DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant's election without traverse of Group I (Invention I) in the reply filed on 03/18/2026 is acknowledged. Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11 are under consideration in this Office Action.
Claim Rejections - 35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ) 2nd Paragraph
. 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 2, 3 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 pre-AIA the applicant regards as the invention.
Claim 2 recites the phrase “the coding sequence of D-lactate dehydrogenase gene is under the control of a Ptrc promoter, a Ppsba promoter, or a Pcpc560 promoter” which renders the claim vague and indefinite since the specific nucleotide sequence and structure of the promoters are not known and not recited in the claim. For examination purposes, the claim will not be limited to any specific promoter of any specific nucleotide sequence and structure.
Claim 5 recites the phrase “wherein: the coding sequence of exogenous d-lactate dehydrogenase gene is derived from Lactobacillus bulgaricus; the coding sequence of exogenous propionyl-CoA transferase gene is derived from Clostridium propionicum; and the coding sequence of exogenous polyhydroxyalkanoate synthase gene is derived from Pseudomonas” which renders the claim vague and indefinite since the specific nucleotide sequence and structure of the coding sequence are known and not recited in the claim. For examination purposes, the claim will not be limited to any specific coding sequence of any specific nucleotide sequence and structure.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a broad and widely varying genus of genetically engineered strains of Synechococcus elongatus, wherein the genome of the genetically engineered strain is integrated with a genus of coding sequences of exogenous D-lactate dehydrogenase gene, genus of coding sequences of exogenous propionyl-CoA transferase gene, and genus of coding sequences exogenous polyhydroxyalkanoate synthase gene, enabling the genetically engineered strain to express exogenous D-lactate dehydrogenase, exogenous propionyl-CoA transferase, and exogenous polyhydroxyalkanoate synthase, where the enzymes have widely varying amino acid sequences and structures. According to MPEP 2163:
“For each claim drawn to a 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 (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., 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 (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014)…”
According to MPEP 2163.02:
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon "reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter." Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
The reference of Chica et al. (Curr Opin Biotechnol. 2005 Aug;16(4):378-84; PTO 892) teaches that the complexity of the structure/function relationship in enzymes has proven to be the factor limiting the general application of rational enzyme modification and design, where rational enzyme modification and design requires in-depth understanding of structure/function relationships. The reference of Singh et al. (Curr Protein Pept Sci. 2017, 18, 1-11; PTO 892) reviews protein engineering methods including directed evolution, rational design, semi-rational design, and de-novo design; and states that despite the availability of a growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see entire publication especially Figs.1 and 3, and page 7, left column, lines 8-17). The reference teachings only provide guidance for searching and screening for the genus of enzymes.
The specification as originally filed does not disclose a representative number of species encompassed by the claimed genus by actual reduction to practice. The specification as originally filed does not provide a correlation between function and structure to enable one of ordinary skill in the art to predict which amino acid sequences and structures correlate with the activities of the recited enzymes which allow for the genus of genetically engineered strains of Synechococcus elongatus to produce more polylactic acid (PLA) compared to a wild type, unmodified strains of Synechococcus elongatus.
Hence, the specification does not provide sufficient written description to inform one of ordinary skill in the art that applicants were in possession at the time the application was filed of the claimed broad and widely varying genus of genetically engineered strains of Synechococcus elongatus, wherein the genome of the genetically engineered strain is integrated with a genus of coding sequences of exogenous D-lactate dehydrogenase gene, genus of coding sequences of exogenous propionyl-CoA transferase gene, and genus of coding sequences exogenous polyhydroxyalkanoate synthase gene, enabling the genetically engineered strain to express exogenous D-lactate dehydrogenase, exogenous propionyl-CoA transferase, and exogenous polyhydroxyalkanoate synthase, where the enzymes have widely varying amino acid sequences and structures.
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 of this title, 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 Hirokawa et al. (A J Biosci Bioeng,Vol.124, No.1, 31 December 2017 (2017-12-31), Page 54-61; IDS filed 03/18/2024) in view of CN107267476 (2017-10-20; IDS filed 03/18/2024), Taguchi et al. (PNAS, November 11, 2008, 105 (45) 17323-17327; PTO 892), WO2011029013 (2011-03-10; PTO 892).
Hirokawa et al. teach construction of a novel D-lactate producing pathway from dihydroxyacetone phosphate of the Calvin cycle in cyanobacterium, Synechococcus elongatus PCC 7942. Hirokawa et al. teach that lactate is a valuable commodity that can be used for the biodegradable plastic, polylactic acid, where D-lactate is a key precursor. Hirokawa et al. teach genetically engineering Synechococcus elongatus PCC 794 to express E.coli mgsA methylglyoxal synthase gene for conversion of DHAP to methylglyoxal. See entire publication and abstract especially MATERIALS AND METHOD section, RESULTS AND DISCUSSION section, and pages 55-59.
The teachings of the reference differ from the claims in that the reference does not teach the claimed genetically engineered strain of Synechococcus elongatus, wherein the genome of the genetically engineered strain is integrated with a coding sequence of exogenous D-lactate dehydrogenase gene, a coding sequence of exogenous propionyl-CoA transferase gene, and a coding sequence of exogenous polyhydroxyalkanoate synthase gene, enabling the genetically engineered strain to express exogenous D-lactate dehydrogenase, exogenous propionyl-CoA transferase, and exogenous polyhydroxyalkanoate synthase.
CN107267476 teaches a recombinant microorganism, which is prepared by introducing, into a starting bacterium, an expression vector containing a gene that encodes D-lactate dehydrogenase, wherein the starting bacterium may be a Synechococcus microorganism. CN107267476 teaches a method for performing illumination culture on the recombinant microorganism to prepare a lactic acid (see entire publication, abstract, and claims; see International Search Report dated October 25, 2022 in International Application No. PCT/CN2022/113485. English translation, cited in IDS filed 03/18/2024; PTO 892)
Taguchi et al. teach genetically engineered E.coli transformed to express propionyl-CoA transferase (PCT), engineered polyhydroxyalkanoate (PHA) synthase, β-ketothiolase, and acetoacetyl-CoA reductase which produces polylactate (PLA) including P(6 mol% LA-co-94 mol% 3HB). See entire publication and abstract especially Fig 2, Materials and Methods section, Discussion section, Results section, and pages 17324-27.
WO2011029013 teaches genetically engineering Synechococcus elongatus to express E.coli ldhA encoding lactate dehydrogenase, and LldP lactate transporter under IPTG-inducible promoters including lacUV5 and trp-lac strong promoters (see entire publication and claims especially paragraphs [0005]- [0016], Examples 1-7, and claims 1-17).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to make the claimed invention by genetically engineering the Synechococcus elongatus of Hirokawa et al. modify the coding sequences of D-lactate dehydrogenase, propionyl-CoA transferase, polyhydroxyalkanoate synthase taught by the above references to be under control of the promoters taught by WO2011029013; and integrating the coding sequences into the genome of the Synechococcus elongatus. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this in order to obtain a genetically engineered Synechococcus elongatus expressing D-lactate dehydrogenase, propionyl-CoA transferase, polyhydroxyalkanoate synthase where each of the enzymes can be isolated and purified from the genetically engineered Synechococcus elongatus, or the genetically engineered Synechococcus elongatus can be used to produce polylactic acid. It would have been obvious to place each of the coding sequences under control of the promoters recited in claims 3, 4 as routine optimization and/or desired in order to overexpress the genes in the genetically engineered strain of Synechococcus elongatus and direct substrates and carbon flow in the genetically engineered strain of Synechococcus elongatus for the production of polylactic acid. It would have been obvious to integrate the acetyl-CoA synthase gene of claim 6 as routine optimization and/or desired in order to direct substrates and carbon flow in the genetically engineered strain of Synechococcus elongatus for the production of polylactic acid by expression of the acetyl-CoA synthase gene. It would have been obvious to integrate of a coding sequence of exogenous sRNA capable of inhibiting the expression of acetate kinase gene into the genome of the genetically engineered strain recited in claim 8 as routine optimization and/or desired in order to direct substrates and carbon flow in the genetically engineered strain of Synechococcus elongatus for the production of polylactic acid by sRNA capable of inhibiting expression of the genes. It would have been obvious to knock out the genes encoding the enzymes of claim 7, 9 as routine optimization and/or desired in order to direct substrates and carbon flow in the genetically engineered strain of Synechococcus elongatus for the production of polylactic acid by deletion or knock out of the recited genes. It would have been obvious to integrate of a coding sequence of exogenous sRNA capable of inhibiting the expression of the genes recited in claim 10 into the genome of the genetically engineered strain as routine optimization and/or desired in order to direct substrates and carbon flow in the genetically engineered strain of Synechococcus elongatus for the production of polylactic acid by sRNA capable of inhibiting expression of the genes. One of ordinary skill in the art at the time the invention was made would have a reasonable expectation of success because genetically modifying Synechococcus elongatus for the production of are known in the art as shown by the reference teachings. Hence, the claimed invention as a whole is prima facie obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
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