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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18May2026 has been entered.
Status of the Claims
The amendments and arguments filed 18May2026 are acknowledged and have been fully considered. Claims 1-4 are pending, currently amended, and examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 63000206 filed 26March2020] and 35 U.S.C. 120 [continuation of 17212665, now US PAT NO. 11999946] is acknowledged. Claims 1-4 maintain an effective filing date of 26March2020.
Withdrawn Objections and/or Rejections
Objections and/or rejections made of record in the final office action dated 16January2026 that are not otherwise discussed herein are withdrawn. In particular:
RE ¶¶ 6 & 6: The obviousness rejections are withdrawn in view of the declaration by Dr. O’Connor (“O’Connor Declaration”) filed 18May2026. As an initial matter, please note that all claims now require the mutant nucleotide sequence, or mutant amino acid sequence encoded thereby, which comprises the FEA2 substitution mutation of P477S or P477C (see the alignment of recited amino acid sequence below, alignment via ClustalOmega multiple sequence alignment). Please note also that the corn plants of claim 1 and produced via the method of claim 2 now also specify that the plant’s ear length “is decreased by less than 15% as compared to an ear of a control corn plant”. The O’Connor Declaration is sufficient to overcome the obviousness rejections because it shows, with evidence and supporting statistical summaries, that a plant comprising the P477S or P477C mutation has an increased KRN as compared toa control plant and an ear length that only decreased by 3-4% as compared to that of a control plant. Materially, the O’Connor Declaration shows that while P477V, P477T, and P477F mutations do increase KRN as compared to a control plant, such mutations also cause a greater than 15% decrease in ear length as compared to a control plant (i.e., the P477S and P477C mutations impact ear length to a lesser degree than do the P477V, P477T, and P477F mutations). Because the different amino acid substitutions at this particular position are shown to have disparate impacts on ear length, the Office agrees with Applicant that a POSA would not have had a reasonable expectation that, of all possible amino acid substitutions which may introduced at position P477, the P477S or P477C substitutions would achieve a “less than 15%” decrease in ear length whereas P477V, P477T, and P477F substitutions would not. Because the claims are tailored to the evidence within the O’Connor Declaration and do not encompass prior art substitution mutations achieving the same phenotype results (i.e., “fea2-1328” P477L mutation taught by BOMMERT et al.); the claimed subject matter appears to be nonobvious.
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Claim Rejections - 35 USC §§ 101, 112 - Utility
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
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 3-4 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility.
Claim 3 is directed to a nucleic acid (not necessarily isolated) that encodes a mutant fea2 protein (please note that the “wherein a corn plant comprising the nucleic acid” phrase is an optional, nonlimiting intended use recitation). Claim 4 is directed to a mutant fea2 protein (not necessarily isolated and, like claim 3, the “wherein a corn plant comprising the modified corn FEA2 protein” phrase is an optional, nonlimiting intended use recitation).
The specification explains that when a corn plant or plant part comprises a nucleic acid encoding a weak, partial loss-of-function mutant fea2 nucleic acid (or the mutant fea2 protein encoded thereby), the corn plant is reasonably expected to have increased Kernel Row Number (KRN) with no substantial negative change to yield (as measured by at least no substantial decrease in ear length).
There is no disclosed, nor well-recognized, specific or substantial use for one such mutant fea2 nucleic acid (or the mutant fea2 protein encoded thereby) when outside of a corn plant/part.
Please amend claim 3 so that it is directed toward a composition, vector, or cell comprising the mutant nucleic acid (see, e.g., pages 33-34 of the specification which describe vectors and compositions for use in transformation). Please also amend claim 4 so that it is directed toward a plant part (such as a cell) comprising the mutant protein (please note that claim 1 already encompasses a corn plant comprising the mutant nucleic acid and/or mutant protein).
To ensure clarity, use of a mutant nucleic acid or protein to, for example, identify a corn plant/part is a general utility applicable to a broad class of corn nucleic acids or proteins (respectively). Thus, use of the claimed nucleic acid or protein in a manner that any other corn nucleic acid or protein is used is not a specific utility under 35 U.S.C. 101) (MPEP § 2107.01(A)). Further, the claimed nucleic acid or protein must be useful as disclosed—the fact that a desirable characteristic/use may be identified at some future date following further research/analysis is not sufficient for meeting the substantial utility requirement of 35 U.S.C. 101 (MPEP § 2107.01(B)).
As summarized at MPEP § 2103 (I)(A): “the claimed invention as a whole must be useful. The purpose of [the Utility] requirement is to limit patent protection to inventions that possess a certain level of ‘real world’ value, as opposed to subject matter that represents nothing more than an idea or concept, or is simply a starting point for future investigation or research” (internal citations omitted). See MPEP §§ 2164.01(c) and 2107.01-.03, e.g., 2107.02(III)(A) (“… a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is a reason for one skilled in the art to question the objective truth of the statement of utility or its scope.”).
[The Following is from Form Paragraph ¶7.05.04, See MPEP 2107.02(III)(B)(IV) → ] Claims 3-4 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific and substantial asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-15, 17-19 of copending Application No. 18669588 (Attny. Dkt. No. 1499.26DV, published as US20240301400A1) in view of BOMMERT et al. (“Quantitative variation in maize kernel row number is controlled by the FASCIATED EAR2 locus” 2013 Nature Genetics 45(3):334-338, of record form PTO-892 15May2025); PENNELL et al. (US2019/0032071 published 31January2019, of record IDS 21May2024); LIPPMAN et al. (WO2018/213547 published 22November2018; of record IDS 12November2025); and CARGILL et al. (US2020/0377900 effectively filed 29May2019 and published 03December2020, of record IDS 21May2024). This is a provisional nonstatutory double patenting rejection.
Please note that an obvious-type double patenting rejection was made in copending Application No. 18669588 over this application 18645465.
This application 18645465 and 18669588 share a priority claim to provisional application 63000206 (filed 26March2020), and this application 18645465 is a continuation of 17212665 whereas 18669588 purports to be a divisional of 17212665. Otherwise, this application 18645465 and 18669588 are not related (e.g., these applications are not related as a continuation or divisional application).
These claims regard corn plants/parts comprising a mutant nucleic acid and/or mutant protein and methods of generating them as well as the nucleic acids and proteins, all encoding or comprising a mutant FEA2 gene including the substitution mutation P477S or P477C (numbered according to SEQ ID NO: 74, which is the same amino acid sequence in both this application and 18669588). These claims are agnostic for the manner in which Pro477 is mutated (= the corn plant/part may be mutated via EMS mutagenesis, CRISPR-Cas gene editing, or another methodology). For completeness, the specification does say that CRISPR-Cas may be used. The 18669588 claims are directed toward CRISPR gene editing systems and methods of using them for introducing a mutation within the fea2 sequence of a corn plant/part. The elected mutation in 18669588 is the P477S mutation, but the claims are broader than that.
BOMMERT et al. teach mutating fea2 within a corn plant/part and that weak, partial-loss-of-function mutations like “fea2-1328” P477L mutation cause a plant to have an increased KRN without a significant decrease in ear length (see the right column on page 335). PENNELL et al., LIPPMAN et al., and CARGILL et al. all teach using CRISPR-Cas technology to edit a corn/Zea mays/maize FEA2 gene.
It would have been obvious to a person of ordinary skill in the art at the time this application was filed (a “POSA”) to generate a mutant nucleic acid or protein as recited in claims 3-4 within a corn plant/part (claim 1) via the method of claim 2 using a CRISPR gene editing system (and associated gene editing methods) as described within the claims of 18669588. One such mutation that a POSA would have found obvious to introduce is the P477S mutation claimed here and examined in 18669588. Doing so would have been no more than “combining prior art elements [P477S mutant of 18669588 with the CRISPR-Cas techniques of PENNELL et al., LIPPMAN et al., CARGILL et al.] according to known methods to yield predictable results” MPEP § 2143(I)(A), the “simple substitution of one known element for another [CRISPR-Cas technology for EMS-mutagenesis] to obtain predictable results” MPEP § 2143(I)(B), the “use of a known technique [CRISPR-Cas] to improve similar products [the weak FEA2 allele of 18669588] in the same way” MPEP § 2143(I)(C), “applying a known technique [CRISPR-Cas] to a known product [the weak FEA2 allele of 18669588] to yield predictable results” MPEP § 2143(I)(D), or at the very least “obvious to try” with a reasonable expectation of successfully utilizing CRISPR-Cas technology to arrive at a weak FEA2 allele from 18669588 MPEP § 2143(I)(E).
Conclusion
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.
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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
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