DETAILED ACTION
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 later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/436,905, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1-10 are directed to the beverage comprising R-1,3-butanediol. Application No. 18/436,905 does not provide support for R-1,3-butanediol.
The disclosure of the prior-filed application, Application No. 18/350,563, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1-10 are directed to the beverage comprising R-1,3-butanediol. Application No. 18/350,563 does not provide support for R-1,3-butanediol.
The disclosure of the prior-filed application, Application No. 16/168,703, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1-10 are directed to the beverage comprising R-1,3-butanediol. Application No. 16/168,703 does not provide support for R-1,3-butanediol.
The disclosure of the prior-filed application, Application No. 15/688,690, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1-10 are directed to the beverage comprising R-1,3-butanediol. Application No. 15/688,690 does not provide support for R-1,3-butanediol.
Hence, Applicant does not receive the benefit of the earlier filing date.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Llosa et al (US 20250011696 A1 published January 9, 2025).
In regard to claims 1 and 6, Llosa et al discloses a beverage comprising water and at least 0.5 percent by volume R-1, 3-butanediol (Claim 1).
In regard to claim 6, Llosa et al discloses a beverage facilitating ketosis ([0001], [0022]).
In regard to claims 2 and 7, Llosa et al discloses the beverage comprising R-1,3-butanediol, and no S-1,3-butanediol (Claim 1). Therefore, Llosa et al discloses enantiomerically pure R-1,3-butanediol.
In regard to claims 3 and 8, Llosa et al discloses the beverage comprising R-1,3-butanediol, and substantially no S-1,3-butanediol (Claim 1). Therefore, Llosa et al discloses enantiomerically enriched R-1,3-butanediol.
In regard to claims 4-6, Llosa et al discloses the beverage that does not require the presence of medium chain fatty acids and esters thereof and beta-hydroxybutyrate salts.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Llosa et al (US 20250011696 A1 published January 9, 2025).
In regard to claims 9 and 10, Llosa et al discloses that R-1,3-butanediol is present at a concentration of at least 0.5 percent by volume (claim 1), greater than 5 percent by volume (claim 4), greater than 19 percent by (claim 5). Llosa et al does not discloses the dosage of R-1,3-butanediol or the amount of R-1,3-butanediol in grams in the beverage. One of ordinary skill in the art would have been motivated to vary the particular concentration/dose of R-1,3-butanediol depending on the desired ketosis initiation and maintenance result.
Response to Arguments
Applicant's arguments filed 07/22/2026 have been fully considered but they are not persuasive.
Applicant presents the following arguments:
A person of ordinary skill would have known that R-1,3-butanediol and D-1,3-butanediol are the same compound and that the names are synonyms. A skilled artisan would have understood this in view of two references: 1) "Metabolism of R- and S-1,3-butanediol in perfused livers from meal-fed and starved rats," Biochem. J. (1992) 285:647-653 ("Desrochers"); and 2) "Suppression of Fee Intake after Parenteral Administration of D-b-Hydroxybutyrate in Pygmy Goats," J. Vet. Med. A (2000) 47:9-16 ("Rossi"). Copies of these references are attached for the Examiner's consideration.
PNG
media_image1.png
304
750
media_image1.png
Greyscale
Applicant demonstrates that compounds in question are metabolized in liver to D-β-hydroxybutyrate and R-3-Hydroxybutyrate. It is also alleged that D-β-hydroxybutyrate and R-3-Hydroxybutyrate is the same compound. However, this does not prove that R-1,3-butanediol and D-1,3-butanediol are the same compound.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERA STULII whose telephone number is (571)272-3221. The examiner can normally be reached Monday-Friday 5:30AM-3:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VERA STULII/Primary Examiner, Art Unit 1791
Prosecution Insights