (R)-b-ketopentanoate, and (S)-b-ketopentanoate. See also [0060], [0062], [0065], [0066], [0067], [0068], [0071], [0072], [0074]. This is incorrect, because there is no chiral center in b-ketopentanoate.
Applicant is invited to correct the Specification by identifying and deleting all recitations of (R)-b-ketopentanoate, and (S)-b-ketopentanoate, or non-racemic b-ketopentanoate.
Claims objection
Claim 1 is objected to because it could read, for better clarity, “a method for treating cognitive impairment in an individual in need thereof”.
Claims 1, 4, 5 are objected to because the text “c5 ketone body” should read --C5 ketone body-- (C from Carbon should be capitalized).
Claim 4 is objected to because the recitation “wherein x is a hydrogen, a metal ion, an amino cation, an amino acid cation, an alkane, an alkenyl, or an aryl.” should read
--wherein X (capital X, because X is a substituent in a chemical formula) is hydrogen, a metal ion, an amino cation, an amino acid cation, alkyl, alkenyl, or aryl.--
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 1-7, 10-16 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.
Newly amended claim 1 recites 100 mg to 25 g of at least one five carbon ketone body, wherein the C5 ketone body is selected from combinations of b-hydroxypentanoate and b-ketopentanoate. The claim is unclear. Claim 1 is consistent with one or more (at least one) C5 ketone body. Yet, it is confusing what is meant by “the C5 ketone body is selected from combinations of b-hydroxypentanoate and b-ketopentanoate”. Is there more than a combination of b-hydroxypentanoate and b-ketopentanoate, are there several combinations of b-hydroxypentanoate and b-ketopentanoate to choose from? If several possible combinations (plural) of b-hydroxypentanoate and b-ketopentanoate exist, how are they different?
Appropriate clarification is required.
Claims 5-7 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 5 and dependent claims 6-7 are unclear because they depend on claim 1 and recite that the C5 ketone body is 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;
and combinations thereof.
Yet, claim 1 does not recite salts of a C5 keto body. As such, there is insufficient antecedent basis for the recitation salt, amino acid salt of C5 ketone body of claim 5, in claim 1.
Appropriate clarification/correction of the claim language is required.
Claim 6 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.
Claim 6 recites that the salt of the C5 ketone body is chloride, phosphate, bicarbonate. It is chemically unclear how a carboxylic acid salt can be chloride, phosphate, or bicarbonate (all anions).
Appropriate correction 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.
Claim 13 recites “coca leaf derivatives”. The Specification does not define the term “coca leaf derivative”. Claims must particularly point out and distinctly claim the invention. In this case, in the absence of a definition for the term “derivative”, one is left with questions regarding what are, chemically speaking, such “derivatives”, and how large they are. In chemistry, a derivative is a compound that is derived from a similar compound by a chemical reaction. But the term “derivative” may also encompass compounds formed by replacing one atom or group of atoms in a compound with another atom or group of atoms. It is unclear whether the term “derivative” encompasses any molecule, no matter how large, that contains cocaine, which is a constituent of coca leaf. It is unclear whether the term “derivative” encompasses modified molecules such that one atom or group of atoms replaced by another atom or group of atoms. There are no examples of “coca leaf derivatives” in the Specification. Because of the lack of definition in the Specification, it is unclear what exactly is meant by the term “coca leaf derivative” in claim 13.
Appropriate clarification is required.
Claim 5 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 5 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 13, 14 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 13 recites the broad recitation “racetams”, and the claim also recites “piracetam, oxiracetam, aniracetam”, which are the narrower statements of the range/limitation. Claim 13 recites the broad recitation “cholinergic compounds”, and the claim also recites “acetylcholine modulators”, which is the narrower statement of the range/limitation.
Claim 14 recites the broad recitation “Herbal products”, and the claim also recites “(garlic (allicin), ginger, echinacea, ginseng, licorice, onion, senna, turmeric (curcumin))”, which are the narrower statement of the range/limitation. Claim 14 recites the broad recitation “dietary enzymes”, and the claim also recites “bromelain, papain”, which are the narrower statements of the range/limitation. Claim 14 recites the broad recitation “Phytonutrients”, and the claim also recites “resveratrol”, which is the narrower statement of the range/limitation. Claim 14 recites the broad recitation “Carotenoids”, and the claim also recites “lycopene”, 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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 depends on claim 1 and states that the C5 ketone body is selected from the group consisting of b-hydroxypentanoate, b-ketopentanoate and combinations thereof. Thus, claim 4 recites 3 possibilities: C5 ketone body can be either (1) b-hydroxypentanoate, or (2) b-ketopentanoate, or (3) combinations of (1) and (2).
Yet claim 1, upon which claim 4 depends, recites 100 mg to 25 g of at least one five carbon ketone body, wherein the C5 ketone body is selected from combinations of b-hydroxypentanoate and b-ketopentanoate. Thus claim 1 is consistent with each C5 ketone body being selected from combinations of b-hydroxypentanoate and b-ketopentanoate. As such, claim 4 fails to further limit the subject matter of claim 1 upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-7, 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson (US 2008/0287372, cited in PTO-892 of 10/07/2025), Martin et al. (US 6,380,244, cited in IDS), Roe et al. (US 2011/0201558, cited in PTO-892 of 10/07/2025), Schiffmann et al. (US 2011/0306663, cited in IDS of 10/07/2025) and Roe, C. (US 2013/0005818, cited in PTO-892 of 10/07/2025).
Henderson (US 2008/0287372) teaches a method of treating cognitive impairment [0016], [0101] in a mammal with a composition capable of elevating ketone bodies in the mammal [0018].
Henderson teaches [0067]-[0068] that compounds capable of elevating ketone body levels (ketogenic compounds) include 3-hydroxyacids of formula
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, wherein R1 is, for example, H, alkyl; R2 and R3 are, for example, H; R4 is, for example, alkyl. The genus of 3-hydroxyacids taught by Henderson encompasses the instant b-hydroxypentanoate as C5 keto body acid or ester, as in instant claims 2, 4.
Henderson also teaches [0067] esters of 3-hydroxyacids as compounds capable of elevating ketone levels, used in the method of treating cognitive impairment.
Henderson teaches that ketogenic compounds (compounds capable of elevating ketone body concentrations in a mammal) effective to improve cognitive function include medium chain triglycerides MCT (Example 3), as in instant claim 11.
Henderson teaches [0101] the method of treating cognitive impairment in patients with age-associated memory impairment, decreased ability to recall, short-term memory loss, decreased learning rate, decreased capacity for learning, decreased problem solving skills, decreased attention span, increased confusion, as compared to a control mammal.
Henderson teaches that the compositions of the invention include supplementary vitamins [0108], as in instant claim 10, supplementary substances that enhance cognition such as Ginkgo biloba, as in instant claim 13, herbal products [0109], as in instant claim 14.
The composition is provided as a food bar, pudding (food product), drink beverage (Example 2), as in instant claim 15.
Martin (US 6,380,244) teaches that administering 3-hydroxyacid esters to a subject elevates the ketone bodies concentration in the blood. Martin teaches (column 8, lines 28-42) that increasing blood ketone levels is useful for example, for treatment of neurodegenerative disorders such as Alzheimer’s disease, in patients as in instant claim 16.
Martin teaches (column 4, lines 19-26) nutritional compositions comprising 3-hydroxyacids, or esters of 3-hydroxyacids; preferred 3-hydroxyacids include, for example, 3-hydroxyvaleric acid, which a C5 keto body of the instant claims.
Roe et al. (US 2011/0201558) teach a method of treating Alzheimer’s disease and aging, and a method of improving cognition (Abstract) with a composition comprising odd-chain triglycerides, such as tripentanoin and triheptanoin [0010], [0013]. The compositions upon administration increase a level of one or more circulating ketone bodies in the blood of the human subject [0012].
Roe teaches [0078] that dietary triheptanoin C7-TG (which is a lipid of instant claim 11) is a precursor of C5 ketone bodies beta-ketopentanoate (BKP) and beta-hydroxypentanoate (BHP), which are C5 keto bodies of the instant claims.
Roe teaches [0080] that tripentanoin C5-TG is a precursor of C5 ketone bodies beta-ketopentanoate (BKP) and beta-hydroxypentanoate (BHP).
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 10, 11.
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 [0086] that the C5-ketone bodies 3 hydroxypentanoate and 3-ketopentanoate cross the blood brain barrier. The transport of C5-ketone bodies across the blood brain barrier has been demonstrated in human patients ([0091], Fig. 1).
Schiffmann teaches that the dietary odd-chain fatty acids of the invention increase mental focus [0037], which is relevant to cognitive function, as in instant claims.
Roe, C. (US 2013/0005818, cited in PTO-892 of 10/07/2025) teaches [0089] 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and/or 3-ketopentanoate (BKP) in the form of free ketone bodies, as in instant claim 2, or as a salt form, as in instant claims 3, 5-7,
which provide the free ketones in vivo after administration [0089].
Roe teaches [0090] C5 ketone bodies BHP and BKP, used directly for therapy.
Importantly, Roe teaches [0089] that diseases that are treated by administration of odd carbon fatty acids C5, C7, C15 [0027] that are converted or metabolized to the C5 ketone bodies 3-hydroxypentanoate and 3-ketoppentanoate, can alternatively be treated by administration of the C5 ketone bodies BHP and BKP in the form of free ketone bodies or in other forms capable of providing the free ketone bodies in vivo after administration.
Roe teaches unit dosage forms containing 100-500 mg of active ingredient ([0071]), which is within the range in instant claim 1.
It would have been obvious to combine the teachings of Henderson, Martin, Roe , Schiffmann, and Roe 2013 to arrive at the instant invention.
Prior art Roe 2011 and Schiffmann teach administration of odd carbon fatty acids C5, C7, C15, or triheptanoin, as precursors of C5 ketone bodies, to treat cognitive impairment. It would be obvious to administer directly the C5 ketone bodies BHP and BKP in the form of free ketone bodies or in other forms such as salts or esters, capable of providing the free ketone bodies in vivo after administration, to treat cognitive impairment.
The person of ordinary skill in the art would have administered C5 keto bodies 3-hydroxypentanoate (BHP) and 3-ketopentanoate (BKP), to an individual, and would have measured mental performance levels, including focus, which is relevant to cognitive function, before and after administration, because
Roe 2011 and Schiffmann teach that ketogenic compositions of odd carbon fatty acids C5, C7, C15, or triheptanoin, capable of providing the C5 ketone bodies in vivo after administration, increase mental focus/improve cognition, and
Roe 2013 teaches that diseases/conditions that are treated by administration of odd carbon fatty acids C5, C7, C15 or triheptanoin that are converted or metabolized to the C5 ketone bodies 3-hydroxypentanoate and 3-ketopentanoate, can alternatively be treated by administration of the C5 ketone bodies BHP and BKP in the form of free ketone bodies or in other forms capable of providing the free ketone bodies in vivo after administration.
Further, since Henderson and Martin teach that administering 3-hydroxyacids or esters thereof to a subject elevates the ketone bodies concentration in the blood, and treats cognitive impairment in an aging mammal, or treats a neurodegenerative disease such as Alzheimer’s disease, a person of ordinary skill in the art would have administered C5 ketone bodies 3-hydroxypentanoate, alone or in a combination with 3-ketopentanoate, in the form of free ketone bodies, to an individual suffering from cognitive impairment or Alzheimer’s disease, with a reasonable expectation that said administration will increase mental focus, and increase mental performance and cognitive function in the individual.
Further, regarding claims 10, 11, a person of ordinary skill in the art would have co-administered to an individual C5 keto bodies 3-hydroxypentanoate (BHP) and 3-ketopentanoate (BKP) or an ester thereof, and a medium chain fatty acid C7 or ester thereof, because Schiffmann teaches 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) and 3-ketopentanoate (BKP), or an ester thereof, and a medium chain fatty acid C7 or ester thereof, with the expectation that the combination increases mental performance levels/focus, 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, 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) 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, and improvement in cognitive performance, in the subject.
As such, claims 1-7, 10-16 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 1-7, 10-16 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 10/07/2025), 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.
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 increase mental performance levels. 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.
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, and increases blood ketone levels in an individual.
Regarding instant claims 10, 11, 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 claims10, 11.
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 the dietary off chain fatty acids of the invention increase mental focus, which is relevant to cognitive performance.
Regarding instant claims 10, 11, 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, 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, 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 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, and improvement in cognitive performance, in the subject.
As such, the instant claims are rendered obvious by claims of U.S. Patent No. 11,337,945.
Claims 1-7, 10-16 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, which are inherently present in β-hydroxypentanoate; 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 and improves focus; improves cognitive function, as in instant claims.
Claims 25-27 of copending Application No. 18/157,788 are drawn to a method for increasing blood ketone levels 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 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, 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.
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, with the expectation that said administration increases mental performance levels.
Regarding instant claims 10, 11, Schiffmann et al. (US 2011/0306663) is as above.
Regarding instant claims10, 11, 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, 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, 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, and improvement in cognitive performance in the subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7, 10-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-3, 5-6 of copending Application No. 17/732,482 (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, 5-6 of copending Application No. 17/732,482 render obvious the instant claims.
It would have been obvious to use the teachings of claims 1-3, 5-6 of copending Application No. 17/732,482 to arrive at the instant invention. 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, and improvement in cognitive performance in the subject.
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, will be effective to increase mental performance levels, including focus, in the individual.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-7, 10-16 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.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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