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 .
Applicant’s Reply, filed on 09/10/2025 is hereby acknowledged.
Applicant’s arguments, when taken together with the claim amendments have overcome the rejection of the claims under 35 USC 103 as being obvious over Bidney et al in view of Zhang.
Claims 24-25, and 29-36 are allowed.
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.
Claims 37and 41-46 remain rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 37 recites a wheat plant having restored male-fertility the wheat plant comprising at least one altered target site that confers modified male-fertility to the wheat plant, however the claim also recites “the altered target site affects the expression level of the one or more endogenousMS45 polynucleotides so that the wheat plant is male sterile”, and then subsequently recites comprising one or more polynucleotides encoding the above gene that confers male fertility to the plant. This is confusing language and it is unclear what the metes and bounds of the claim are. Is the claim requiring both mutated and normal copies of the same gene? There is no indication how this would result in make fertile plant based on the claim construction as currently written. The claim appears to be intended to be a product by process claim in which male fertility is restored by modification. It is not currently constructed such that this is the broadest reasonably interpretation and it is respectfully pointed out that if this were the intention of the claim that a CRISPR-Cas modified polynucleotide that is modified to encode the original natural gene that is male fertile, that in addition to reading on prior art wheat plants that have no modification whatsoever, there would also be a consideration of 101 issues for such a product claim. However, in it’s current form it appears that the wheat plant must comprise some type of additional sequence. In the instant case, however it is unclear what the endogenous gene is supposed to be and what the additional genes are supposed to be. It appears as currently written that the endogenous gene would be a restored male-fertile gene and that the additional sequences would also encode male fertility. However, it is also possible that the endogenous gene is a male-sterile gene and that the additional polynucleotides are restorer genes, however it is then unclear what the modification of the endogenous gene is in such a scenario.
Claims 41-46 depend from claim 37 and are rejected on the same basis.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/BRENT T PAGE/Primary Examiner, Art Unit 1663