The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. The Office acknowledges the receipt of Applicant’s restriction election filed October 3, 2025. Applicant elects Invention I, Amaranthus, SEQ ID NO:1 and SEQ ID NO:448. As no traverse is presented, this election is considered as without traverse. Claims 1-21 are pending. Claims 3 and 13-21 are withdrawn from examination. Claims 1, 2 and 4-12, to the extent of SEQ ID Nos. 1 and 448, are examined in the instant application.
The restriction is made FINAL.
SEQ ID NO:448 is first disclosed in PCT/EP2017/062182 filed May 19, 2017.
Information Disclosure Statement (IDS)
2. Applicant’s IDS filed January 14, 2025 has been considered only to the extent of the documents and the English translations submitted.
Specification
3. The disclosure is objected to because of the following: the status of parent Application No. 16/302,202 is not updated on page 1 of the specification.
Appropriate correction is required.
Claim Objections
4. Claims 2, 4, 7 and 8 are objected to because of the following:
In claim 2, “Amaranthus” should be italicized.
Claims 4 and 8 recite non-elected inventions. These sequences do not share a common structure or motif which distinguishes them from prior art sequences, and Applicant does not indicate on the record they are obvious variants of each other.
In claim 7, “PPO” should be spelled out the first time it is used, with the abbreviation “(PPO)” in parentheses.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
5. 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.
6. Claims 1, 2 and 4-12 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 pre-AIA the applicant regards as the invention.
In claim 1, “dual transit peptide” is not adequately defined. The paragraph on page 26 states:
As used herein, the term "dual transit peptide" refers to the N-terminal portion of a chloroplast and/or mitochondrial precursor protein and is instrumental for specific recognition of the chloroplast and/or mitochondrial surface and in mediating the post-translational translocation of pre-proteins across the chloroplast envelope and into the various subcompartments within the chloroplast (e.g. stroma, thylakoid and thylakoid membrane) and/or mitochondrion. Thus, as used herein, a polypeptide having "dual transit peptide activity" comprises a polypeptide which when operably linked to the N-terminal region of a protein of interest facilitates translocation of the polypeptide of interest to the chloroplast and/or mitochondrion.
This phrase is not adequately defined because it is unclear where the N-terminal portion begins and ends. Additionally, the “and/or” recitation does not indicate that the peptide has dual functions and implies that the peptide can have a single function, i.e., targeting chloroplast or mitochondrion.
In claims 4 and 8, the definition for “fragment” on page 29 encompasses a two-nucleotide sequence, which does not appear to be Applicant’s intention.
In claims 4 and 8, “variant” is unclear because its definition of “substantially similar sequences” on page 29 does not indicate what parameters are used to objectively determine “substantially similar”, e.g., percent sequence identity. The metes and bounds of “variant” are unclear because “substantially similar” is unclear.
In claim 5, it is unclear what level of expression constitutes “overexpressed”.
In claims 11 and 12, “a plant cell” and “a plant” should be amended to “the plant cell” and “the plant”, respectively, for proper antecedence.
In claim 12, it is unclear what is retained in the derived product. It is suggested “derived” be amended to “obtained”.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 101
7. 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.
8. Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature. Due to gene segregation during sexual hybridization, the claimed seed is not required to contain the expression cassette of its parent plant. Thus, the claimed seed is indistinguishable from a product of nature, i.e., a naturally-occurring seed.
Double Patenting
9. 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€ 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.
10. Claims 1, 2 and 4-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,959,086 (hereafter ‘086) in view of Evdokimov et al. (US Pub. No.20170037427 (A)). Claim 1 of ‘086 states that the dual transit peptide comprising SEQ ID NO:1 is heterologous to the PPO sequence comprising SEQ ID NO:320. It would have been obvious to substitute the PPO sequence comprising SEQ ID NO:320 with another known PPO sequence, such as the PPO sequence comprising SEQ ID NO:1 of Evdokimov, also known to confer tolerance to PPO-inhibiting herbicides (claim 1), to produce a recombinant chimeric nucleic acid molecule for controlling undesired vegetation and weeds in a plant cultivation site. Evdokimov also teaches operably linking said PPO encoding sequence to a sequence encoding a dual transit peptide [0056]. Accordingly, the claimed invention is not patentably distinct from the claims of ‘086.
Claim Rejections - 35 USC § 112(a)
11. 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.
12. Claims 1, 2 and 4-12 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention lacks adequate written description because a dual transit peptide from Amaranthus is not representative of dual transit peptides from other sources. Applicant does not disclose whether dual transit peptides share a common structure or have conserved domains to allow one skilled in the art to predict the structures of other dual transit peptides. This is precisely the situation in University of California v. Eli Lilly and Co., 43 USPQ2d 1398 (Fed. Cir. 1997), which teaches that the disclosure of the sequence encoding a rat insulin protein does not provide adequate written description for the sequence encoding a human insulin protein. Applicant failed to disclose a representative number of species within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Furthermore, the claims encompass mutants and allelic variants of SEQ ID NOs:1 and 448 and thus imply that structural variants exist in nature, yet no structural variant has been disclosed. The implication is that there is a sequence other than that disclosed which exists in nature, but the structure thereof is not known. The disclosure of SEQ ID NO:1 isolated from Amaranthus is not representative of other transit peptides from other sources. Thus, there are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine such mutants and allelic variants of other sequences, absent further guidance. With regard to “fragment thereof”, while one skilled in the art can generate a population of sequences having any number of nucleotides of SEQ ID NOs:1 and 448, from two nucleotides to the full-length sequence minus one nucleotide, it is unpredictable which species within the population would also encode a dual transit peptide or a polypeptide having protoporphyrinogen oxidase (PPO) activity. Variants are also not adequately described because it is not known what sequences are “substantially similar” to SEQ ID Nos. 1 and 448 and would have the dual transit peptide function and PPO activity, respectively. Accordingly, there is lack of adequate description to inform a skilled artisan that Applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines at https://www.uspto.gov/sites/default/files/web/menu/written.pdf.
Claim Rejections - 35 USC § 102
13. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
14. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
15. Claims 1 and 5-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Evdokimov et al. (US Pub. No.20170037427, published 02/19/2017 (A)). Evdokimov teaches a recombinant chimeric nucleic acid molecule comprising a nucleic acid sequence encoding a dual transit peptide operably linked to a heterologous nucleic acid sequence encoding a polypeptide having PPO activity for conferring tolerance to PPO-inhibiting herbicides and comprises SEQ ID NO:1 ([0056], claim 1). SEQ ID NO:1 of Evdokimov was obtained from Enterobacter cloacae, a prokaryote, and has 100% sequence identity to Applicant’s SEQ ID NO:448. Evdokimov also teaches an expression cassette with an operably linked promoter, plant cell, plant and seed (claims). Accordingly, the claimed invention is anticipated by the prior art.
Claim Rejections - 35 USC § 103
16. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
17. Claims 2 and 4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Evdokimov et al. (US Pub. No.20170037427 (A)), as applied to claims 1 and 5-12 above, and in view of Tranel et al. (US 20100100988 (Applicant’s IDS)) and in light of Patzoldt et al. (Published Applications Database, US20100100988, SEQ ID NO:14, published 22 April 2010 (Applicant’s IDS)).
The teachings of Evdokimov have been discussed above.
Evdokimov does not teach SEQ ID NO:1 as the dual transit peptide.
Tranel teaches the dual transit peptide from Amaranthus having 100% sequence identity to Applicant’s SEQ ID NO:1. Specifically, Tranel teaches the PPO polypeptide from Amaranthus for conferring herbicide resistance, and its N-terminal region is a dual transit peptide targeting expression to both the chloroplast and mitochondrion [0070]. Tranel identified the region of the Amaranthus PPO sequence that is the dual transit peptide [0086], see positions 1-98 of SEQ ID NO:14 from Patzoldt (same publication) below.
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Tranel states, “The PPO gene of the present invention advantageously contains both chloroplast and mitochondrial transit peptides. Others known to the art can be substituted, if deemed advantageous.” [0070]. Thus, signal sequences and genes of interests may be heterologous to each other. Tranel further states:
“With regards to herbicide-resistance evolution, it remains to be determined if a herbicide-resistant PPX2 gene must contain dual-targeting sequences to provide resistance at the whole plant level. If this characteristic promotes resistance, it is believed that weeds containing a PPX2L gene would evolve resistance to PPO-inhibitors faster than those lacking a dual-targeted PPX2” [0087]
For clarification, PPX2 and PPX2L refer to structurally the same Amaranthus PPO sequence containing the dual transit peptide. Tranel postulated that a dual transit peptide operably linked to a PPO sequence confers whole plant level and faster-evolving PPO-inhibiting herbicide resistance than a PPO sequence lacking the dual transit peptide [0087].
It would have been prima facie obvious at the time of filing to substitute the generic dual transit peptide of Evdokimov with the Amaranthus dual transit peptide of Tranel having 100% sequence identity to Applicant’s SEQ ID NO:1 for directing the expression of the PPO sequence to the mitochondria and/or chloroplast for the purpose of producing a PPO-herbicide resistant plant as taught by Evdokimov. Tranel teaches a dual transit peptide from Amaranthus having 100% sequence identity to Applicant’s dual transit peptide of SEQ ID NO:1 and the advantages of using said dual transit peptide: translocating the operably linked expressed PPO sequence to both chloroplast and mitochondrion to confer whole plant level and faster-evolving PPO-inhibiting herbicide resistance than those lacking the dual transit peptide. Accordingly, one skilled in the art would have been motivated to produce the claimed invention with a reasonable expectation of success.
Conclusion
18. No claim is allowed.
19. Any inquiry concerning this communications from the Examiner should be directed to Phuong Bui, whose telephone number 571-272-0793.
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, for sending official correspondence, is 571-273-8300.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663