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 .
Election/Restrictions
The Office acknowledges the receipt of Applicant’s restriction election filed June 26, 2026. Applicant elects Group II, claims 8-13 and the species Gossypium, SEQ ID NO: 7 encoding SEQ ID NO: 8, without traverse. Claims 1-19 are pending. Claims 1-7 and 14-19 are non-elected. Claims 8-13 are examined to the extent of the elected species. The restriction is made FINAL.
Applicant claims foreign priority benefit of Application No. CN2002210263097.X filed March 17, 2022. However, no certified English translation has been submitted.
Specification
The specification is objected to for the following reasons:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. For example, see page 11, line 4 and page 16, lines 20-21.
On page 13, lines 24-25, Applicant identifies Gh_A09G0741 as a GhJAZ13 sequence. However, Li et al. discloses Gh_A09G0741 is a GhJAZ14-A sequence (Li et al., Scientific Reports, 7:2788, pgs. 1-14, doi:10.1038/s41598-017-03155-4, 5 Jun. 2017 (U)). It is unclear whether Gh_A09G0741 is a GhJAZ13 or GhJAZ14-A sequence. Additionally, Applicant identifies Gh_A10G0388 as a GhJAZ14 sequence. However, Li et al. discloses Gh_A10G0388 is a GhJAZ8-A sequence.
Clarification and/or correction is required.
Claim Objections
Claims 8-13 are objected to because of the following:
In claim 8, “GhJAZ” should be spelled out the first time it is recited.
In claim 8, “NGR” should be spelled out the first time it is recited.
In claim 8, line 8, “an” should be amended to “the”, because there is only one SEQ ID NO:17. See also claim 12(3).
In claim 12(2), “an end” should be amended to “the end”, because each sequence has only one beginning and one end.
Dependent claims are included.
Appropriate correction is required.
Double Patenting
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.
Claims 8-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39-44 of copending Application No. 18/570,164 (here after ‘164). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of ‘164 is directed to same population of plants, utilizes the same sequence and have the same steps. SEQ ID NO: 26 of ‘164 was obtained from Gossypium and has 100% sequence identity to Applicant’s SEQ ID NO: 17. Therefore, the plant produced in the method of ‘164 would inherently have the insect / Lepidoptera plant pest resistance phenotype. SEQ ID NO: 48 of ‘164 has 100% sequence identity to Applicant’s SEQ ID NO: 8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112(b)
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 8-13 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.
In claim 8, the insect resistance in the transgenic plant should be compared to that of a control plant and not to a target plant, because the target plant is defined as having the NGR domain (line 8).
Claim 11, the recitation of “derived” is unclear because it is not known what is retained in the derived product. It is suggested “derived” be amended to “obtained”. See also claim 12 (2), which recites “derived obtained”.
Claim 12 (2), the recitation of “activity” is unclear because no activity is recited in the claim. A protein activity is not the same as a plant phenotype.
In claim 12(3), it is unclear whether Applicant intends for the protein to comprise SEQ ID NO:7 and SEQ ID NO:17, i.e., two NGR domains, because SEQ ID NO:7 already has SEQ ID NO:17.
In claim 13(2), it is unclear what conditions are necessary for the DNA molecule to be capable of hybridizing with the defined DNA sequence. It is suggested that “capable of hybridizing” be amended to “hybridizes”.
In claim 13(2), “the defined DNA sequence” lacks antecedence. See also claim 13(3).
Claim 13 (2), “harsh” is a subjective term that is not clearly defined by those skilled in the art.
In claim 13(2), no function is recited for the DNA molecule. Also, “having the same function” lacks a comparative basis—having the same function as what? See also claim 13(3).
In claim 13(2), a DNA molecule that hybridizes to SEQ ID NO:8 is a negative sense strand and does not encode a protein having any function.
In claim 13(2), a DNA molecule that hybridizes to SEQ ID NO: 8 encompasses a sequence having as little as two nucleotides, or encoding a sequence having as little as two amino acids, which does not appear to be Applicant’s intention.
In claim 13(3), it is unclear whether ___% homology is determined by sequence comparison or by evolutionary relatedness. It is suggested that “homology” be amended to “sequence identity”.
Correction and/or clarification is required.
Claim Rejections - 35 USC § 112(a )(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 8-13 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’s disclosure is as follows.
GhJAZ13 is SEQ ID NO:8 encoding SEQ ID NO:7, which comprises the NGR domain having SEQ ID NO:17. Example 2 show that SEQ ID NO:7 causes apoptosis in ovarian cells of army worm, a plant Lepidoptera pest, in vitro. GhJAZ8, a homolog of GhJAZ13, has resistance against Lepidoptera pests armyworm, bollworm and Cnaphalocrocis medinalis in transgenic rice, corn, cotton and tobacco (Example 4).
The claimed invention lacks adequate written description for the following reasons.
Claim 8 is directed to a method for cultivating an insect resistant transgenic plant comprising increasing the content of a GhJAZ protein comprising an NGR domain having SEQ ID NO:17. SEQ ID NO:17 has 15 amino acids. The disclosure of a 15-amino-acid NGR domain is not representative of the genus of GhJAZ proteins and does not allow one skilled in the art to predict the structure of the full-length GhJAZ protein. It is unlikely that the NGR domain alone would confer the claimed phenotype but it is unpredictable what structure comprising said NGR domain would. Accordingly, a GhJAZ protein comprising SEQ ID NO:17 lacks adequate written description. Claims 9-11 do not address the structure of the GhJAZ protein.
Claim 12(2) is not rejected under written description because the claim defines the derivative protein as having SEQ ID NO:7 and a tag sequence at the end of SEQ ID NO:7.
With regard to claim 12(3), while one skilled in the art can generate a population of sequences having 95-99% sequence identity to SEQ ID NO:7, one skilled in the art cannot predict which sequence(s) within said population would confer insect resistance when expressed in a plant. Neither the state of the prior art nor Applicant’s disclosure teaches regions within SEQ ID NO:7 that must be conserved for insect resistance. Accordingly, GhJAZ proteins comprising 95-99% sequence identity to SEQ ID NO:7 and further comprising SEQ ID NO:17 for conferring insect resistance lacks adequate written description.
Claim 13(2) lacks adequate written description because the claim is not defined by having any particular structure or length, the DNA molecule is a negative sense molecule, and no function for the molecule is recited. No structure and function relationship is disclosed. In fact, no functional activity for SEQ ID NO:7 is disclosed at all, let alone a functional activity for the negative sense DNA molecule.
Claim 13(3) lacks adequate written description because in addition to a lack of a recitation of function, one skilled in the art cannot predict which sequence(s) within a population having 70-99% sequence identity to SEQ ID NO:8 would confer insect resistance when expressed in a plant. Neither the state of the prior art nor Applicant’s disclosure teaches regions within SEQ ID NO:8 that must be conserved for insect resistance. Accordingly, a nucleic acid molecule encoding a GhJAZ protein comprising 70-99% sequence identity to SEQ ID NO:8 for conferring insect resistance lacks adequate written description.
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 published in Federal Register/ Vol.66, No. 4/ Friday, January 5, 2001/ Notices; p. 1099-1111.
Claim Rejections - 35 USC § 112 (Enablement)
Claims 8-13 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Enablement factors to consider include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Applicant’s disclosure is as set forth above. The claimed invention is not enabled for the following reasons.
The nature of the invention is a method of producing an insect resistant plant by expressing a GhJAZ protein in the plant.
With regard to insect resistance, the scope of the claims encompasses all insects in all their life cycles. The state of the prior art does not teach a single protein for conferring resistance to all insect plant pests. Applicant’s working examples are resistance against Lepidoptera plant pests only. It is unpredictable whether SEQ ID NO:7 would confer resistance against other insect plant pests such as whiteflies, which have a different mode of attack on plants. Accordingly, one skilled in the art cannot practice the claimed method against all insect plant pests as commensurate in scope with the claims without undue experimentation.
With regard to claims that recite 95-99% sequence identity to SEQ ID NO:7 or 70-99% sequence identity to SEQ ID NO:8, the less than 100% sequence identity scope encompasses nucleotide / amino acid deletions, insertions, substitutions and any combination thereof anywhere in these sequences, so long as they retain the 95-99% sequence identity or 70-99% sequence identity. While one skilled in the art can readily make mutations to a sequence, further guidance is necessary as to what region(s) of these sequences must be retained, and what regions can tolerate mutations, for the insect resistance phenotype. Applicant has no working example of mutated sequences having 95-99% sequence identity to SEQ ID NO:7 or 70-99% sequence identity to SEQ ID NO:8 that can confer insect resistance. The state of the prior art does not teach particular domains of a GhJAZ sequence that are essential for conferring the insect resistance phenotype. It is unpredictable what mutations can be made to SEQ ID NO:8 or to a sequence encoding SEQ ID NO:7 without adversely affecting the claimed phenotype. Accordingly, Applicant has not enabled 95-99% sequence identity to SEQ ID NO:7 and 70-99% sequence identity to SEQ ID NO:8 for conferring insect pest resistance in a plant as commensurate in scope with the claims without undue experimentation.
Given the breadth of the claims, the state of the prior art, the lack of predictability, and the lack of guidance and working examples, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation required to make the claimed invention would likely be extensive and undue.
Weighing all the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Scientific Reports, 7:2788, pgs. 1-14, doi:10.1038/s41598-017-03155-4, 5 Jun. 2017 (U)).
Li teaches a method for cultivating a transgenic tobacco plant comprising increasing the expression of a nucleic acid molecule encoding a GhJAZ protein from Gossypium comprising a domain having 100% sequence identity to Applicant’s NGR domain as set forth in SEQ ID NO:17 (Fig. 2, see ZIM domain of the first 6 GhJaz proteins; Fig. 6, GhJAZ7-A). Because the method of Li is applied to the same population of plants, utilizes the same reagents (a nucleic acid molecule encoding a GhJAZ protein), and has the same result (GhJaz expression in a transgenic plant), the method of Li would inherently produce a plant that is resistant to insect plant pest Lepidoptera.
Therefore, the claimed invention is anticipated by the prior art.
Claim Rejections - 35 USC § 103
14. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
15 Claims 8-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al., (Frontiers in Plant Science, Vol. 8:1963, doi: 10.3389/fpls.2017.01963.2017.01963 (V)) in view of Chen et al. (UniProt Database, Accession No. A0A1U8HW36, Nat. Genet., 52:525-533. 2020 (W), see Result 1).
Tang teaches overexpressing defense related genes in Nicotiana tabacum which enhances plant resistance to Ralstonia solanacearum (Abstract).
Tang does not teach expressing Applicant’s SEQ ID NO:7.
Chen teaches a GhJAZ defense response protein from Gossypium which has 100% sequence identity to Applicant’s SEQ ID NO:7 (see sequence alignment and description).
Therefore, prior to the effective filing date of the instant application, it would have been prima facie obvious to one of ordinary skill in the art to substitute a defense related gene of Tang with a different defense protein, such as the defense protein of Chen, to increase a plant’s defense response and improve plant growth. A plant expressing the sequence of Chen would inherently have resistance to insect plant pest Lepidoptera. The nucleic acid molecule encoding the sequence of Chen appears to have at least 70% sequence identity to Applicant’s SEQ ID NO:8, or is at least capable of hybridizing to a sequence that is complementary to Applicant’s SEQ ID NO:8 under “a harsh condition”, however “harsh” is defined. Accordingly, one skilled in the art would have been motivated to produce the claimed invention with a reasonable expectation of success.
Conclusion
16. No claim is allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JOSE ORDAZ whose telephone number is (703)756-1967. The examiner can normally be reached 8:30 am-5:00 pm.
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 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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/C.J.O./Examiner, Art Unit 1663
/PHUONG T BUI/Primary Examiner, Art Unit 1663
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