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 16-28 are currently pending and under examination (claim set as filed on 12/18/2024). Claims 1-15 are cancelled.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. EP 22180983.3, filed on 6/23/2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, and thus the effective filing date of this application is 6/24/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/4/2025 were considered, initialed, and attached hereto. The submissions 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 19 and 26-28 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.
Regarding claim 19, the limitation "the 20 canonical amino acids" is recited. There is insufficient antecedent basis for this limitation in the claim. Although the applicant recites amino acids in the independent claim, the specified additional language of canonical was not introduced prior to claim 19. Regarding claim 26, the phrase "especially" renders the claim indefinite because it is unclear whether the limitation following the phrase is part of the claimed invention or merely exemplary language. See MPEP § 2173.05(d).
Regarding claim 27, the phrase “such as” renders the claim indefinite because it is unclear whether the limitation following the phrase is part of the claimed invention or merely exemplary language. See MPEP § 2173.05(d).
Regarding claim 28, the claim recites “A use of methanogenic microorganisms of the genus Methanothermobacter for producing amino acids” which renders the claim indefinite as there are no actionable steps to produce amino acids provided in the claimed process. The claim merely recites the steps of harvesting amino acids from a fermentation broth but is silent regarding the actual steps of using the Methanothermobacter microbes to produce the amino acids. The claim recites the use of methanogenic microorganisms of the genus Methanothermobacter for producing amino acids, but it does not recite any active steps regarding the use thereof to limit how the use is practiced. See MPEP 217.05(q).
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 28 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 it attempts to recite a process of use without also properly setting forth any active steps for carrying out said process. Claim 28 merely recites process steps for harvesting amino acids from the fermentation broth but does not provide actionable steps for the use of methanogenic microorganisms of the genus Methanothermobacter for producing amino acids. Thus, the claimed invention is not supported by a specific utility. See MPEP 2173.05(q).
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.
Claims 16-25 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Bradshaw (Pre-Grant Publication No. US 2019/0194630 A1 – date of publication 6/27/2019) and further in view of Yang (Yang et al., “Effect of ammonia on methane production, methanogenesis pathway, microbial community and reactor performance under mesophilic and thermophilic conditions”, 2018 Mar 13, Renewable Energy, 125, pgs. 915-925).
Bradshaw’s general disclosure relates to a method of using microorganisms to convert hydrogen and carbon gases into amino acids (see abstract).
Regarding claims 16 and 28, Bradshaw teaches the batch fermentation of methanogenic archaea in a bioreactor (see [0149]) to produce an aspartate pathway amino acid (see [0157]), and wherein the archaea comprise Methanothermobacter spp. (see [0162]). Bradshaw teaches the Methanothermobacter spp. can metabolize a H2COx substrate, as well as other components such as sulfur and nitrogen containing compounds, into amino acids (see [0015] and [0020]). The nitrogen source comprises an ammonia and its derivative (see pg. 29, claim 6) and wherein the derivative comprises alkali metal salts/alkali earth metal salts such as ammonium salt (see [0038]). Bradshaw teaches the harvesting of a liquid culture which comprises broth, microorganisms, and amino acids (see [0193]). Bradshaw teaches the fermentation is a continuous culture with cell retention wherein media and cells are removed from the bioreactor and then added back (see [0152]). Bradshaw also teaches the amino acids, such as glycine were harvested after 72 hours at a concentration of 7 mg/L (see Example 5, Table 2), which calculates to 1.3 µmol/L/hr and is more than the claimed amount of at least 0.1. The claimed units are in µmol/g/hr; however, the prior art teaches the microorganism suspended in a liquid culture and thus the unit is changed to liters, however considering the significant difference in values, the conversion to grams for a solid culture would still read on the claim. As noted in the 112b and 101 rejections above, claim 28 is a “use claim” which renders the claim indefinite as there are no actual steps limiting the process nor is it considered to be a proper process claim as it lacks clear requisite steps to produce the amino acids as stated in the preamble instead of merely harvesting them. See MPEP 2173.05(q).
Bradshaw does not teach that the ammonium was at a concentration of 0.1-200 mmol/L.
Yang’s general disclosure relates to the effects of ammonia on methane production in microorganisms (see abstract) and optimal ammonium concentrations and which cause microbial inhibition (see pg. 915, ¶ 2).
Regarding claim 16, Yang teaches ammonium supplementation to methanogenic microbial fermenter tanks at concentrations from 1-7 g/L (see pg. 916, ¶ 6). This prior art range calculates to 55.44-388.05 mmol/L which overlaps with the claimed range of 0.1-200 mmol/L.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to optimize the concentration to the claimed range as taught overlapping in Yang of the ammonium taught in Bradshaw. One would be motivated to do so because Yang teaches that ammonium is at an optimal concentration below a threshold of <200 mg/L and wherein higher levels can directly inhibit the growth of microorganisms (see Yang pg. 915, ¶ 2). The ordinary artisan could have used Yang’s disclosure about optimal ammonium concentration to improve upon Bradshaw’s suggestion that components of the culture could be modulated that affect cell growth such as gas nutrients (see Bradshaw [0153]). Furthermore, it would have been within the skill of the ordinary artisan to modify the concentration of ammonium to desired levels as long as it was below the 200 mg/L threshold and would have only required routine experimentation to do so.
Regarding claim 17, modified-Bradshaw-Yang teaches that amino acids were present in the harvested fermentation broth but is silent on the presence of proteins. Therefore, the ordinary artisan would find it obvious to have a protein content of less than 1000 µg/mL as the prior art teaches a protein content of zero which is less than the claimed amount.
Regarding claim 18, modified-Bradshaw-Yang teaches a continuous culture system wherein the cells are retained and recycled back into the bioreactor (see Bradshaw [0152]), and thus it would be obvious to the ordinary artisan that at least 50% of the cells would remain viable both prior and during the harvesting in order to keep using them, and one could assume all cells were viable as the prior art makes no mention of differentiation of dead and viable cells during this process.
Regarding claim 19, modified-Bradshaw-Yang teaches at least two of the canonical amino acids, glycine and threonine (see Bradshaw Example 5, Table 2).
Regarding claim 20, modified-Bradshaw-Yang teaches a total amino acid content of the harvested fermentation broth is 7 mg/L of glycine (or 93.3 µmol/L) and 31 mg/L of threonine (or 260.24 µmol/L) (see Bradshaw Example 5, Table 2), which calculates to 353 µmol/L and is greater than the claimed at least 1 µmol/L.
Regarding claim 21, modified-Bradshaw-Yang teaches the microorganism species Methanothermobacter marburgensis (see Bradshaw [0041]).
Regarding claim 22, modified-Bradshaw-Yang teaches the amino acids, such as glycine were harvested after 72 hours at a concentration of 7 mg/L (see Example 5, Table 2), which calculates to 1.3 µmol/L/hr and is more than the claimed amount of at least 0.1 µmol/L/h.
Regarding claim 23, modified-Bradshaw-Yang teaches the fermentation method can be a closed batch process or a continuous batch process (see Bradshaw [0149-0150]).
Regarding claim 24, modified-Bradshaw-Yang teaches the fermentation culture can be supplemented with an ammonia nitrogen substrate (see Bradshaw [0020]), wherein 100% of all nitrogen atoms in the ammonia are in the form of a nitrogen-containing gas because ammonia is naturally in a gaseous form.
Regarding claim 25, modified-Bradshaw-Yang teaches carbon monoxide enriched feedstock which has a total amount of carbon monoxide up to 99% (see Bradshaw [0146]) which, when the carbon is split evenly with the oxygen in the gas mixture, is at least 50% carbon molecules.
Regarding claim 27, modified-Bradshaw-Yang teaches hydrogen gas is fed to the fermentation broth in the bioreactor (see Bradshaw [0020]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Bradshaw (Pre-Grant Publication No. US 2019/0194630 A1 – date of publication 6/27/2019), in view of Yang (Yang et al., “Effect of ammonia on methane production, methanogenesis pathway, microbial community and reactor performance under mesophilic and thermophilic conditions”, 2018 Mar 13, Renewable Energy, 125, pgs. 915-925), and further in view of Hu (Hu et al., “Sulfide assessment in bioreactors with gas replacement”, 2010 Feb 9, Biochemical Engineering Journal, 49, pgs. 429-434).
Modified-Bradshaw-Yang’s general disclosure is set forth above.
Regarding claim 26, modified-Bradshaw-Yang teaches the fermentation broth can be supplemented with a sulfur source such as sulfide (see Bradshaw [0020]).
However, modified-Bradshaw-Yang does not teach the concentration of the sulfide was 0.001-150 mg/L.
Hu’s general disclosure relates to optimal sulfide supplementation in fermentation bioreactors for growing cells (see pg. 429, ¶ 2-3).
Regarding claim 26, Hu teaches a fermentation bioreactor for growing cells which is supplemented with sodium sulfide at a concentration range of 1.3-136 mM (see pg. 429, ¶ 3). The prior art range calculates to 41.68-4360.16 mg/L, and which overlaps with the claimed range of 0.001-150 mg/L.
It would have been obvious to one of ordinary skill in the art before the effective filing date to optimize the concentration to the claimed range as overlapping in Hu of the sulfide taught in modified-Bradshaw-Yang. One would be motivated to do so because Hu teaches that a sulfide concentration range of 41.68-4360.16 mg/L is optimal for growing microorganisms in a fermentation bioreactor (see Hu pg. 429, ¶ 3). This would be an advantage to modified-Bradshaw-Yang’s disclosure which states that factors, such as gaseous nutrients, that affect cell growth can be modulated (see Bradshaw [0153]). Therefore, the ordinary artisan could utilize Hu’s suggestion for an optimal sulfide range for growing cells in a bioreactor to improve upon modified-Bradshaw-Yang’s disclosure which manipulates amount of gaseous nutrients to optimize cell growth in a bioreactor as well.
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 16-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-29 of copending Application No. 18/876,089.
This is a provisional nonstatutory double patenting rejection. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed towards:
Method of producing amino acids via fermentation in a bioreactor using methanogenic microorganisms and wherein the amino acids are harvested at a specified rate and the microorganisms are recycled back into the bioreactor (claims 16-28)
Wherein some of the amino acids are one of the 20 canonical amino acids (claim 19)
Wherein the methanogenic microorganism is a Methanothermobacter (claims 16-28)
Wherein the method is a specified batch process (claim 23)
Wherein the method comprises a nitrogen, carbon, and sulfur source at specified concentrations (claims 24-26)
Wherein hydrogen gas, acetate, and/or methanol are fed to the bioreactor (claim 27)
Copending Application No. 18/876,089 claims are directed towards:
Method of producing amino acids via fermentation in a bioreactor using methanogenic microorganisms and wherein the amino acids are harvested at a specified rate and the microorganisms are recycled back into the bioreactor (claims 16-29)
Wherein some of the amino acids are one of the 20 canonical amino acids (claim 18)
Wherein the methanogenic microorganism is a Methanothermobacter (claim 19)
Wherein the method is a specified batch process (claim 23)
Wherein the method comprises a nitrogen, carbon, and sulfur source at specified concentrations (claims 24-26)
Wherein hydrogen gas, acetate, and/or methanol are fed to the bioreactor (claim 17)
As such, the instant application and the copending application no. 18/876,089 both are directed towards overlapping subject matter.
Claims 16-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/876,283.
This is a provisional nonstatutory double patenting rejection. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims are directed towards:
Method of producing amino acids via fermentation in a bioreactor using methanogenic microorganisms and wherein the amino acids are harvested at a specified rate and the microorganisms are recycled back into the bioreactor (claims 16-28)
Wherein some of the amino acids are one of the 20 canonical amino acids (claim 19)
Wherein the methanogenic microorganism is a Methanothermobacter (claims 16-28)
Wherein the method is a specified batch process (claim 23)
Wherein the method comprises a nitrogen and carbon source at specified concentrations (claims 24-26)
Wherein hydrogen gas, acetate, and/or methanol are fed to the bioreactor (claim 27)
Copending Application No. 18/876,283 claims are directed towards:
Method of producing amino acids via fermentation in a bioreactor using methanogenic microorganisms and wherein the amino acids are harvested at a specified rate and the microorganisms are recycled back into the bioreactor (claims 1-13)
Wherein some of the amino acids are one of the 20 canonical amino acids (claim 5)
Wherein the methanogenic microorganism is a Methanothermobacter (claim 6)
Wherein the method is a specified batch process (claim 9)
Wherein the method comprises a nitrogen and carbon source at specified concentrations (claims 10-11)
Wherein hydrogen gas, acetate, and/or methanol are fed to the bioreactor (claim 3)
As such, the instant application and the copending application no. 18/876,283 both are directed towards overlapping subject matter.
Conclusion
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/EMMALEE R WILLIAMS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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