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
Applicant’s election without traverse of (A) SEQ ID NO: 69 and (B) SEQ ID NO: 13 in the reply filed on 30June2026 is acknowledged.
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).
Status of the Claims
The amendments and arguments filed 30June2026 are acknowledged and have been fully considered. Claims 1-5, 12, 14-31, 41, 44, 46-47, and 49 are canceled. Claims 6-11, 13, 32-40, 42-43, 45, 48, 50-51 are pending and examined on the merits herein. Claims 9-10, 13, 35, 37, 39-40, 42-43, 45 are original. Claims 7, 11, and 50-51 were previously presented. Claims 6, 8, 32-34, 36, 38, 48 are currently amended.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) [US provisional 62724276 filed 29August2018], 35 U.S.C. 365(c) [national stage entry of PCT/US19/47660 filed 22August2019], 35 U.S.C. 121 [divisional of 17269314 filed 18February2021, now US Pat No 11878999 the subject of Reissue Appl. No. 19639493], and 35 U.S.C. 120 [continuation of 18544571 filed 19December2023]. Claims 6-11, 13, 32-40, 42-43, 45, 48, 50-51 have an effective filing date of 29August2018 (see Table 4 on page 70 of the specification for US provisional 62724276).
Comment on the Claims & Utility
Because the specification describes polypeptides having at least 90% sequence identity to SEQ ID NO: 69 (as well as polynucleotides encoding them) as having an about 196 IC50 value against Spodoptera frugiperda (Fall Armyworm, referred to as “FAW” in the specification) (see Table 4 on page 70 of the specification), and because such insecticidal polypeptides/polynucleotides are known in the art to be useful as a topical application (e.g., a seed coating or soil application as described at least at lines 21-24 on page 49 of the specification); a person with even ordinary skill in the art would recognize that the subject matter of claims 6-8, 32, 34-37 have a specific and substantial utility.
Claim Rejections - 35 USC § 112 - Indefiniteness
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 35-37 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.
The rejected claims all refer back to claim 34, from which “recombinant” is now removed. Because claims 35-37 all still reference “the recombinant”, these claims are indefinite for a lack of antecedent basis.
If Applicant would like to remove “recombinant” from all claims, please amend claims 35-37 to remove “recombinant” (please note that “recombinant” is recited twice within claim 36).
Claim Rejections - 35 USC § 112 – 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 32-37, 42, 45 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.
Claim 32 encompasses any fragment of an amino acid sequence that has 95% sequence identity to SEQ ID NO: 69 and that maintains insecticidal activity.
The specification describes polypeptides having at least 90% sequence identity to SEQ ID NO: 69 (as well as polynucleotides encoding them) as having an about 196 IC50 value against Spodoptera frugiperda (Fall Armyworm, referred to as “FAW” in the specification), but the specification does not explain what portion of that sequence is minimally sufficient to confer that insecticidal effect. Therefore, the specification does not describe what fragment size or sequence would be minimally sufficient to confer that insecticidal effect.
The prior art does not supplement the deficiencies of this specification.
Absent evidence to the contrary, a skilled artisan would not reasonably recognize Applicant as being in possession of a fragment of the insecticidal polypeptide having at least 95% sequence identity to SEQ ID NO: 69 that maintains insecticidal activity (i.e., that Applicant was in possession of what portion of SEQ ID NO: 69 is minimally sufficient to confer insecticidal activity against Spodoptera frugiperda (Fall Armyworm, referred to as “FAW” in the specification)).
Please delete the reference to “fragments” in claim 32.
Conclusion
The following is a statement of reasons for the indication of allowable subject matter: this family of applications appear to be the first to disclose a domain-shuffled insecticidal protein having the claimed structure of an amino acid sequence with at least 90% sequence identity to SEQ ID NO: 69 (as well as the polynucleotides encoding it) and its use to confer insecticidal activity against Spodoptera frugiperda (Fall Armyworm, referred to as “FAW” in the specification) (see Table 4 on page 70 of the specification). The closest prior art may be identified as BRAMLETT et al. WO2017003811 which generally describe the use of domain swapping to generate a recombinant Cry protein with insecticidal activity against S. frugiperda (Fall Armyworm).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
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 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.
/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
Prosecution Insights