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 .
Status of the Claims
Claims 1-11, 14, and 16-20 are pending. Claims 1-10 are withdrawn. Claims 11, 14, and 16-20 are rejected.
Response to Amendments/Arguments/Interview/Declaration
Regarding the Interview from 7/20/2026, Applicant wrote on p. 5 of 7/28/2026 response that “the Examiners indicated that the proposed claim amendments as presented herein appear to overcome the cited references in the record”. Examiner respectfully disagrees that this was the language used. As per Examiner’s Interview Record mailed 7/30/2026, Examiner clarified that any amendments would require a novel search and examination.
Examiner acknowledges the Declaration under 37 CFR 1.132 submitted by Applicant on 7/28/2026 but it does not overcome the prima facie obviousness described below. “An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness.” In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). See MPEP 716.02(e). The declaration did not report any unexpected or surprising results comparing data of the prior art product to that of the instant claims. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Additionally, the 103 rejection was updated below as necessitated by amendment and biobased content would have been obvious to a skilled artisan with a reasonable expectation of success.
Applicant’s amendments, (particularly the removal of “R” from R-BHB in claim 11, deletion of “a biological fermentation or a bio-enzymatic method” from claim 11, and cancellation of claim 13), filed 7/28/2026, with respect to 112b rejections have been fully considered and are persuasive. The 112b rejections of claims 11-20 have been withdrawn.
Applicant's amendments and arguments filed 7/28/2026, specifically regarding the 103 rejection, have been fully considered but they are not persuasive. The 103 rejection has been maintained and any changes have been necessitated by Applicant’s amendments. Remarks will be addressed accordingly here.
On p. 6-7 of the response, Applicant states that JP ‘861 does not disclose or suggest the construction of a recombinant bacterial strain for BHB production. Examiner respectfully disagrees that this overcomes the findings of prima facie obviousness described below. Two references were combined to arrive at the obviousness conclusion. Adelstein teaches non-naturally occurring microbial organisms (construction of recombinant strains-encompass bacteria, see para. [0018]). On p. 7 of the response, Applicant recites: “Adelstein’s methods are directed to the production of (3R)-hydroxybutyl (3R)-hydroxybutyrate, a distinct ester compound, and its precursors, not to the preparation of BHB acid or salt with pure biobased carbon content as recited in the instant claims”. Examiner respectfully disagrees that this overcomes the findings of prima facie obviousness below. Adelstein teaches the production of BHB and products having biobased content (including up to 100% as determined by carbon-14 dating). Similar arguments are made on p. 8 of the response, for which Examiner respectfully disagrees in view of the 103 rejection below and arguments made herein.
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, 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) 11, 14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP6384861 (furnished, with English translation, by a 3rd party submission to the file wrapper on 9/10/2024), in view of Adelstein et al. (US20160108442).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
JP6384861 discloses a method for producing 3-hydroxybutyric acid or salt thereof (see claim 1), a source of energy (see para. [0003]). [3-hydroxybutyric acid is also known as beta-hydroxybutryate (BHB) acid.] The method of JP6384861 (claim 1) comprises aerobically cultivating a halophilic bacterium belonging to the genus Halomonas that produces poly-3-hydroxybutyrate in a medium containing an organic carbon source and an inorganic salt (“step 1”) (biosynthesis process). The method of JP6384861 ultimately recovers 3-hydroxybutyric acid or a salt thereof from the culture solution. “The aerobic bacteria used in the production method according to the present invention can be used alone as an organic carbon source or in combination with other organic carbon sources…In addition, xylose, arabinose, or the like of pentose, which is obtained in ethanol fermentation using yeast cells and is difficult to use, can also be effectively used as an organic carbon source” (see para. [0016]). JP6384861 describes the simplicity of the purification step in their production method (see para. [0018]). Also, “[t]he inorganic salt blended in the culture medium used in step 1 is not particularly limited, and examples of metal salts such as phosphate, nitrate, carbonate, sulfate, sodium, magnesium, potassium, manganese, iron, zinc, copper, and cobalt are cited” (see para. [0036]).
JP6384861 does not specifically disclose the construction of a recombinant bacterial strain, fermentation of a recombinant bacteria, or 100% biobased carbon content in prepared BHB acid. Adelstein teaches non-naturally occurring microbial organisms (construction of recombinant strains-encompass bacteria, see para. [0018]) having an enzyme pathway (bio-enzyme catalysis) for production of (3R)-hydroxybutyl (3R)-hydroxybutyrate and (3R)-hydroxybutyrate (differs from an acid of the instant claims by one hydrogen and can convert in various pH environments), for example (see abstract and claim 1). See Figure 2 of Adelstein (arrow added by Examiner):
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. The letters by the arrows represent enzymes (bio-enzyme catalysis).
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“For the production of (3R)-hydroxybutyl (3R)-hydroxybutyrate, the recombinant strains are cultured in a medium with carbon source and other essential nutrients” (also known as the fermentation process) (see para. [0112]).
Adelstein teaches that some of the embodiments provide a biobased composition comprising up to 100% bioderived (3R)-hydroxybutyl (3R)-hydroxybutyrate or bioderived (3R)- hydroxybutyl (3R)-hydroxybutyrate pathway intermediate (see para. [0219]) as determined by carbon-14 dating techniques (see para. [0213]). The bioderived formulation may be ingested safely (see para. [0220]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not have a single embodiment of preparing BHB acid or salt with pure biobased carbon comprising construction of recombinant strain, fermentation of the recombinant bacteria, extraction and purification of BHB acid or salt. Additional dependent limitations will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 11, it would have been obvious to a PHOSITA to prepare BHB acid or salt with pure biobased carbon through a biosynthetic process because such compound was prepared by fermenting biological strains that have an enzymatic pathway for production of BHB acid and a wide variety of organic carbon sources were feasible for such production. Additionally, the construction of a recombinant bacterial strain to extract and purify a similar compound made with pure biobased content (determined by carbon-14 techniques) was successfully demonstrated and made safe to ingest. A skilled artisan would have been motivated to explore similar biobased formulation techniques for the instantly claimed acid with a reasonable expectation at arriving at a safe to ingest acid or salt and a product overall safer for human health.
Regarding instant claim 14, it would have been obvious to arrive at the instant step, as bio-enzyme catalysis was previous demonstrated to prepare BHB successfully. Fig. 2 of Adelstein shown supra, relies on enzymes from recombinant strains to produce
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, similar to the instantly claimed acid by one proton/hydrogen. Regarding the limitation “after the process of fermentation”, this would have been obvious to a PHOSITA because fermentation “grows” the microbes with nutrients which then in turn can perform enzyme reactions.
Regarding instant claims 16-18, an obvious method would inherently yield obvious products. The prior art described above can be combined to yield predictable results. Specifically, regarding the “ethyl ester”, para. [0011] of the instant specification recites: the BHB “acid further comprises an ethyl alcohol which reacts with the BHB acid to form a BHB ethyl ester”. JP6384861 refers to carbon sources and ethanol fermentation, wherein the presence of ethanol (ethyl alcohol) would have predictably yielded the BHB ethyl ester. Specifically, regarding the “metal salt”, JP6384861 teaches sodium may be blended with the culture medium, wherein a product would have predictably yielded a sodium BHB salt.
Regarding instant claim 19 and stereochemistry of the BHB salt, “An optically active isomer is unpatentable over a prior art racemate or optical isomer of opposite rotation in the absence of unexpected or unobvious beneficial properties”. In re Adamson et al. (CCPA) 1960 275 F2d 952, 125 USPQ 233. Therefore, various stereochemistry forms of the BHB would have been obvious as a result of an obvious method. Additionally, regarding instant claim 20, the purity of the final product would have been inherent as a result of an obvious method. Purification techniques known to one of skill in the art would have yielded predictable results, chemical purity of at least about 95%, with a reasonable expectation of success.
Conclusion
Applicant’s amendments necessitated the new ground(s) of rejection presented in this Office Action. Accordingly, 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 extension fee 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 MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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