DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 12/03/2025 has been entered.
Claims 21, 23-25 are pending and under consideration in this Office Action.
Claim Rejections - 35 USC § 103
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 of this title, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21, 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over
US20140350105(11/27/2014; reference of record) in view of US20060280721 (12/14/2006; PTO 892), Le Sann et al. (Org Biomol Chem. 2005 May 7;3(9):1719-28. Epub 2005 Mar 31; IDS filed 05/30/2024), US20110237666 (09/29/2011; reference of record), US20120329742 (12/27/2012; reference of record), US20150065571 (03/05/2015; PTO 892).
US20140350105 teaches the use of ketogenic precursors to quickly produce elevated and sustained levels of ketone bodies in the blood and methods for assisting the body's transition into nutritional ketosis; specifically, the use of a combination of medium chain triglycerides (MCT) with mineral salts of beta-hydroxybutyrate (.beta.HB) is presented to provide an easy and accelerated method for inducing and sustaining nutritional ketosis (see paragraph [0003]). US20140350105 teaches a composition, comprising: at least one medium chain fatty acid or ester thereof; and at least one beta-hydroxybutyrate compound, wherein the beta-hydroxybutyrate compound is comprised of a beta-hydroxybutyrate salt, or a combination of beta-hydroxybutyrate precursor and beta-hydroxybutyrate salt, see claim 1; wherein the at least one beta-hydroxy butyrate compound is racemic DL-beta hydroxybutyrate or the single isomer R-beta hydroxybutyrate, see claim 5. The R-beta hydroxybutyrate is also referred to as D-beta-hydroxybutyrate and is considered enantiomerically pure. US20140350105 teaches the composition is delivered in the form of a ready-to-drink formula, see para [0041] which reads on foodstuff. US20140350105 teach the at least one beta-hydroxybutyrate compound comprises one or more of: a beta-hydroxybutyrate salt comprising sodium beta-hydroxybutyrate, arginine beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, lithium beta-hydroxybutyrate, lysine beta-hydroxybutyrate, histidine beta-hydroxybutyrate, ornithine beta-hydroxybutyrate, creatine beta-hydroxybutyrate, agmatine beta-hydroxybutyrate, or citrulline beta-hydroxybutyrate; a salt mixture further comprising beta-hydroxy butyrate sodium salt, beta-hydroxy butyrate potassium salt, beta-hydroxy butyrate calcium salt, beta-hydroxy butyrate magnesium salt or combination thereof; or a combination of a beta-hydroxybutyrate salt and 1,3-butanediol, beta-hydroxybutyrate salt and ethyl acetoacetate, beta-hydroxybutyrate salt and ethyl beta-hydroxybutyrate, a salt mixture and 1,3-butanediol, a salt mixture and ethyl acetoacetate, or a salt mixture and ethyl beta-hydroxybutyrate, see claim 2. Such teaching of beta-hydroxy butyrate sodium salt, beta-hydroxy butyrate potassium salt, beta-hydroxy butyrate calcium salt would be considered enantiomerically enriched beta-hydroxy butyrate sodium salt, enantiomerically enriched beta-hydroxy butyrate potassium salt, and enantiomerically enriched beta-hydroxy butyrate calcium salt. See entire publication and claims especially claims 1-10 and paragraphs [0032]-[0043]. US20140350105 teaches the following:
[0033] As such, a composition of ketone precursors is disclosed which comprises at least one medium chain fatty acid, or an ester thereof such as a medium chain triglyceride, and a .beta.-hydroxybutyrate ketone source or precursor. There are numerous sources of ketones and ketogenic precursors. Nonlimiting examples of the beta-hydroxybutyrate compound include beta-hydroxybutyrate salts such as sodium beta-hydroxybutyrate and arginine beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, lithium beta-hydroxybutyrate, lysine beta-hydroxybutyrate, histidine beta-hydroxybutyrate, ornithine beta-hydroxybutyrate, creatine beta-hydroxybutyrate, agmatine beta-hydroxybutyrate, citrulline beta-hydroxybutyrate, beta-hydroxy butyrate sodium salt, beta-hydroxy butyrate potassium salt, beta-hydroxy butyrate calcium salt, beta-hydroxy butyrate magnesium salt, or a combination of salts. Nonlimiting examples of combinations of beta-hydroxybutyrate salts include sodium beta-hydroxybutyrate and arginine beta-hydroxybutyrate, or beta-hydroxy butyrate sodium salt and beta-hydroxy butyrate potassium salt. Other .beta.-hydroxybutyrate ketone sources include, without limiting the scope, 1,3-butanediol, ethyl acetoacetate, and ethyl beta-hydroxybutyrate. The compounds, are optionally administered between 2 grams and 50 grams, between 5 grams and 30 grams, or between 10 grams and 20 grams. For example, the ketone compounds are optionally administered at 2 grams, 4 grams, 5 grams, 6 grams, 7 grams, 8 grams, 9 grams, 10 grams, 11 grams, 12 grams, 13 grams, 14 grams, 15 grams, 17 grams, 19 grams, 20 grams, 22 grams, 24 grams, 26 grams, 28 grams, 30 grams, 32 grams, 34 grams, 36 grams, 38 grams, 40 grams, 42 grams, 44 grams, 46 grams, 48 grams, or 50 grams.
Claim 2. The composition of claim 1, wherein the at least one beta-hydroxybutyrate compound comprises one or more of: a beta-hydroxybutyrate salt comprising sodium beta-hydroxybutyrate, arginine beta-hydroxybutyrate, potassium beta-hydroxybutyrate, calcium beta-hydroxybutyrate, magnesium beta-hydroxybutyrate, lithium beta-hydroxybutyrate, lysine beta-hydroxybutyrate, histidine beta-hydroxybutyrate, ornithine beta-hydroxybutyrate, creatine beta-hydroxybutyrate, agmatine beta-hydroxybutyrate, or citrulline beta-hydroxybutyrate; a salt mixture further comprising beta-hydroxy butyrate sodium salt, beta-hydroxy butyrate potassium salt, beta-hydroxy butyrate calcium salt, beta-hydroxy butyrate magnesium salt or combination thereof; or a combination of a beta-hydroxybutyrate salt and 1,3-butanediol, beta-hydroxybutyrate salt and ethyl acetoacetate, beta-hydroxybutyrate salt and ethyl beta-hydroxybutyrate, a salt mixture and 1,3-butanediol, a salt mixture and ethyl acetoacetate, or a salt mixture and ethyl beta-hydroxybutyrate.
The teachings of the reference differ from the claims in that the reference does not teach the recited foodstuff comprising β-hydroxbutyric acid salts and 1,3- butanediol, wherein the β-hydroxybutyric acid and 1,3-butanediol are each enriched in their D-isomers at the recited molar ratio of 5:4.
US20060280721 teaches nutritional supplements and therapeutic compositions comprising (R)-3-hydroxybutyrate derivatives and compositions for inducing ketosis by elevating ketone body concentrations in blood where the compositions can be used therapeutically to treat several diseases and also can be used as nutritional supplements to increase metabolic efficiency (see claims 1-24 and paragraph [0020]). US20060280721 teaches that to maintain elevated blood ketone body concentrations over a 24 hour period, delayed release formulations can be used; and that the release of the (R)-3-hydroxybutyrate derivatives can be controlled by a number of formulation techniques such as enteric coatings, film coatings, microencapsulation and the like which can be used to retard release of the (R)-3-hydroxybutyrate derivatives (see [0058]). US20060280721 teaches that although (R)-3-hydroxybutyrate and acetoacetate could be administered directly to achieve elevated levels of ketone bodies in a subject, however, direct administration of these compounds is impractical and dangerous. For example, direct administration of either (R)-3-hydroxybutyrate or acetoacetate in their acid form can result in significant acidosis following rapid absorption from the gastrointestinal tract. Administration of the sodium salt of these compounds is also unsuitable due to a potentially dangerous sodium overload that would accompany administration of therapeutically relevant amounts of these compounds.
Le Sann et al. teach enantioselective syntheses of β-hydroxycarbonyl compounds which can be used to make enantiomerically pure (D)-β-hydroxybutyrate (see entire publication especially pages 1719-23 and schemes 1-2).
US20110237666 teaches hyydroxybutyrate ester and medical use thereof encompassing a compound which is 3-hydroxybutyl 3-hydroxybutyrate (Ketone Ester of instant application) enantiomerically enriched with respect to (3R)-hydroxybutyl (3R)-hydroxybutyrate of formula (I) which is an effective and palatable precursor to the ketone body (3R)-hydroxybutyrate and may therefore be used to treat a condition which is caused by, exacerbated by or associated with elevated plasma levels of free fatty acids in a human or animal subject, for instance a condition where weight loss or weight gain is implicated, or to promote alertness or improve cognitive function, or to treat, prevent or reduce the effects of neurodegeneration, free radical toxicity, hypoxic conditions or hyperglycaemia. See entire publication especially claims 1-9 and paragraphs [0008]-[0033].
US20120329742 teaches the stomach acid inhibitors ranitidine and famotidine used to treat upper GI conditions inhibiting the action of histamine on the parietal cell which inhibits acid secretion (see paragraph [0007]).
US20150065571 teaches a beverage comprising water and a ketone body ester comprising a monoester of D-beta-hydroxybutyrate with R-1,3-butanediol (Abstract, [0001]); and discloses “[e]xamples of beverages include soft beverages, alcoholic beverages, energy beverages, dry drink mixes, nutritional beverages and herbal teas for infusion or herbal blends for decoction in water” ([0077]). US20150065571 teaches the following:
[0040] Examples of suitable ketone body or ketone body esters or compounds which provide a ketone body in situ include hydroxybutyrates and derivatives thereof, for example esters and oligomers of hydroxybutyrate including D-.beta.-hydroxybutyrate and derivatives thereof, including esters derived from alcohols and compounds containing one or more free hydroxyl groups. The-D .beta.-hydroxybutyrate moiety is preferably monomeric. Monoesters are especially preferred and esters where two or more hydroxyl groups have been esterified but the esterified hydroxyl groups are not in a "beta-relationship, in which the hydroxyl groups are not attached to adjacent carbon atoms.
[0041] Suitable alcohols include butanediol, especially, 1,3-butanediol, altrose, arabinose, dextrose, erythrose, fructose, galactose, glucose, glycerol, gulose, idose, lactose, lyxose, mannose, ribitol, ribose, ribulose, sucrose, talose, threose, xylitol, xylose. Preferably the alcohol is selected from R-1,3-butanediol and glycerol.
[0055] The composition in liquid form suitably comprises the dry composition diluted with a suitable liquid, for example water, fruit juice or milk, preferably at a ratio of 1:1 to 1:10, more preferably 1:3 to 1:7 of dry composition to liquid. The level of ketone body which is organoleptically acceptable will vary according to the precise composition and its form and the effect of other components of the composition.
[0056] The composition may be solid, for example a powder, tablet, bar, confectionary product or a granule and intended for use as a solid oral dose form. In another embodiment, the solid composition may be mixed before use with a liquid, preferably water, fruit based liquid or a dairy product, for example milk and yoghurt, to provide a liquid drink for the user. Milk, fruit juice and water are especially preferred as a carrier for the composition. The composition may be provided, as desired, as a liquid product in a form ready for consumption or as a concentrate or paste suitable for dilution on use. The diluent for use with the liquid composition is preferably milk, fruit juice or water.
[0047] The invention further comprises a method of reducing muscle breakdown by administration of a ketone body ester in a dose regime wherein the regime comprises administering in at least one dose of a ketone body ester to provide a circulating level of hydroxybutyrate and acetoacetate in the blood from 0.1- or 1 to 20 mM, preferably 0.5- or 1 to 10 mM and optimally 1 to 8 mM for example 2 to 5 mM wherein at least one dose comprises a ketone body ester in an amount of at least 0.1 g/kg bodyweight of the subject per dose and preferably 0.3 to 1.5 g/kg for example at least 0.3 to 0.75 g/kg bodyweight.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the claimed invention by modifying and/or combining the reference teachings by making a foodstuff comprising enantiomerically enriched (D)-β-hydroxybutyrate as taught by US20140350105 or enantiomerically pure (D)-β-hydroxybutyrate made by the enantioselective syntheses of Le Sann et al. or β-hydroxybutyrate salt; 1,3-butanediol of US20140350105, racemic 1,3-butanediol, enantiomerically pure (D)-1,3-butanediol, or wherein the 1,3-butanediol is enriched with respect to (D)-1,3-butanediol; and 3-hydroxybutyl 3-hydroxybutyrate (Ketone Ester) taught by US20110237666 or (D)-3- hydroxybutyl (D)-3-hydroxybutanoate, where the β-hydroxybutyrate and 1,3-butanediol are present in a molar ratio of 5:4. In regard to the amount/concentration of β-hydroxybutyrate and 1,3-butanediol, it is noted that: 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) (MPEP 2144.05, II A). Further, it is noted that 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). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). One of ordinary skill in the art at the time the invention was made would have been motivated to do this in order to obtain a foodstuff composition that can be used to produce elevated and sustained levels of ketone bodies in the blood and for inducing and sustaining nutritional ketosis taught by US20140350105 and US20060280721. One of ordinary skill in the art would have been motivated to prepare the foodstuff composition having the recited ratio and amounts of components of the foodstuff as routine experimentation and/or as desired. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because making foodstuff comprising β-hydroxybutyrate salts for elevating levels of ketone bodies in the blood and for inducing and sustaining nutritional ketosis are known in the art as shown by the reference teachings. Thus, the claimed invention was within the ordinary skill in the art to make and use at the time the invention was made, and was as a whole clearly prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 21, 23-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US Patent 11760963 (09/19/2023; PTO 892). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or specification of the patent are directed toward a beverage comprising water and at least 0.5 percent by volume D-1,3-butanediol and no, or substantially no, L-1,3-butanediol, the beverage further optionally comprising one or more additives selected from the group consisting of D ethyl 3-hydroxybutyrate; D beta hydroxybutyrate salts; D beta hydroxybutyrate, D 1,3-butanediol monoester; 3-hydroxy-, 3-ethoxy-l-methyl-3-oxopropyl ester; D hydroxybutyric acid; ethanol; and combinations thereof. The claims and/or specification of the patent teach the claimed foodstuff comprising a mixture of β-hydroxybutyric acid and 1,3-butanediol, wherein the β-hydroxybutyric acid and 1,3-butanediol are each enriched in their D-isomers. Thus, the teachings anticipate the claimed invention
Claims 21, 23-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application 18436905. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims and/or specification of the copending application teach the claimed foodstuff comprising a mixture of β-hydroxybutyric acid and 1,3-butanediol, wherein the β-hydroxybutyric acid and 1,3-butanediol are each enriched in their D-isomers. Thus, the teachings anticipate the claimed invention. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652