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 .
Claims 1, 5-6, 9, 12, 15, 19-21, 25, 28, 35, 38, 41, 44-47, and 51 are pending and examined on their merit herein.
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 9, 19-20, 21, 25, 35, 41, 44-45, 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 9 is rejected as being indefinite for the recitation of “preferably no more than the N-terminal 38 amino acids”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). Use of a narrow numerical range that falls within a broader range in the same claim may render the claim indefinite when the boundaries of the claim are not discernible (MPEP 2173.05(c)). In the instant case, the narrower range of “no more than the N-terminal 38 amino acids” and the broader range of “no more than the N-terminal 42 amino acids” are stated in a single claim, while the narrower range is expressed as a preference which leads to confusion over the intended scope of the claim. It is not clear whether the claimed narrower range is a limitation. Therefore, the metes and bounds are not clear.
Similarly, claims 15, 21, 25, 35, 41 and 46 are also rejected for reciting limitations as preference in view of the otherwise broader scopes of the claims.
Corresponding dependent claims are included in this rejection for their failure to correct the deficiency above of the base claims.
Claims 20, 44, and 45 are rejected as being indefinite for the recitation of “significant proportion”. The term “significant proportion” is a relative term which renders the claim indefinite. The term “significant proportion” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much is a significant portion.
Claims 19-20 and 44-45 each recites the limitation "the pathogen effector" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 19-20 and 44-45 are also rejected as being indefinite for the recitation of “the mutation” being “substitution of all or a proportion of the N-terminal portion of the HD1 domain (or RNBS-C motif) for a corresponding portion in a second NLR protein, wherein the second NLR protein is not inhibited by the pathogen effector”. On one hand, “the mutation” is interpreted as a mutation in a “first” NLR protein of the base claims (in which the “second NLR” has not been brought up). However, since the swapping is taken place in the second NLR and resulting in an altered second NLR, it is not clear if “the mutation” is referring a different mutation (which would be subject for rejections on the ground of lacking antecedence) or not. Therefore, the claims are indefinite.
Claims 15 and 41 are rejected as being indefinite since it is not clear what the amino acid numbering is based on. For example, SEQ ID NO: 47 does not have a D at position 317.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 9, 12, 15, 28, 35, 38, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harris (Proceedings of the National Academy of Sciences 110.52 (2013): 21189-21194.).
Claim 1 is drawn to a genetically altered plant that comprises at least one mutation in a nucleic acid sequence encoding a nucleotide-binding domain and leucine-rich repeat-containing (NLR) protein, wherein the NLR protein comprises a HD1 domain, and wherein the at least one mutation is a mutation of one or more amino acids in an N-terminal portion of the HD1 domain.
Claim 5 is drawn to a genetically altered plant that expresses a nucleic acid construct comprising a nucleic acid sequence encoding a mutated NLR protein, wherein the NLR protein comprises a HD1 domain, and wherein the NLR protein comprises a mutation of one or more amino acids in an N-terminal portion of the HD1 domain.
Harris discloses nucleotide sequences, constructs, encoding mutated potato NB-LRR (i.e., NLR) protein Rx, and genetically altered Nicotiana tabacum plant that comprises/expresses such (see, Abstract, Results, and Fig. 1, e.g.).
Harris discloses that at least one of the mutations is a missense mutation resulted in a M293L substitution in the Rx protein, which is located in the RNBS-C motif. As defined in the instant Specification, this position is in the N-terminal portion of the HD1 domain.
Regarding claim 9, it is noted that the RNBS-C motif as defined in the instant Specification, is in the N-terminal 42 aa of the HD1 domain.
Regarding claim 12, it is noted that the SEQ ID NO: 3, 6, …… are recited as options.
Regarding claim 15, Harris discloses M293L as a substitution.
Regarding claims 28, 35, 38, Harris discloses transforming plants with the mutant Rx construct RxS1*M1 which has the M293L substitution and resulting resistance to PopMV (Abstract, and Results at p21192, left, para. 3; and Fig. 5). Regarding claim 41, it is noted that other than requiring the mutation to a substitution, the rest of the limitations are optional.
Therefore, claims 1, 5, 9, 12, 15, 28, 35, 38, and 41 are anticipated by Harris.
Claims 1, 5-6, 9, 12, 15, 20, 25, 28, 35, 38, 41, 46, and 51, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sueldo (New Phytologist 208.1 (2015): 210-223).
Sueldo discloses site-directed mutagenesis of tomato (Solanum lycopersicum) NRC1, which is an NB-LRR protein containing an “HD1” domain as described in the instant application. Sueldo discloses substitution mutations, such as E318G (“Mutant F), and G341R (“Mutant C”) (see Supplemental Fig. S2). As defined in the instant Specification, G341 is located in the “N-terminal portion” of the “HD-1 domain” (according to Fig. 1 and Fig. 3, and p. 59 regarding SlNRC1); and E318 is more than certainly in the “N-terminal portion” of the “HD-1 domain”.
Regarding claims 9, 12, 20, 35, 38, the mutations above are in the “N-terminal” 42, or 38 aa of the HD domain, or in the case of E318, in the RNBS-C motif, as defined in the instant Specification.
Sueldo discloses Nicotiana tabacum L. cv SR1 plants genetically altered to express the mutant proteins, which is a solanaceous plant, and a classic cigar cultivar utilized in the cultivation of cigars, therefore a crop plant.
Regarding claim 46, tomato NRC1 is a homologue of the listed sequences.
Therefore, claims 1, 5-6, 9, 12, 15, 20, 25, 28, 35, 38, 41, 46, and 51, are anticipated by the prior art.
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 19-20, 44-45 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Harris (Proceedings of the National Academy of Sciences 110.52 (2013): 21189-21194.) as applied to claims 1, 9, and 28 as discussed above, in view of Slootweg (Plant physiology 162.3 (2013): 1510-1528).
Claims 19-20, 44-45 are drawn to the plant or method, wherein the mutation is a substitution of all or a significant proportion of the N-terminal portion of the HD1 domain for a corresponding portion of the HD 1 domain in a second NLR protein, wherein the second NLR protein is not inhibited by the pathogen effector.
For the purpose of examination, the claims are interpreted as swapping the mutated NLR protein (a first NLR) with the corresponding portion of the second NLR.
As discussed above, Harris teaches a mutation in the potato Rx1 NLR protein that reads on the limitation set forth in the base claims. Harris does not teach the domain swapping or resistance to potato cyst nematode.
Slootweg teaches structural determinants governing the interaction between the NB-ARC and LRR in the highly homologous plant immune receptors Gpa2 and Rx1, which recognize the potato cyst nematode Globodera pallida and Potato virus X, respectively. (Abstract)
Slootweg teaches swapping portions of Gpa2 with Rx1, e.g., see Fig. 1A. In at least constructs 9, 10, etc., the portion of Gpa2 is substituted with the corresponding portion of Rx1 comprising the equivalent of HD1 domain, and show enhanced resistance.
As Harris teaches the Rx1 mutant comprising the M293L substitution has enhanced disease resistance, it would have been prima facie obvious for a person having ordinary skills in the art to swap the Rx1 mutant comprising the M293L with Gpa2 to further enhance the resistance activity in Gpa2 (i.e., the second NLR protein), therefore increase Gpa’s ability to resistant to potato cyst nematode.
Therefore, the claimed invention as a whole is prima facir obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663
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