Detailed Action
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, 3-5 and 7-24, 27-29, 33-38 are pending.
Claims 22-24, 27-29 and 34 are withdrawn.
Claims 36-38 are newly added.
Claims 1, 3-5, 7-21, 33 and 35-38 are examined.
Election/Restriction
Claims 36-38 are examined with Group I because these claims would have been included in the elected group as defined in the requirement for restriction filed 9/16/2024.
Withdrawn rejections
The rejection of claims 1, 3-5, 7-21, 33 and 35 under 35 USC 112(b) is withdrawn in light of amendments made by Applicant.
The rejection of claim 11 under 35 USC 112(d) is withdrawn in light of amendments made by Applicant.
Claim Objections
Claims 1 and 9 are objected to because the scope of what is within the parentheses must be the same as that which precedes the parentheses. The use of parentheticals to recite “modified PPO protein” and “mutated HLS1 gene” in claims 1 and 9, respectively, introduces ambiguity into the claim language because, for example, in claim 1, “modified PPO protein” is recited in parentheses immediately following “SEQ ID NO: 5”, which is the wild-type protein. It is suggested that Applicant delete these parenthetical recitations.
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, 3-5, 7-21, 33 and 35 remain rejected and claims 36-38 are 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 claims contain 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.
Applicant claims a watermelon plant comprising a modified PPO gene and its encoded protein conferring a phenotype of the seed having a pale color. The scope of the modified PPO gene and the protein it encodes claimed by Applicant encompasses modifications to any PPO gene and its respectively encoded protein, for example, a watermelon plant comprising a modification to any PPO gene resulting in the KFDV and DWL domains lacking in the encoded protein would read on at least embodiment (a) of claim 1 because that modified PPO can reasonably be compared generically to the unmodified, wild-type SEQ ID NO: 5 recited in claim 1. Applicant is broadly claiming a watermelon plant comprising a modified PPO protein from a genus of modified PPO proteins.
Applicant describes two indel modifications of the PPO of SEQ ID NO: 1 conferring the pale seed color phenotype: insertion of an A at position cl_97103_v1_Chr3:5706705 leading to the introduction of a premature stop codon in the PPO gene of SEQ ID NO: 1, it is not clear from the Specification where this insertion is relative to SEQ ID NO: 1, and insertion of a T between nucleotides 711 and 712 of SEQ ID NO: 1, leading to a frameshift and a premature stop codon at position 751-753 of the modified PPO gene (SEQ ID NO:2) (Specification, paragraphs 145 and 147).
He et al. (He et al. BMC Genomics (2021) 22:731) teaches that PPO proteins function considerably different in plants (page 2, left column, paragraph 3). He et al. also teaches that among 18 PPO genes, only two did not have the KFDV, DWL and Tyrosinase domains referred to in the instant claims (paragraph bridging pages 4 and 5).
Applicant does not describe the genus of watermelon plants comprising a modified PPO protein conferring pale seed color as broadly claimed. Applicant does not describe a representative number of species across the breadth of the genus which encompasses a watermelon plant comprising a modification to any PPO gene resulting in pale seed color. The described embodiments are not representative of the breadth of the claimed genus such that one of ordinary skill in the art would be able to envision which members of the claimed genus possess a modified PPO protein conferring the pale seed color phenotype. Applicant does not describe a structure-function relationship to cure the lack of a representative number of species described across the breadth of the genus claimed.
The teachings of He et al. demonstrate that this deficiency is not cured by the level of knowledge in the prior art because other PPO genes may not play a role in conferring the claimed phenotype given the teachings of He et al., that PPO proteins have diverse functions despite that they all normally have the instantly claimed domains. It is therefore not clear that modifying any PPO gene, regardless of how it is modified, would confer the claimed pale seed color phenotype and that the domains referred to in the claims do not have a clear structure-function relationship known in the art to cure the deficiency of the instant disclosure.
Given the breadth of the genera encompassed by the claims the lack of a representative number of species and structure-function relationship described by Applicant in view of the known variability in the art, Applicant has not satisfied the written description requirement for the claimed invention.
Scope of enablement
Claims 1, 3-5, 7-21, 33 and 35 remain rejected and claims 36-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a watermelon plant comprising a premature stop codon modification to a specific PPO gene resulting in a pale seed color, does not reasonably provide enablement for modifying any PPO gene resulting in a pale seed color. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Applicant claims a watermelon plant comprising a modified PPO gene and its encoded protein conferring a phenotype of the seed having a pale color. The scope of the modified PPO gene and the protein it encodes claimed by Applicant encompasses modifications to any PPO gene and its respectively encoded protein, for example, a watermelon plant comprising a modification to any PPO gene resulting in the KFDV and DWL domains lacking in the encoded protein would read on at least embodiment (a) of claim 1 because that modified PPO can reasonably be compared generically to the unmodified, wild-type SEQ ID NO: 5 recited in claim 1. Applicant is broadly claiming a watermelon plant comprising a modified PPO protein from a genus of modified PPO proteins.
Applicant teaches two indel modifications of the PPO of SEQ ID NO: 1 conferring the pale seed color phenotype: insertion of an A at position cl_97103_v1_Chr3:5706705 leading to the introduction of a premature stop codon in the PPO gene of SEQ ID NO: 1, it is not clear from the Specification where this insertion is relative to SEQ ID NO: 1, and insertion of a T between nucleotides 711 and 712 of SEQ ID NO: 1, leading to a frameshift and a premature stop codon at position 751-753 of the modified PPO gene (SEQ ID NO:2) (Specification, paragraphs 145 and 147).
He et al. (He et al. BMC Genomics (2021) 22:731) teaches that PPO proteins function considerably different in plants (page 2, left column, paragraph 3). He et al. also teaches that among 18 PPO genes, only two did not have the KFDV, DWL and Tyrosinase domains referred to in the instant claims (paragraph bridging pages 4 and 5).
Applicant does not teach the genus of watermelon plants comprising a modified PPO protein conferring pale seed color as broadly claimed. the lack of predictability in the art and the lack of guidance provided by Applicant would not have enabled one of ordinary skill in the art to make and use a watermelon plant comprising a modification to any PPO gene resulting in pale seed color. Applicant’s teachings do not enable one of ordinary skill in the art make and use a watermelon plant with a modified PPO protein conferring the pale seed color phenotype without undue experimentation. The teachings of He et al. demonstrate that this deficiency is not cured by the level of knowledge in the prior art because other PPO genes may not play a role in conferring the claimed phenotype given that PPO proteins have diverse functions despite that they often all have the instantly claimed domains. It is therefore not clear that modifying any PPO gene, regardless of how it is modified, would confer the claimed pale seed color phenotype.
Therefore, Applicant has not satisfied the enablement requirement for the claimed invention.
Applicant’s arguments regarding rejection under 35 USC 112(a)
Applicant's arguments filed 9/12/2025 and 11/12/2025 have been fully considered but they are not persuasive.
Applicant argues on pages 14-16 that the instant disclosure is in compliance with both the written description and enablement requirements. Applicant argues on page 16 that the claims are drawn to a watermelon plant comprising a modified protein of SEQ ID NO: 5. Applicant argues that one of ordinary skill in the art would understand how to modify a protein such that an embodiment of (a) through (i) of claim 1 would be able to achieve a pale seed phenotype without undue experimentation.
This argument has been fully considered but it is not persuasive. While claim 1 refers to the wildtype PPO gene of SEQ ID NO: 1 and the protein encoded by it, SEQ ID NO: 5, the limitations of the modified protein encompass any PPO with modifications that read on the specific embodiments of (a) through (i). For example, the limitations of (a) would be met by introducing a premature stop codon to any PPO gene such that the KFDV and DWL domains are lacking because the claimed modified protein is only in comparison to the wildtype. He at al., as referenced in the rejections above, teaches that many PPO genes, which have different functions, have these domains. Therefore, it is not clear that introducing a premature stop codon or other modifications to a PPO which can be compared to SEQ ID NO: 5 would confer the pale seed color phenotype.
Closest prior art
While the scope of the claimed invention is broadly drawn to a watermelon plant comprising a modified PPO protein, and watermelons with pale seeds were known in the prior art, there is no teaching or suggestion in the prior art prior art that can reasonably be interpreted as teaching or suggesting a watermelon plant comprising a modified PPO gene resulting in pale seed color.
The closest prior art is Paudel (Paudel et al. Frontiers in Plant Science. June 2019. 10(788); IDS filed 5/10/2022), which teaches identification of loci associated with multiple seed colors including “tan1” (Figure 1), which reads on Applicant’s definition of “pale seed color” as including “beige” (paragraph 0045). Paudel teaches tan1 segregates from a single gene with red seed color in a region other than the R locus (page 6). Paudel teaches identification of a SNP associated with the tan1 phenotype on chromosome 5. In contrast, the instantly claimed PPO gene is located on chromosome 3 (paragraph 146). Paudel does not teach or suggest modification of a PPO gene resulting in pale seed color nor a gene in the instantly claimed region associated with pale seed color.
Therefore, the claimed invention is found to be free of the prior art.
Conclusion
Claims 1, 3-5, 7-21, 33 and 35-38 are rejected.
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 DAVID R BYRNES whose telephone number is (571)270-3935. The examiner can normally be reached 9:00 - 5:00 M-F.
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/DAVID R BYRNES/Examiner, Art Unit 1662
/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662