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 .
Status of the Claims
The amendments and arguments filed 08June2026 are acknowledged and have been fully considered. Claims 1-37 were previously canceled, claims 39 and 46-47 are now canceled. Claims 38, 40-45, 48-57 are pending and examined on the merits herein. Claims 38, 51, and 56 are currently amended. Claims 40-45, 48-50, 52-55, and 57 were previously presented.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 62698363 filed 16July2018], 35 U.S.C. 365(c) [national stage entry of PCT/US2019/041993 filed 16July2019], and 35 U.S.C. 121 [divisional of 17250407 (now US Pat. NO. 12065657) filed 18January2021] is acknowledged. Claims 38, 40-45, 48-57 maintain an effective filing date of 16July2018.
Withdrawn Objections and/or Rejections
Objections and/or rejections made of record in the nonfinal office action dated 09March2026 which are not otherwise addressed herein are withdrawn. In particular:
RE ¶ 5: The indefiniteness rejection regarding “about” is withdrawn in view of the claim amendments (removing “about” from claim 56);
RE ¶ 6: The Subject Matter Eligibility rejection is withdrawn in view of the amendment to the claims (now specifying that the diploid potato plant/part is Solanum tuberosum);
RE ¶ 7: The anticipation rejection over RU2505957 is withdrawn in view of the amendments to the claims (adding the sequence structures of claim 39 up into claim 38);
RE ¶ 9: The anticipation rejection over MATTON et al. is withdrawn in view of the amendments to the claims (now specifying that the diploid potato plant/part is Solanum tuberosum—please note that claim 38 requires the S-RNAse being mutated is endogenous and MATTON et al. regards Solanum chacoense).
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.
Claims 38, 42-43, 48 REMAIN rejected and claims 40-41 and 49-50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by The SAES-422 Multistate Research Activity Accomplishments Report dated 13June2017, 7 total pages (summarizing the discussion had during an annual meeting that took place 05December2016 and 06December2016; hereinafter the “2017 Report”; of record IDS 10July2024).
As amended 08June2026, claim 38 is now amended to say that the plant is S. tuberosum and that the endogenous S-RNAse gene being mutated comprises a sequence that is at least 95% identical to SEQ ID NO: 1, 2, or 3.
The Report provides the following (see page 3 of 7):
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The 2017 Report teaches a diploid potato plant referred to as “X914-10” edited using CRISPR-Cas to have a knockout mutation within its S-RNAse gene. As evidenced by this specification, “X914-10” plants are hybrids with a S. chacoense and S. tuberosum pedigree.1
The Office previously stated that The 2017 Report does not teach the sequence features now recited at claim 38, but, after conducting a further search of the art and re-reading the specification, the Office believes that these sequence features are inherent to the 2017 Report because the specification states that S-RNAses were obtained from “[t]he diploid self-incompatible lines DRH-195, DRH-310, and MSX914-10” and used to generate S-RNAse knock out lines (see copied text below).2
Absent clarifying information from Applicant, The 2017 Report is believed to anticipate these claims.
The 2017 report does not appear to teach the mutant S-RNAse sequence structures of claims 44-45 because it says that the obtained events “will be confirmed for SRNAse-like gene knockdown”, suggesting that the presence of knockdown/knock out mutations had not yet been done at the time of publication (hence, claims 44-45 are not rejected here) and the 2017 report does not appear to teach breeding methods (hence, claims 51-57 are not rejected here).
Applicant should please correct the Office if SEQ ID NOs: 1, 2, and 3 are not inherently taught by The 2017 Report (Applicant is in the best place to know since The 2017 Report appears to be Applicant’s own work via inventor F. Enciso-Rodriquez of the University of Michigan). To that end, Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001).
For the sake of a clear record, this rejection contradicts certain statements made within the nonfinal 09March2026 because the nonfinal did not mention inherency.
Absent an explanation from Applicant explaining why The 2017 Report does not teach (including inherently) the structures of these rejected product claims, Applicant may wish to consider (1) amending 38, 40-43, 48-50 so that they incorporate the mutation particulars set forth in claims 44 and/or 45 or (2) amending claim 38 to that the claimed S. tuberosum plant is “selected for having an endogenous S-RNAse gene comprising a nucleotide sequence with at least 95% sequence identity to SEQ ID NO: 1, 2, or 3” [← please note that some interpret the “selected for” language of suggestion (2) as indefinite because it suggests a method step in a product claim; but this Examiner has previously utilized such language for introducing possession of an inherent feature and, therefore, to overcome inherent anticipation (see claim 13 within application 17220669 (now claim 7 of US Pat. No. 11773405)]. Of course, Applicant could do both (1) and (2) (but that would require introducing some additional independent claims). In any event, the Office defers to Applicant with respect to remedial amendments (feel free to email or call the Examiner for discussing proposed claim amendments, including in advance of filing an RCE).
For completeness, the claims of parent application 17250407 (now Pat. No. 12065657) are methods of “introducing a mutation” into an endogenous diploid potato plant’s SRNAse gene (an SRNAse gene that comprises at least 99% sequence identity to SEQ ID NO: 1 or at least 95% sequence identity to SEQ ID NOs: 2 or 3). Therefore, practicing the method claims of parent application 17250407 (now Pat. No. 12065657) requires possession of SRNAse gene structure (i.e., its sequence) at least because knowledge of the endogenous target would be necessary before being able to target it for mutation. In comparison, the currently rejected product claims of this application do not require possession of SRNAse gene structure (i.e., its sequence) and, therefore, inherent anticipation rules/laws apply to these claims but are not believed to apply to the method claims of parent 17250407 (now US Pat. 12065657).
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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.
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 38, 40-43, 48-57 are rejected under 35 U.S.C. 103 as being unpatentable over The SAES-422 Multistate Research Activity Accomplishments Report dated 13June2017, 7 total pages (summarizing the discussion had during an annual meeting that took place 05December2016 and 06December2016; hereinafter the “2017 Report”; of record IDS 10July2024) as applied to claims 38, 40-43, 48-50 above, and further in view of RU2505957 (of record IDS 10July2024) as evidenced by SMITH et al. (“An improved Solanum verrucosum genome provides insight into potato centromeres and epigenetic regulation” 2025 bioRxiv doi: https://doi.org/10.1101/2025.10.17.683038 (25 total pages); of record form PTO-892 09March2026) and JANSKY et al. (“Reinventing Potato as a Diploid Inbred Line-Based Crop” 2016 Crop Science 56: 1412-1422).
As an initial matter, please note that RU2505957 was cited in the Office Actions of parent application 17250407 (now US Pat. No. 12065657) as being relevant to the method claims thereof (see the Nonfinal dated 01August2023 at ¶9 on page 6). RU2505957 was also previously cited as an anticipatory reference in this application’s nonfinal 09March2026.
As amended 08June2026, claim 38 is now amended to say that the plant is S. tuberosum and that the endogenous S-RNAse gene being mutated comprises a sequence that is at least 95% identical to SEQ ID NO: 1, 2, or 3.
The Report provides the following (see page 3 of 7):
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The 2017 Report teaches a diploid potato plant referred to as “X914-10” edited using CRISPR-Cas to have a knockout mutation within its S-RNAse gene. As evidenced by this specification, “X914-10” plants are hybrids with a S. chacoense and S. tuberosum pedigree.3 The Office believes that the sequence features of claims 38, 40, and 41 are inherent to the 2017 Report because the specification states that S-RNAses were obtained from “[t]he diploid self-incompatible lines DRH-195, DRH-310, and MSX914-10” and used to generate S-RNAse knock out lines.4
The 2017 report does not appear to teach breeding methods.
RU2505957 teaches introducing a mutant S-RNAse gene from diploid wild potato (e.g., from Solanum verrucosum) into cultivated Solanum tuberosum potato via various crossing schemes and to overcome self-incompatibility. RU2505957 teaches the generation of both F1 and F2 hybrids using selfing and/or backcrosses, for example, as well as growing plants from seeds5 and regenerating plants from tubers6. For clarity of the relevance, naturally occurring diploid Solanum verrucosum comprises a transposable element insertion mutation within the promoter region of its S-RNAse gene7 on chromosome 1 that does not knock-out gene expression, but causes gene expression to be so low (likely due to DNA methylation) that S. verrucosum is self-compatible8.
RU2505957 does not specifically address numbers of selfing or inbreeding generations (RE claim 56). JANSKY et al. is cited to evidence that selfing or inbreeding “five to seven times” is a well-known practice in the art (including for potato).
Absent evidence to the contrary from Applicant, a person with ordinary skill in the art would have found it obvious to apply breeding methods (as taught by RU2505957 as evidenced by SMITH et al. and JANKSY et al.) to the edited X914-10 line of The 2017 Report and, thereby, arrive at the subject matter of claims 51-57 because it would have been no more than “applying a known technique [breeding methods] to a known product [the edited X914-10 line of The 2017 Report] ready for improvement to yield predictable results” (MPEP § 2143(I)(D)) and/or “obvious to try” with a reasonable expectation of success (MPEP § 2143(I)(D)).
Consistent with suggestion (2) above for product claim 38, Applicant may wish to consider amending method claim 51 to say that “… the first potato plant is a diploid Solanum tuberosum plant selected for having an endogenous S-RNAse gene comprising a nucleotide sequence with at least 95% sequence identity to SEQ ID NO: 1, 2, or 3 …” and amend method claim 57 to say “… propagated from a diploid Solanum tuberosum plant selected for having an endogenous S-RNAse gene comprising a nucleotide sequence with at least 95% sequence identity to SEQ ID NO: 1, 2, or 3; and regenerating a whole potato plant from the part wherein the part comprises an endogenous S-RNAse gene comprising a nucleotide sequence with at least 95% sequence identity to SEQ ID NO: 1, 2, or 3.”
Conclusion
Claims 44-45 are objected to as being dependent upon a rejected base claim (claim 38), but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad ABRAHAM can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
1 Specification at page 60.
2 Specification at the Examples on pages 57 and 70, copied below.
3 Specification at page 60.
4 Specification at the Examples on pages 57 and 70, copied below.
5 See RU2505957 at page 5 describing figure 5 and at pages 6-7.
6 See RU2505957 at page 7.
7 See the Abstract of SMITH et al.
8 See SMITH et al. at pages 9-10.
Prosecution Insights