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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 in the reply filed on 7/14/26 is acknowledged.
Claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/14/26.
Applicant’s election without traverse of SEQ ID NO 2 in the reply filed on 7/14/26 is acknowledged.
Claims 3 and 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/14/26.
Claims 1-2, 4, and 6-14 are under examination herein.
Priority
Application claims priority to 63/298,426 provisional application with an effective filing date of 1/11/22. Claims of the instant application are supported by the provisional application and thus have a priority date of 1/11/22.
Information Disclosure Statement
The IDS filed on 7/29/24 has been fully considered except where references have been lined through.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4 and 6-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the claim requires the use of an upstream region sequence linked to a hydrogenase enzyme. Applicant has only described hydrogenase-1 in the specification (example 1). As evidenced by Greening, there are 3286 currently known non-redundant hydrogenases (abstract). Applicant has not provided any structure-function relationship between the upstream region sequence and the coding region sequence for the hydrogenase. There is no evidence that the upstream region sequence would result in the activation of any of the known 3286 hydrogenase genes. The claim could further encompass modified hydrogenase genes and there is no structure function relationship provided as to what domains are essential to the functionality of the hydrogenase protein. Therefore, the claims are drawn to an extremely broad genus of an upstream region coupled to any modified or unmodified hydrogenase genus. Applicant has not provided sufficient structure-function relationship between either the upstream region sequence and any hydrogenase.
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 1-2 and 6-14 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.
The term “about” in claims 1, 6-7, 9, and 11-12 is a term of approximation which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a specific range encompassed by the term “about”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Different persons of ordinary skill in the art may interpret the error range of the term “about” differently, leading to conflicting interpretations of what % match to SEQ ID NO:2, level of expression, level of product, rime, quantity, or percent of product would infringe the claimed invention. Thus, one of ordinary skill in the art would not be able to clearly determine the metes and bounds of the claim limitation.
Regarding claims 6-7, the claims require “similar culturing conditions”. This is not defined by the claims or the specification and one of ordinary skill in the arts understands that this could involve comparing cultures of two different microorganisms. One of ordinary skill in the arts understands that microorganisms can exhibit different growth rates, time courses, optimal conditions, and nutritional requirements among others. No direction in provided in the specification as to how many nutrients could be added or missing, the variance in culture temperature, the amount of liquid or solid growth media needed to still be considered “similar culturing conditions”. Therefore, the metes and bounds of the claims are unclear.
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.
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 1-2, 4, 8, and 10-14 are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 (in the case of claim 11) as obvious over Simpson (US20210024961A1, of record) as evidenced by Wang (of record).
Regarding claims 1, 2 and 4, Simpson teaches secondary acetate fermentation (title). Simpson teaches a method of producing a product from a gaseous substrate comprising CO and Co2 (abstract and [0015]). Simpson teaches broth can be recycled (claim 21-23). Simpson teaches this comprises a bioreactor (claim 1). Simpson teaches the method comprises a bacterium and a liquid nutrient media (claim 1). Simpson teaches ethanol can be produced (oxygenated product as evidenced by instant claim 2) (claim 12). Simpson teaches that Clostridium ragsdalei can be used ([0011]) and as evidenced by Wang (appendix), this bacterium comprises an upstream region with a 100% match to claimed SEQ ID NO 2 before a hydrogenase gene (acetogenic carboxydotophic bacterium).
Regarding claim 11, while Simpson does not measure the amount of ethanol produced per liter, Simpson teaches that increased production is desirable ([0034]). Therefore, it would be obvious to use routine experimentation to one of ordinary skill in the arts to experiment within the inventive confines of Simpson to increase production of desired products.
Regarding claim 8, Simpson teaches the bioreactor comprises a bacteria culture ([0004]).
Regarding claim 10, Simpson teaches a target product can be ethanol (claim 12). Simpson teaches that a portion of the broth can be removed from the bioreactor (removed broth) ([0043]). Simpson teaches that the target product can be removed from the removed broth (at least 1 oxygenated product, creating product-depleted removed broth) ([0043]). Simpson teaches the microbial cells can be removed from the broth ([0043]). Simpson teaches the cell free permeate after products removed (product depleted removed broth) can be returned to the bioreactor ([0043]).
Regarding claim 12 Simpson teaches that “at least a portion” can comprise the entirety (100%) ([0054]). Simpson teaches that at least a portion of the cell free permeate can be returned to the bioreactor ([0046]).
Regarding claim 13 and 14, Simpson teaches the microbial cells can be used as animal feed and/or fertilizer ([0021]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Simpson (US20210024961A1, of record) as evidenced by Wang (of record), as applied to claims 1-2, 4, 6-8, and 10-14 above, and further in view of Nagaraju (US20170183690A1)
Regarding claim 9, Simpson teaches that the fermentation can be continuous (abstract). Simpson does not explicitly teach the production of products over 24 hours.
Nagaraju teaches methods of producing ethanol from CO or CO2 using microorganisms (abstract). Nagaraju teaches the fermentation can be continuous ([0077]). Nagaraju teaches products can be produced for 140 hours (more than 1 day) (fig 1c). Nagaraju teaches that improved production of products is desirable ([0003]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure the continuous fermentation of Simpson produces a product for more than 1 day as taught by Nagaraju. One of ordinary skill in the art would be motivated to do so because Nagaraju teaches that increased production of products is desirable. There would be a reasonable expectation of success as both Simpson and Nagaraju are in the same field of endeavor of using continuous fermentation to produce ethanol from CO and CO2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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