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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/27/2025 has been entered.
Response to Amendments
Applicant's amendments filed 10/27/2025 to claims 1-12 have been entered. Claims 13-59 are canceled. Claims 1-12 remain pending, and are being considered on their merits. No claims are withdrawn from consideration at this time. References not included with this Office action can be found in a prior action.
The instant amendments to claims 1 have overcome the 35 U.S.C. § 112(b) and 35 U.S.C. § 102 rejections of record, which are withdrawn. New grounds of rejection are set forth below, necessitated by the instant amendments.
Any other rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
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 1-12 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation of Alfalfa Rhizobia, wherein the broadest reasonable interpretation consistent with the specification is any Rhizobia sp. obtained from Alfalfa (i.e. lucerne, Medicago sativa), and the claim also recites R. meliloti followed in parentheses, which is the narrower statement of the range/limitation and is a specific taxonomic species of Rhizobia sp.. R. meliloti (i.e. Sinorhizobium meliloti) is not the only taxonomic species of Rhizobia sp. as evidenced by Wang et al. (Soil Biology and Biochemistry (available online Nov. 2017), 116, 340-350; Reference U) (see the Abstract). Therefore, the claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In so much that claims 2-12 depend from claim 1 and do not resolve the point of confusion, these claims must be rejected with claim 1 as indefinite.
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 nonobviousness.
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.
Claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Beynon et al. (US 6,548,289).
In view of the indefiniteness rejection above and in the interest of compact prosecution, this rejection addresses the narrower embodiment wherein Rhizobium meliloti is negatively excluded from the scope of the claim 1.
Beynon teaches an Rhizobium meliloti microbe transformed with a plasmid, the
plasmid having a selectable marker gene and a gene construct comprising a gene for an R. meliloti nifA gene and a gene promoter selected from the group consisting of a Bradyrhizobium japonicum nifH activatable gene promoter and a B. japonicum nifD activatable gene promoter the R. meliloti microbe having a phenotype expressed by the selectable marker gene and further having an increased capacity to fix nitrogen and a capacity to increase biomass of a plant inoculated with the R. meliloti (claim 6), reading in-part on claim 1. Beynon teaches Beynon teaches that nitrogen fixing microorganisms such as R. meliloti endogenously comprise the “nif” genes (Col. 1, lines 9-13 and Col. 2, lines 4-26), reading in-part claim 9. In a separate embodiment, Beynon teaches that any Rhizobium or Bradyrhizobium strain is a suitable host, particularly those strains which are effective nodulators such as R. meliloti strain RCR2011, strain SU47 and
strain 41, B. japonicum strain USDA 136; B. japonicum strains USDA 110 and USDA 123 (Col. 12, lines 1-14), reading on claim 1. Beynon teaches a vector comprising the R. meliloti nifA gene, and another vector comprising the R. japonicum nifA gene (Fig. 1 and 2), reading in-part on claim 1. Beynon teaches that R. japonicum is capable of fixing nitrogen in the free-living state (Col. 1, lines 24-29), reading on claim 1.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the R. meliloti strain of Beynon with any of the B. japonicum strains of Beynon. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because and the skilled artisan would have been motivated to do so because Beynon expressly considers the substitution and teaches that any Rhizobium or Bradyrhizobium strain would be predictably advantageous as a suitable host.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Beynon as applied to claim 1 above, and further in view of Cannon et al. (Proc. Natl. Acad. Sci. USA (1977), 74(7), 2963-2967).
The teachings of Beynon are relied upon as set forth above.
Regarding claim 2, Beynon does not teach an exogenous nif cluster obtained from Gammaproteobacteria. This rejection addresses the embodiment of Klebsiella pneumoniae for the Gammaproteobacteria of claim 2.
Cannon teaches Klebsiella pneumoniae comprising cloned fragments from Klebsiella pneumoniae containing the nif gene cluster such as to confer a nitrogen fixing phenotype (Abstract and Table 1, Nif+ phenotypic transformants), anticipating claim 1, the embodiment of Klebsiella pneumoniae for the diazotroph embodiments for claim 2, and claim 9.
It would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the nifA of Beynon with the nif gene cluster of Cannon. A person of ordinary skill in the art would have had a reasonable expectation of success in substituting nifA with nif gene cluster for because they are both explicitly taught as being useful for THE SAME PURPOSE as exogenous genes to confer a nitrogen fixing phenotype on bacterial cells. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 3, 4, 6-8, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Beynon as applied to claim 1 above, and further in view of Temme et al. (PNAS (2012), 109(18), 7085-7090).
The teachings of Beynon are relied upon as set forth above.
Regarding claim 3, Beynon does not teach wherein the exogenous nif cluster is an inducible refactored nif cluster. Regarding claim 4, Beynon does not teach wherein the inducible refactored nif cluster is an inducible refactored Klebsiella nif cluster. Regarding claim 6, Beynon does not teach wherein the exogenous nif cluster comprises 6 nif genes or operons. Regarding claim 7, Beynon does not teach wherein the 6 nif genes or operons are nifHDK(T)Y, nifEN(X), nifJ, nifBQ, nifF, and nifUSVWZM. Regarding claim 8, Beynon does not teach wherein each exogenous nif gene or operon is preceded by a T7 promoter. Regarding claim 10, Beynon does not teach wherein the exogenous nif cluster further comprises a terminator. Regarding claim 11, Beynon does not teach wherein the T7 promoter has a terminator and wherein the terminator is downstream from the T7 promoter.
Temme teaches a refactored nitrogen fixation gene cluster from Klebsiella oxytoca (Abstract). Temme teaches refactored gene clusters are advantageous to remove all native regulation, such as by removing all noncoding DNA, regulatory proteins, and nonessential genes and selecting codons that produce a DNA sequence that is as distant as possible from the WT sequence to remove internal and potentially undiscovered genetic regulation (Abstract; paragraph spanning both columns on p7085; schematic of Fig. 1), reading on claims 3 and 4. Temme teaches inducible and 4 refactored operons comprising nifHDK(T)Y, nifEN(X), nifJ, nifBQ, nifF, and nifUSVWZM, each of the refactored operons being under the control of a T7 promoter and being operable to reduce acetylene as a measurement of nif cluster nitrogenase activity (Fig. 3; p7087, subheading “Complete Refactored Gene Cluster”; subheading “Nitrogenase Activity Assay” spanning p7089-7090), reading on claims 6-8. Temme teaches that the refactored nif cluster is no longer negatively regulated by ammonia (paragraph spanning p7087-7088 and Fig. 5C), reading on claim 7. Temme teaches that the recoded genes are organized into operons and placed under the control of synthetic parts (promoters, ribosome binding sites, and terminators) that are functionally separated by spacer parts (Abstract; Fig. 4), reading on claims 10 and 11.
Regarding claims 3, 4, 6, 7, 10, and 11, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the exogenous nifA of Beynon with refactored nif clusters from Klebsiella oxytoca of Temme. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Beynon and Temme are directed towards exogenous nif. The skilled artisan would have been motivated to do so because Temme teaches that refactored gene clusters are advantageous to remove all native regulation and in this case would be predictably advantageous to remove negative genetic regulation by ammonia, thus improving upon Beynon’s microorganism as a nitrogen-fixer to then lack said negative genetic regulation by ammonia.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Beynon and Temme applied to claims 1 and 11 above, and further in view of Venkateshwaran (Chapter 42 in B. Lugtenberg (ed.), Principles of Plant-Microbe Interactions (2015), p403-410).
The teachings of Beynon and Temme are relied upon as set forth above.
Regarding claim 5, Beynon and Temme do not teach rhizobium strain IRBG74, i.e. Rhizobium sp. strain IRBG74. Regarding claim 12, Beynon and Temme do not teach a refactored nif cluster obtained from rhizobium strain IRBG74, i.e. Rhizobium sp. strain IRBG74.
Venkateshwaran teaches that Rhizobium sp. strain IRBG74 is a nitrogen-fixing symbiont in the Agrobacterium/Rhizobium clade that modulates the aquatic legume Sesbania sp. and can infect rice endophytically, improving plant growth, health, and yield, making it a good model system for determining the mechanisms of Rhizobium-cereal interactions (paragraph starting “Rhizobium sp. strain IRBG74…” on p409), reading on claims 5 and 12. Venkateshwaran teaches that Rhizobium sp. strain IRBG74 genome was known and available at that time (paragraph starting “Rhizobium sp. strain IRBG74…” on p409), reading on claim 12.
Regarding claim 5, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the R. japonicum comprising an exogenous R. meliloti nifA of Beynon with the Rhizobium sp. strain IRBG74 of Venkateshwaran. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Venkateshwaran and Beynon are directed in-part towards nitrogen-fixing microorganisms. The skilled artisan would have been motivated to do so because Venkateshwaran teaches that Rhizobium sp. strain IRBG74 is predictably advantageous as a good model system for determining the mechanisms of Rhizobium-cereal interactions, thus improving upon the microbial composition of Beynon as a model system for studying Rhizobium-cereal interactions.
Regarding claim 12, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the exogenous nifA of Beynon with refactored nif clusters from Rhizobium sp. strain IRBG74 in view of Temme and Venkateshwaran. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Venkateshwaran and Beynon are directed in-part towards nitrogen-fixing microorganisms and Beynon is directed in-part towards exogenous nifA. The skilled artisan would have been motivated to do so because Venkateshwaran teaches that Rhizobium sp. strain IRBG74 is predictably advantageous as a good model system for determining the mechanisms of Rhizobium-cereal interactions, and so the nif clusters of Rhizobium sp. strain IRBG74 would likely be advantageous to improve upon the microbial composition of Beynon as a model system for studying Rhizobium-cereal interactions.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Response to Arguments
Applicant's arguments on pages 4-9 of the reply have been fully considered, but not found persuasive of error for the reasons given below.
On pages 5 of the reply and with respect to the modified 35 U.S.C. § 103 rejection above, Applicant alleges that Beynon does not teach any nif cluster. This is not found persuasive of error because Applicant is relying on an overly narrow interpretation of the scope of the claims that is not the broadest reasonable interpretation. See M.P.E.P. § 2111. In this case and in spite of Applicant’s definition of “cluster” on p25 of the specification, “nif cluster” as claimed does not distinguish between 1) a cluster comprising one or more nif genes, and 2) a cluster comprising one nif gene and one additional (and generic) gene, such as the selectable marker(s) taught by Beynon above.
On pages 5-7 of the reply and with respect to the modified 35 U.S.C. § 103 rejection above, Applicant alleges that cited microorganisms of Beynon are inoperable and are not capable of fixing nitrogen. This is not found persuasive because Beynon expressly teaches that R. japonicum is capable of fixing nitrogen in the free-living state (Col. 1, lines 24-29), reading on claim 1. Applicants arguments regarding Cannon and Nelson are not persuasive in so much that those references are no longer applied to reject the claims at this time.
On pages 7-8 of the reply and with respect to the modified 35 U.S.C. § 103 rejection above, Applicants rely on arguments traversing the above rejection of claims 1 and 9 over Beynon to traverse the rejection of claims 3, 4, 6-8, 10, and 11 further in view of Temme, and to traverse the rejection of claims 5 and 12 further in view of Venkateshwaran. Therefore, the response set forth above to arguments also applies to this rejection.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653