DETAILED ACTION
Claims 1-16 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A preliminary amendment of the abstract as submitted in a communication filed on
12/15/2023 is acknowledged.
A preliminary amendment of the specification as submitted in a communication filed on
12/15/2023 is acknowledged.
A preliminary amendment of claims 1, 3-9, and 12-13 and addition of claim 16 as
submitted in a communication filed on 12/15/2023 is acknowledged.
Applicant’s election of Group I, drawn in part to a method for producing PHA comprising: a) growing bacteria under heterotrophic conditions in a media; and b) cultivating the bacteria under autotrophic conditions under an atmosphere of CO2, H2 and optional O2, wherein the amount of O2 if present is less than 10 % (v/v) and pressure is at least 1 barg, wherein at least one carbon source is added before and/or during step b). Applicant elected (1) polyols as a carbon source in claim 4 and (2) dimethyl carbonate as an extractant in claim 12. in the reply filed on 05/29/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 13-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a nonelected invention. Claims 1-12 are at issue and will be examined only to the extent they encompass the elected invention.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d) to European patent document 21180902.5 filed on 06/22/2021. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file. The instant application is a 371 national stage application of PCT/EP2022/067053 filed on 06/22/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/15/2023, 10/24/2025, 11/21/2025 and 01/13/2026 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 1 and 12 are objected to because of the following informalities: Claims 1 and 12 contain the acronym PHA. PHA should be defined the first time it is used in the claims. Appropriate correction is required.
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 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Gonzalez et al. (Catalysis Today, published 06/28/2014, IDS citation # 6, 12/15/2023) in view of Garrigues et al. (New Biotechnology, published 11/12/2019).
Garcia-Gonzalez et al. teaches a two-stage cultivation method for sustainable autotrophic polyhydroxybutyrate (PHB) production, which is a polyhydroxyalkanoate (PHA), in Cupriavidus necator using a gas mixture of H2, O2 and CO2 and where the cell mass growth was under heterotrophic conditions (see abstract and Section 2.3 Fermentation). Garcia-Gonzalez et al. teaches a gas composition at a ratio of H2:O2:CO2 = 84:2.8:13.2 vol% (see Sections 2.2.3. Gas control system and 2.3 Fermentation). Garcia-Gonzalez et al. teaches that the oxygen transfer rate must be enhanced to achieve higher PHB accumulation and operation at elevated pressure is one way to achieve this (see pg. 243, column 1, Lines 60-63). Garcia-Gonzalez et al. teaches Cupriavidus necator is capable of shifting between heterotrophic growth (utilizing organic compounds as carbon and energy source) and autotrophic growth (utilizing CO2 as carbon source and H2 or formate as energy source) (see pg. 237, Introduction, column 2, Lines 4-7). Garcia-Gonzalez et al. teaches the use of two different organic substrates, glucose and waste glycerol, as carbon sources for cell mass growth (see pg. 238, column 2, Lines 4-7). Therefore, Garcia-Gonzalez et al. teaches the carbon source as a sugar or a polyol. Garcia-Gonzalez et al. teaches the cell mass concentration increased exponentially under heterotrophic conditions (cells grown over glucose) before autotrophic cultivation was initiated (see pg. 241, second paragraph).
Garcia-Gonzalez et al. does not teach a pressure of at least 1 barg (2.013 bar absolute pressure). Garcia-Gonzalez et al. does not teach a pressure of at least 2 barg. Garcia et al. does not teach a pressure range from 2 to 20 barg. Garcia-Gonzalez et al. does not teach a H2 content between 50 % and 80 % and H2 content between 50 % and 75 %.
Garrigues et al. teaches autotrophic growth of Cupriavidus necator (H16 ΔphaCAB) (see strains, pg. 17) with an exponential growth throughout cultivation with a step-wise increase in total reactor pressure up to > 3 bars (~2 barg) and a final pressure up to 4.2 bars (~3.2 barg) to maintain dissolved oxygen at a low level (see pg. 18, column 2, Lines 22-27). Garrigues et al. teaches optimal gas composition for cultivation of Cupriavidus necator under autotrophic conditions of H2/O2/CO2 = 7:1:1, H2/O2/CO2 = 7:2:1 or H2/O2/CO2 = 6:2:1. Garrigues et al. teaches that these gas mixtures lie within the explosive composition range which is regarded as above 6 % O2 in the presence of H2 (see pg. 16, Introduction, column 2, Lines 17-18). Garrigues et al. teaches the use of a gas mixture of 60:2:10:28 (molar % of H2/O2/CO2/N2) (see pg. 17, Culture conditions and bioreactor system). Garrigues et al. teaches the use of Fructose as the only carbon source in the culture media (see pg. 17, Media, column 1).
Claims 1-11 are directed in part to a method for producing PHA comprising a) growing bacteria under heterotrophic conditions in a media; and b) cultivating the bacteria under autotrophic conditions under an atmosphere of CO2, H2 and optional O2, wherein the amount of O2 if present is less than 10 % (v/v) and pressure is at least 1 barg, wherein at least one carbon source is added before and/or during step b), wherein the bacterium can be wild type, wherein the bacterium can be Cupriavidus necator, wherein the carbon source can be a sugar, polyol, organic acid or salts or esters thereof, wherein the bacteria can be grown under exponential growth conditions, wherein the pressure can be at least 2 barg, wherein the pressure can be in the range of 2 to 20 barg, wherein the CO2 level can be between 2 % and 90 %, wherein the H2 content can be between 50 % and 92 %, 50 % and 80 % and 50 % and 75 % (v/v).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the two-step cultivation method for autotrophic polyhydroxybutyrate (PHB) production of Garcia-Gonzalez et al. by changing the CO2 and H2 parameters and increasing the pressure up to 4.2 bars as taught in Garrigues et al. to avoid gas-limited conditions while preventing gas detonation.
A person of ordinary skill in the art is motivated to modify the two-step cultivation method for autotrophic polyhydroxybutyrate (PHB) production of Garcia-Gonzalez et al. because Garcia-Gonzalez et al. teaches that the oxygen transfer rate must be enhanced to achieve higher PHB accumulation and operation at elevated pressure is one way to achieve this (see pg. 243, column 1, Lines 60-63).
One of ordinary skill in the art has a reasonable expectation of success at modifying the two-step cultivation method for autotrophic polyhydroxybutyrate (PHB) production of Garcia-Gonzalez et al. to arrive at the claimed invention because Garcia-Gonzalez et al. is directed to a method of producing PHA under a two-step heterotrophic and autotrophic conditions comprising a wild type bacterium (Cupriavidus necator) using carbon sources and it is well known in the art as evidenced by Garrigues et al., that Cupriavidus necator can be cultivated at higher pressure and optimal H2/O2/CO2 ranges to obtain larger biomass, leading to more product. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Garcia-Gonzalez et al. (Catalysis Today, published 06/28/2014) in view of Garrigues et al. (New Biotechnology, published 11/12/2019) as applied to claims 1-11 above, and further in view of Mozumder et al. (Process Biochemistry, published 03/2014, IDS citation #3, 11/21/2025) and Samorì et al. (Green Chemistry, published 10/24/2014).
The teachings of Garcia-Gonzalez et al. have been discussed above. Garcia-Gonzalez et al. teaches PHB extraction as previously described in Mozumder et al (see pg. 239, 2.6 PHB extraction and characterization).
Mozumder et al. teaches PHB extraction by resuspending lyophilized cells in chloroform for 24 h with vigorous agitation at room temperature, cell debris was separated from solubilized PHB via filtration then precipitated with cold ethanol precipitation. The precipitated polymer was then filtered and dried (see pg. 368, 2.9. PHB extraction).
The teachings of Garrigues et al. have been discussed above.
Samorì et al. teaches the recovery of PHA polymers can be accomplished in two main ways: (i) PHA solubilization/recovery with organic solvents or (ii) selective dissolution of non-PHA cell mass (NCPCM) with chemicals (e.g. surfactants or chelating agents) or enzymes (see pg. 1047, Introduction, right column, lines 25-26 – pg. 1048, left column, lines 1-3). Samorì et al. teaches chloroform and dichloromethane are the best performing organic solvents, but they are problematic both for humans and the environment rendering them undesirable for industrial applications (see pg. 1048, left column, lines 4-7). Samorì et al. teaches that dimethyl carbonate (DMC) is versatile as a reagent and solvent, and has a relatively low toxicity for human health and for the environment as it is fully biodegradable, non-irritating and has no mutagenic effects by either contact or inhalation (see pg. 1048, left column, lines 54-56 – right column, lines 1-2). Samorì et al. teaches extraction of P(3HB) with DMC at 90 °C and yielded 88 ± 6 % recovery (see pg. 1049, left column, lines 16-17). Samorì et al. teaches a 1 h extraction of P(3HB) at 90 °C for re-suspended biomass concentrations of 50 and 100 g/L yielded 85 ± 6 % and 92 ± 6 % and from “fresh” microbial slurry at the same biomass concentration yielded 94 ± 9 % (see pg. 1050, left column, lines 3-8 and Figure 4). Samorì et al. teaches the recovery and purity of polymers extracted using DMC were very high and the thermophysical characteristics of the recovered polymers were excellent due to the relatively low extraction temperature applied (see pg. 1054, left column, lines 6-10).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to substitute the chloroform extraction method used in Garcia-Gonzalez et al. and Mozumder et al. with the DMC method taught by Samorì et al.
A person of ordinary skill in the art is motivated to substitute the chloroform extraction taught by Garcia-Gonzalez et al. and Mozumder et al. with the DMC method taught by Samorì et al. because Samorì et al. teaches that chloroform is problematic for human health and the environment and DMC has a low toxicity and fully biodegradable while still extracting high yield and high quality PHA from Cupriavidus necator.
One of ordinary skill in the art has a reasonable expectation of success at obtaining high yield and highly pure PHB from Cupriavidus necator using DMC instead of chloroform for extraction because Samorì et al. teaches that this substitution yields polymers with thermophysical characteristics that are excellent due to the relatively low temperature that is required for extraction. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art.
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 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-9 of copending Application No. 17/785,981 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims pertain to a method of producing PHA comprising a) growing bacteria under heterotrophic conditions in a media; and b) cultivating the bacteria under autotrophic conditions under an atmosphere of CO2, H2 and O2, wherein the amount of O2 is below 10 % v/v and pressure is at least 1 barg, wherein at least one carbon source is added before and/or during step b). Claim 1 of the instant application is broad in scope and comprises any media that can have at least one carbon source (in the media during growing) or the carbon source can be added to the media during cultivation, which includes the media in claim 1 of co-pending application 17/785,981 (media comprising at least one phosphate salt or at least one ammonium salt and a feed added during growing (growing; step a of the instant application) comprises 150 to 300 g/L of C, 1 to 5 g/L of N and 1 to 10 g/L of P). The pressure is at least 1 barg (e.g. 1 barg, 2 barg, 3 barg etc.) in the instant application includes the pressure of at least 2 barg in co-pending application 17/785,981. Claim 8 of the instant application has a broad range for the content of CO2 during cultivation (between 2 % and 90 % v/v). Claim 8 of co-pending application 17/785,981 claims a CO2 content during cultivating between 2 % and 25 %, which is included in the between 2 % and 90 % CO2 content of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALTON EDWARD KIEFER whose telephone number is (571)272-1235. The examiner can normally be reached M-F 7:30-5 EST.
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/DALTON EDWARD KIEFER/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
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