Status of the Application
This Office Action is in response to the Amendment and Remarks filed 16 February 2026.
The Examiner notes that Applicant has cancelled claims 13-17 directed to a non-elected invention. The Restriction of record is now moot.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The listing of references on pages 157-158 of the Specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The Substitute Specification filed 16 February 2026 is approved by the Examiner.
The objections to the Specification are withdrawn in view of Applicant’s amendments there to.
The rejection on the ground of nonstatutory double patenting is withdrawn in view of Applicant’s amendments to the claims.
The rejection under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments to the claims.
The rejection under 35 U.S.C. 102(a)(2) is withdrawn in view of Applicant’s response/argument under 35 U.S.C. 102(b)(2)(c).
The rejection under 35 U.S.C. 103 is withdrawn in view of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112
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, 6-8, 12, 18-21 and claim 25 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 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.
The claims are drawn to a plant, plant part or plant cell comprising a polynucleotide encoding mutant TriA polypeptides at least 80% identical to the amino acid sequence of SEQ ID NO. 2, wherein the mutated polypeptide differs from the wildtype amino acid sequence of a TriA polypeptide at one or more positions corresponding to the following positions of SEQ ID NO: 2: 69, 74, 82, 87, 89, 93, 129, 130, 131, 170, 174, 180, 182, 216, 246, 247, 248, 249, 250, 251, 298, 301, 302 and 304.
The specification describes producing herbicide tolerant plants transformed with either wildtype or mutant polynucleotides encoding TriA polypeptides. The mutations corresponding to positions 69, 74, 82, 87, 89, 93, 129, 130, 131, 170, 174, 180, 182, 216, 246, 247, 248, 249, 250, 251, 298, 301, 302 and 304 of SEQ ID NO: 2 which show substantial variation in their ability to either deaminate melamine (the enzyme function of instant SEQ ID NO: 2, TriA) or to degrade a triazine herbicide as shown in Table 3 on pages 146-151 of the amended Specification. In fact, there are multiple mutations of instant SEQ ID NO: 2 that do not retain melamine deaminase activity. The art teaches that TriA (melamine deaminase) from Pseudomonas sp. strain NRRL B-12227 differs from AtzA (atrazine chlorhydrolase) from Pseudomonas sp. differs by only 9 amino acids including amino acids 84, 92, 217, 219 and 328 of instant Seq. ID NO: 2 as recited in instant claim 5 (Seffernick et al 2001, J. Bact. 183(8): 2405-2410).
Applicant further claims wherein the mutated TriA polypeptide is a functional variant that can vary by as much as 80% from instant SEQ ID NO: 2, but a review of the instant Specification and the teachings in the prior art shows that TriA polypeptides range at most at least 90% identical to instant SEQ ID NO: 2. Applicant does not appear to have described any species below 90% sequence identity to instant SEQ ID NO: 2 nor the variations within such a genus as required by the instant claims as presently amended.
Hence, it is unclear that Applicant was in possession of the invention as broadly claimed. The decision in AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. 111 USPQ2d 1780 (Fed. Cir. 2014) seems to be germane to the instant case. In Abbvie, an analogy is drawn between a claimed genus and a plot of land (see pages 1789-1791). Using this analogy, the Court offered that “[I]f the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus. He only described a portion of it.” Similar to the analogy drawn in Abbvie, in the case of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010), the court (at page 1171) offered: [M]erely drawing a fence around the outer limits of purposed genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
Applicant argues that Claim 1 has been amended to recite that the amino acid sequence is at least 80% identical to SEQ ID NO; 2 and that the mutated TriA has melamine deaminase activity and that the expression of the polynucleotide confers tolerance to triazine herbicide (page 8 of the Remarks).
This argument is not found persuasive as addressed above. Neither Applicant nor the art describes TriA polypeptides less than 90% identical to instant SEQ ID NO: 2, hence the claims essentially include half of the genus that has not been described by either application or the art as a whole. Hence, the rejection is maintained.
Allowable Subject Matter
Claims 22-24, 26 and 27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on (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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/David H Kruse/
Primary Examiner, Art Unit 1663
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