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 1-20 are pending in the instant application.
Claims 1-20 are being examined on their merits herein.
Priority
This application is a Continuation in Part of U.S. Patent Application 18/319,334, filed on 05/17/2023, which is a Continuation in Part of U.S. Patent Application 18/157,788, filed on 01/20/2023, which is a Continuation in Part of U.S. Patent Application 17/732,482, filed on 04/28/2022, which is a Continuation in Part of U.S. Patent Application 16/306,412, filed on 11/30/2018, now U.S. Patent 11,337,945, which is a 371 of PCT/IB2017/054679, filed on 08/01/2017, which claims benefit of U.S. Provisional Patent Application 62/343,941, filed on 06/01/2016.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 21 July 2023, 17 March 2025 and 3 June 2025, are acknowledged and considered.
Objection to the Specification
The Specification is objected to because it recites [0075] A composition containing b-ketopentanoate may comprises at least one stereoisomer selected from (R)-b-ketopentanoate, and (S)-b-ketopentanoate. See also [0077], [0079], [0082], [0083], [0084], [0085], [0088], [0089], [0091]. 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.
Claim objection
Claim 12 is objected to because it does not end with a period.
Claim 16 is objected to because it recites “hyperinsulinemia and/or hyperinsulinemia”. Removal of the duplicate is required.
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 5-9 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 6-9 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;
one or more ester of the C5 ketone body;
one or more acid of the C5 ketone body;
one or more polymer of the C5 ketone body; and combinations thereof.
Yet, claim 1 does not recite salts, esters, acids or polymers of a C5 keto body. As such, there is insufficient antecedent basis for the recitation salt, amino acid salt, ester, acid, or polymer of C5 ketone body of claim 5, in claim 1.
Appropriate clarification/correction of the claim language is required.
Claim 19 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 19 is unclear because it depends on claim 17 and recites 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;
one or more ester of the C5 ketone body;
one or more acid of the C5 ketone body;
one or more polymer of the C5 ketone body; and combinations thereof.
Yet, claim 17 does not recite salts, esters, acids or polymers of a C5 keto body. As such, there is insufficient antecedent basis for the recitation salt, amino acid salt, ester, acid, or polymer of C5 ketone body of claim 19, in claim 17.
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.
Claims 5, 19 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 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 same analysis applies to claim 19.
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.
Claim 16 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 16 recites that an administration of the composition “aids in treating symptoms […]”. It is unclear what is meant by the term “aids” in treating symptoms. According to the dictionary, the verb “to aid” means to help, assist or support in the achievement of something. As such, the expression “aids in treating symptoms” seems to indicate that the symptoms are already being treated, perhaps with another therapeutic agent, while the C5 ketone bodies are just aiding/helping that treatment. There is explanation in the Specification regarding what it is encompassed by such “aid in treating symptoms”. Rather, the Specification teaches [0006] that C5 ketone bodies are administered to treat symptoms of metabolic dysfunction, reduce or inhibit progression of symptoms of metabolic dysfunction. Appropriate clarification of the claim language is required.
Further, 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 16 recites the broad recitation “cardiovascular conditions”, and the claim also recites “such as coronary artery disease, heart attack, and stroke”, which are the narrower statements of the range/limitation. Claim 16 recites the broad recitation “neuropathy symptoms”, and the claim also recites “such as numbness, tingling, or pain in the extremities”, which are the narrower statements of the range/limitation. Claim 16 recites the broad recitation “skin conditions”, and the claim also recites “such as bacterial and fungal infections, slow wound healing, and foot ulcers”, which are the narrower statements of the range/limitation.
Further, regarding claim 16, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Appropriate correction is required.
Claim Rejections- 35 USC 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 5, 8, 9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Roe, C. (US 2013/0005818, cited in PTO-892).
Roe teaches [0089] a method of treating GSDII in humans and polysaccharide storage diseases in horses and other animals, which are metabolic dysfunctions, comprising administering to a subject 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and/or 3-ketopentanoate (BKP) in the form of free ketone bodies, that ameliorate the symptoms of the disease (Abstract), as in instant claim 1.
3-hydroxypentanoate (BHP) is a C5-ketone body of instant claims 3, 4, and is an acid, as in instant claim 5, 9.
3-ketopentanoate (BKP) is a C5-ketone body of instant claims 3, 4 and is an acid, as in instant claim 5, 9.
Roe teaches [0090] that the C5 ketone bodies BHP and BKP can be used directly for therapy.
Roe also teaches [0089] that forms of BHP and/or BKP as a triglyceride form, which is triester of glycerin, as in instant claims 5, 8, can be used in the method.
Roe also teaches administration of the 5 carbon ketone bodies BHP and/or BKP as a polymeric form, or a salt form, as in instant claim 5.
As such, instant claims 1, 3, 4, 5, 8, 9 are anticipated by Roe.
Claim Rejections- 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”). See MPEP 2111.02. In this case, the body of claims 17-20 fully and intrinsically set forth all the limitations of the claimed invention, namely a kit comprising more than 0% and less than 100% wt. of at least one C5 ketone body; the preamble “for administering a treatment of cognitive impairment to an individual” only states the intended use of the composition. Thus, the preamble is not given any patentable weight.
"[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002).
It is well settled that “intended use” of a composition or product, e.g., “for use as a medicament”, will not further limit claims drawn to a composition or product, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount, as the instantly claimed. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In re Hack 114, USPQ 161
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Roe, C. (US 2013/0005818, cited in PTO-892).
Roe 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 18, or as a triglyceride (ester) form, a polymeric form, or a salt form, as in instant claim 19,
which provide the free ketones in vivo after administration [0089].
Roe teaches [0090] C5 ketone bodies BHP and BKP, used directly for therapy.
Roe also teaches [0076] pharmaceutical kits comprising a composition of the invention, one or more containers with one or more pharmaceutically acceptable diluents, carriers, additional containers, printed instructions, indicating quantities of the components to be administered, guidelines for administration, and/or guidelines for mixing the components.
Roe teaches unit dosage forms containing 100-500 mg of active ingredient ([0071]), which is within the range in instant claim 17.
Roe teaches pharmaceutical compositions comprising ketone [0016], further comprising vitamins, minerals, lipids, and combinations thereof, as in instant claim 20.
Roe does not teach a kit comprising C5 ketone bodies BHP or/and BKP, a container, and a measuring device such as a spoon to hold a unit dose of the composition, as in instant claims 17-20.
It would have been obvious to use the teachings of Roe to arrive at the instant invention.
The person of ordinary skill in the art would have added a measuring device such as a spoon to a kit comprising a C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) and a container, taught by Roe, because adding a spoon to measure a predetermined amount of a composition is routine, well within the skill of the artisan.
As such, claims 17-20 are rejected as prima facie obvious.
Claims 1, 2, 5-7, 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Roe, C. (US 2013/0005818, cited in PTO-892), Martin et al. (US 6,380,244, cited in IDS), Schiffmann et al. (US 2011/0306663, cited in IDS) and Henderson (US 2008/0287372, cited in PTO-892).
Roe teaches [0089] a method of treating glycogen storage disease GSDII in humans and polysaccharide storage diseases in horses and other animals, which are metabolic dysfunctions, comprising administering to a subject 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and/or 3-ketopentanoate (BKP) in the form of free ketone bodies, that ameliorate the symptoms of the disease (Abstract), as in instant claim 1.
3-hydroxypentanoate (BHP) is a C5-ketone body of instant claims and is an acid, as in instant claim 5.
3-ketopentanoate (BKP) is a C5-ketone body of instant claims and is an acid, as in instant claim 5.
Roe teaches [0090] that the C5 ketone bodies BHP and BKP can be used directly for therapy.
Roe also teaches [0089] that forms of BHP and/or BKP as a triglyceride form, which is triester of glycerin, as in instant claim 5, can be used in the method.
Roe also teaches administration of the 5 carbon ketone bodies BHP and/or BKP as a polymeric form, or a salt form, as in instant claim 5.
Roe teaches unit dosage forms for oral administration containing 100-500 mg of active ingredient ([0071]), which is within the range in instant claim 2.
Roe teaches pharmaceutical compositions comprising ketone [0016], further comprising vitamins, minerals, lipids, and combinations thereof, as in instant claim 10.
Martin (US 6,380,244) teaches that administering 3-hydroxyacid esters or oligomers 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 diabetes and other insulin resistant states in which the normal insulin signaling pathways are disordered (claim 6), which is consistent with metabolic dysfunction, as in instant claim 1.
Martin teaches (column 4, lines 19-26) nutritional compositions comprising 3-hydroxyacids, esters of 3-hydroxyacids, or oligomers of 3-hydroxyacids; preferred 3-hydroxyacids include, for example, 3-hydroxyvaleric acid, which a C5 keto body of the instant claims. Martin teaches (column 5, lines 25-39) oligomers of 3-hydroxyvalerate, which are oligomers/polymers of a C5 ketone body, as in instant claim 5.
Schiffmann et al. (US 2011/0306663) teach a method of treating adult polyglucosan body disease (APBD), which is a metabolic dysfunction, specifically a glycogen storage disorder (GSD type IV) by administering 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 3 hydroxypentanoate and 3-ketopentanoate [0086].
Schiffmann teaches that the dietary odd-chain fatty acids of the invention are effective to treat APBD, which is a metabolic dysfunction, as in instant claims.
Henderson (US 2008/0287372, cited in PTO-892) teaches a composition capable of elevating ketone bodies in the mammal [0018], such as 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 C5 keto body acid or ester, as in instant claim 5. Henderson also teaches [0067] esters of 3-hydroxyacids, or linear or cyclic oligomers of 3-hydroxyacids, as compounds capable of elevating ketone levels; this genus encompasses oligomers of 3-hydroxyvalerate, which are oligomers/polymers of a C5 ketone body, as in instant claim 5.
Henderson teaches that ketogenic compounds (compounds capable of elevating ketone body concentrations in a mammal) include medium chain triglycerides MCT (Example 3), as in instant claim 11.
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.
It would have been obvious to combine the teachings of Roe, Martin, Schiffmann and Henderson, 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), to an individual, to treat a metabolic dysfunction, because Roe, Martin and Schifmann teach that ketogenic compositions capable of providing the C5 ketone bodies in vivo after administration are effective to treat a metabolic dysfunction.
Regarding claims 6, 7, the person of ordinary skill in the art would have administered a sodium salt or an amino acid salt of C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) to an individual suffering from metabolic dysfunction, because Roe teaches salt of BHP and/or BKP being administered in the method, to treat symptoms of metabolic dysfunction.
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) or/and 3-ketopentanoate (BKP) or an ester of oligomer 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) or/and 3-ketopentanoate (BKP), or an ester or an oligomer thereof, and a medium chain fatty acid C7 or ester thereof, with the expectation that the combination is effective to treat a metabolic dysfunction, 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, and treat a metabolic dysfunction, 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 treatment of metabolic dysfunction, in the subject.
Regarding claims 10, 12-15, the person or ordinary skill in the art would have added a citrate salt, or supplementary vitamins, as in instant claim 10, supplementary substances that enhance cognition such as Ginkgo biloba, as in instant claim 13, herbal products, as in instant claim 1, and would have provided the composition as a food bar, pudding (food product), drink beverage, as in instant claim 15, because Henderson teaches these features in a composition comprising C5 ketone bodies for oral administration.
Regarding claim 16, the person of ordinary skill in the art would have administered C5 keto bodies 3-hydroxypentanoate (BHP) or/and 3-ketopentanoate (BKP) to an individual suffering from diabetes, because Martin teaches that administering 3-hydroxyacid esters or oligomers to a subject elevates the ketone bodies concentration in the blood, which is useful for treatment of diabetes and other insulin resistant states in which the normal insulin signaling pathways are disordered.
Thus, a person of ordinary skill in the art would have administered C5 ketone body to an individual suffering from diabetes, with a reasonable expectation that said administration will treat diabetes, and improve symptoms of diabetes in the individual.
As such, claims 1, 2, 5-7, 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 1-16 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), 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 3, 4, 9
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, treats metabolic syndrome/dysfunction, 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 treating metabolic syndrome/dysfunction, in the subject.
As such, the instant claims are rendered obvious by claims of U.S. Patent No. 11,337,945.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-3, 13-21, 25-27 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, 25-27 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, and treats metabolic syndrome/dysfunction, as in instant claim 1, and diabetes, as in instant claim 16.
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.
It would have been obvious to use the teachings of claims 1-3, 13-21, 25-27 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 treats metabolic syndrome/dysfunction, as in instant claim 1, and diabetes.
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 treats metabolic syndrome/dysfunction.
Since all compounds for co-administration herein are known to be useful to treat metabolic syndrome/dysfunction, 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 treating metabolic syndrome/dysfunction in the subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 7-12 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 7-12 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 treating metabolic syndrome/dysfunction 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 treat metabolic syndrome/dysfunction in the individual.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-20 are rejected.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629