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 1-14 are pending in the instant application.
Claims 1-14 are examined herein.
Priority
The instant application is a CON of PCT/EP2023/0552062, filed on 01 March 2023, and claims benefit of foreign priority to EP22159658.8, filed on 01 March 2022. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 01 March 2022.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 27 August 2024, is acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Claim Interpretation
Claims 1-13 are directed to a composition; as such, the intended use (i.e. for use in controlling ketosis associated with a ketogenic diet in a subject adhering to a ketogenic diet) does not alter the chemical structure(s) of composition and is therefore not further limiting. See MPEP 2111.02.II:
[S]tatements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-13 are directed to a natural product. The Examiner has followed the guidance set forth in MPEP 2106 and has concluded that the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter.
Eligibility Step 1: The Four Categories of Statutory Subject Matter
As described in MPEP § 2106.03, Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? The claims recite a naturally occurring compound, butyric acid or caproic acid, set forth in independent claim 1, and propionic acid, set forth in independent claim 10. Accordingly, the answer to the question of Step 1 is Yes, because claims 1-13 are considered directed to a composition of matter, which is eligible subject matter.
Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception
Step 2A, Prong One
Step 2A, Prong One asks if the claim recites a natural phenomenon. In the instant case, the compound of claim 1 is recited as butyric or caproic acid, and the compound of claim 10 is propionic acid. The characteristics of these compounds are not markedly different from the naturally occurring counterparts in their natural state, because as claimed it has the identical chemical structure as it has in nature. Butyric acid is found in animal fats, plant oils, and dairy products (https://www.hmdb.ca/metabolites/HMDB0000039), caproic acid is found naturally in animal fats and oils (https://www.hmdb.ca/metabolites/HMDB0000535) and propionic acid is found in dairy products (https://www.hmdb.ca/metabolites/HMDB0000237).
MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.” MPEP 2106.04 (c)(I) states that “if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.”
In the instant case, the nature-based products of butyric acid, caproic acid, and propionic acid have the identical structures that they have in nature for the reasons outlined above. Accordingly, there is no need to perform the markedly different characteristics analysis, because the limitation is by definition directed to a naturally occurring product and is not markedly different from what occurs in nature.
Therefore, the answer to the question of Step 2A, Prong One is Yes, because claims 1-13 are considered directed to a product of nature.
Step 2A, Prong Two
Step 2A, Prong Two, asks if the claim recites additional elements that integrate the judicial exception into a practical application. In the instant case, the judicial exception is not integrated into a practical application because the claims merely recite the compound and its properties without reciting any additional steps or elements that rely on or use the compound for any practical purpose.
Eligibility Step 2B: Whether a Claim Amounts to Significantly More
As described in MPEP 2106.05, Step 2B asks if claims recite additional elements that amount to significantly more than the judicial exception. In the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because there are no “additional elements” required by the present claims since they are directed only to the naturally occurring substance itself. The limitations set forth in dependent claims 2-9 and 11-13 are also composition claims which are directed to the product itself and do not require any “additional elements”.
Thus, the answer to Step 2B is No. Therefore, claims 1-13 are not directed to patent eligible subject matter.
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 1-13 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 1 recites “in non-ketogenic amounts,” this phrase is unclear as the assessment of what is a non-ketogenic amount is undefined. Page 10, line 20 of the specification provides a definition of “non-ketogenic composition” and within that states “Non-ketogenic amounts as used herein thus indicate amounts of a compound wherein such a compound in itself does not serve as a substrate for, or lead to the formation of more than just minimal amounts of ketone bodies. Accordingly, the amount of systemic and/or blood ketone bodies do not rise in reaction thereto.” Again, an exact threshold is not provided as “just minimal amounts” is subjective. Therefore, the phrase is indefinite. As the dependent claims do not remedy the issues, they are subject to the rejection as well.
Claim 1 recites steps a and c, claim 2 recites a step b. It is unclear whether the limitations of claim 2 must proceed the optional step c of claim 1, in which case the dependency of the claims is improper.
Claim 1 recites “for controlling ketosis.” As the term is not defined within the specification it is unclear whether the applicant is claiming maintaining ketosis in those on a ketogenic diet to sustain the body’s burning of fat, or reducing ketosis to prevent side effects. Therefore, the phrase is indefinite. As the dependent claims do not remedy the issues they are subject to the rejection as well.
Claim 10 recites “i) for controlling the effect of a ketogenic diet and/or ii) controlling ketone body production.” As the terms are not defined within the specification it is unclear whether the applicant is claiming control by increasing or decreasing the effects of a ketogenic diet or increasing or decreasing ketone body production. Therefore, the phrases are indefinite. As the dependent claims do not remedy the issues they are subject to the rejection as well.
Claim Rejections - 35 USC § 112
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.
Claims 2-4 and 7-9 are 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. As the intended use is not limiting, the above recited claims fail to further limit claim 1.
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.
Claims 11-13 are 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. As the intended use is not limiting, the above recited claims fail to further limit claim 10.
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 § 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.
Claim(s) 1-4 and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by St-Pierre et al. (Journal of Functional Foods.2017;32:170-175; cited by Applicant on 1449 IDS).
Regarding claims 1 and 8, St-Pierre teaches supplementation of butyric acid increases total plasma ketones and prolongs ketosis (page 172).
Regarding claim 2, St-Pierre teaches the measurement of blood ketone levels (page 172).
Regarding claims 3 and 9, St-Pierre does not teach the optional second composition. As the second composition is optional, the limitation is still met.
Regarding claim 4, as the intended use is not limiting, St-Pierre teaches the composition.
Claim(s) 1, 3-4 and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagel (US20190313682A1; cited by Applicant on 1449 IDS).
Regarding claims 1 and 8, Nagel teaches a composition comprising at least one beta-hydroxybutyrate salt, at least one agent comprising D-Ribose (claim 1), and at least on medium chain fatty acid or ester (claim 2), wherein the fatty acid or ester is hexanoic acid, also known as caproic acid (clam 4). Nagel teaches the composition for use in subjects adhering to a ketogenic diet (Abstract).
Regarding claims 3 and 9, Nagel does not teach the optional second composition. As the second composition is optional, the limitation is still met.
Regarding claim 4, Nagel teaches the composition for use in patients suffering from insulin resistance (paragraph [0063]).
Regarding claim 7, Nagel teaches the medium chain fatty acid in a dose from 1 g to 5 g (paragraph [0017]). Assuming an average adult male weight of 80 kg, the instant limitation is a range of 0.480 g to 13.2 g.
Claim(s) 1, 3, and 8-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brass et al. (Biochem. J. 1988;250:819-825; cited by Applicant on 1449 IDS).
Regarding claims 1 and 8, Brass teaches a first composition comprising butyrate or hexanoate to increase ketogenesis and a second composition comprising propionate (Table 1).
Regarding claim 3, Brass teaches administering the first composition then the second.
Regarding claim 9, Brass teaches administering the second composition to decrease ketone production.
Regarding claims 10-12, Brass teaches administering a composition of propionate to decrease ketone production after a first composition of butyrate or hexanoate (Table 1).
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 (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 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 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.
Claim(s) 1-5 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over St-Pierre et al. (cited above) in view of Fan et al. (Aging Cell. 2021 Oct 31;20(12):e13510; cited by Applicant on 1449 IDS).
The teachings of St-Pierre are disclosed above and incorporated by reference herein.
Regarding claim 5, St-Pierre does not teach the addition of citrate to the first composition.
Fan teaches the anti-aging benefits of citrate supplementation by mechanistic means of increasing ketogenesis.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong A of KSR applies – combining known compounds for the same purpose of controlling ketogenesis. It would be prima facie obvious to one skilled in the art to combine the compounds taught by St-Pierre and Fan to promote ketogenesis as both butyric acid and citrate are taught to do so.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claim 7, St.Pierre teaches administration of butyric acid at 2 g or 4 g. The instant invention (assuming an average male weight of 80 kg) teaches a range of 16 mg to 960 mg. Reduction of the dose would be routine optimization in the absence of criticality. See MPEP 2144.05.II.A. The skilled artisan would know higher doses of butyric acid can lead to unpleasant side effects and would be motivated to reduce the dose especially if combining with another compound that serves the same purpose.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over St-Pierre et al. (cited above) in view of Fan et al. (cited above) and in further view of Elamin et al. (Front Mol Neurosci. 2017 Nov 14;10:377).
The teachings of St-Pierre and Fan are disclosed above and incorporated by reference herein.
Regarding claim 6, St-Pierre and Fan do not teach the addition of nicotinamide or nicotinamide riboside to the first composition.
Elamin teaches that ketogenesis increases the availability of NAD+ and the ratio of NAD+ to NADH. Elamin also teaches the NAD+ precursors nicotinamide or nicotinamide riboside are marketed as supplements to mimic the effect of ketogenesis (Conclusion).
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong A of KSR applies – combining known compounds for the same purpose of controlling ketogenesis. It would be prima facie obvious to one skilled in the art to additionally add nicotinamide or nicotinamide riboside, as taught by Elamin, to the combination taught by St. Pierre and Fan to promote ketogenesis. The skilled artisan would be motivated to combine these components as they all provide the same metabolic effects.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Claim(s) 1, 3, 8-12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brass et al. (cited above) in view of Gaedke (KetoConnect. The Best Keto Meal Delivery Options. 2021. https://www.ketoconnect.net/best-keto-meal-delivery/).
The teachings of Brass are disclosed above and incorporated by reference herein.
Claim 14 is directed to a kit containing 1) a ketogenic composition, 2) a first composition of butyric or caproic acid, 3) a second composition of propionic acid. The instant specification provides a ketogenic diet as an example of a ketogenic composition. Brass teaches the first and second composition but does not teach a kit containing both and a ketogenic composition.
Ketogenic diets are well known in the art and several services offer delivery kits composed of ketogenic meals, which meets the instant definition of a ketogenic composition. Gaedke teaches several keto delivery kit options.
It would be prima facie obvious to one of ordinary skill in the art to provide the first and second composition, as taught by Brass, with a kit comprising a keto based meal, as taught by Gaedke, to provide the subject adhering to the ketogenic diet with the tools required to maintain and control their ketogenesis.
Conclusion
Claims 1-14 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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