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 24 April 2025, in which claims 1, 2, 5, 6, 10, 11, 13-17, 19, 20 have been amended, is acknowledged.
Claims 1-20 are pending in the instant application.
Claims 1-20 are being examined on their merits herein.
Response to arguments of 24 April 2026
On 24 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 amendment to the Specification is not entered.
The Objection to the Specification is herein maintained.
In view of Applicant’s amendment of 24 April 2026, the objection to claim 16 is herein withdrawn. Applicant has deleted the recitation “hyperinsulinemia” from the claim.
On 24 April 2026, Applicant has amended independent claim 1 to recite
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New rejections are made below, based on Applicant’s amendment of 24 April 2026.
In view of Applicant’s amendment of 24 April 2026, the rejection of claims 1, 3, 4, 5, 8, 9 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Roe is herein withdrawn. New rejections are made below, based on Applicant’s amendment of 24 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. 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 24 April 2026.
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 4 is objected to because the recitation “having a chemical structure” (2 instances) is unnecessary.
Claim 4 is objected to because the recitation “an alkane, an alkenyl or an aryl” should read –alkyl, alkenyl or aryl--.
Claim 8 is objected to because the text “is from the group consisting of” should read –is selected from the group consisting of--.
Claim 8 is objected to because the text “is provided as a food product, beverage or food supplement”, added by amendment to the end of the claim, contains duplicates of elements already recited by the claim.
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 1-20 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.
Independent claim 1, as amended on 24 April 2026, is drawn to:
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Claims 1-20 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.
First, there are grammatical errors in the text in claim 1. What does it mean “administration of the composition (which composition, the claim recites a first composition and a second composition) is at least one of preventing and/or decreasing symptoms [..]”? How can administration be preventing of some symptoms?
The text on the last 4 lines in claim 1 refer to “administration of the composition”, without mentioning which composition (when the claim actually recites a first and a second composition), followed by “and administration of the first and the second composition is effective to prevent symptoms”. This double recitation renders the claim confusing. The claim, as written, seems to be a very poor choice of words put together with little concern regarding the meaning, clarity or sense of what is actually being claimed.
Claim 1 is indefinite because it does not recite –administering a second composition--. Rather, claim 1 recites “orally administering a first composition […]; and a second composition”, which implies that the second composition must be orally administered, and both compositions are administered simultaneously. This directly contradicts the subsequent clauses reciting separate and distinct doses (“a first dose” versus “a second dose”) and resulting blood ketone levels, since it is unclear how the second composition can “maintain increased levels” that have not yet been achieved.
Further, claim 1 recites “wherein the first composition comprises a non-long-acting form of the C5 ketone body”, and “wherein the second composition comprises a long-acting form of the C5 ketone body”. The claim provides no standard or quantitative metric to determine what constitutes “long acting” versus “non-long acting” in terms of, for example, elimination t1/2, Tmax, or sustained release duration. Claim 1 recites “form of the C5 ketone body”. C5 ketone bodies are small organic molecules that do not inherently possess “long acting” chemical forms without chemical intervention, for example, esterification, oligomerization, polymerization. If “form of the C5 ketone body” refers to a chemical derivative, for example, ester or polymer, the claim fails to specify what chemical structure constitutes a “long acting” form. If chemically altered as polymer, is such a polymer “at least one C5 ketone body”? If the term “form” refers to a formulation, for example immediate release versus extended release matrix, the claim fails to specify that, and/or fails to recite any excipients or matrix agents that would render the composition/form “long acting”. Furthermore, “non-long acting” defines the first form purely by negative exclusion. Because the term “long acting” is undefined and lacks objective boundaries, its negative counterpart “non-long acting” is indefinite, because a POSITA cannot ascertain where “long acting” ends and “non-long acting” begins.
Regarding the recitations in claim 1, the first composition “is administered in a first dose effective to increase blood ketone levels in the individual”; and the second composition “is administered in a second dose effective to maintain the increased blood ketone levels in the individual”. Regarding the step of administration, a question arises: must the first composition/first dose be administered at the same time (see analysis above) as the second composition/second dose, or is the administration sequential- and if it is, in what order? The claim fails to specify that.
Further, claim 1 recites “increase blood ketone levels”, “maintain increased blood ketone levels”, without explaining whether there is any relationship between these levels. Are the increased ketone blood levels the levels achieved upon administration of the first composition? If they are, the claim should specify that.
To “maintain increased blood ketone levels”, the second composition administered in a second dose must act while the increase caused by the first composition is present. If the second composition is administered after the first composition’s ketone elevation decayed back to the baseline, the second composition cannot “maintain the increased levels”. If the second composition is administered before the first composition, it cannot maintain an increase that has not yet occurred. If the first composition and the second composition are administered simultaneously, does the second composition maintain an increase from the first composition, or does it contribute to its own increase?
Further, claim 1 recites “increased blood ketone levels”. It is unclear how the increase is to be measured, as the claim fails to establish a standard or threshold level. For example, the increase could be relative to another sample taken from the same subject previously, either before acquiring the metabolic dysfunction or after acquiring metabolic dysfunction. Alternatively, the increase could be relative to a healthy subject, i.e., a different subject than the subject currently afflicted with metabolic dysfunction. It is noted that blood ketone levels fluctuate drastically based on diet, fasting state, exercise, and metabolic disease.
Furthermore, claim 1 recites maintaining the increased blood ketone levels, yet the claim fails to provide a temporal duration for “maintain”- for 2 hours, 12 hours, 24 hours, indefinitely?.
In other words, it appears that claims 1-20 are directed towards measuring levels of blood ketone levels in two different biological samples and comparing said levels between the two different biological samples to establish that an increase occurs; however, the claims fail to clearly establish the reference or standard by which one would make a comparison of levels of the one or more biological molecules. One wishing to practice the instantly claimed invention would thus not recognize the metes and bounds for which Applicant seeks protection.
As for the recitation “composition comprising more than 0% and less than 100%, by weight, of at least one five carbon (C5) ketone body”, such recitation covers every non-zero concentration imaginable. Claim 1 is further indefinite for reciting “the first composition […] is administered in a first dose effective to increase blood ketone levels in the individual” and “wherein the second composition […] is administered in a second dose effective to maintain the increased blood ketone levels in the individual” because one of ordinary skill in the art could not reasonably determine the metes and bound of the functional-descriptive limitations. Specifically, there is a relationship between the dose of the first composition administered such that the method achieves a certain effect, namely it increases blood ketone levels in the individual. And there is a relationship between the dose of the second composition administered such that the method achieves a certain effect, namely it maintains increased blood ketone levels in the individual. The point related to the term “increase” being indefinite in the absence of a threshold, was made above. Here, the effect, certain blood ketone levels, must be achieved by an unspecified first dose or an unspecified second dose.
The specification provides little clarification other than speculation, as there are no working examples showing what is the actual dose administered such that the administration would initiate the claimed effects. Because the composition ranges and dose amounts are not quantitatively limited in claim 1, the claim hinges on whether the administration produces three effects: an increase in blood ketones; maintenance of that increase; and prevention/decrease of symptoms of metabolic dysfunction.
Claim 1 recites that administration of the first composition and the second composition is effective to decrease symptoms of the metabolic dysfunction in the individual. Again, the term “decrease” renders the claim indefinite, because it is unclear how the decrease is to be measured, as the claim fails to establish a standard or threshold level. For example, the decrease could be relative to the level of symptoms in the same subject previously, before administration of the compositions. However, if the patient is asymptomatic at the time of administration and remains asymptomatic, a POSITA has no way to verify whether the absence of symptoms is the result of the claimed method (“preventing”) or simply the natural history of the individual’s condition.
Claim 2 is drawn to the method of claim 1, wherein a unit dose of the first composition […]; yet claim 1 does not recite a unit dose. As such, there is insufficient antecedent basis for the recitation “a unit dose” of claim 2, in claim 1.
Claim 5 depends on claim 1 and recites that at least one of the first composition and the second composition provides the C5 ketone body in a form selected from […]. It is unclear what is meant that the composition(s) provide the C5 ketone body in a form, because claim 1 recites that the composition(s) comprise a form of C5 ketone body. As such, there is insufficient antecedent basis for the recitation “composition provides the C5 ketone body in a form” of claim 5, in claim 1.
Claim 10 is indefinite because it recites: The method of claim 1, wherein the composition further comprises at least one additional compound selected from the group consisting of: at least one of the first composition and the second composition further comprises […]. Claim 10 is interpreted as depending on claim 1, wherein the at least one of the first composition and the second composition further comprises […].
Claim 11 is indefinite because the phrase “a medium chain fatty acid C7 or an ester thereof” is vague and indefinite because the term “or an ester” would mean that the claim is open ended in the closed Markush expression “the group consisting of”.
Claim 13 depends on claim 1 and recites wherein at least one of the first composition and the second composition is provided as a powder, liquid, gel, tablet, or capsule, and wherein components of the composition are provided together or separately for sequential or concurrent administration. It is unclear what is meant by composition is provided, since claim 1 does not recite providing a composition. Further, claim 1 does not recite any components of a composition, and it is unclear how such components of the composition are provided together or separately (as separate components, yet the composition is made of those components?).
Claim 14 is drawn to the method of claim 10, wherein the one or more first composition and the second composition is selected from the group consisting of administered according to an administration schedule selected to elevate and/or maintain blood ketone levels, increase and/or maintain ketosis, and reduce fasting glucose levels and/or improve glucose metabolism. This makes no sense. Applicant seems to have deleted portions of the claims, left other parts of the claim, and added new text to the claim without underlining the newly added text to show the amendment. Claim 14 depends on claim 10 and recites “the one or more first composition and the second composition”, while claim 10 recites “at least one of the first composition and the second composition” (which is interpreted to mean one of the 2 compositions, or both). As such, there is insufficient antecedent basis for the recitation “the one or more first composition and the second composition” of claim 14, in claim 10. Further, what does it mean “the one or more first and second”? More than what?
Claim 14 is further indefinite because it recites “administered according to an administration schedule selected to elevate and/or maintain blood ketone levels, increase and/or maintain ketosis, and reduce fasting glucose levels and/or improve glucose metabolism”. Claim 14 does not define the administration schedule and one of ordinary skill in the art could not reasonably determine the metes and bound of the functional-descriptive limitations. Specifically, there is a relationship between the administration schedule (unspecified) of the first composition such that the method achieves a certain effect, namely it increases and/or mainatins blood ketone levels in the individual. The terms “increase or elevate”, “maintain”, “reduce”, “improve” are indefinite in the absence of a threshold.
Claim 15 is drawn to the method of claim 1, wherein the composition is provided. It is unclear which composition claim 15 refers to, since claim 1 recites a first composition and a second composition.
Claim 17 is indefinite because it recites a second composition comprising “another carbon length ketone body”, without defining what such “another length” ketone body is.
Claim 19 recites the kit of claim 17, wherein the C5 ketone body is selected from the group consisting of the at least one C5 ketone body of the first composition is provided in a purified form, and the another carbon length ketone body or the C7 fatty acid or ester thereof of the second composition is provided in a purified form. The text makes no sense, because part of the claim was deleted, yet not completely. The claim is further unclear because it recites that the first composition “is provided”, the second composition “is provided”, yet claim 17 does not recite a step of providing compositions; rather, claim 17 is drawn to a kit comprising two containers. Further, it is unclear what is meant by “a purified form” versus perhaps an unpurified form?
Claim 20 is indefinite because it recites “wherein the composition further comprises at least one additional compound selected from the group consisting the second composition comprises triheptanoin”. Again, as in claim 19, part of the claim was deleted, yet not completely. Further, it is unclear what it is meant by “the composition”, since claim 17 recites a fits composition and a second composition. Which composition is “the composition” in claim 20?
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.
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 at least one C5 ketone body; the preamble “for administering a treatment of metabolic dysfunction in 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 IDS) and Schiffmann et al. (US 2011/0306663).
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,
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.
Schiffmann et al. (US 2011/0306663) teach [0089] that after ingestion of triheptanoin, peripheral tissues receive heptanoate and C5 ketone bodies 3 hydroxypentanoate and 3-ketopentanoate [0086].
Roe and Schiffmann do not teach a kit comprising a first container containing a first composition comprising C5 ketone bodies BHP or/and BKP; a second container containing a second composition comprising triheptanoin; 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 and Schiffmann to arrive at the instant invention. The person of ordinary skill in the art would have prepared a kit comprising a first container containing C5 keto bodies 3-hydroxypentanoate (BHP), and a second container containing triheptanoin, for co-administration, because Schiffmann teaches that triheptanoin provides C5 ketone bodies upon in vivo after administration. Thus, the person of ordinary skill in the art would have prepared a first container containing C5 keto bodies 3-hydroxypentanoate (BHP), and a second container containing triheptanoin, for co-administration, with the expectation that the combination is effective to increase blood ketone levels in the individual. Since all compounds for co-administration herein are known to be useful to increase blood ketone levels, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
Further, 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 triheptanoin in containers, 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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Roe, C. (US 2013/0005818, cited in IDS), 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 IDS).
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, 9.
3-ketopentanoate (BKP) is a C5-ketone body of instant claims and is an acid, as in instant claim 5, 9.
BHP and BKP are not long acting forms of C5 ketone bodies, as in instant first composition in claim 1.
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.
Polymeric forms of BHP and/or BKP are long acting forms of C5 ketone bodies, as in instant second composition in claim 1.
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.
Roe does not teach administering a first composition comprising BHP or BKP acid (non-long acting forms of C5 ketone bodies) and a second composition comprising BHP or BKP in polymeric form (long acting form of C5 ketone bodies) in the method.
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, 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) 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.
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. The person of ordinary skill in the art would have administered a first composition comprising BHP or BKP, and a second composition comprising a polymer of BHP or BKP as long acting form of C5 ketone bodies, with the expectation that said co-administration will result in increased blood C5 ketone bodies in vivo, being 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 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, 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 1-16 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.
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Claims 1- are rejected on the ground of nonstatutory double patenting as being unpatentable at least over claims 1-11, 13-20 of U.S. Patent No. 11,337,945 (cited in PTO-892), in view of Roe, C. (US 2013/0005818, cited in IDS), and 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 1-11, 13-20 of U.S. Patent No. 11,337,945 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 1-7, 9 recite a method of aiding weight loss or fat loss in an individual, and claim 6 recites decreasing blood glucose levels. 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. β-hydroxypentanoate, β-ketopentanoate, are not long acting forms of C5 ketone bodies, as in instant first composition in claim 1.
Roe teaches [0089] administering to a subject 5 carbon ketone bodies 3-hydroxypentanoate (BHP) and/or 3-ketopentanoate (BKP) in the form of free ketone bodies, to increase blood ketone levels and treat metabolic dysfunction.
BHP and BKP are not long acting forms of C5 ketone bodies, as in instant first composition in claim 1.
Roe also teaches administration of the 5 carbon ketone bodies BHP and/or BKP as a polymeric form, to increase blood ketone levels. Polymeric forms of BHP and/or BKP are long acting forms of C5 ketone bodies, as in instant second composition in claim 1.
Schiffmann teaches [0089] that after ingestion of triheptanoin, peripheral tissues receive heptanoate and C5 ketone bodies [0089].
It would have been obvious to use the teachings of claims 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 first composition comprising β-hydroxypentanoate or salt thereof, the composition further comprising β-ketopentanoate, and a second composition comprising a polymer of β-hydroxypentanoate as long acting form of C5 ketone bodies (as taught by Roe), with the expectation that said administration increases blood ketone levels in an individual, which results in treatment of metabolic dysfunction.
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 triheptanoin to a composition comprising β-hydroxypentanoate or β-ketopentanoate, and would have administered said composition to an individual, with the expectation that said administration 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 triheptanoin, 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.
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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