DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of claims
Claims 1-24 as filed on 11/20/2024 are pending and under examination in the instant office action.
Claim Rejections - 35 USC § 112
Indefinite
Claims 1-18 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.
Claim 1 is unclear and indefinite with regard to returning the biomass combination (combination of PHA-reduced biomass with PHA-containing/rich biomass) of step (d) to step (b) since step (b) is drawn to separation of the biomass into PHA-reduced biomass and PHA-containing/rich biomass or to separation of the combination. Thus, the claim language encompasses doing-undoing of the same protocol without moving forwards to the goal of producing and/or increasing PHA by a culture of microorganisms producing/generating PHA.
Claim 8 is indefinite and uncertain with regard to recitation about increasing PHA in culture by extracting PHA from culture since this manipulation as recited therein appears to reduce rather than to increase PHA amount in the culture.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 and 11-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Helm et al. (Journal of Applied Microbiology. 2006, 101, 387-395) taken with US 6,472,188 (Lee et al), Wendlandt et al (Journal of Biotechnology, 2005, 117, 119-129) and Braunegg et al (Journal of Biotechnology, 1998, 65, pages 127-161).
The cited reference by Helm et al teaches a process for producing polyhydroxyalkanoate (PHA) such as polyhydroxybutyrate (PBH) by a mixed culture of microorganisms, wherein the process comprises several steps:
As applied to step (a): the reference by Helm teaches providing a culture of microorganisms comprising microbial cells, thus, “microorganism-derived biomass” within the meaning of the claims. The culture of microorganisms is capable of metabolizing methane to synthesize PHA (see entire document by Helm), thus, the microbial biomass is “biomass comprising PHA” within the meaning of the claims. In particular, the mixed culture comprises Methylocystis as a dominant species (page 388, col.1, par. 5) and some accompanying bacteria including Acidovorax (page 390, col. 2, par. 1). The microorganism Methylocystis is a methanotrophic microorganism capable of metabolizing methane (or “carbon containing gas” as claimed) to synthesize PHA (see entire document by Helm). The accompanying bacteria including Acidovorax utilizes various complex carbon sources (see abstract of Helm) and, thus, capable of metabolizing “a PHA-reduced cellular biomass” to synthesize PHA since it is well known that Acidovorax bacteria accumulate PHA as evidenced by US 6,472,188; for example: see col. 5, lines 32-41. As applied to claimed limitation drawn to “a carbon within PHA-reduced cellular biomass” as a substrate for microbial growth: the cited Helm explicitly teaches that the bacteria utilize cell lysis product such as proteins, nucleic acids of methanotrophic bacteria (see page 393, col. 1, par. 1, lines 11-16; see figure 5). In view of instant specification “a PHA-reduced cellular biomass” provides for carbon source (par. 0114) and microorganism-derived biomass “cellular” materials include polymers, amino acids, nucleic acids, carbohydrates and metabolic derivatives (par. 0116). Therefore, in the method of Helm the bacteria utilize the same carbon source as encompassed the claimed phrase “PHA-reduced cellular biomass” within the meaning of the claims and when read in the light of specification.
As applied to step (b): the cited reference by Helm discloses removal of a portion of said culture of microorganism for extraction of PHA (see page 388, col. 1, last par.) as intended to measure growth and PHA accumulation. Although Helm does not disclose how much of PHA is removed from total biomass, it would be reasonably to conclude that PHA content is reduced upon extraction of PHA from total biomass to a least some extent. Moreover, cell lysis products such as proteins, nucleic acids of the methanotrophic bacteria are compounds free of PHA.
As applied to step (c): the cited reference by Helm teaches culturing the mixed culture of microorganisms for producing PHA, thus, increasing concentration of PHA and producing PHA-rich biomass within the meaning of the claims.
Further, with regard to step (d): the cited reference by Helm indicates and/or suggests that the cell lysis product of biomass is returned to and utilized by the culture of microorganisms producing PHA (see figure 5); thereby, combining lysis products (“PHA-reduced biomass” as claimed) with a culture of microorganisms producing PHA (“PHA-rich biomass” as claimed). The cell lysis products are additional carbon sources or substrate to provide additional PHA within the meaning of the claims. The process is circular and continuous (figure 5) and, thus, the step (d) is incorporated or suggested to be incorporated into the process for providing biomass with PHA and removing PHA as encompassed by the claims 1, 19 and 21. Moreover, the claimed concept of recycling back extra carbon is a common well-known practice. For example: the IDS reference by Braunegg teaches that incomplete utilization of substrates is often encountered in a culture of microorganisms producing PHA and that extra carbon is recycled back into the process for the benefit in decreasing losses and increasing production profitability (see page 150, col.1, par. 3).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to practice the method of Helm for producing PHA by a mixed culture of microorganisms with a return of non-utilized carbon source and/or cell lysis products (proteins as acknowledged by Helm) to the cell culture as secondary carbon sources in addition to primary carbon source (methane) as taught/suggested by Helm (figure 5) with a reasonable expectation of success in producing PHA because Helm clearly recognizes cell lysis products as additional secondary carbon source for the mixed culture that provides a stable production of PHA as acknowledged by Helm and because recycling back of unutilized substrates into the process of PHA production is a common practice intended for the benefit in decreasing losses and increasing production profitability (Braunegg).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
As applied to claims 2, 3 and 5: in the method of Helm cell lysis products include cell proteins, nucleic acids as acknowledged by Helm that are “non-PHA carbon” within the meaning of the claims.
As applied to claim 4: in the method of Helm the claim-recited “converted biomass” is CO2 produced by methanotrophic Methylocystis as result of converting methane as a primary source as evidenced by Hansen (see figure 1).
As applied to claim 6: in the method of Helm the culture of microorganisms is a mixed culture of methanotrophic and heterotrophic microorganisms as explained above.
As applied to claims 7-9 and 20 (that appear to be drawn to extraction of PHA from biomass): the cited reference by Helm describes accumulation of specific and elevated PHA amounts, wherein PHA is extracted by protocol of the referenced by Wendlandt-2001, that include water, solvents, methanol, dichloethane (page 129, it 2.4.5.1) as required by the pending claims.
As applied to claims 11 and 12: Helm discloses that source of methane is a natural gas stream; and methane or natural methane is derived from anaerobic decomposition within the meaning of the claims.
As applied to claims 13-18: Helm discloses that methanotrophic PHA producing microorganisms are grown/manipulated in a culture medium and under conditions of Wendlandt (page 388, section “materials and methods) that include mineral salts as “at least one nutrient” (see Wendlandt, page 128, section 2.1) and also manipulation of nutrients such as nitrogen and phosphorus during subsequent stages of cultivation including growth and PHA accumulation stages (see Wendlandt, page 128, section 2.3) within the broadest reasonable meaning of the instant claims.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Helm et al. (Journal of Applied Microbiology. 2006, 101, 387-395) taken with US 6,472,188 (Lee et al), Wendlandt et al (Journal of Biotechnology, 2005, 117, 119-129) and Braunegg et al (Journal of Biotechnology, 1998, 65, pages 127-161) as applied to claims 1-9 and 11-21 above, and further in view of Verlinden et al (Journal of Applied Microbiology. 2007, 102, 1437-1449).
The cited references by Helm et al, US 6,472,188 (Lee et al) and Wendlandt et al are relied upon as explained above.
The method of Helm does not appear to comprise utilization of light during culturing due to apparent absence of photosynthetic microbes.
However, as applied to claims 10 and 22-24, drawn to step of introducing light during growth of mixed microbial cultures, it is noted that photosynthetic microorganism such as Spirulina have been known and used for production of PHA. For example: see Verlinden et al. (table 3).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was made to modify method of Helm by utilizing light as claimed when the light-required microbes are present in the mixed culture with a reasonable expectation of success in producing biomass with PHA because photosynthetic microorganism require light for growth and used for production of PHA in view of Verlinden et al. Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
Therefore, the claimed invention as a whole was clearly prima facie obvious to one having ordinary skill in the art at the time the claimed invention was made, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
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 1-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,037,628.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to similar methods for producing PHA by a mixed culture of microorganisms comprising gas-utilizing and PHA producing microorganisms and heterotrophic microorganisms utilizing PHA-reduced biomass, wherein both methods comprises retuning PHA-reduced biomass to serve as additional carbon source.
The issued claims are narrower for explicitly reciting at least two specific types microorganisms; and the pending claims are broader for reciting a generic culture comprising microorganisms that can metabolize gas and carbon source of PHA-reduced biomass.
Accordingly, the claimed methods in the issued patent and in the present application are obvious variants.
Therefore, the inventions as claimed are co-extensive.
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Vera Afremova
June 4, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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