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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) is acknowledged. As such, the effective filing date of Claims 1, 3-4, 6-7, 9-11, 13, 15, 17, 19-20, 22, 24, 27-29, 31-32, and 34 is 06/22/2020.
Election/Restrictions
Applicant’s election of SEQ ID NO: 12, corresponding to SEQ ID NO: 147, in the reply filed on 04/06/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of the Claims
Amendments dated 07/25/2025 have been entered.
Claims 1, 3-4, 6-7, 9-11, 13, 15, 17, 19-20, 22, 24, 27-29, 31-32, and 34 are pending.
Claims 1, 3-4, 6-7, 9-11, 13, 15, 17, 19-20, 22, 24, 27-29, 31-32, and 34 are examined herein.
All objections to the specification have been withdrawn in view of Applicant’s amendments to the specification and abstract dated 07/25/2025.
The objections to Claims 2, 4, 13, 19, and 32 are withdrawn in view of Applicant’s amendments to the claims dated 07/25/2025.
The rejections to Claims 3-4, 6-7, 9-11, 13, 15, 17, 19-20, 22, 24, 27-29, 31-32, and 34 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are withdrawn in view of Applicant’s amendments to the claims.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1, lines 2-3 should be amended to recite “…wherein the nrp1 protein comprises…” rather than “…wherein the npr1 comprises…”
In Claim 7, the term “TBF 1” should be amended to recite “TBF1” to remain consistent with the recitation in Claims 4 and 6.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
---This is a new rejection from those set forth in the Office Action dated 02/25/2025 made in view of further examination of the claims, which reopens prosecution.---
Claim 31 is 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 31 recites the broad recitation “high temperature”, and the claim also recites “heat shock which is the narrower statement of the range/limitation. Claim 31 also recites the broad recitation “low temperature”, and the claim also recites “cold shock” in parentheticals which is the narrower statement of the range/limitation. 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.
Claim Rejections - 35 USC § 112
Written Description
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.
---These are new rejections from those set forth in the Office Action dated 02/25/2025 made in view of Applicant’s amendments to the claims dated 07/25/2026. Applicant’s Remarks dated 07/25/2025 have been acknowledged and reviewed, but are deemed inapposite to the new rejections.---
Claims 1, 3-4, 6-7, 9-11, 13, 15, 17, 19, 22, 24, 27-29, 31-32, and 34 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 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 Federal Circuit has clarified the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or]chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material". Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the species of the claimed genus, and that one of skill in the art should be able to "visualize or recognize the identity of the members of the genus". Id.
The claims are broadly directed to a nucleic acid encoding a variant Nonexpressor of Pathogenesis-Related Genes 1 (npr1) protein, wherein the npr1 comprises: a protein having at least 90% identity to a protein comprising the amino acid sequence of any of SEQ ID NO: 1-12 and 30-34, wherein the protein comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, plants or plant cell comprising the mutated npr1 protein, and methods of increasing stress tolerance in a plant, comprising expressing in the plant the mutated npr1 protein.
Applicant describes:
A nonmutated NPR1 from Arabidopsis thaliana that contains three redox-sensitive intrinsically disordered regions (RDR) located at amino acids 140-160, 368-404, and 510-539 relative to SEQ ID NO: 1 (paragraph 0052)
Methods of identifying homologs and/or orthologues of the A. thaliana NPR1 RDR2 (paragraph 0053)
Nonmutated orthologues of SEQ ID NO: 1 denoted as SEQ ID NOs: 2-12 and 30-34 (paragraph 0052)
Mutated nucleic acid sequences (cysteine residue substitutions) encoding NPR1 proteins denoted as SEQ ID NOs: 134-160 (paragraph 0066)
Mutations to A. thaliana NPR1 proteins performed in the instant invention and known in the art at the time of filing (paragraph 00153; Table 4)
Polypeptide sequences having at least 90% sequence identity relative to SEQ ID NO: 12 (elected species) encompass variant npr1 protein sequences having approximately 58 insertions, deletions, or substitutions relative to the 583 amino acid residues of SEQ ID NO: 12. Polypeptides with 58 amino acid substitutions relative to SEQ ID NO: 12 encompass approximately 1958(5.80E80) unique variant npr1 protein sequences, of which an adequate number would need to be provided by the Applicant. Applicant fails to describe which amino acids of SEQ ID NO: 12 can be altered and/or duplicated, and to which amino acids, and also which amino acids must not be changed, to maintain the functional activity of the variant npr1 protein when it comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1. Applicant fails to describe which amino acids can be deleted and which region of the sequence can tolerate insertions and still have any function as a variant npr1 protein when it comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1.
As currently amended, it should be noted by Applicant that the claimed sequence variance relative to instant SEQ ID NO: 12 encompasses amino acid residue substitutions that would render the rdr2 region of the variant npr1 protein (the region corresponding to residues 386-404 of SEQ ID NO: 1) free of any cysteines to be mutated as required by the instant claims. It is unclear to one of ordinary skill in the art how sequence variants of SEQ ID NO: 12, comprising zero cysteines in the region corresponding to residues 386-404 of SEQ ID NO: 1 would maintain the functional activity of the variant npr1 protein when it comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1.
As currently amended, it should be noted by Applicant that the claimed sequence variance relative to instant SEQ ID NO: 12 encompasses amino acid residue substitutions that would render the entire rdr2 region of the variant npr1 protein (the region corresponding to residues 386-404 of SEQ ID NO: 1) to only contain cysteine residues, that could all be subsequently mutated as recited by the instant claims. It is unclear to one of ordinary skill in the art how sequence variants of SEQ ID NO: 12, comprising only cysteines in the region corresponding to residues 386-404 of SEQ ID NO: 1 would maintain the functional activity of the variant npr1 protein when it comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, as the scope of claim 1 includes an embodiment of the invention where all of the cysteines in the proposed sequence variant would be subject to mutation.
Other than SEQ ID NO: 147, which is the mutated variant of SEQ ID NO: 12 comprising a single cysteine to alanine substitution at a position corresponding to residue 394 of SEQ ID NO: 1, Applicant does not describe any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12. Applicant does not describe any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12, comprising mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1. Applicant does not describe any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12, comprising mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, much less wherein the variant npr1 protein has increased interaction with CUL3 compared to a wild-type NPR1 in the absence of salicylic acid. Applicant does not teach any plant or plant cells, from any diverse source, comprising any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12. Applicant does not teach any plant or plant cells, from any diverse source, comprising any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12, comprising mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1. Applicant does not describe any method of increasing stress tolerance in any plant known in the art comprising expressing any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12. Applicant does not describe any method of increasing stress tolerance in any plant known in the art, comprising expressing any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12, comprising mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1. Applicant does not describe any method of increasing stress tolerance in any plant known in the art, comprising expressing any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12, comprising mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, wherein the variant npr1 proteins of SEQ ID NO: 12 increases stress tolerance of any plant known in the art, much less any know biotic or abiotic stress known in the art. Applicant does not describe any method of increasing stress tolerance in any plant known in the art, comprising expressing any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12, comprising mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, wherein the variant npr1 proteins of SEQ ID NO: 12 increases stress tolerance of any plant known in the art, much less increased pathogen resistance, increased heat shock tolerance, cold shock tolerance, oxidative stress tolerance, or DNA damage tolerance. Applicant does not describe any method of increasing stress tolerance in any plant known in the art, comprising expressing any variant npr1 proteins with 90-99% sequence identity relative to SEQ ID NO: 12, comprising mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, wherein the mutated sequence variant of SEQ ID NO: 12 increases stress tolerance of any plant known in the art, much less decreasing programmed cell death, decreasing ETI-induced cell death, increased NPR1 condensates, or degradation of EDS1 and WRKY transcription factors.
The other polypeptides disclosed in the specification have less than 79.8% sequence identity relative to instant SEQ ID NO: 12.
Describing the exemplified species of amino acid substitutions in variant npr1 protein comprising SEQ ID NO: 12 is unpredictable. While it is known that many amino acid substitutions, additions or deletions are generally possible in any given protein, the positions within the protein’s sequence where such amino acid changes can be made with a reasonable expectation of success (without altering protein function) are limited. Certain positions in the sequence are critical to the protein’s structure/function relationship, for example various sites or regions directly involved in binding, activity, and in providing the correct three-dimensional spatial orientation of binding and active sites. These regions can tolerate only relatively conservative substitutions or no substitutions at all. See Keskin et al., 2004, Protein Science 13: 1043-1055, who teach that proteins with similar structure may have different functions (Abstract; pages 1043-1044). See also Guo et al., 2004, Proceedings of the National Academy of Sciences USA 101: 9205-9210, who teach that there is a probability factor of 34% that a random amino acid replacement in a given protein will lead to its inactivation (Abstract; page 9206; Table 1). In the instant case, such a probability factor will be much higher as the claims encompass more than a single amino acid change in the protein set forth in SEQ ID NO. 12. Furthermore, Thornton et al., 2000, Nature Structural Biology, structural genomic supplement, November 2000: 991-994, teach that structural data may carry information about the biochemical function of a protein, while its biological role in the cell or organism is much more complex and additional experimentation is needed to elucidate actual biological function (page 992, left column, paragraph 2).
Based on the disclosure of the instant specification and teachings in the prior art, one of ordinary skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features that identify members of the genus of variant npr1 proteins, and because the genus is vast and highly diverse, SEQ ID NO: 12 and 147 are insufficient to describe the claimed genus of variant npr1 proteins having at least 90% sequence identity relative to SEQ ID NO: 12.
The number of species describe by Applicant are insufficient to describe the recited genus by virtue of example, given the vast size of the recited genus and the lack of written description in the instant specification with regard to the structural and functional characteristics of the claimed compositions.
Hence, Applicant has not, in fact, described the claimed compositions within the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
Claim Rejections - 35 USC § 112
Scope of Enablement
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.
Claims 1, 3-4, 6-7, 9-11, 13, 15, 17, 19, 22, 24, 27-29, 31-32, and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a nucleic acid encoding a variant npr1 protein, wherein the npr1 comprises a protein having at least 99% identity to a protein comprising the amino acid sequence of SEQ ID NO: 12, wherein the protein comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1 or a nucleic acid encoding a variant npr1 protein comprising SEQ ID NO: 147; a plant or plant cell comprising, a nucleic acid encoding a variant npr1 protein, wherein the npr1 comprises a protein having at least 99% identity to a protein comprising the amino acid sequence of SEQ ID NO: 12, wherein the protein comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1 or a nucleic acid encoding a variant npr1 protein comprising SEQ ID NO: 147, and a method of increasing stress tolerance in a plant comprising expressing in a plant a nucleic acid encoding a variant npr1 protein, wherein the npr1 comprises a protein having at least 99% identity to a protein comprising the amino acid sequence of SEQ ID NO: 12, wherein the protein comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1 or a nucleic acid encoding a variant npr1 protein comprising SEQ ID NO: 147, does not reasonably provide enablement for a nucleic acid, a plant or plant cell, a method of increasing stress tolerance of a plant, comprising a variant npr1 protein, wherein the npr1 comprises: a protein having at least 90% identity to a protein comprising the amino acid sequence of SEQ ID NO: 12, wherein the protein comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
In re Wands, 858 F.2d 731 (Fed. Cir. 1988) lists the following eight factors for determining whether undue experimentation would be required to practice an invention: (1) quantity of experimentation necessary; (2) amount of direction or guidance supplied; (3) presence or absence of working examples; (4) nature of the invention; (5) state of the prior art; (6) relative skill of those in the art; (7) predictability or unpredictability or the prior art; (8) breadth of the claims.
The claims are broadly directed to a nucleic acid encoding a variant Nonexpressor of Pathogenesis-Related Genes 1 (npr1) protein, wherein the npr1 comprises: a protein having at least 90% identity to a protein comprising the amino acid sequence of any of SEQ ID NO: 1-12 and 30-34, wherein the protein comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, plants or plant cell comprising the mutated npr1 protein, and methods of increasing stress tolerance in a plant, comprising expressing in the plant the mutated npr1 protein.
Applicant teaches:
A nonmutated NPR1 from Arabidopsis thaliana that contains three redox-sensitive intrinsically disordered regions (RDR) located at amino acids 140-160, 368-404, and 510-539 relative to SEQ ID NO: 1 (paragraph 0052)
Methods of identifying homologs and/or orthologues of the A. thaliana NPR1 RDR2 (paragraph 0053)
Nonmutated orthologues of SEQ ID NO: 1 denoted as SEQ ID NOs: 2-12 and 30-34 (paragraph 0052)
Mutated nucleic acid sequences (cysteine residue substitutions) encoding NPR1 proteins denoted as SEQ ID NOs: 134-160 (paragraph 0066)
Mutations to A. thaliana NPR1 proteins performed in the instant invention and known in the art at the time of filing (paragraph 00153; Table 4)
Despite having potentially identifying information on npr1 sequences, Applicant has not provided sufficient enabling guidance regarding the predictability of variant npr1 proteins having at least 90% sequence identity relative to instant SEQ ID NO: 12.
Polypeptide sequences having at least 90% sequence identity relative to SEQ ID NO: 12 (elected species) encompass variant npr1 protein sequences having approximately 58 insertions, deletions, or substitutions relative to the 583 amino acid residues of SEQ ID NO: 12. Polypeptides with 58 amino acid substitutions relative to SEQ ID NO: 12 encompass approximately 1958(5.80E80) unique variant npr1 protein sequences. Applicant fails to teach which amino acids of SEQ ID NO: 12 can be altered and/or duplicated, and to which amino acids, and also which amino acids must not be changed, to maintain the functional activity of the variant npr1 protein when it comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1. Applicant fails to teach which amino acids can be deleted and which region of the sequence can tolerate insertions and still have any function as a variant npr1 protein when it comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1.
The amount of substitutions recited in the scope of the claims includes a vast number of unique polypeptides that would require undue experimentation to determine their use as a variant nonexpressor of pathogenesis-related genes 1 protein, in the nucleic acid, plant and plant cell, and methods of the claimed invention. As such, even though the claimed sequences are limited to having at least 90% sequence identity relative to instant SEQ ID NO: 12, the claimed sequence identity at the amino acid level is not adequate to predict the function of the variant npr1 protein nor is it adequate to determine the use of the variant npr1 protein in the methods, plant and plant cell, and nucleic acid of the instant invention.
As currently amended, it should be noted by Applicant that the claimed sequence variance relative to instant SEQ ID NO: 12 encompasses amino acid residue substitutions that would render the rdr2 region of the variant npr1 protein (the region corresponding to residues 386-404 of SEQ ID NO: 1) free of any cysteines to be mutated as required by the instant claims. It is unclear to one of ordinary skill in the art how sequence variants of SEQ ID NO: 12, comprising zero cysteines in the region corresponding to residues 386-404 of SEQ ID NO: 1 would maintain the functional activity of the variant npr1 protein when it comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, and therefore it would require undue experimentation by one of ordinary skill in the art to determine their use as a variant nonexpressor of pathogenesis-related genes 1 protein the methods, plant and plant cell, and nucleic acid of the instant invention.
As currently amended, it should be noted by Applicant that the claimed sequence variance relative to instant SEQ ID NO: 12 encompasses amino acid residue substitutions that would render the entire rdr2 region of the variant npr1 protein (the region corresponding to residues 386-404 of SEQ ID NO: 1) to only contain cysteine residues, that could all be subsequently mutated as recited by the instant claims. It is unclear to one of ordinary skill in the art how sequence variants of SEQ ID NO: 12, comprising only cysteines in the region corresponding to residues 386-404 of SEQ ID NO: 1 would maintain the functional activity of the variant npr1 protein when it comprises mutations at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, as the scope of claim 1 includes an embodiment of the invention where all of the cysteines in the proposed sequence variant would be subject to mutation, and therefore it would require undue experimentation by one of ordinary skill in the art to determine their use as a variant nonexpressor of pathogenesis-related genes 1 protein the methods, plant and plant cell, and nucleic acid of the instant invention.
Thus, from the guidance of the instant specification, it would appear that one of ordinary skill in the art would need to make the variant npr1 protein comprising the claimed sequence variants of SEQ ID NO: 12 by making random amino acid deletions, substitutions, and insertions which would be unpredictable.
Teaching the exemplified species of amino acid substitutions in variant npr1 protein comprising SEQ ID NO: 12 is unpredictable. While it is known that many amino acid substitutions, additions or deletions are generally possible in any given protein, the positions within the protein’s sequence where such amino acid changes can be made with a reasonable expectation of success (without altering protein function) are limited. Certain positions in the sequence are critical to the protein’s structure/function relationship, for example various sites or regions directly involved in binding, activity, and in providing the correct three-dimensional spatial orientation of binding and active sites. These regions can tolerate only relatively conservative substitutions or no substitutions at all. See Keskin et al., 2004, Protein Science 13: 1043-1055, who teach that proteins with similar structure may have different functions (Abstract; pages 1043-1044). See also Guo et al., 2004, Proceedings of the National Academy of Sciences USA 101: 9205-9210, who teach that there is a probability factor of 34% that a random amino acid replacement in a given protein will lead to its inactivation (Abstract; page 9206; Table 1). In the instant case, such a probability factor will be much higher as the claims encompass more than a single amino acid change in the protein set forth in SEQ ID NO. 12. Furthermore, Thornton et al., 2000, Nature Structural Biology, structural genomic supplement, November 2000: 991-994, teach that structural data may carry information about the biochemical function of a protein, while its biological role in the cell or organism is much more complex and additional experimentation is needed to elucidate actual biological function (page 992, left column, paragraph 2).
Accordingly, the instant specification does not provide a representative number of species to adequately enable the use of the broadly claimed genus of all possible claimed polypeptides containing the variant npr1 sequences within the given limitation of at least 90% sequence identity relative to SEQ ID NO: 12. The instant specification does not provide adequate guidance with respect to expression, biological activity, or modifying the functional activity of the claimed genera of polypeptides.
In the absence of guidance from either the instant disclosure or the art, and the unpredictability discussed above, it would require undue trial and error experimentation for a skilled artisan to use the broadly claimed genus of variant npr1 proteins comprising a protein sequence having at least 90% sequence identity relative to SEQ ID NO: 12, much less comprising a protein sequence having at least 90% sequence identity relative to SEQ ID NO: 12, wherein the protein comprises mutation at one or more cysteines located in a region corresponding to residues 368-404 of SEQ ID NO: 1, with no reasonable expectation of success. For this reason, the specification does not teach a person of ordinary skill in the art how to use the subject matter within the full scope of the claims.
Closest Prior Art
The claims appear to be free of the prior art in regards to SEQ ID NOs: 12 and 147. The closest prior art can be found in GenBank Accession No. ACG45791.1 (dated 12/10/2008) which teaches a Zea mays regulatory protein NPR1 with 82% sequence identity relative to instant SEQ ID NO: 12 and 81.8% sequence identity relative to instant SEQ ID NO: 147. While GenBank Accession No. ACG45791.1 has 100% sequence identity relative to SEQ ID NO: 12 (See sequence alignment between SEQ ID NO: 12 and below GenBank Accession No. ACG45791.1) across the amino acid sequences corresponding to residues 368-404 of SEQ ID NO: 1, neither the corresponding literature associated with the GenBank accession, nor the prior art teach any rationale or motivation to mutate the existing cysteines in that region of GenBank Accession No. ACG45791.1 (of which one is present), much less the mutation of the single cysteine in the sequence and further integration of the amino acid sequence into a plant or plant cell, or methods of increasing stress tolerance in plant expressing a mutated version of GenBank Accession No. ACG45791.1.
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Conclusion
No claims are allowed.
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and being limited to the currently examined elected species (SEQ ID NO: 147).
This action is NON-FINAL.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY L. MCWILLIAMS whose telephone number is (703)756-4704. The examiner can normally be reached M-F 08:00-17:30.
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/KELSEY L MCWILLIAMS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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