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 Claims
Claims 16-29 are pending and under examination herein.
Priority
This application is a 371 of PCT/EP2023/067076 (6/23/2023) which claims priority to EP22180982.5 (6/24/2022).
Information Disclosure Statement
The information disclosure statements (IDS) filed on 2/7/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 17, 19, and 29 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 17 and 29 recite the broad recitation “a secondary alcohol”, and the claim also recites “such as 2-propanol or 2-butanol” which is the narrower statement of the range/limitation. Claim 17 additionally recites “wherein hydrogen gas, acetate, a methyl compound selected from methylamines, methyl sulfides and methanol, any other alcohol, a secondary alcohol such as 2-propanol or 2-butanol, a methoxylated aromatic compound and/or formate are fed to the bioreactor”, and the claim also recites “wherein hydrogen gas, acetate, methanol or combinations thereof are fed to the bioreactor” which is the narrower statement of the range/limitation.
Claim 19 recites “the methanogenic microorganisms comprise archaea selected from Methanobacteriaceae, Methanocaldococcaceae, and Methanococcaceae”; and the claim also recites “and selected from Methanothermobacter, Methanothermococcus, and Methanocaldococcus” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
For the purposes of examination, only the limitations of the broader recitation are considered to be required.
Claim 29 is directed to a use of methanogenic microorganisms for producing amino acids, but does not set forth any active method steps for how the process is practiced. Claim 29 recites components that the amino acids are produced from, but these are not positively recited method steps. For this reason, it is unclear how the claimed method is to be performed, rendering the claim indefinite. Applicant is directed to MPEP § 2173.05(q).
Claim 29 recites the limitation "the bioreactor" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim. Claim 29 does not recite “a bioreactor”, so it is unclear what “the bioreactor” in claim 29 refers to.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 24 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 24 recites the method of claim 16, wherein at least 50% of all nitrogen atoms
of all nitrogen sources fed to the bioreactor are fed to the bioreactor in the form of nitrogen gas. However, this limitation is already recited in claim 16. Therefore, claim 24 does not further limit the subject matter of claim 16, upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 29 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because claim 29 is directed to a use of methanogenic microorganisms for producing amino acids, but does not set forth any active method steps for how the process is practiced. See MPEP § 2173.05(q).
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anton et al., WO 2020/252335, as evidenced by JCM METHANOCOCCUS McC MEDIUM.
Regarding claims 16, 24, and 29, Anton teaches fermentation methods for producing products including amino acids using a bioreactor (p. 2 para. 4). Anton teaches that the microorganisms used in the bioreactor are methanogenic archaea, including Methanobacterium (which are in the order Methanobacteriales) and Methanococcus (which are in the order Methanococcales) (p. 17 para. 62).
Anton teaches that the method comprises feeding a gaseous mixture comprising CO2 or CO, a nitrogen source, and a sulfur source to a bioreactor containing microorganisms in a fermentation medium (p. 5 para. 21; p. 16 para. 60). Anton teaches that the bioreactor is under conditions such that the microorganisms produce at least one fermentation product (p. 15 para. 55), which may be an amino acid (p. 29 para. 104). Anton teaches that the nitrogen source may be nitrogen gas (p. 23 para. 79). Anton teaches that the fermentation products (amino acids) are purified, or harvested, from the bioreactor (Anton p. 5 para. 22). Anton teaches that H2- is fed to the bioreactor (p. 5 para. 21). H2- is a preferred electron donor for methanogenic microorganisms, see instant specification p. 5.
Anton teaches that the fermentation medium comprises ammonium. The medium used for producing amino acids from Methanococcus maripaludis is McC plus 2x NH4CI and 2x iron (p. 66 para. 174). McC medium comprises 1 g/L of NH4CI, and thus 2x NH4CI would be 2 g/L (see JCM McC medium reference). NH4CI has a molar mass of 53.492 g/mol, and 2 g/L NH4CI is equal to 37.36 mmol/L of ammonium (2 g/L / 53.492 g/mol), which is within the claimed range.
Anton teaches that nitrogen gas is a suitable nitrogen source to be fed to the bioreactor (p. 23 para. 79). Anton teaches that a variety of nitrogen sources can be used, with suitable sources being ammonia (NH3) and ammonia derivatives (e.g., ammonium hydroxide, ammonium acetate, etc.), as well as nitrogen gas (N2), nitric oxide (NO), nitrous oxide (N2O), or any combination thereof (p. 23 para. 79). A skilled artisan would have recognized that any of these nitrogen sources could be used as the sole nitrogen source, including using only nitrogen gas as the nitrogen source that is fed to the bioreactor. As Anton teaches that nitrogen gas may be selected from a defined, finite list of suitable options for the nitrogen source being fed to the bioreactor, a person having ordinary skill in the art could at once envisage a method wherein nitrogen gas is the sole nitrogen source being fed to the bioreactor. When nitrogen gas is the only nitrogen source, then all of the nitrogen atoms (over 50%) fed to the bioreactor are from nitrogen gas.
Regarding claims 17 and 29, Anton teaches that H2- (hydrogen gas) is fed to the bioreactor (p. 5 para. 21).
Regarding claim 18, Anton teaches that the fermentation product may be a standard (canonical) amino acid (p. 29 para. 104).
Regarding claim 19, Anton teaches that the methanogenic microorganisms include Methanothermobacter, Methanothermococcus, Methanocaldococcus, Methanococcus (p. 17 para. 62), which are in the families Methanobacteriaceae, Methanocaldococcaceae and Methanococcaceae.
Regarding claim 20, Anton teaches that the methanogenic microorganisms may be at least two different species (p. 17 para. 63).
Regarding claims 21 and 22, the limitations of these claims are directed to outcomes of the fermentation process, i.e. a rate at which amino acids are produced when the process is performed. Anton teaches the positively recited method steps of claim 16, as set forth above. Therefore, it is expected that the method as taught by Anton, comprising the same steps as claimed, would result in the total amino acid production rate per volume or per biomass as claimed.
Regarding claim 23, Anton teaches that the method is a batch culture, fed-batch
culture, or continuous culture (p. 25 para. 86).
Regarding claim 25, Anton teaches that the gaseous mixture which is fed to the bioreactor contains H2 in addition to CO and/or CO2 (Anton p. 5 para. 21; pp. 22-23 “Substrates”). Thus, the only carbon sources being fed to the bioreactor in the fermentation process are CO and/or CO-2, and therefore all (over 50%) of the carbon atoms of the carbon sources being fed to the bioreactor are in the form of carbon dioxide gas and/or carbon monoxide gas.
Regarding claim 26, Anton teaches that the sulfur source that is fed to the bioreactor comprises sulfide (p. 23 para. 80). Anton teaches that the fermentation medium (McC) comprises sulfide, 0.5 g/L Na-2S x 9 H2O (see JCM McC medium reference; Anton p. 66 para. 174). The molar mass of Na-2S x 9 H2O is 240.2 g/mol, and the molar mass of sulfur is 32.06 g/mol, or 13.35% of the molar mass. Thus, the fermentation medium comprises 0.5 g/L x 0.1335 = 0.06674 g/L, or 66.74 mg/L of sulfide, which is within the claimed range.
Regarding claim 27, Anton teaches that methane is harvested from the bioreactor (p. 31 para. 111-112).
Regarding claim 28, Anton teaches that the fermentation is started with the methanogenic microorganisms in chemically defined media (p. 24 para. 86; p. 66 para. 174).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16-19, 21-26, and 28-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-28 of copending Application No. 18/876,312 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to a method of producing ammo acids by fermentation in a bioreactor.
Regarding instant claim 16, claim 16 of ‘312 recites a method of producing amino acids by fermentation in a bioreactor, wherein the bioreactor comprises methanogenic microorganisms of the genus Methanothermobacter in a fermentation broth, wherein the fermentation broth comprises ammonium at a concentration of 0.1 mmol/L to 200 mmol/L, the method comprising at least the steps of feeding a gaseous carbon source comprising carbon dioxide and/or carbon monoxide, a nitrogen source and a sulfur source to the bioreactor under conditions such that the methanogenic microorganisms produce the amino acids; and harvesting at least a portion of the amino acids from the supernatant of the fermentation broth. Claim 24 of ‘312 recites that the nitrogen source comprises nitrogen gas; wherein at least 50% of all nitrogen atoms of all nitrogen sources fed to the bioreactor are fed to the bioreactor in the form of nitrogen gas. Claim 27 of ‘312 recites that hydrogen gas (an electron donor) is fed to the bioreactor.
Regarding dependent claims 17-19, 21-26, and 28-29, the limitations of these dependent claims are recited in claims 16-28 of ‘312.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 20 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-28 of copending Application No. 18/876,312 in view of Anton et al., WO 2020/252335.
The teachings of ‘312 regarding claim 16 is set forth above. ‘312 does not recite that the methanogenic microorganisms comprise at least two different species (claim 20) or that methane is harvested from the bioreactor (claim 27).
Regarding claims 20 and 27, Anton teaches fermentation methods for producing products including amino acids using a bioreactor (p. 2 para. 4). Anton teaches that the microorganisms used in the bioreactor are methanogenic archaea, including Methanobacterium (p. 17 para. 62). Anton teaches that the method comprises feeding a gaseous mixture comprising CO2 or CO, a nitrogen source, and a sulfur source to a bioreactor containing microorganisms in a fermentation medium (p. 5 para. 21; p. 16 para. 60). Anton teaches that the methanogenic microorganisms may be at least two different species (p. 17 para. 63). Anton teaches that methane is harvested from the bioreactor (p. 31 para. 111-112).
It would have been obvious for a skilled artisan to combine the teachings of Anton with ‘312, arriving at a method of producing amino acids by fermentation in a bioreactor as recited in ‘312, wherein methanogenic microorganisms from multiple species are used and methane is harvested. Both ‘312 and Anton are directed to fermentation processes using the same steps and components to produce amino acids. It would have been obvious that a process as recited in ‘312 could utilize multiple different species of methanogenic archaea, and that methane would be produced and could be harvested, as taught by Anton for a similar process comprising the steps as recited in instant claim 16.
This is a provisional nonstatutory double patenting rejection.
Claims 16-25 and 28-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-28 of copending Application No. 18/876,283 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed to a method of producing ammo acids by fermentation in a bioreactor.
Regarding instant claim 16, claim 16 of ‘283 recites a method of producing amino acids by fermentation in a bioreactor, wherein the bioreactor comprises methanogenic microorganisms in a fermentation broth, the method comprising at least the steps of: feeding a gaseous carbon source comprising carbon dioxide and/or carbon monoxide, a nitrogen source comprising nitrogen gas and a sulfur source to the bioreactor under conditions such that the methanogenic microorganisms produce the amino acids, wherein the fermentation broth comprises ammonium at a concentration of at least 0.1 mmol/L and harvesting at least a portion of the amino acids from the bioreactor; wherein an electron donor compound suitable for the methanogenic microorganisms is fed to the bioreactor. Claim 20 of ‘283 recites that the methanogenic microorganisms comprise archaea selected from Methanobacteriales or Methanococcales. Claim 24 of ‘283 recites that at least 50% of all nitrogen atoms of all nitrogen sources fed to the bioreactor are fed to the bioreactor in the form of nitrogen gas.
Regarding dependent claims 17-25 and 28-29, the limitations of these dependent claims are recited in claims 16-28 of ‘283.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 26-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-28 of copending Application No. 18/876,283 in view of Anton et al., WO 2020/252335.
The teachings of ‘283 regarding claim 16 are set forth above. ‘283 does not recite that the sulfur source comprises cysteine and/or sulfide, wherein the fermentation broth comprises sulfide at a concentration of 0.001 - 150 mg/L (claim 26); or that methane is harvested from the bioreactor (claim 27).
The teachings of Anton regarding claim 27 are set forth above. Regarding claim 26, Anton teaches that the sulfur source that is fed to the bioreactor comprises sulfide (p. 23 para. 80). Anton teaches that the fermentation medium (McC) comprises sulfide, 0.5 g/L Na-2S x 9 H2O (Anton p. 66 para. 174). The molar mass of Na-2S x 9 H2O is 240.2 g/mol, and the molar mass of sulfur is 32.06 g/mol, or 13.35% of the molar mass. Thus, the fermentation medium comprises 0.5 g/L x 0.1335 = 0.06674 g/L, or 66.74 mg/L of sulfide, which is within the claimed range.
It would have been obvious for a skilled artisan to combine the teachings of Anton with ‘283, arriving at a method of producing amino acids by fermentation in a bioreactor as recited in ‘283, wherein methane is harvested. Both ‘283 and Anton are directed to fermentation processes using the same steps and components to produce amino acids. It would have been obvious that in a process as recited in ‘283 methane would be produced and could be harvested, as taught by Anton for a similar process comprising the steps as recited in instant claim 16. Further, it would have been obvious to use sulfide as the sulfur source that is fed to the bioreactor, and to use a fermentation broth comprising sulfide at a concentration of 0.001 - 150 mg/L, as taught by Anton for a similar process comprising the steps as recited in instant claim 16.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 16-29 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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/EMILY F EIX/Examiner, Art Unit 1653
/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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