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 1-20 are pending. Claims 1-10 are withdrawn. Claims 11-20 are rejected.
Priority
Foreign Priority documents were received 12/29/2023.
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Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 11/22/2023 was considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 11-20) in the reply filed on 4/1/2026 is acknowledged.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claims 11-20 are 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.
Claim 11 recites the limitation "the prepared R-BHB" in line 3. There is insufficient antecedent basis for this limitation in the claim because line one does not refer to stereochemistry (R vs. S) of the BHB. Examiner recommends removing the “R” from line 3 reference. Claims 12-20 are additionally rejected for depending from claim 11 and failing to remedy its deficiencies.
In the last line of claim 11, the following is recited: “comprises a biological fermentation or a bio-enzymatic method”. It is unclear if the “or” between these two processes is appropriate because para. [0022] of the instant specification recites the following:
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, wherein BOTH an enzyme and fermentation process may occur within the overall method. Examiner requests clarification of this issue.
Claim 13 recites the limitation "the recombinant bacteria" in line 2. There is insufficient antecedent basis for this limitation in the claim. To remedy this issue, Examiner recommends clarifying the “strains” may only be bacterial strains in the previous reference within claim 13 to “strains”. Claim 14 is additionally rejected for depending from claim 13 and failing to remedy its deficiencies.
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) 11-20 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 fermentation of a recombinant bacteria. Adelstein teaches non-naturally occurring microbial organisms (construction of recombinant strains) having an enzyme pathway (bio-enzyme catalysis) for production of (3R)-hydroxybutyl (3R)-hydroxybutyrate and (3R)-hydroxybutyrate (compound of the instant claims), for example (see abstract and claim 1). See Figure 2 of Adelstein (arrow added by Examiner pointing to the same structure as the instant claims “BHB acid”):
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. The letters by the arrows represent enzymes.
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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]).
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. Additional dependent limitations will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 11-12 and 15, 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 and a wide variety of organic carbon sources were feasible for such production. “Organic carbon sources” embrace “pure biobased carbon” and determination of carbon content by carbon-14 analysis would have been obvious as a result of routine experimentation. A skilled artisan would have been motivated to arrive at the instant claims to prepare the energy source of BHB from pure biobased carbon with a reasonable expectation of success. 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.
Regarding instant claims 13 and 14, it would have been obvious to arrive at the instant steps, as they were previous demonstrated to prepare the instant BHB successfully. Fig. 2 of Adelstein shown supra, relies on enzymes from recombinant strains to produce
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, also known as the instant BHB acid (bio-enzyme catalysis-specifically letters “H” and “I” represent enzymes). Purification of the final product would also have been obvious as a result of routine experimentation, well known to one of skill in the art.
Regarding instant claims 16-18, an obvious method would inherently yield obvious products. 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.
Conclusion
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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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
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