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 filed 30September2025 are acknowledged and have been fully considered. Claims 2-12 are cancelled. Claims 1, 13-16 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(a)-(d) and (f) [EP21305528.8 filed 22April2021] and 35 U.S.C. 365(c) [national stage of PCT/EP2022/060184 filed 15April2022] is acknowledged. Claims 1, 13-16 have an effective filing date of 22April2021.
Withdrawn Objections and/or Rejections
Objections and/or rejections made of record in the nonfinal office action dated 30June2025 that are not otherwise discussed herein are withdrawn. In particular:
RE ¶¶ 6-7: The objections regarding “No” and “of protein of” are withdrawn in view of the amendments to the claims;
RE ¶ 8: The indefiniteness rejection regarding “preferably” is withdrawn in view of the amendments to the claims;
RE ¶ 9: The indefiniteness rejection regarding “after alignment” is withdrawn in view of the amendments to the claims;
RE ¶ 10: The improper dependency rejection is withdrawn in view of the amendments to the claims;
RE ¶ 11: The improper dependency rejection of claim 12 is withdrawn in view of the amendments to the claims; and
RE ¶ 12: The anticipation rejection is withdrawn in view of claim 1 now reciting “non-functional mutant alleles” (which is interpreted as excluding mere suppression of those alleles) and claim 13 requiring that the plant be selected for having particular alleles suppressed or mutated (which requires possession of the relationship between downregulating HB40 and female-to-hermaphrodite flower transition as well as Fruit Shape index score.
Specification
The disclosure REMAINS objected to because of the following informalities: ¶25 on page 5 of the specification appears to recite a hyperlink. Please remove any and all hyperlinks from the specification.
Appropriate correction is required.
Response to Applicant’s Amendment(s) or Remarks Dated 30September2025:
Applicant has not addressed this objection with either an amendment or remarks in the reply filed 30September2025. For efficiency, please be sure to check the specification for any other hyperlinks that may be therein (other than the one at ¶25 on page 5).
Claim Objections
Claim 13 REMAINS objected to because of the following informalities: this claim recites a percent identity “with a sequence” and then recite a sequence identifier. This remains an informality, please amend this claim to recite “identity to” rather than “identity with” (as in “… identity to the sequence”). Appropriate correction or clarification is required.
Response to Applicant’s Amendment(s) or Remarks Dated 30September2025:
Applicant has amended claim 1 to address this objection (and claims 5, 7, 9, and 11 are now cancelled). As currently amended, claim 13 perpetuates this informality.
Claim 13 is further objected to because of the following informalities: as amended, it appears as though “abolished” (that concept) was accidentally deleted from the claim. Please see the indefiniteness rejection of claims 15-16 herein below (regarding antecedent basis) for a remedial amendment at claim 13. Appropriate correction is required.
Claim 13 is further objected to because of the following informalities: please italicize the genus and species names in the claim (like they are in claim 1, as in “Cucumis melo” → “Cucumis melo”). 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.
Claims 1 and 13 (therefore, also claims 14-16 which refer thereto without correcting the issue) 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.
Claims 1 and 13 recite “by genetic engineering techniques” but, as evidenced by the explicit language of claim 14, Applicant intends these claims to encompass chemical mutagenesis (such as EMS mutagenesis). The phrase “genetic engineering techniques” would not reasonably be interpreted as encompassing chemical mutagenesis such as EMS mutagenesis. Therefore, the presence of this phrase in claims 1 and 13 renders the claims indefinite. It is recommended that the phrase “by genetic engineering techniques” is deleted from the claims because (1) it is not believed to be necessary for claims scope at least because a person with even ordinary skill in the art would understand that suppressing or mutating an HB40 allele may be done using genetic engineering techniques such as CRISPR/Cas techniques as well as using chemical mutagenesis such as EMS and (2) the phrase is confusing (as explained herein above).
Claims 15-16 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.
Due to the amendments at claim 13, the phrase “the abolition of the expression and/or the function of the protein” in claims 15 and 16 now lack antecedent basis. Further to the objection of claim 13 herein above, it is recommended that claim 13 be amended to something like the following (which would remedy this antecedent basis issue, correct the objection to claim 13, and address the indefiniteness issue of claim 13 regarding “by genetic engineering techniques”):
“… Cucurbitaceae plant or plant part, wherein the suppressing and/or mutating causes abolition of the expression and/or function of the protein; (i) wherein ….”
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.
Claims 1, 13-16 REMAIN 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.
As amended 30September2025, issues (1), (2), (3), and (4) of this Written Description rejection1 are overcome in view of the claim amendments and remarks filed 30September2025. Regarding (1), please note that Applicant relies upon figure 4 as evidence of synteny (same or similar loci location) for the HB40 gene across the claimed Cucurbitaceae plants and Applicant argues that an artisan would expect shared HB40 function across the claimed Cucurbitaceae plants—absent evidence to the contrary, that is sufficient for overcoming issue (1). Issue (5) remains and is the basis for this rejection being maintained.
These claims now (5) recite endogenous HB40 sequences/structures that have 90% sequence identity to their respective HB40 sequence identifiers (as rejected in the nonfinal action dated 30June2025, the claimed percent identity was down to 70%).
The specification identifies HB40 genes and proteins from C. melo, C. sativus, C. pepo, C. lanatus, and L. siceraria plants (i.e., HB40 sequences/structures having 100% sequence identity to their respective sequence identifiers).2 The specification also describes functional analysis for Cucumis melo and Cucumis sativus HB40 proteins (referred to as “MELO3C007809” or “CmHB40” and “Csa6G501990” or “CsHB40”, respectively, within the specification3).4 In particular, the specification shows that a Cucumis melo plant homozygously comprising a non-functional CmHB40 protein (therein, a truncated protein generated by chemical mutagenesis) or a Cucumis sativus plant homozygously comprising a non-functional CsHB40 protein (therein, a truncated protein generated by chemical mutagenesis) results in wild type female flowers now being bisexual/hermaphrodite and did not significantly impact fruit shape (which distinguishes the impact of HB40 from other proteins such as “ACS”) defined by being a Fruit Shape index change of 20% or less (as compared to a wild type plant’s fruit).5
The prior art does not supplement the specification at least because the prior art did not appear to describe the particular HB40 proteins being claimed (from representative Cucurbitaceae plants or, specifically, from the C. melo, C. sativus, C. pepo, C. lanatus, and L. siceraria plants of these claims) and/or the prior art did not appear to correlated the claimed HB40 proteins with either female-to-hermaphrodite flower transition or invariable FSi values (i.e., a change of 20% or less).
Without more from Applicant, a skilled artisan at the time the present application was filed would not reasonably recognize Applicant as being in possession of the full scope of subject matter being claimed. In particular, a skilled artisan would not reasonably recognize Applicant as being in possession of an endogenous C. melo HB40 with as little as 90% sequence identity to SEQ ID NO: 3, an endogenous C. sativus HB40 with as little as 90% sequence identity to SEQ ID NO: 5, an endogenous C. pepo HB40 with as little as 90% sequence identity to SEQ ID NO: 9 or 10, an endogenous C. lanatus HB40 with as little as 90% sequence identity to SEQ ID NO: 8, an endogenous L. siceraria HB40 with as little as 90% sequence identity to SEQ ID NO: 11. It would be remedial of this issue (5) to amend the claims so that the HB40 protein has an at least 95% identity to the referenced sequence.
Allowable Subject Matter
Copied from the Nonfinal 30June2025 for Clarity of the Record (please note that some of these claim amendment suggestions were incorporated into the claims filed 30September2025):
The following is a statement of reasons for the indication of allowable subject matter: this application appears to be the first to describe a correlation within Cucumis melo or Cucumis sativus between targeted downregulation of its HB40 so as to have a non-functional HB40 protein (comprising SEQ ID NO: 3 or 5, respectively) and a female-to-hermaphrodite flower transition as well as a Fruit Shape index score that differs from that of a wild type plant by 20% or less. Therefore, absent evidence to the contrary, claims directed toward making such plants, as well as plants obtained thereby, appear to be allowable. In view of Applicant’s post-filing publication RASHID et al. and the discussion of the “TK4” andromonoecy Cucumis melo plant therein, as well as the other issues raised within this action, the Office recommends amending the claims to something such as the following for the purpose of allowance:
1. A modified Cucurbitaceae plant, characterized by having:
(a) mutant alleles of an endogenous gene so that the protein(s) encoded by all of the alleles are non-functional,
(i) wherein the Cucurbitaceae plant is Cucumis melo and the endogenous gene encodes a protein comprising an amino acid sequence with at least 95% sequence identity to the sequence SEQ ID NO: 3 or
(ii) wherein the Cucurbitaceae plant is Cucumis sativus and the endogenous gene encodes a protein comprising an amino acid sequence with at least 95% sequence identity to the sequence SEQ ID NO: 5;
(b) hermaphrodite flowers in a location corresponding to female flowers of a wild type plant;
and
(c) a Fruit Shape index score that varies by 20% or less as compared to that of a wild type plant.
2. A method of making the modified Cucurbitaceae plant of claim 1, comprising:
(A) suppressing the expression of all alleles of an endogenous gene within a Cucurbitaceae plant or plant part, and/or mutating all alleles of an endogenous gene within a Cucurbitaceae plant or plant part so that the protein(s) encoded by all alleles are non-functional,
(i) wherein the Cucurbitaceae plant or plant part is Cucumis melo and the endogenous gene encodes a protein comprising an amino acid sequence with at least 95% sequence identity to the sequence SEQ ID NO: 3 or
(ii) wherein the Cucurbitaceae plant or plant part is Cucumis sativus and the endogenous gene encodes a protein comprising an amino acid sequence with at least 95% sequence identity to the sequence SEQ ID NO: 5;
(B) optionally, obtaining a plant from the plant part of (A);
and
(C) selecting a Cucurbitaceae plant for having
(1) the modification(s) of (A),
(2) hermaphrodite flowers in a location corresponding to female flowers of a wild type plant, and
(3) a Fruit Shape index score that varies by 20% or less as compared to that of a wild type plant.
3. The method of claim 2, wherein (A) mutating all alleles of an endogenous gene within a Cucurbitaceae plant or plant part so that the protein(s) encoded by all alleles are non-functional is performed by Ethyl Methane Sulfonate (EMS) treatment and/or Targeting Induced Local Lesions in Genomes (TILLING).
4. The method of claim 2, wherein the Cucurbitaceae plant is selected for having (C)(1) a nonsense mutation at an amino acid located at the position corresponding to position 107 or position 113 of the sequence SEQ ID NO: 3.
Conclusion
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.
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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
1 Nonfinal action dated 30June2025 at ¶13 on pages 9-10.
2 ¶75 on pages 12-13 of the specification.
3 See ¶75 on pages 12-13 as well as Examples 5-6 on pages 13-14 of the specification.
4 Examples 5-6 on pages 13-14 of the specification.
5 Examples 5-6 at ¶¶76-80 on pages 13-14.