DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendments filed on September 22, 2023 and February 4, 2026, have been received and entered. Applicant is reminded to use the right status identifiers such as “currently amended, previously presented, original, new, withdrawn, and withdrawn and amended. However, there is no “currently pending’ identifier.
3. Applicant’s election of Group I (with species) without traverse on February 4, 2026, is acknowledged.
Claim Disposition
4. Claims 1-38 have been cancelled. Claims 39-57 are pending. Claims 39-48 are under examination. Claims 49-57 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Specification Objection
5. The specification is objected to for the following informalities:
The specification is also objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. See pages 28 and 38, for example. It is suggested that http:// is deleted.
Information Disclosure Statement
6. The Information Disclosure Statements filed on June 27, 2024 and February 22, 2024, have been considered. A copy of the PTO-1449 form is attached herein. Note that some references have been lined through that do not have a proper date citation.
Drawings
7. The drawings filed on September 22, 2023 are accepted by the examiner.
Claim objection
8. Claims 39-48 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1is amended to clearly recite what the mixture comprises. It appears the list of bacteria in the mixture is not clearly defined and the ‘dash lines’, commas and semi-colon. For example, “…….biopolymer-, renewable polymer- or biodegradable polymer-producing methanotrophic bacterium; and a polyhydroxyalkanoate….”. Not clear what is a list or grouping with the extraneous punctuation (i.e., ‘A non-natural mixture or consortium of bacteria, comprising:
a methanotrophic bacteria and an aerobic chemolithoautotrophy bacteria that produces PHA….’. The dependent claims hereto are also included. See claim 48 with similar language.
Claims 41-43 are objected to because the organism names are not italicized.
Claim 43 is objected to because it does not have proper Markush language.
Claim 44 is objected to for the recitation of ‘etc’, because limitations are not fully described.
For clarity and precision of claim language it is suggested that claim 45 is amended to recite “…obtained [[derived]] from a bacterium in the [[a]] mixture or consortium [[as set forth in]] of claim 40, and wherein [[where the characteristics of microorganisms are obtained due to mutations]] the bacterium has genetically-engineered mutation, and/or selection -pressure………mutation[[having contained therein]] comprising at least one……encoding an enzyme [[involved in]] that catalyzes synthesis of a biopolymer……(PHA) [[synthesis]]”. See claim 48 with similar language.
For clarity and consistency it is suggested that claim 47 is amended to read, “….[[having contained therein]] comprises a heterologous…….”. See claim 48 with similar language.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
9. Claims 39-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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.
The claimed invention is directed to “a non-natural mixture or consortium of bacteria, comprising a PHA-producing methanotrophic bacterium or biopolymer ….;.and PHA-producing aerobic chemolithoautotrophy bacterium or a biopolymer… .”. The claimed invention encompasses a large variable genus of bacteria, biopolymers, biodegradable polymers and the like. The claimed invention is also directed to any genetically engineered bacterium that comprises any mutations. The genetically engineered bacterium also comprises any heterologous nucleic acid that encodes an enzyme involved in for example, biopolymer or PHA synthesis. There are no indicia as to all the possible mutations, genes and the involvement of the enzyme in the synthesis of varied polymers and PHA. No structure function correlation is made and the claim language is broad and encompasses a large variable genus of products. Thus the claimed invention is not adequately described.
The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
10. Claims 39-48 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 39 and the dependent claims hereto are indefinite for the recitation of “a non-natural mixture or consortium of bacteria….”, and both bacteria is recited as being PHA producing, because the claim language does not clearly establish if the mixture or consortium is to produce an increased amount of PHA. The claim language is also ambiguous with the recitation of “non-natural mixture or consortium of bacteria” because the non-natural mixture means that it does not exist in nature, the consortium however does not necessarily mean that it does not exist in nature. A consortium of bacterial is recognized in the art as a cooperative group of two or more different microbial species living symbiotically and interacting in a shared environment. The art also discloses that generally an oyster can have both of the claimed bacteria living symbiotically in their shells. Thus the recitation of “consortium” does not necessarily denote “non-natural”.
Claim 44 is indefinite for the recitation of “PHA biorenewable etc.” because it means ‘the rest’ or ‘other similar things’. Represents language/limitations not found in the claims.
Claim 45 and the dependent claims hereto lacks clear antecedent basis for the recitation of ”the characteristics of microorganisms”.
Claims 45 and 48 are indefinite for the recitation of “involved in” because the involvement is not defined. What is the necessary participation of a specific protein to act as a biological catalyst in facilitating, speeding up or controlling chemical reactions.
Claim Rejections - 35 USC § 103
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.
11. 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.
12. Claim(s) 39-43 and 45-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over University of Washington (US 2016/0237398, of record in the application) in view of Criddle et al. (US 2013/0052681, of record in the application), The Regents of The University of California (US 2014/0377857, of record in the application), Dedysh et al.(Int’l J. of Systematic and Evolutionary Microbiology, of record in the application) and Anzai et al. (Int’l J. of Systematic and Evolutionary Microbiology, of record in the application).
University Of Washington Through Its Center For Commercialization (hereinafter, "Washington") discloses a non-natural mixture or consortium of bacteria (compositions relating to the fermentation of methane by methantrophic microorganisms, Para. [0008]; culturing bacteria in a non-natural environment, Para. [0045]; microorganisms can include Methylomicrobium alcaliphilum or Methylomicrobium buryatense, Methylomonas spp, or mixtures thereof, Para. [0056]). Washington fails to explicitly disclose comprising one member of each of the following groups: (a) a polyhydroxyalkanoate (PHA)-producing methanotrophic bacterium or biopolymer-, renewable polymer- or biodegradable polymer-producing methanotrophic bacterium comprising a 16sRNA of SEQ ID NO: 1; and; (b) a polyhydroxyalkanoate (PHA)-producing aerobic chemolithoautotrophy bacterium or a biopolymer-, renewable polymer- or biodegradable polymer-producing aerobic chemolithoautotrophy bacterium comprising a 16sRNA of SEQ ID NO: 4. Criddle et al. (hereinafter, "Criddle") is in the field of type Il methanotrophs (Abstract) and teaches comprising one member of (a) a polyhydroxyalkanoate (PHA)-producing methanotrophic bacterium or biopolymer-, renewable polymer- or biodegradable polymer-producing methanotrophic bacterium (growth of methanotrophs and PHA production. The feedstock is used in aerobic microbial biosynthesis of PHA polymers using a mixed bacterial community, preferably including methanotrophs, Para. [0050]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of ordinary skill in the art at the time of the invention to modify Washington with the teaching of Criddle for the purpose of producing bioplastics from renewable feedstocks (Criddle, Para. [0003]).
The Regents Of The University Of California (hereinafter, "California") California teaches about bioreactors (Abstract) and; a polyhydroxyalkanoate (PHA)-producing aerobic chemolithoautotrophy bacterium or a biopolymer-, renewable polymer- or biodegradable polymer-producing aerobic chemolithoautotrophy bacterium (a chemolithoautotroph, Ra. eutropha is able to derive its energy and reducing power from inorganic compounds or elements, such as H2 or formate, to drive CO2 fixation through the CBB cycle. Ra. autropha is metabolically active and versatile, grows reasonably fast, and has been extensively studied for industrial production of polyhydroxyalkanoate (PHA), Para. [0095]).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify Washington with the teaching of California for the purpose of using recombinant microorganisms to take advantage of biological C-C bond formation capability without relying on inefficient photo energy conversion (California, Para. [0005]). Dedysh is in the field of strains of methane-oxidizing bacteria (Abstract) and teaches a 16sRNA of SEQ ID NO: 1 (Methylosinus trichosporium NCIMB 11131T, determined for reference purposes, have EMBL}GenBank} DDBJ nucleotide sequence databases accession numbers Y18945, Pg. 958, right-hand column, fourth paragraph; where accession number Y18945 of Dedysh comprises a polynucleotide with 100% identical SEQ ID NO: 1 of the instant application).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify Washington with the teaching of Dedysh for the purpose of producing phospholipid ester-linked fatty acids which are 18:1 acids (Dedysh, Pg. 967, left-hand column, fourth Anzai paragraph). is in the field of Pseudomonas 16s rRNAs (Abstract) and teaches a 16sRNA of SEQ ID NO: 4 (Hydrogenophaga flava ..AB021420, Pg. 1564, Table 1 middle of page; where accession number AB021420 of Anzai comprises a polynucleotide with 100% identity to SEQ ID NO: 4 of the instant application).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify Washington with the teaching of Anzai for the purpose of using a bacterium which produces PHA from inexpensive carbon sources such as whey from dairy industry purposes, have EMBL}GenBank} DDBJ nucleotide sequence databases accession numbers Y18945, Pg. 958, right-hand column, fourth paragraph; where accession number Y18945 of Dedysh comprises a polynucleotide with 100% identical SEQ ID NO: 1 of the instant application).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify Washington with the teaching of Dedysh for the purpose of producing phospholipid ester-linked fatty acids which are 18:1 acids (Dedysh, Pg. 967, left-hand column, fourth Anzai paragraph). is in the field of Pseudomonas 16s rRNAs (Abstract) and teaches a 16sRNA of SEQ ID NO: 4 (Hydrogenophaga flava ..AB021420, Pg. 1564, Table 1 middle of page; where accession number AB021420 of Anzai comprises a polynucleotide with 100% identity to SEQ ID NO: 4 of the instant application).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify Washington with the teaching of Anzai for the purpose of using a bacterium which produces PHA from inexpensive carbon sources such as whey from dairy industry.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching of the references render the claimed invention as obvious. Motivation exists to combine the references because they are analogous art.
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Conclusion
13. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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