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 .
Applicant's election without traverse of Group I (Invention I) in the reply filed on 08/17/2026 is acknowledged. Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-3, 5-9 are under consideration in this Office Action.
Title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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 1-3, 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over US20140350105(11/27/2014; PTO 892) 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 05/13/2026), US20110237666 (09/29/2011; PTO 892), US20120329742 (12/27/2012; 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].
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.
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]).
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; and administering to a subject in a fasted state or having consumed a diet with limited dietary carbohydrates to induce ketosis and further comprising administering glucose to the subject. 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 of at least 0.5 mmol/L in the blood of the subject 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 1-3, 5-9 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 teach the claimed method of inducing ketosis in a subject, the method comprising administering a foodstuff comprising R 1,3 butanediol, wherein the foodstuff is free of medium chain fatty acids and esters thereof and free of ketone ester; wherein the foodstuff is enriched in the R 1,3 butanediol relative to the S 1,3 butanediol. Thus, the teachings anticipate the claimed invention.
Claims 1-3, 5-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the following copending applications: claims 1-16 of copending Application 18436905, claims 1-16 of 18436905, claims 1-20 of 19544257, claims 1-18 of 19578476, claims 1-17 of 19534368, claims 1-7 of 19676494, claims 1-12 of 19544207, claims 1-18 of 19174611. 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 method of inducing ketosis in a subject, the method comprising administering a foodstuff comprising R 1,3 butanediol, wherein the foodstuff is free of medium chain fatty acids and esters thereof and free of ketone ester; wherein the foodstuff is enriched in the R 1,3 butanediol relative to the S 1,3 butanediol. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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