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 .
Claim Objections
Claim 2 is objected to because of the following informalities: in claim 2, the language “wherein the bacterium is selected from E.coli and Cyanobacterium”. Since applicant is not reciting Markush language, the examiner suggests using “or” instead of “and” .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-7, 9, and 12-15, and Species 1 (Claims 1,6,7, and 12): FeoB and HemA, Species 2 (Claims 2 and 14): E.coli, Species 3 (Claims 3 and 5): exogenous heme-containing protein, Species 4 (Claim 4): cyanoglobin, and Species 5 (claim 15): PT7 is acknowledged. Claim 7 is further withdrawn because it is directed to a non-elected endogenous embodiment.
Claims 7, 16-19,21,25,29, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The restriction requirement Species 2 (Claims 2 and 14) and Species 5 (Claim 15), as set forth in the Office action mailed on January 30, 2026, has been reconsidered and is hereby withdrawn. In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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 1-6, 9, and 12-15 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 recites "selected from a group comprising". Here, the grouping requires a material selected from an open list of alternatives, such as by reciting "selected from a group comprising...”. It is unclear what other alternatives are intended to be encompassed by the claim and therefore the claim is indefinite. See MPEP 2173.05(h) regarding Markush Groups.
Claims 4, 6, 12 and 15 suffer from a similar deficiency as claim 4, in reciting "selected from a group comprising".
Dependent claims 2-6, 9, 12-15 also inherit and fail to cure the deficiency of claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, and 15, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McConnell, M. et al., Production of Heme-Containing Proteins in Cyanobacteria.(WO2019079135A1; published 2019-04-25) as evidenced by NCBI Reference Sequence, WP_330204673.
Regarding claims 1-6, and 15 McConnell, M. et al., discloses a genetically modified Cyanobacterium species (page 17, paragraph 00104) using promoter PcpcB (claim 15) (page 5, paragraph 0031), and with exogenous expression (claim 3) of the heme protein, cyanoglobin (claim 4 and 5) (page 35, paragraph 00164); Cyanobacterium species naturally encode polynucleotide sequence(s) for HemA, as essential enzymes of the C5 pathway as expressed by cyanobacteria, see reference WP_330204673.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 9,12-14 are rejected under 35 U.S.C. 103 as being unpatentable over McConnell, M. et al., Production of Heme-Containing Proteins in Cyanobacteria.(WO2019079135A1; published 2019-04-25), and further in view of Li, H. et al., Pattern of cyanophycin accumulation in nitrogen-fixing and non-nitrogen-fixing cyanobacteria. Arch Microbiol. 2001; (176); pp. 9–18.
The teachings of McConnell, M et al., are discussed previously.
Further, regarding claims 12, 13, and 14, McConnell et al., previously teaches a Cyanobacterium species with exogenous cyanoglobin expression in strain(s) which encode polynucleotide sequence(s) for Hem A.
McConnell, M et al., does not teach the knockout of cyanophycin synthetase (cphA) and cyanophycinase (cphB), (claim 9).
However, regarding claim 9, Li, H. et al., teaches methods for creating knockout(s) of cphA and/or cphB in a cyanobacteria, Synechocystis species (page 13, Figure 3) whose functions include cyanophycin metabolism and nitrogen fixation.
It would have been obvious to one of ordinary skill in the art at the effective date of filing, to have combined the teaching of McConnell, M et al., with Li, H. et al., to produce Cyanobacterium strain(s) with cphA and/or cphB gene knockouts. As McConnell M et al., also teaches a genetically modified Cyanobacterium strains able to express heme groups and/or heme-associated proteins – the incorporation of said knockouts using previously taught methods, technology, and Cyanobacterium strain(s) would then produce strains with modified microbial cellular activity, through altered regulation of nitrogen fixation pathways.
Since, McConnell et al., teaches a genetically modified Cyanobacterium strain it would have been obvious to an artisan skilled in the art to introduce the combination of (1) the engineered Cyanobacterium cells of McConnell et al, which express exogenous cyanoglobin under the promoter of PcpcB, and further introduce (2) the gene knockouts for cphA and/or cphB , which are inherently expressed by cyanobacterial species as taught by Li, H et al. The Cyanobacterium strain(s) of McConnell et al., are designed to express genes associated with heme synthesis and/or heme protein integration, therefore further engineering of these strains to knockout cphA and/ cphB, expressed by all cyanobacteria, will be compatible modifications.
The motivation to combine the teachings of McConnell, et al., and Li, et al., are to suspend the metabolic/cellular pathways associated with cphA and/or cphB and to prevent alternate cellular activity associated with pathways that are otherwise constitutive to cyanobacteria, as noted in the literature, and which otherwise decrease and/or deplete heme- protein and/or heme group synthesis—thus, enhance the conditions for heme protein and/or heme group synthesis.
One would have expected success with the combined methods and technology taught by the prior art, to produce a Cyanobacterium strain with nucleotide sequences for heme groups, able to express exogenous cyanoglobin, and gene knockouts for cphA and cphB, since all are previously taught in engineered cyanobacteria. The combined technology of the prior art, which include: (1) the methods of McConnell et al., for the expression of exogenous cyanoglobin, in Cyanobacterium, with nucleotide sequence for HemA in addition to (2) the gene knockout(s) for photosensitive and nitrogen-fixing genes, cphA and/or cphB, are the same necessary methods, technology, genes, and known microorganism(s) taught by the combined prior art, to successfully create said genetic modifications, in a Cyanobacterium strain.. Therefore, it is prima facie obvious, as the combined art is able to produce the same outcome in a genetically modified Cyanobacterium.
Conclusion
No claims are deemed allowable.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENUSHA KARUNASENA whose telephone number is (571)272-3972. The examiner can normally be reached Monday-Friday 7:30am-5pm.
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/ENUSHA KARUNASENA/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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