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 Status
Claims 53, 59-66 & 69-70 are under examination on the merits.
Claims 67 & 68 are withdrawn from consideration as being drawn to an invention nonelected without traverse in the response filed 02-06-2025.
Claims 1-52 & 54-58 are cancelled.
Previous 112(d) rejection of claims 57 & 58 is withdrawn in view of Applicant’s claim amendment.
Previous 103 rejection of claims 53 & 59-66 is withdrawn.
Specification
Objections to the specification are withdrawn in view of Applicant’s amendments.
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 53, 59, 61 & 63 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 53 lists a polynucleotide construct comprising various encoded Nif peptides including Nif [F, J, Q, W, X, Y or Z]. Dependent claims 59, 61 & 63 go on to recite fusion protein(s) comprising Nif peptides not previously listed, including Nif [D, K or H]. As written, the relationship is unclear between the groups of Nif subunits separately drawn to in the dependent claim series, nor is it clear what the ultimate structure or form of the claimed fusion protein is. Currently, one would not be able to ascertain the metes and bounds of these claims.
Because of this, claims 53, 59, 61 & 63 are rejected as indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 59, 61 & 63 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
As described above, there is a 112(b) issue of indefiniteness as regards these claims. Because these claims are indefinite and it is unclear how the Nif subunit groupings separately drawn to are related, they are also rendered to be of improper dependent form. As currently written, the subunit groupings of claims 59, 61 & 63 do not appear to be a further limiting subset of those recited in claim 53. Because of this they are rejected.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 53, 59-66 & 69-70 are rejected under 35 U.S.C. 103 as being unpatentable over Donovan [PG Pub US 2016/0304842; Published 10-20-2016] in view of Smanski [Smanski et al. Nature Biotechnology. Volume 32, Number 12, December 2014; Published 11-24-2014].
The claims are drawn to transgenic plant cells expressing one or more Nif fusion polypeptides in the mitochondria wherein the fusion protein comprises a mitochondrial targeting polypeptide (MTP), specific Nif proteins recited including the previously elected NifZ [See Applicant response to restriction requirement, 02-06-2025], and various length linker sequences impacting function.
Donovan teaches generation of fusion proteins comprising the various Nif polypeptides in clusters, including those combining the various claimed NifK, NifD, NifH [p.1, par.0008 & p.7, par.0096]. They indicate combinations of Nif subunits and other elements can be made into fusion clusters including varied structural components that alter protein activity [par.0099].
They teach that their synthesis of Nif gene clusters could be used to transfer nitrogenase activity to mitochondria in higher organisms via use of MTPs for expression of dinitrogenase reductase or dinitrogenase (i.e. making transgenic plants) [par.0080, 0105]. They teach which Nif enzymes are dinitrogenase reductase or dinitrogenase and list relevant associated enzymes [p.9, par.112; p.10, Tables 1 & 2].
They teach MTPs which can be used in making such constructs [p.14, Tables 4 & 5]. They teach that inclusion of various length spacer sequences of nucleotides or amino acids can be used with mitochondrial targeting components to regulate activity, and that additions in the range of 2-8 additional residues from the end of the MTP can modify enzyme activity [0142]. This is within the 5-11 amino acid range utilized as a spacer or linker, and currently claimed by Applicant.
They teach plants in which such constructs can be expressed, including wheat [p.7, par.101]. They teach via demonstration the expression of said constructs in tobacco plants [p.20, Example 12; p.11, par.123].
Donovan does not teach methods generating fusion proteins involving NifZ.
However, Smanski teaches it would be obvious for one skilled in the art to try such combinations. In addition to the Nif subunits described by Donovan, Smanski includes NifZ and other combinatorial variations of the nitrogenase complex [p.1242, col.2, par.2]. Further, Smanski teaches how hundreds of such constructs can be created and tested, directly stating that equivalent functionality can be achieved by different constructs [p.1245, col.1, par.3 & p.1248, col.1, par.4].
They teach that similar chimeric constructs can have varied activity, wherein some had different activity based solely on size of bind sites and/or spacer length [p.1243, par.2]. Smanski teaches that one should make numerous variants of potential nitrogenase constructs and vary structural elements as well as Nif and MTP subcomponents, including NifZ, and then test or optimize them for expression within their target system [p.1248, par.1].
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply methods of transgenic nitrogenases taught by Donovan utilizing routine optimization inclusive of NifZ, as described in Smanski. One of ordinary skill in the art would have been motivated to do so because they would plainly see the advantages of constructing of a fusion peptide having one or more Nif genes and a transport protein, as described by Donovan, to engineer components of the nitrogenase system into plant mitochondria. It would be obvious to try various combinations of known Nif proteins or potential subunit components relevant to such a fusion polypeptide.
This would include NifD, NifH, NifK and any supplemental Nif subcomponents that may enable or enhance nitrogenase activity, as outlined in Donovan’s 2016 patent application. It would include the relevant promoters or structural features required of a construct intended to be expressed in a plant. The research report of Smanski would provide further specific teachings on how to optimize such combinations and additional nitrogenase components to be considered, such as NifZ.
Regarding amended claim 53 and newly added claim 70, drawn to specific linker sequence sizing reciting a range of 5-11 amino acids; the optimization of linker sequences, or other common structural features of transgenic constructs, is routine. Testing of different size linking and/or spacer sequences, or even that of swapping promoters or allelic subunits of a fusion protein in order to determine an optimal construct is standard practice in the art. One would be motivated to experimentally attempt numerous fusion combinations to determine which varied form gave optimal results. Such routine testing of construct libraries is informative, but not inventive.
Moreover, all components limited to in the claims of the instant application (NifD, NifH, NifK, NifZ, MTPs, structural elements) are collectively described by Donovan and/or Smanski in creation of transgenic nitrogenase constructs. Smanski clearly teaches such constructs would require routine optimization based on specific structural element changes and provides the relevant methods.
One of ordinary skill in the art would have been motivated to perform such optimization work because the value of transgenic nitrogen fixation in crop plants would be groundbreaking to agriculture and address a multitude of economic and environmental concerns surrounding the use of synthetic nitrogen fertilizers, as indicated by both Donovan [par.0006] and Smanski [p.1241, col.2, par.2].
Because of this, claims 53 & 59-64 are obvious and are rejected.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEITH R WILLIAMS whose telephone number is (571)272-3911. The examiner can normally be reached Mon - Fri, 9:30 - 5:30 EST.
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/KEITH R. WILLIAMS/Examiner, Art Unit 1663
/Anne Kubelik/Primary Examiner, Art Unit 1663