CTNF 18/921,529 CTNF 91793 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 1-7 are pending and examined herein. Specification 07-29 AIA The disclosure is objected to because of the following informalities: Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). In the instant case, the Specification has multiple instances (e.g., p.6, lines 5-10) of reciting the motifs with sequences more than 5 amino acids in length which should be accompanied by a Sequence Identifier. Required response – Applicant must provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter . Appropriate correction is required. Claim Objections 07-29-01 AIA Claim s 2-3 are objected to because of the following informalities: Claim 2 recites 3 motifs that are longer than 3 amino acids in length. However, there are no sequence identifiers following the motif recitation. The claim should be amended to include the corresponding SEQ ID Nos after each of the motifs. Claims 2 and 3 in multiple instances, e.g., item c of claim 2 and item a of claim 3, recites “by by”. It is suggested to change to –by --. Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-01 AIA 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. Written Description 07-31-01 Claims 1, 4, 6, and 7 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. Applicant clams a method for controlling undesired vegetation comprising the use of any nucleotide sequence encoding any wild-type or mutated PPO, or variant thereof, that is resistant to any phenylpyridine herbicide of formula (I). Applicant describes the full-length SEQ ID NO: 1, 2, 3, ……etc., as a wild-type full-length amino acid sequences of the PPO from various organisms (see Sequence Listing) Applicant describes amino acid substitution at positions “mutation sites 1, 2, 3, 4, and 5” (Table 2a). Applicant does not describe, however, the broadly claimed “variants” having any mutations in the rest of the PPO amino acid sequence that are either resistant to phenylpyridine herbicides of formula (I) or are able to confer said resistance in plants or cells. For example, only the mutants R128A_F420I, L397E_F420M, and L397D_F420M are expressly classified as being able to confer the claimed resistance (Table B). In addition, Applicant has not described any structural features that the genus of variant of any of the PPO proteins such that one having ordinary skill in the art would be able to identify the members of the genus resistant to any phenylpyridine herbicide of formula (I) encompassed by the claims. For these reasons, it is unclear whether at the time of filing Applicant was in possession of the invention as broadly claimed. Scope of Enablement 07-31-03 AIA Claim s 1, 4, 6, and 7 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 PPO polypeptide comprises one or more of the motifs 1, 2, and/or 3 and the substitutions at amino acids corresponding to positions 128, 397 and 420 of SEQ ID NO: 1 to confer herbicide resistance or tolerance to phenylpyridine of formula (I) , does not reasonably provide enablement for any wild-type or mutated PPO, or variant thereof, to confer herbicide resistance or tolerance to phenylpyridine of formula (I) . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. In re Wands, 858 F.2d 731 (Fed. Cir. 1988) lists the following eight factors for determining whether undue experimentation would be required to practice an invention: (1) quantity of experimentation necessary; (2) amount of direction or guidance supplied; (3) presence or absence of working examples; (4) nature of the invention; (5) state of the prior art; (6) relative skill of those in the art; (7) predictability or unpredictability or the prior art; (8) breadth of the claims. Applicant clams a method for controlling undesired vegetation comprising the use of any nucleotide sequence encoding any wild-type or mutated PPO, or variant thereof, that is resistant to any phenylpyridine herbicide of formula (I). Applicant teaches the full-length SEQ ID NO: 1, 2, 3, ……etc., as a wild-type full-length amino acid sequences of the PPO from various organisms (see Sequence Listing) Applicant describes amino acid substitution at positions “mutation sites 1, 2, 3, 4, and 5” (Table 2a). Applicant teaches mutagenizing PPO proteins using site-directed mutagenesis at positions “mutation sites 1, 2, 3, 4, and 5” (Table 2a). Applicant does not teach any of the broadly claimed “variants” having any mutations in the rest of the PPO amino acid sequence that are either resistant to phenylpyridine herbicides of formula (I) or are able to confer said resistance in plants or cells. For example, only the mutants R128A_F420I, L397E_F420M, and L397D_F420M are expressly classified as being able to confer the claimed resistance (Table B). Applicant does not supply any evidence that any variants of any of the PPOs are resistant to phenylpyridine herbicides of formula (I). The prior art indicates that it would be highly unpredictable to attempt to practice the instant invention through the full scope of its claims. There is no indication in the art that the any unspecified substitutions anywhere in the PPO protein would be sufficient to confer herbicide resistance. Given the breadth of the claims, the lack of guidance and examples, the unpredictability of the art, and the state of the art as discussed above, undue trial and error experimentation would be required to practice the claimed invention . Double Patenting 08-33 AIA 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. 08-34 AIA Claim s 1 and 6-7 rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 15-22 of U.S. Patent No. US11247980B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because : Instant claims are drawn to a method for controlling undesired vegetation at a plant cultivation site, the method comprising the steps of: a) providing, at said site, a plant that comprises at least one nucleic acid comprising a nucleotide sequence encoding a protoporphyrinogen oxidase (PPO) polypeptide which is resistant or tolerant to a "PPO inhibiting herbicide"; b) applying to said site an effective amount of said herbicide, wherein the PPO inhibiting herbicide is a uracilpyridine of formula (1) including their agriculturally acceptable salts or derivatives, provided the compounds of formula (1) have a carboxyl group, and wherein the effective amount of said herbicide does not kill or inhibit the growth of the herbicide-tolerant plant of a); wherein the plant comprises at least one additional heterologous nucleic acid comprising a nucleotide sequence encoding a herbicide tolerance enzyme; or wherein the uracilpyridine of formula (I) is applied in conjunction with one or more additional herbicides. The patented claims are drawn to a method of controlling undesired vegetation, which comprises allowing an herbicidally active amount of at least one uracilpyridine of formula (I) to act on plants, their environment or on seed. The herbicidal compound of uracilpyridine of formula (I) is the same compound in both applications. The patented application is drawn generically to any plant, including both non-transgenic plant and transgenic plant comprising any PPO polypeptide which is resistant or tolerant to a PPO inhibiting herbicide. How, it is nonetheless obvious for a person skilled in the art to have applied the compound and method to any transgenic plant comprising any PPO polypeptide which is resistant or tolerant to a PPO inhibiting herbicide, as taught by prior art such as Hutzler et al (US 20150252379 A1, published Sept. 10, 2015) which teaches controlling undesired vegetation at plant cultivation site involves providing plant having nucleic acid(s) comprising sequence encoding wild-type or mutated protoporphyrinogen oxidase resistant/tolerant to benzoxazinone-derivative herbicide . 08-34 AIA Claim s 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-11 of U.S. Patent No. US11479786B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because : The patented claims are drawn to a method for controlling undesired vegetation at a plant cultivation site, the method comprising providing, at said site, a plant that comprises at least one nucleic acid comprising a nucleotide sequence encoding a protoporphyrinogen oxidase (PPO) polypeptide which is resistant or tolerant to a PPO inhibiting herbicide; applying to said site an effective amount of said herbicide, wherein the PPO inhibiting herbicide is a uracilpyridine of formula (I). The uracilpyridine herbicide of formula (I) is the same herbicide of the instant application . 08-34 AIA Claim s 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of U.S. Patent No. US12123010B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because : The patented claims are drawn to a method for controlling undesired vegetation at a plant cultivation site, the method comprising providing, at said site, a plant that comprises at least one nucleic acid comprising a nucleotide sequence encoding a protoporphyrinogen oxidase (PPO) polypeptide which is resistant or tolerant to a PPO inhibiting herbicide; applying to said site an effective amount of said herbicide, wherein the PPO inhibiting herbicide is a uracilpyridine herbicide selected from the group consisting of: ethyl 2-[[3-[2-chloro-4-fluoro-5-[3-methyl-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]phenoxy]-2-pyridyl]oxy]acetate; ethyl 2-[[3-[[3-chloro-5-fluoro-6-[3-methyl-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]-2-pyridyl]oxy]-2-pyridyl]oxy]acetate; 2-[[3-[[3-chloro-5-fluoro-6-[3-methyl-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl]-2-pyridyl]oxy]-2-pyridyl]oxy]acetic acid; and so on. The uracilpyridine herbicide of the patented claims are species of the herbicide defined in the formula (I) and working active compunds of the instant application. Conclusion No claims are allowed. Claims 1-7 are free of the prior art, because there is no prior art reasonably teaching or suggesting the claimed method of weed control comprising applying PPO inhibiting phenylpyridine herbicide of Formula (I) to a plant having a protoporphyrinogen oxidase (PPO) polypeptide which is resistant or tolerant to said herbicide. The closest prior art is Patent No. 10041087 (published in 2014) which teaches a method for controlling weed comprising applying an effective amount of a benzoxazinone-derivative herbicide to plants that comprises a herbicide-tolerant mutant protoporphyrinogen oxidase (PPO) enzyme comprising an amino acid substitution at a position corresponding to position Leu397 of SEQ ID NO:2 and an amino acid substitution at a position corresponding to position Phe420 of SEQ ID NO:2, wherein the amino acid corresponding to position Leu397 of SEQ ID NO:2 is substituted with aspartate, glutamate, or glutamine, and wherein the amino acid corresponding to position Phe420 of SEQ ID NO:2 is substituted with valine or methionine. The prior art SEQ ID NO: 2 is the same sequence as the instant SEQ ID NO: 1, whereas the prior art F420 and L397 are those defined in the instant claim 2 and 3 at items b) and c). However, there is no prior art teaching or suggesting the novel herbicide chemical represented in phenylpyridine herbicide of Formula (I), or the method of using in applying said herbicide to a plant comprising the herbicide tolerant PPOX mutant. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5. 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 A 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. WEIHUA . FAN Primary Examiner Art Unit 1663 /WEIHUA FAN/Primary Examiner, Art Unit 1663 Application/Control Number: 18/921,529 Page 2 Art Unit: 1663 Application/Control Number: 18/921,529 Page 3 Art Unit: 1663 Application/Control Number: 18/921,529 Page 4 Art Unit: 1663 Application/Control Number: 18/921,529 Page 5 Art Unit: 1663 Application/Control Number: 18/921,529 Page 6 Art Unit: 1663 Application/Control Number: 18/921,529 Page 7 Art Unit: 1663 Application/Control Number: 18/921,529 Page 8 Art Unit: 1663 Application/Control Number: 18/921,529 Page 9 Art Unit: 1663 Application/Control Number: 18/921,529 Page 10 Art Unit: 1663 Application/Control Number: 18/921,529 Page 11 Art Unit: 1663
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