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 .
Priority
The present application does not claim priority to any other application.
Claim Status
This Office Action is in response to Applicant’s Response to Restriction Requirement filed 16 February 2026, wherein Applicant amended claims 24-60 and withdrew claims 7, 12-15, 20, 23-41, 53-56.
Because the Restriction Requirement mailed 17 November 2025 restricted the application improperly as a National Phase filing (371 application), the Restriction Requirement mailed 17 November 2025 has been rescinded.
Accordingly, claims 1-60 are pending, and the application is re-restricted as a 111(a) application.
1. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-22, drawn to a method of treating for improving metabolic performance via a supplement formulation via a selected administration route, classified in A61K 2300/00.
II. Claims 23-41, drawn to a composition for oral supplementation, classified in A61K 9/20.
III. Claims 42-60, drawn to a composition for transdermal supplementation, classified in A61K 9/06.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process can be practiced with a materially different product. Peeling (Int. J. Sport Nutrition and Exercise Metabolism, 2018, 28, 178-187) teaches improving metabolic performance via creatine (page 179, column 2, paragraph 3; page 180, column 1, paragraph 1).
Inventions I and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process can be practiced with a materially different product. Peeling (Int. J. Sport Nutrition and Exercise Metabolism, 2018, 28, 178-187) teaches improving metabolic performance via creatine (page 179, column 2, paragraph 3; page 180, column 1, paragraph 1).
Inventions II and III are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the product of claim 23 (a composition for oral supplementation) has a materially different design and mode of operation than the product of claim 42 (a composition for transdermal supplementation). Goldstajn (Archives of Gynecology and Obstretrics¸ 2023, 307, 1727-1745) teaches that transdermal administration of a hormone replacement therapeutic has different pharmacodynamics than the oral administration route with different safety profiles (page 1739, column 1, paragraph 2). Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
the inventions have acquired a separate status in the art in view of their different classification
the inventions have acquired a separate status in the art due to their recognized divergent subject matter
the inventions require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
In view of the distinct product and process steps, Groups I and II are distinctly classified and require different fields of search in view of the distinct process steps as required in Group II and distinct compounds as required in Group I. See MPEP 803 and 808.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The application contains claims directed to the following patentably distinct species:
-Different species of administration route, and
-Different species of composition,
The species are independent or distinct because the administration routes are distinct in formulation and pharmacology, and the compositions are disparate in structure, function, and/or combinations thereof, would not necessarily result in a comprehensive search for any one or more other claimed compound or disease with the genus as claimed.
In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect:
-A single disclosed species of administration route, such as one of those recited in instant claim 20 or 21,
-A single disclosed species of composition, wherein the composition is a single disclosed combination of:
-species of a plurality of medium-chain triglycerides, such as those recited in claim 2,
-species of a plurality of amino acids, such as those recited in claims 3-7,
-species of a hormone supplement, such as those recited in claims 8-9,
-species of a plurality of forms of beta-hydroxybutyrate, such as those recited in claims 10-15,
or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claims 23-60 are generic for a composition, and claims 1-22 are generic for a method of treating.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
the inventions have acquired a separate status in the art in view of their different classification
the inventions have acquired a separate status in the art due to their recognized divergent subject matter
the inventions require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
In view of the great number of unrelated species encompassed by administration route, the great number of unrelated species encompassed by a composition, and the great number of combinations encompassed by these individual species, different fields of search are required for each species, and combinations of species. See MPEP 803 and 808.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the species to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Erin Johnston on 3 June 2026 a provisional election was made without traverse to prosecute the invention of Group III (claims 42-60) and species (transdermal route of administration, medium chain triglycerides: caprylic acid, amino acid: L-carnitine fumarate, hormone supplement: HGH, beta-hydroxybutyrate: sodium cation). Affirmation of this election must be made by applicant in replying to this Office action.
Claim 1-41 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention (Groups I: claim 1-22; Group II: claims 23-41), there being no allowable generic or linking claim.
Claim 46-48, 50, and 53-56 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention (species), there being no allowable or linking claim. Claim 46 specifies a plurality of cetylated fatty acids, which does not read on the elected species. Claim 47 specifies the plurality of cetylated fatty acids comprises cetyl myristoleate, which does not read on the elected species. Claim 48 specifies the plurality of cetylated fatty acids comprises cetylated alpha-linoleic acid, which does not read on the elected species. Claim 50 specifies the hormone supplement comprises L-DOPA, which does not read on the elected species. Claim 53 specifies that the salt cation comprises a transition metal ion, which does not read on the elected species. Claim 54 specifies that the plurality of forms of beta-hydroxybutyrate comprises an ester, which does not read on the elected species. Claim 55 specifies that the ester comprises an organyl group, which does not read on the elected species. Claim 56 specifies that the organyl group comprises at least one of alkyl, alkenyl, acyl, or aryl, which does not read on the elected species.
Thus, claims 42-45, 49, 51-52, and 57-60 are pending.
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.
2. Claim 59 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 as evidenced by Merriam-Webster (“Plurality,” Merriam-Webster, 2026, <merriam-webster.com/dictionary/plurality>, accessed 9 June 2026).
Claim 59 recites the limitation “the plurality of zeatin” in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim, because claim 42 (the claim upon which claim 59 depends) recites “and zeatin.” The specification does not define “a plurality,” but Merriam-Webster defines a plurality to be the state of being numerous or a large number or quantity (page 1; entry 1b; page 1, entry 1c). Claim 42 distinguishes five components and specifies a plurality for three of the components (medium-chain triglycerides, amino acids, and forms of beta-hydroxybutyrate), which all are elements with sub-components, which can correspond to different species (e.g. e.g. leucine and valine are amino acids as opposed to the element, zeatin). Accordingly, claim 59 lacks antecedent basis.
Additionally, claim 59 recites the limitation “the human subject” in line 3 of the claim. There is insufficient antecedent basis for this limitation in the claim, because claim 42 does not recite a human subject. Claim 42 is drawn to a composition and a human subject is not relevant to a composition. Accordingly, claim 59 is vague and indefinite and thus lacks antecedent basis.
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.
3. Claim(s) 42-45, 49, 51-52, and 57-60 are rejected under 35 U.S.C. 103 as being unpatentable over D’Agostino (US 2014/0350105, published 27 Nov 2014) in view of Jaffe (US 2007/0243211, published 18 Oct 2007) and Nutritech (“Dermatropin®,” Daily Med, 2020, <dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a98ec18d-719a-66bb-e053-2a95a90a74eb>, accessed 4 June 2026) as evidenced by Healthline (“Caprylic Acid: Coconut Oil’s Secret,” Healthline, 17 Aug 2021, < healthline.com/health/caprylic-acid-coconut-oil>, accessed 4 June 2026) and Wikipedia (“Zeatin,” Wikipedia¸2026, <en.wikipedia.org/wiki/Zeatin>, accessed 4 June 2026).
D’Agostino teaches compositions of at least one medium chain triglyceride and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis (abstract). D’Agostino teaches the medium chain triglyceride is caprylic acid ([0066]). D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function ([0039]). D’Agostino also teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]). D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin as evidenced by Wikipedia (page 1, paragraph 2), as well as administering a composition to a 100 kg male subject ([0076]). D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects ([0012]) and that the supplements therein are also an anti-aging supplement ([0040]).
Regarding claim 42, D’Agostino fails to teach the amino acid is L-carnitine fumarate and the hormone supplement is HGH.
Jaffe teaches compositions that are useful in regulating disorders and maintain a healthy metabolism having medium chain triglycerides (abstract). Jaffe teaches a composition comprising at least one or more oxidative fat metabolizer, one or more neurotransmitters, one or more algins or algin equivalents, and one or more medium chain triglycerides (claim 1). Jaffe teaches the amino acid (as the oxidative fat metabolizer) is L-carnitine fumarate ([0187]). Jaffe teaches that administration of gamma-aminobutyric acid stimulates the anterior pituitary, leading to higher levels of human growth hormone (HGH), which contributes significantly to muscle growth and prevent creation of fat cells ([0096]-[0097]). Additionally, Jaffe teaches that HGH depletion leads to sleep disorders ([0097]). Jaffe also teaches transdermal administration of the compositions therein ([0164]; [0166]).
Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles (page 1, paragraph 1; page 1, package label display). Nutritech also teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep (page 1, paragraph 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition of D’Agostino with the compositions of Jaffe and Nutritech to improve metabolism and aid in anti-aging effects to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to select the compositions of D’Agostino, Jaffe, and Nutritech, because:
-D’Agostino teaches compositions of at least one medium chain triglyceride and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis,
-D’Agostino teaches the medium chain triglyceride is caprylic acid,
-D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function,
-D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate,
-D’Agostino teaches that science-based improvements in efficiency of cellular metabolism, managed through ketone supplementation, has beneficial impacts on physical, cognitive health, psychological health, warfighter resilience, and a possible long-term impact on health with respect to the common avoidable diseases such as obesity, neurodegenerative diseases, diabetes, and cancer ([0004]),
-D’Agostino teaches administering 5-50g of coconut milk, which contains zeatin as evidenced by Wikipedia, as well as administering a composition to a 100 kg male subject,
-D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects and that the supplements therein are also an anti-aging supplement,
-Jaffe teaches compositions that are useful in regulating disorders and maintain a healthy metabolism having medium chain triglycerides,
-Jaffe teaches a composition comprising at least one or more oxidative fat metabolizer, one or more neurotransmitters, one or more algins or algin equivalents, and one or more medium chain triglycerides,
-Jaffe teaches the amino acid is L-carnitine fumarate,
-Jaffe teaches that administration of gamma-aminobutyric acid stimulates the anterior pituitary, leading to higher levels of human growth hormone (HGH), which contributes significantly to muscle growth and prevent creation of fat cells,
-Jaffe teaches that HGH depletion leads to sleep disorders,
-Jaffe also teaches transdermal administration of the compositions therein,
-Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles, and
-Nutritech teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep.
Thus, one of ordinary skill in the art would have selected the composition of D’Agostino with the compositions of Jaffe and Nutritech to create a transdermal composition having an aqueous gel that comprises a plurality of caprylic acid, a plurality of L-carnitine fumarate, HGH, sodium beta-hydroxybutyrate, and zeatin.
Regarding claim 43, D’Agostino teaches the medium chain triglyceride is caprylic acid ([0066]).
Regarding claim 44, Jaffe teaches the amino acid is L-carnitine fumarate ([0187]).
Regarding claim 45, Jaffe teaches the amino acid is L-carnitine fumarate ([0187]).
Regarding claim 49, Nutritech teaches the hormone supplement is HGH wrinkles (page 1, paragraph 1; page 1, package label display).
Regarding claim 51, D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 52, D’Agostino teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 57, Jaffe teaches administering 800 mg of the medium chain triglyceride as raw coconut oil ([0186]), which contains caprylic acid as evidenced by Healthline (page 1, paragraph 4).
Regarding claim 58, Jaffe teaches administering 500 mg of L-carnitine fumarate ([0186]).
Regarding claim 59, D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin as evidenced by Wikipedia (page 1, paragraph 2), as well as administering a composition to a 100 kg male subject ([0076]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin. D’Agostino teaches that the compositions therein produced blood ketone levels at a rate and peak level greater than what was achieved with either component alone and that the combination of medium chain triglyceride, which D’Agostino defines coconut milk to be a source of medium chain triglycerides ([0037]), and beta-hydroxybutyrate allows for lower dosing of the components as compared to the individual compounds, thereby reducing side effects and maintaining low and controlled blood glucose ([0074]; [0075]). Thus, an artisan having ordinary skill in the art would recognize that optimizing via lowering the amount of active component (zeatin) would reduce unwanted side effects. Accordingly, D’Agostino teaches a dosing amount of between 0.1-1 mg/kg body weight of the human subject.
Regarding claim 60, D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject ([0076]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject, which is 18.1 g beta-hydroxybutyrate ([0076]). D’Agostino teaches administering about 2-50 g beta-hydroxybutyrate ([0033]), and approximately 45 g of beta-hydroxybutyrate is about 10% beta-hydroxybutyrate. Thus, the range of D’Agostino overlaps with the range of the claimed invention. Further, the range of the claimed invention does not provide an unexpected result in view of D’Agostino, who describes compositions of beta-hydroxybutyrate and medium chain triglycerides (abstract). D’Agostino teaches that the amount of beta-hydroxybutyrate salts in combination with medium chain triglycerides depends on the absorption, distribution, metabolism, and excretion rates of the composition, method of administration, and the particular disorder being treat ([0071]). D’Agostino further teaches that the administration should be adjusted according to individual need and professional judgement of a person administering the composition ([0071]). D’Agostino teaches that the body is able to burn fat for fuel in ketosis, because the fat stores in the body are utilized to create the water-soluble ketone bodies, beta-hydroxybutyrate, which are then used by the body as the primary energy source ([0008]). Accordingly, D’Agostino teaches beta-hydroxybutyrate is present in a concentration between 10-40%.
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.
4. Claims 42-45, 49, 51-52, 57-58, and 60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-35 and 40-42 of copending Application No. 18/338,304 (reference application) in view of Jaffe (US 2007/0243211, published 18 Oct 2007), Nutritech (“Dermatropin®,” Daily Med, 2020, <dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a98ec18d-719a-66bb-e053-2a95a90a74eb>, accessed 4 June 2026), and Rattan (Rejuvenation Research¸2005, 8(1)) as evidenced by Healthline (“Caprylic Acid: Coconut Oil’s Secret,” Healthline, 17 Aug 2021, < healthline.com/health/caprylic-acid-coconut-oil>, accessed 4 June 2026).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/338,304 claims a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a plurality of medium-chain triglycerides, a plurality of amino acids, a plurality of forms of beta-hydroxybutyrate (claim 30). Further, ‘304 claims that the medium-chain triglyceride is caprylic acid, the amino acid is L-carnitine fumarate, that the beta-hydroxybutyrate is an ionic salt, and that the salt cation is sodium (claims 31-35).
Regarding claim 42, the claims of ‘304 do not recite that the hormone supplement is HGH and do not recite zeatin.
Jaffe teaches compositions that are useful in regulating disorders and maintain a healthy metabolism having medium chain triglycerides (abstract). Jaffe teaches the amino acid is L-carnitine fumarate ([0187]). Jaffe teaches that administration of gamma-aminobutyric acid stimulates the anterior pituitary, leading to higher levels of human growth hormone (HGH), which contributes significantly to muscle growth and prevent creation of fat cells ([0096]-[0097]). Additionally, Jaffe teaches that HGH depletion leads to sleep disorders ([0097]). Jaffe also teaches transdermal administration of the compositions therein ([0164]; [0166]).
Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles (page 1, paragraph 1; page 1, package label display). Nutritech also teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep (page 1, paragraph 1).
Rattan teaches that zeatin has gerontomodculatory, youth preserving, and anti-aging effects on human skin cell fibroblasts (abstract). Rattan teaches that anti-aging and beneficial effects of zeatin were observed without any induction of additional cell proliferation or an increase in the maximum proliferative capacity, thus ruling out any potentially harmful and carcinogenic effects (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition of ‘304 with the compositions of Jaffe, Nutritech, and Rattan to improve metabolism and aid in anti-aging effects to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to select the compositions of ‘304, Jaffe, Nutritech, and Rattan, because:
-‘304 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a plurality of medium0chain triglycerides, a plurality of amino acids, a plurality of forms of beta-hydroxybutyrate,
-‘304 teaches that the medium-chain triglyceride is caprylic acid, the amino acid is L-carnitine fumarate, that the beta-hydroxybutyrate is an ionic salt, and that the salt cation is sodium,
-Jaffe teaches compositions that are useful in regulating disorders and maintain a healthy metabolism having medium chain triglycerides,
-Jaffe teaches the amino acid is L-carnitine fumarate,
-Jaffe teaches that administration of gamma-aminobutyric acid stimulates the anterior pituitary, leading to higher levels of human growth hormone (HGH), which contributes significantly to muscle growth and prevent creation of fat cells,
-Jaffe teaches that HGH depletion leads to sleep disorders,
-Jaffe also teaches transdermal administration of the compositions therein,
-Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles,
-Nutritech teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep,
-Rattan teaches that zeatin has gerontomodculatory, youth preserving, and anti-aging effects on human skin cell fibroblasts, and
-Rattan teaches that zeatin has gerontomodculatory, youth preserving, and anti-aging effects on human skin cell fibroblasts.
Thus, one of ordinary skill in the art would have selected the composition of ‘304 with the compositions of Jaffe, Nutritech, and Rattan to create a transdermal composition having an aqueous gel that comprises a plurality of caprylic acid, a plurality of L-carnitine fumarate, HGH, sodium beta-hydroxybutyrate, and zeatin.
Regarding claim 43, ‘304 teaches the medium chain triglyceride is caprylic acid (claim 31).
Regarding claim 44, ‘304 teaches the amino acid is L-carnitine fumarate (claim 32-33).
Regarding claim 45, ‘304 teaches the amino acid is L-carnitine fumarate (claim 32-33).
Regarding claim 49, Nutritech teaches the hormone supplement is HGH wrinkles (page 1, paragraph 1; page 1, package label display).
Regarding claim 51, ‘304 teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate (claim 34-35)
Regarding claim 52, ‘304 teaches sodium beta-hydroxybutyrate (claim 35).
Regarding claim 57, Jaffe teaches administering 800 mg of the medium chain triglyceride as raw coconut oil ([0186]), which contains caprylic acid as evidenced by Healthline (page 1, paragraph 4).
Regarding claim 58, Jaffe teaches administering 500 mg of L-carnitine fumarate ([0186]).
Regarding claim 60, ‘304 teaches that the beta-hydroxybutyrate is present in a concentration between 10-40% (claim 42).
5. Claims 42-45, 49, 51-52, and 57-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 26-29 and 34-36 of copending Application No. 18/329,534 (reference application) in view of D’Agostino (US 2014/0350105, published 27 Nov 2014) and Nutritech (“Dermatropin®,” Daily Med, 2020, <dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a98ec18d-719a-66bb-e053-2a95a90a74eb>, accessed 4 June 2026) as evidenced by Healthline (“Caprylic Acid: Coconut Oil’s Secret,” Healthline, 17 Aug 2021, < healthline.com/health/caprylic-acid-coconut-oil>, accessed 4 June 2026) and Wikipedia (“Zeatin,” Wikipedia¸2026, <en.wikipedia.org/wiki/Zeatin>, accessed 4 June 2026).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/329,534 claims a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a plurality of medium-chain triglycerides, a plurality of amino acids, a plurality of forms of cannabinoids, and zeatin (claim 26). Further, the claims of ‘534 recite that the medium-chain triglyceride is caprylic acid and that the amino acid is L-carnitine fumarate (claims 27-29).
Regarding claim 42, the claims of ‘534 fail to recite that the hormone supplement is HGH and that the form of beta-hydroxybutyrate is a sodium salt.
D’Agostino teaches compositions of at least one medium chain triglyceride and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis (abstract). D’Agostino teaches the medium chain triglyceride is caprylic acid ([0066]). D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function ([0039]). D’Agostino also teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]). D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin as evidenced by Wikipedia (page 1, paragraph 2), as well as administering a composition to a 100 kg male subject ([0076]). D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects ([0012]) and that the supplements therein are also an anti-aging supplement ([0040]).
Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles (page 1, paragraph 1; page 1, package label display). Nutritech also teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep (page 1, paragraph 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition of ‘534 with the compositions of D’Agostino and Nutritech to improve metabolism and aid in anti-aging effects to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to select the compositions of ‘534, D’Agostino, and Nutritech, because:
-‘534 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a plurality of medium-chain triglycerides, a plurality of amino acids, a plurality of forms of cannabinoids, and zeatin,
-‘534 teaches that the medium-chain triglyceride is caprylic acid and that the amino acid is L-carnitine fumarate,
-D’Agostino teaches compositions of at least one medium chain triglycerides and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis,
-D’Agostino teaches the medium chain triglyceride is caprylic acid,
-D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function,
-D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate,
-D’Agostino teaches that science-based improvements in efficiency of cellular metabolism, managed through ketone supplementation, has beneficial impacts on physical, cognitive health, psychological health, warfighter resilience, and a possible long-term impact on health with respect to the common avoidable diseases such as obesity, neurodegenerative diseases, diabetes, and cancer ([0004]),
-D’Agostino teaches administering 5-50g of coconut milk, which contains zeatin as evidenced by Wikipedia, as well as administering a composition to a 100 kg male subject,
-D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects and that the supplements therein are also an anti-aging supplement,
-Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles, and
-Nutritech teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep.
Thus, one of ordinary skill in the art would have selected the composition of ‘534 with the compositions of D’Agostino and Nutritech to create a transdermal composition having an aqueous gel that comprises a plurality of caprylic acid, a plurality of L-carnitine fumarate, HGH, sodium beta-hydroxybutyrate, and zeatin.
Regarding claim 43, ‘534 teaches the medium chain triglyceride is caprylic acid (claim 27).
Regarding claim 44, ‘534 teaches the amino acid is L-carnitine fumarate (claim 28-29).
Regarding claim 45, ‘534 teaches the amino acid is L-carnitine fumarate (claim 28-29).
Regarding claim 49, Nutritech teaches the hormone supplement is HGH wrinkles (page 1, paragraph 1; page 1, package label display).
Regarding claim 51, D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 52, D’Agostino teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 57, ‘534 teaches the therapeutically-effective amount of the plurality of medium-chain triglycerides is between 0.1 and 2 grams (claim 34).
Regarding claim 58, ‘534 teaches the therapeutically-effective amount of the plurality of amino acids is between 0.1 and 1 grams (claim 35).
Regarding claim 59, ‘534 teaches the therapeutically-effective amount of the plurality of zeatin is between 0.1 and 1 milligram per kilogram bodyweight of the human subject (claim 36).
Regarding claim 60, D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject ([0076]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject, which is 18.1 g beta-hydroxybutyrate ([0076]). D’Agostino teaches administering about 2-50 g beta-hydroxybutyrate ([0033]), and approximately 45 g of beta-hydroxybutyrate is about 10% beta-hydroxybutyrate. Thus, the range of D’Agostino overlaps with the range of the claimed invention. Further, the range of the claimed invention does not provide an unexpected result in view of D’Agostino, who describes compositions of beta-hydroxybutyrate and medium chain triglycerides (abstract). D’Agostino teaches that the amount of beta-hydroxybutyrate salts in combination with medium chain triglycerides depends on the absorption, distribution, metabolism, and excretion rates of the composition, method of administration, and the particular disorder being treat ([0071]). D’Agostino further teaches that the administration should be adjusted according to individual need and professional judgement of a person administering the composition ([0071]). D’Agostino teaches that the body is able to burn fat for fuel in ketosis, because the fat stores in the body are utilized to create the water-soluble ketone bodies, beta-hydroxybutyrate, which are then used by the body as the primary energy source ([0008]). Accordingly, D’Agostino teaches beta-hydroxybutyrate is present in a concentration between 10-40%.
6. Claims 42-45, 49, 51-52, and 58-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28, 30-33, and 38-39 of copending Application No. 18/338,310 (reference application) in view of D’Agostino (US 2014/0350105, published 27 Nov 2014) and Nutritech (“Dermatropin®,” Daily Med, 2020, <dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a98ec18d-719a-66bb-e053-2a95a90a74eb>, accessed 4 June 2026) as evidenced by Healthline (“Caprylic Acid: Coconut Oil’s Secret,” Healthline, 17 Aug 2021, < healthline.com/health/caprylic-acid-coconut-oil>, accessed 4 June 2026) and Wikipedia (“Zeatin,” Wikipedia¸2026, <en.wikipedia.org/wiki/Zeatin>, accessed 4 June 2026).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/338,310 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of a plurality of amino acids and a plurality of forms of beta-hydroxybutyrate (claim 28). Further, ‘310 teaches that the amino acid is L-carnitine fumarate and that the beta-hydroxybutyrate is an ionic salt, and that the salt cation is sodium (claims 30-33).
Regarding claim 42, ‘310 fails to teach the medium-chain triglyceride is caprylic acid, hormone supplement is HGH, and zeatin.
D’Agostino teaches compositions of at least one medium chain triglycerides and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis (abstract). D’Agostino teaches the medium chain triglyceride is caprylic acid ([0066]). D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function ([0039]). D’Agostino also teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]). D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin as evidenced by Wikipedia (page 1, paragraph 2), as well as administering a composition to a 100 kg male subject ([0076]). D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects ([0012]) and that the supplements therein are also an anti-aging supplement ([0040]).
Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles (page 1, paragraph 1; page 1, package label display). Nutritech also teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep (page 1, paragraph 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition of ‘310 with the compositions of D’Agostino and Nutritech to improve metabolism and aid in anti-aging effects to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to select the compositions of ‘310, D’Agostino, and Nutritech, because:
-‘310 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of a plurality of amino acids and a plurality of forms of beta-hydroxybutyrate,
-‘310 teaches that the amino acid is L-carnitine fumarate and that the beta-hydroxybutyrate is an ionic salt, and that the salt cation is sodium,
-D’Agostino teaches compositions of at least one medium chain triglycerides and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis,
-D’Agostino teaches the medium chain triglyceride is caprylic acid,
-D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function,
-D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate,
-D’Agostino teaches that science-based improvements in efficiency of cellular metabolism, managed through ketone supplementation, has beneficial impacts on physical, cognitive health, psychological health, warfighter resilience, and a possible long-term impact on health with respect to the common avoidable diseases such as obesity, neurodegenerative diseases, diabetes, and cancer ([0004]),
-D’Agostino teaches administering 5-50g of coconut milk, which contains zeatin as evidenced by Wikipedia, as well as administering a composition to a 100 kg male subject,
-D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects and that the supplements therein are also an anti-aging supplement,
-Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles, and
-Nutritech teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep.
Thus, one of ordinary skill in the art would have selected the composition of ‘534 with the compositions of D’Agostino and Nutritech to create a transdermal composition having an aqueous gel that comprises a plurality of caprylic acid, a plurality of L-carnitine fumarate, HGH, sodium beta-hydroxybutyrate, and zeatin.
Regarding claim 43, D’Agostino teaches the medium chain triglyceride is caprylic acid ([0066]).
Regarding claim 44, ‘310 teaches the amino acid is L-carnitine fumarate (claim 30-31).
Regarding claim 45, ‘310 teaches the amino acid is L-carnitine fumarate (claim 30-31).
Regarding claim 49, Nutritech teaches the hormone supplement is HGH wrinkles (page 1, paragraph 1; page 1, package label display).
Regarding claim 51, ‘310 teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate (claims 32-33).
Regarding claim 52, ‘310 teaches sodium beta-hydroxybutyrate (claims 32-33).
Regarding claim 58, ‘310 teaches the therapeutically-effective amount of the plurality of amino acids is between 0.1 and 1 grams (claim 38).
Regarding claim 59, D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin as evidenced by Wikipedia (page 1, paragraph 2), as well as administering a composition to a 100 kg male subject ([0076]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin. D’Agostino teaches that the compositions therein produced blood ketone levels at a rate and peak level greater than what was achieved with either component alone and that the combination of medium chain triglyceride, which D’Agostino defines coconut milk to be a source of medium chain triglycerides ([0037]), and beta-hydroxybutyrate allows for lower dosing of the components as compared to the individual compounds, thereby reducing side effects and maintaining low and controlled blood glucose ([0074]; [0075]). Thus, an artisan having ordinary skill in the art would recognize that optimizing via lowering the amount of active component (zeatin) would reduce unwanted side effects. Accordingly, D’Agostino teaches a dosing amount of between 0.1-1 mg/kg body weight of the human subject.
Regarding claim 60, ‘310 teaches beta-hydroxybutyrate is present in a concentration between 10-40% (claim 39).
7. Claims 42-45, 49, 51-52, and 57-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-27 and 31-33 of copending Application No. 18/299,416 (reference application) in view of D’Agostino (US 2014/0350105, published 27 Nov 2014) and Nutritech (“Dermatropin®,” Daily Med, 2020, <dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a98ec18d-719a-66bb-e053-2a95a90a74eb>, accessed 4 June 2026) as evidenced by Healthline (“Caprylic Acid: Coconut Oil’s Secret,” Healthline, 17 Aug 2021, < healthline.com/health/caprylic-acid-coconut-oil>, accessed 4 June 2026) and Wikipedia (“Zeatin,” Wikipedia¸2026, <en.wikipedia.org/wiki/Zeatin>, accessed 4 June 2026).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/299,416 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a plurality of medium-chain triglycerides, a plurality of amino acids, and zeatin (claim 24). Further, ‘416 teaches that the medium-chain triglyceride is caprylic acid and that the amino acid is L-carnitine fumarate (claims 25-27).
Regarding claim 42, ‘416 fails to teach the hormone supplement is HGH and the form of beta-hydroxybutyrate is an sodium salt.
D’Agostino teaches compositions of at least one medium chain triglycerides and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis (abstract). D’Agostino teaches the medium chain triglyceride is caprylic acid ([0066]). D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function ([0039]). D’Agostino also teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]). D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin as evidenced by Wikipedia (page 1, paragraph 2), as well as administering a composition to a 100 kg male subject ([0076]). D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects ([0012]) and that the supplements therein are also an anti-aging supplement ([0040]).
Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles (page 1, paragraph 1; page 1, package label display). Nutritech also teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep (page 1, paragraph 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition of ‘416 with the compositions of D’Agostino and Nutritech to improve metabolism and aid in anti-aging effects to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to select the compositions of ‘416, D’Agostino, and Nutritech, because:
-‘416 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a plurality of medium-chain triglycerides, a plurality of amino acids, and zeatin,
-‘416 teaches that the medium-chain triglyceride is caprylic acid and that the amino acid is L-carnitine fumarate,
-D’Agostino teaches compositions of at least one medium chain triglycerides and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis,
-D’Agostino teaches the medium chain triglyceride is caprylic acid,
-D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function,
-D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate,
-D’Agostino teaches that science-based improvements in efficiency of cellular metabolism, managed through ketone supplementation, has beneficial impacts on physical, cognitive health, psychological health, warfighter resilience, and a possible long-term impact on health with respect to the common avoidable diseases such as obesity, neurodegenerative diseases, diabetes, and cancer ([0004]),
-D’Agostino teaches administering 5-50g of coconut milk, which contains zeatin as evidenced by Wikipedia, as well as administering a composition to a 100 kg male subject,
-D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects and that the supplements therein are also an anti-aging supplement,
-Nutritech teaches that Dermatropin® is a transdermal HGH gel that promotes brighter, youthful looking skin and may reduce wrinkles, and
-Nutritech teaches that HGH helps speed up healing, repairs muscles tissue after exercise, builds muscles, boosts the immune system, burns fat, and improves sleep.
Thus, one of ordinary skill in the art would have selected the composition of ‘416 with the compositions of D’Agostino and Nutritech to create a transdermal composition having an aqueous gel that comprises a plurality of caprylic acid, a plurality of L-carnitine fumarate, HGH, sodium beta-hydroxybutyrate, and zeatin.
Regarding claim 43, ‘416 teaches the medium chain triglyceride is caprylic acid (claim 25).
Regarding claim 44, ‘416 teaches the amino acid is L-carnitine fumarate (claim 26-27).
Regarding claim 45, ‘416 teaches the amino acid is L-carnitine fumarate (claim 26-27).
Regarding claim 49, Nutritech teaches the hormone supplement is HGH wrinkles (page 1, paragraph 1; page 1, package label display).
Regarding claim 51, D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 52, D’Agostino teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 57, ‘416 teaches the therapeutically-effective amount of the plurality of medium-chain triglycerides is between 0.1 and 2 grams (claim 31).
Regarding claim 58, ‘416 teaches the therapeutically-effective amount of the plurality of amino acids is between 0.1 and 1 grams (claim 32).
Regarding claim 59, ‘416 teaches the therapeutically-effective amount of the plurality of zeatin is between 0.1 and 1 milligram per kilogram bodyweight of the human subject (claim 33).
Regarding claim 60, D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject ([0076]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject, which is 18.1 g beta-hydroxybutyrate ([0076]). D’Agostino teaches administering about 2-50 g beta-hydroxybutyrate ([0033]), and approximately 45 g of beta-hydroxybutyrate is about 10% beta-hydroxybutyrate. Thus, the range of D’Agostino overlaps with the range of the claimed invention. Further, the range of the claimed invention does not provide an unexpected result in view of D’Agostino, who describes compositions of beta-hydroxybutyrate and medium chain triglycerides (abstract). D’Agostino teaches that the amount of beta-hydroxybutyrate salts in combination with medium chain triglycerides depends on the absorption, distribution, metabolism, and excretion rates of the composition, method of administration, and the particular disorder being treat ([0071]). D’Agostino further teaches that the administration should be adjusted according to individual need and professional judgement of a person administering the composition ([0071]). D’Agostino teaches that the body is able to burn fat for fuel in ketosis, because the fat stores in the body are utilized to create the water-soluble ketone bodies, beta-hydroxybutyrate, which are then used by the body as the primary energy source ([0008]). Accordingly, D’Agostino teaches beta-hydroxybutyrate is present in a concentration between 10-40%.
8. Claims 42-45, 49, 51-52, and 57-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-33, 37, and 40-42 of copending Application No. 18/329,537 (reference application) in view of D’Agostino (US 2014/0350105, published 27 Nov 2014) as evidenced by Healthline (“Caprylic Acid: Coconut Oil’s Secret,” Healthline, 17 Aug 2021, < healthline.com/health/caprylic-acid-coconut-oil>, accessed 4 June 2026) and Wikipedia (“Zeatin,” Wikipedia¸2026, <en.wikipedia.org/wiki/Zeatin>, accessed 4 June 2026).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/299,537 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a plurality of medium-chain triglycerides, a plurality of amino acids, a hormone supplement, and zeatin (claim 30). Further, ‘537 teaches that the medium-chain triglyceride is caprylic acid and that the amino acid is L-carnitine fumarate (claims 31-33).
Regarding claim 42, ‘537 fails to teach the form of beta-hydroxybutyrate is an sodium salt.
D’Agostino teaches compositions of at least one medium chain triglycerides and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis (abstract). D’Agostino teaches the medium chain triglyceride is caprylic acid ([0066]). D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function ([0039]). D’Agostino also teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]). D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin as evidenced by Wikipedia (page 1, paragraph 2), as well as administering a composition to a 100 kg male subject ([0076]). D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects ([0012]) and that the supplements therein are also an anti-aging supplement ([0040]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition of ‘537 with the compositions of D’Agostino to improve metabolism and aid in anti-aging effects to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to select the compositions of ‘537 and D’Agostino, because:
-‘537 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a plurality of medium-chain triglycerides, a plurality of amino acids, a hormone supplement, and zeatin,
-‘537 teaches that the medium-chain triglyceride is caprylic acid and that the amino acid is L-carnitine fumarate,
-D’Agostino teaches compositions of at least one medium chain triglycerides and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis,
-D’Agostino teaches the medium chain triglyceride is caprylic acid,
-D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function,
-D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate,
-D’Agostino teaches that science-based improvements in efficiency of cellular metabolism, managed through ketone supplementation, has beneficial impacts on physical, cognitive health, psychological health, warfighter resilience, and a possible long-term impact on health with respect to the common avoidable diseases such as obesity, neurodegenerative diseases, diabetes, and cancer ([0004]),
-D’Agostino teaches administering 5-50g of coconut milk, which contains zeatin as evidenced by Wikipedia, as well as administering a composition to a 100 kg male subject, and
-D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects and that the supplements therein are also an anti-aging supplement.
Thus, one of ordinary skill in the art would have selected the composition of ‘537 with the compositions of D’Agostino to create a transdermal composition having an aqueous gel that comprises a plurality of caprylic acid, a plurality of L-carnitine fumarate, HGH, sodium beta-hydroxybutyrate, and zeatin.
Regarding claim 43, ‘537 teaches the medium chain triglyceride is caprylic acid (claim 31).
Regarding claim 44, ‘537 teaches the amino acid is L-carnitine fumarate (claim 32-33).
Regarding claim 45, ‘537 teaches the amino acid is L-carnitine fumarate (claim 32-33).
Regarding claim 49, ‘537 teaches the hormone supplement is HGH wrinkles (claim 37).
Regarding claim 51, D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 52, D’Agostino teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 57, ‘537 teaches the therapeutically-effective amount of the plurality of medium-chain triglycerides is between 0.1 and 2 grams (claim 40).
Regarding claim 58, ‘537 teaches the therapeutically-effective amount of the plurality of amino acids is between 0.1 and 1 grams (claim 41).
Regarding claim 59, ‘537 teaches the therapeutically-effective amount of the plurality of zeatin is between 0.1 and 1 milligram per kilogram bodyweight of the human subject (claim 42).
Regarding claim 60, D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject ([0076]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject, which is 18.1 g beta-hydroxybutyrate ([0076]). D’Agostino teaches administering about 2-50 g beta-hydroxybutyrate ([0033]), and approximately 45 g of beta-hydroxybutyrate is about 10% beta-hydroxybutyrate. Thus, the range of D’Agostino overlaps with the range of the claimed invention. Further, the range of the claimed invention does not provide an unexpected result in view of D’Agostino, who describes compositions of beta-hydroxybutyrate and medium chain triglycerides (abstract). D’Agostino teaches that the amount of beta-hydroxybutyrate salts in combination with medium chain triglycerides depends on the absorption, distribution, metabolism, and excretion rates of the composition, method of administration, and the particular disorder being treat ([0071]). D’Agostino further teaches that the administration should be adjusted according to individual need and professional judgement of a person administering the composition ([0071]). D’Agostino teaches that the body is able to burn fat for fuel in ketosis, because the fat stores in the body are utilized to create the water-soluble ketone bodies, beta-hydroxybutyrate, which are then used by the body as the primary energy source ([0008]). Accordingly, D’Agostino teaches beta-hydroxybutyrate is present in a concentration between 10-40%.
9. Claims 42-45, 49, 51-52, and 57-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24 and 27 of copending Application No. 18/411,771 (reference application) in view of D’Agostino (US 2014/0350105, published 27 Nov 2014) and Jaffe (US 2007/0243211, published 18 Oct 2007) as evidenced by Healthline (“Caprylic Acid: Coconut Oil’s Secret,” Healthline, 17 Aug 2021, < healthline.com/health/caprylic-acid-coconut-oil>, accessed 4 June 2026) and Wikipedia (“Zeatin,” Wikipedia¸2026, <en.wikipedia.org/wiki/Zeatin>, accessed 4 June 2026).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
U.S. Application No. 18/411,771 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a hormone supplement and a plurality of collagen peptides and elastin peptides (claim 24). Further, ‘771 teaches that the hormone supplement is HGH (claim 27).
Regarding claim 42, ‘771 fails to teach the medium-chain triglyceride (caprylic acid), the amino acid (L-carnitine fumarate), the form of beta-hydroxybutyrate (sodium salt) and zeatin.
D’Agostino teaches compositions of at least one medium chain triglyceride and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis (abstract). D’Agostino teaches the medium chain triglyceride is caprylic acid ([0066]). D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function ([0039]). D’Agostino also teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]). D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin as evidenced by Wikipedia (page 1, paragraph 2), as well as administering a composition to a 100 kg male subject ([0076]). D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects ([0012]) and that the supplements therein are also an anti-aging supplement ([0040]).
Jaffe teaches compositions that are useful in regulating disorders and maintain a healthy metabolism having medium chain triglycerides (abstract). Jaffe teaches a composition comprising at least one or more oxidative fat metabolizer, one or more neurotransmitters, one or more algins or algin equivalents, and one or more medium chain triglycerides (claim 1). Jaffe teaches the amino acid (as the oxidative fat metabolizer) is L-carnitine fumarate ([0187]). Jaffe teaches that administration of gamma-aminobutyric acid stimulates the anterior pituitary, leading to higher levels of human growth hormone (HGH), which contributes significantly to muscle growth and prevent creation of fat cells ([0096]-[0097]). Additionally, Jaffe teaches that HGH depletion leads to sleep disorders ([0097]). Jaffe also teaches transdermal administration of the compositions therein ([0164]; [0166]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the composition of ‘771 with the compositions of D’Agostino and Jaffe to improve metabolism and aid in anti-aging effects to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to select the compositions of ‘771, D’Agostino, and Jaffe, because:
-‘771 teaches a composition for transdermal supplementation comprising an aqueous gel comprising therapeutically effective amounts of: a hormone supplement and a plurality of collagen peptides and elastin peptides,
-‘771 teaches that the hormone supplement is HGH,
-D’Agostino teaches compositions of at least one medium chain triglyceride and at least one beta-hydroxybutyrate for improving metabolic biomarkers related to insulin resistance, diabetes, weight loss, and physical performance via inducing ketosis,
-D’Agostino teaches the medium chain triglyceride is caprylic acid,
-D’Agostino teaches the amino acid is carnitine, which is a nutritional co-factor that assists in mitochondrial function,
-D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate,
-D’Agostino teaches that science-based improvements in efficiency of cellular metabolism, managed through ketone supplementation, has beneficial impacts on physical, cognitive health, psychological health, warfighter resilience, and a possible long-term impact on health with respect to the common avoidable diseases such as obesity, neurodegenerative diseases, diabetes, and cancer ([0004]),
-D’Agostino teaches administering 5-50g of coconut milk, which contains zeatin as evidenced by Wikipedia, as well as administering a composition to a 100 kg male subject,
-D’Agostino teaches that other advantages to the ketogenic diet includes anti-aging and mood stabilizing effects and that the supplements therein are also an anti-aging supplement,
-Jaffe teaches compositions that are useful in regulating disorders and maintain a healthy metabolism having medium chain triglycerides,
-Jaffe teaches a composition comprising at least one or more oxidative fat metabolizer, one or more neurotransmitters, one or more algins or algin equivalents, and one or more medium chain triglycerides,
-Jaffe teaches the amino acid is L-carnitine fumarate,
-Jaffe teaches that administration of gamma-aminobutyric acid stimulates the anterior pituitary, leading to higher levels of human growth hormone (HGH), which contributes significantly to muscle growth and prevent creation of fat cells,
-Jaffe teaches that HGH depletion leads to sleep disorders, and
-Jaffe also teaches transdermal administration of the compositions therein.
Thus, one of ordinary skill in the art would have selected the composition of ‘771with the compositions of D’Agostino and Jaffe to create a transdermal composition having an aqueous gel that comprises a plurality of caprylic acid, a plurality of L-carnitine fumarate, HGH, sodium beta-hydroxybutyrate, and zeatin.
Regarding claim 43, D’Agostino teaches the medium chain triglyceride is caprylic acid ([0066]).
Regarding claim 44, Jaffe teaches the amino acid is L-carnitine fumarate ([0187]).
Regarding claim 45, Jaffe teaches the amino acid is L-carnitine fumarate ([0187]).
Regarding claim 49, ‘771 teaches the hormone supplement is HGH (claim 27).
Regarding claim 51, D’Agostino teaches mineral salts of beta-hydroxybutyrate and specifically teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 52, D’Agostino teaches sodium beta-hydroxybutyrate ([0036]).
Regarding claim 57, Jaffe teaches administering 800 mg of the medium chain triglyceride as raw coconut oil ([0186]), which contains caprylic acid as evidenced by Healthline (page 1, paragraph 4).
Regarding claim 58, Jaffe teaches administering 500 mg of L-carnitine fumarate ([0186]).
Regarding claim 59, D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin as evidenced by Wikipedia (page 1, paragraph 2), as well as administering a composition to a 100 kg male subject ([0076]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). D’Agostino teaches administering 5-50g of coconut milk ([0037]), which contains zeatin. D’Agostino teaches that the compositions therein produced blood ketone levels at a rate and peak level greater than what was achieved with either component alone and that the combination of medium chain triglyceride, which D’Agostino defines coconut milk to be a source of medium chain triglycerides ([0037]), and beta-hydroxybutyrate allows for lower dosing of the components as compared to the individual compounds, thereby reducing side effects and maintaining low and controlled blood glucose ([0074]; [0075]). Thus, an artisan having ordinary skill in the art would recognize that optimizing via lowering the amount of active component (zeatin) would reduce unwanted side effects. Accordingly, D’Agostino teaches a dosing amount of between 0.1-1 mg/kg body weight of the human subject.
Regarding claim 60, D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject ([0076]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05(I). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05(II)(A). D’Agostino teaches administering 4% beta-hydroxybutyrate to a 100 kg male subject, which is 18.1 g beta-hydroxybutyrate ([0076]). D’Agostino teaches administering about 2-50 g beta-hydroxybutyrate ([0033]), and approximately 45 g of beta-hydroxybutyrate is about 10% beta-hydroxybutyrate. Thus, the range of D’Agostino overlaps with the range of the claimed invention. Further, the range of the claimed invention does not provide an unexpected result in view of D’Agostino, who describes compositions of beta-hydroxybutyrate and medium chain triglycerides (abstract). D’Agostino teaches that the amount of beta-hydroxybutyrate salts in combination with medium chain triglycerides depends on the absorption, distribution, metabolism, and excretion rates of the composition, method of administration, and the particular disorder being treat ([0071]). D’Agostino further teaches that the administration should be adjusted according to individual need and professional judgement of a person administering the composition ([0071]). D’Agostino teaches that the body is able to burn fat for fuel in ketosis, because the fat stores in the body are utilized to create the water-soluble ketone bodies, beta-hydroxybutyrate, which are then used by the body as the primary energy source ([0008]). Accordingly, D’Agostino teaches beta-hydroxybutyrate is present in a concentration between 10-40%.
Conclusion
No claim is allowed.
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/MADELINE M. DEKARSKE/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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