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 Genus A (i.e., claims 1-2, 9-10, and 14-15, wherein the carbon dioxide reduction process being electrochemical reduction), Genus B (i.e., claims 1 and 12-13, wherein the fermentation product is a protein), Genus C (i.e., claims 1 and 11, wherein the methylotrophic microorganism is Methylophilus) in the reply filed on 09/29/2025 is acknowledged.
After further consideration, the Examiner has decided to withdraw the requirement for electing within Genus C.
Claims 3, 8, and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 09/29/2025.
Status of Claims
Claims 1-15 are currently pending.
Claims 1-2, 4-7, and 9-15 are under consideration, as claims 3 and 8 are withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/EP2021/084781 filed on 12/08/2021 and claims priority to European patent application EP20212569.6, filed on 12/08/2020. Acknowledgment is made of applicant's claim for foreign priority and papers submitted under 35 U.S.C. 119 (a)-(d). The present application and all claims are being examined with an effective filing date of 12/08/2020. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/07/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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.
Claim 10 is 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 “increased” in claim 10 is a relative term which renders the claim indefinite. The term “increased” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In particular, use of the term “increased” renders the pressure at which the fermentation and recovery of carbon dioxide are performed indefinite, because the claim fails to specify the baseline pressure from the “increase” is measured, and the magnitude of the increase. For example, it is unclear whether “increased pressure” is relative to atmospheric pressure, relative to the operating pressure of the electrochemical reduction unit, or some other undefined baseline. For examination purposes and in the interest of compact prosecution, the examiner interprets “increased pressure” as referring to pressures above atmospheric pressure during fermentation and recovery of carbon dioxide.
Claim Rejections - 35 USC § 112(a)
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, 4-7, and 9-14 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.
It is noted that MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow. Claim 1 has been broadly interpreted as encompassing a genus of methods for producing a genus of products, comprising reducing carbon dioxide to a genus of C1 compounds, contacting said compound with a culture comprising a genus of methylotrophic microorganisms, and fermenting said compound and said microorganism to produce said genus of products. The breadth of these steps encompasses numerous microorganism–substrate–product combinations falling within widely diverse biological and biochemical classes.
MPEP 2163 I. states that to “satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
MPEP 2163. II.A.3.(a) states that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. A satisfactory disclosure of a representative number of species depends on whether one of ordinary skill would recognize that the applicant was in possession of the common attributes or features possessed by the members of the genus. For inventions in an unpredictable art, adequate written description of a genus that embraces widely variant species cannot be achieved by disclosing only limited species; rather, the disclosure must reflect the structural or functional diversity of the genus or establish a reasonable structure–function correlation.
In the instant case, the specification identifies broad lists of methylotrophic microorganisms spanning bacteria, archaea, fungi, and protists, and further identifies broad lists of C1 substrates and fermentation products, including proteins, amino acids, lipids, hydrocarbons, wax esters, vitamins, carotenoids, isoprenoids, polysaccharides, pharmaceuticals, and commodity chemicals. However, the specification provides no working examples, no representative embodiments, and no structural or functional characteristics that would allow a skilled artisan to understand which specific microorganism–substrate–product combinations are operative. Given the substantial metabolic and functional diversity within the listed organisms and the disparate biochemical pathways required to generate the range of fermentation products recited, the specification does not adequately describe the scope of the claimed genus or demonstrate possession of the full breadth of the invention.
With respect to dependent claims 6, 7, 11, and 13, these limitations do not remedy the deficiencies discussed above. Claims 6 and 7 limit the genus of C1 compounds recited in claim 1 to methanol, formaldehyde, formic acid, formate, or methanol alone; however, these claims do not restrict the breadth of the methylotrophic microorganisms or the fermentation products encompassed by claim 1. Claim 11 limits the microorganism to 23 genera spanning bacteria, yeasts, fungi, and other taxa across multiple biological domains, without restriction to particular species or strains within those genera, thereby still encompassing an extremely large and heterogeneous population that is not adequately supported by the specification. Claim 13 limits the fermentation product to a wide variety of unrelated biological and chemical classes, including enzymes, proteins, amino acids, chemicals, lipids, biomass, vitamins, polysaccharides, bioplastics, growth enhancers, foods, and pharmaceuticals. While these dependent claims introduce certain clarifications to the genera recited in claim 1, each limitation addresses only one dimension of the microorganism–substrate–product combinations encompassed by the independent claim, and none sufficiently narrow the remaining breadth to reflect possession of the claimed invention. Moreover, even within the dimension addressed by each claim, the breadth of possibilities remains substantial and is not supported by representative species or identifying characteristics in the specification.
Thus, claims 2, 4-7, and 9-14 have been included in this rejection as they directly or indirectly depend from claim 1 and fail to remedy the lack of representative species or identifying characteristics described above. Accordingly, claims 1-2, 4-7, and 9-14 do not meet the written description requirement of 35 U.S.C. § 112(a).
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.
Claims 1-2, 4-8 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noorman, Hendrick Jan (EP3715464A1, herein “Noorman”, cited in the IDS).
Regarding claims 1, 6-7 and 11, Noorman discloses a method for cultivating a microorganism capable of utilizing an organic feedstock wherein CO₂ from one or more bioreactors is captured (in a capturing unit) and reduced to an organic feedstock in a reduction unit (para 0003 and claim 1). Furthermore, the “a 'CO2 capturing unit' is a physical means suitable for capturing CO2 from the from the off-gas of the one or more bioreactors”, thereby teaching the recovery and recycling of carbon dioxide for further reduction (para 0004). Additionally, Noorman teaches the microorganisms “comprise at least one polynucleotide coding for a compound of interest or a compound involved in the production of a compound of interest by the cell,” thereby meeting the limitation of “producing a fermentation product.” With respect to the microorganism, Noorman teaches that the preferred microorganism includes bacteria, specifically Methylobacterium (para 0016 and 0020). It is noted that Methylobacterium is a methylotrophic microorganism (instant specification, pg. 4, lines 13-20). With respect to the “organic feedstock”, Noorman teaches it is preferably a CO2 energy carrier, including methanol (para 0008 and claim 2), correlating to a C1 compound (methanol). Therefore, Noorman teaches reducing CO₂ to a C1 compound, contacting the C1 compound with a methylotrophic microorganism (Methylobacterium), fermenting the C1 compound to form a product, and recycling CO₂ from the bioreactor to a reduction unit, as required by instant claims 1, 6-7 and 11.
Regarding claim 2, Noorman teaches the method above, further comprising the step of “electrolyzing water into H₂ and O₂ in an electrolysis unit” and that the O₂ generated is then fed to the bioreactors to maintain aerobic conditions (para 0042 and 0044).
Regarding claim 4, Noorman teaches that capturing CO₂ from the off-gas of the one or more bioreactors and reducing the captured CO₂ to organic feedstock in a reduction unit is preferably carried out by electrochemical reduction of CO2 (para 0013).
Regarding claim 5, as described above, in Noorman’s method, carbon dioxide is reduced to methanol (i.e., C1 compound), which is well known to persons of ordinary skill in the art to be soluble in water.
Regarding claims 12-13, as described above, Noorman teaches that the microorganisms comprise at least one polynucleotide coding for a compound of interest or a compound involved in the production of a compound of interest by the cell. Noorman further teaches that the compound of interest can be any biological compound, including a biopolymer (para 0023), wherein the biopolymer may be a polypeptide, or protein (para 0026). It is noted that even the simplest proteins possess carbon backbones comprising more than 5 carbons. Furthermore, Noorman discloses several enzymes, including oxidoreductase and catalase, as the polypeptide produced in the method above – both of which are well known in the art to have carbon backbones in the hundreds.
Regarding claims 14-15, Noorman discloses an apparatus for producing a fermentation product, as described above, wherein said apparatus comprises a reduction unit for reducing carbon dioxide, one or more bioreactors for cultivating the methylotrophic microorganism, a capturing unit for capturing (i.e., recovering) carbon dioxide from the one or more bioreactors, and an electrolysis unit for the electrolysis of water. Noorman further discloses one or more conduits for transport of the organic feedstock (i.e., the C1 compound) and gases (e.g., carbon dioxide, H2, oxygen) (para 0060 and Fig. 1).
Thus, claims 1-2, 4-8 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noorman.
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.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Noorman, as applied to claims 1 and 4 above, and further in view of Ma et al. (Electrochemical conversion of CO2 to useful chemicals: current status, remaining challenges, and future opportunities, Current Opinion in Chemical Engineering Vol 2, Iss 2, May 2013, pg. 191-199, cited in PTO-892) and Follonier et al. (Pressure to kill or pressure to boost: a review on the various effects and applications of hydrostatic pressure in bacterial biotechnology, Appl Microbiol Biotechnol (2012) 93:1805–1815, cited in PTO-892).
The teachings of Noorman as they apply to claims 1 and 4 have been discussed above. Briefly, Noorman discloses a system in which CO₂ is captured from a bioreactor off-gas and electrochemically reduced to an organic feedstock (C1 compound – e.g., methanol) and fermenting said feedstock with a methylotrophic microorganism to produce a product.
Regarding claims 9 and 10, while Noorman teaches the electrochemical reduction of carbon dioxide to methanol and a further step of electrolyzing water into H₂ and O₂, wherein the O₂ generated is then fed to the bioreactors to maintain aerobic conditions (see claim 2 rejection above), Noorman does not teach wherein oxygen is co-generated during electrochemical reduction of CO2. Likewise, while Noorman describes pressure used for water electrolysis (para 0041), Noorman does not expressly teach performing fermentation or CO2 recovery at pressures above atmospheric pressure (see 112b rejection above).
Ma et al. teaches that in low-temperature CO₂ electroreduction (CO₂RR) systems, CO₂ reduction occurs at the cathode, while the oxygen-evolution reaction (OER) occurs at the anode, producing oxygen as the coupled half-reaction (pg. 191, right column -2nd para and pg. 192, left column – 2nd para). Thus, Ma et al. teaches that oxygen is co-generated in an electrochemical CO₂-reduction system.
Follonier et al. teaches that applying elevated pressure (up to ~10 bar) in microbial bioprocesses can enhance oxygen-transfer rates, improve gas–liquid mass transfer, and boost productivity of aerobic cultures (Abstract). Thus, Follonier et al. teaches that performing fermentation at pressures above atmospheric increases O2 and CO2 transfer efficiency.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, given Noorman’s teaching of electrochemical CO₂ reduction and aerobic fermentation, Ma et al.’s teaching that oxygen is inherently co-generated at the anode during electrochemical CO₂ reduction, and Follonier et al.’s teaching that aerobic fermentations conducted at pressures above atmospheric enhance oxygen transfer and overall bioprocess performance, it would have been obvious to a person of ordinary skill in the art to utilize the generated oxygen from electrochemical reduction of CO2 to maintain aerobic conditions, and perform the fermentation and CO2-recovery steps at “increased pressure” to improve transfer rates and process efficiency. Such a combination represents a predictable use of known electrochemical and high-pressure bioreactor principles to improve the performance of a CO2-to-bioproduct conversion system. There is a reasonable expectation of success, given Ma et al.’s disclosure of oxygen co-generation in electrochemical CO₂RR cells, and enhanced oxygen transfer under elevated pressure in aerobic cultures, as taught by Follonier et al. Said practitioner would have readily predicted that the combination of teachings would successfully result in a method for producing a fermentation product, using oxygen generated from electrochemical reduction of CO2 to maintain aerobic conditions, carried out at increased pressure. Therefore, the invention as a whole as recited in Claims 9 and 10 would have been prima facie obvious before the effective filing date of the claimed invention.
Thus, claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Noorman, further in view of Ma et al. and Follonier et al.
Conclusion
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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/NAGHMEH NINA MOAZZAMI/Examiner, Art Unit 1652
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652