Prosecution Insights
Last updated: April 19, 2026
Application No. 17/605,724

CODON OPTIMIZED SYNTHETIC NUCLEOTIDE SEQUENCES ENCODING CRY2Ai PROTEIN AND USES THEREOF

Final Rejection §101§103§112§DP
Filed
Sep 21, 2022
Examiner
COLLINS, CYNTHIA E
Art Unit
1662
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Dcm Shriram Limited
OA Round
2 (Final)
82%
Grant Probability
Favorable
3-4
OA Rounds
2y 5m
To Grant
92%
With Interview

Examiner Intelligence

Grants 82% — above average
82%
Career Allow Rate
1079 granted / 1309 resolved
+22.4% vs TC avg
Moderate +9% lift
Without
With
+9.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
28 currently pending
Career history
1337
Total Applications
across all art units

Statute-Specific Performance

§101
4.4%
-35.6% vs TC avg
§103
15.3%
-24.7% vs TC avg
§102
17.4%
-22.6% vs TC avg
§112
52.4%
+12.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1309 resolved cases

Office Action

§101 §103 §112 §DP
DETAILED ACTION The Amendment filed August 22, 2025 has been entered. Claims 2, 4-5, 7, 10, 16-17 and 19-20 are cancelled. Claims 1, 6 and 9 are currently amended. Claims 1, 3, 6, 8-9, 11-15, 18 and 21-23 are pending. Claims 11-15, 18 and 21-23 are withdrawn. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. All previous objections and rejections not set forth below have been withdrawn. 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 . Withdrawn Claim Objections The objection to claim 1 is withdrawn in light of the amendment of claim 1. The objection to claim 6 is withdrawn in light of the amendment of claim 6. Withdrawn Claim Rejections The rejection of claim 1 under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more is withdrawn in light of the amendment of claim 1, and in light of Applicant’s arguments. The rejection of claims 1, 3, 6, 8 and 9 under 35 U.S.C. 103 as being unpatentable over are rejected under 35 U.S.C. 103 as being unpatentable over Bramlett et al (US 2018/0194813, published 12 July 2018) in view of GenBank Accession ACV97158.1 (2012, https://www.ncbi.nlm.nih.gov/protein/ACV97 158.1), Viallalobos et al (Gene Designer: a synthetic biology tool for constructing artificial DNA segments. BMC Bioinformatics. 2006 Jun 6:7:285), Murray et al (Codon usage in plant genes. Nucleic Acids Research. Volume 17, Number 2, 1989) and Perlak et al (Modification of the coding sequence enhances plant expression of insect control protein genes. Proc. Natl. Acad. Sci. USA Vol. 88, pp. 3325-3328, April 1991) is withdrawn in light of the amendment of claim 1, and in light of Applicant’s arguments. The provisional rejection of claims 1, 3, 6, 8 and 9 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7 and 9 of copending Application No. 17/625,904 (reference application) is withdrawn in light of the amendment of claim 1. Election/Restrictions Claim 1 allowable. Claims 11-15, 18, and 21-23, previously withdrawn from consideration as a result of a restriction requirement, require all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among inventions I-III as set forth in the Office action mailed on November 21, 2024, is hereby withdrawn and claims 11-15, 18, and 21-23 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. Claim Objections Claim 18 is objected to because of the following informalities: in lines 2-3, “Cry2Ai protein” lacks an article. Also, in line 3, “amino acid sequence” lacks an article. In order to overcome the objection, it is suggested that claim 18 be amended to recite “a Cry2Ai protein”, and “the amino acid sequence”. Claim Rejections - 35 USC § 112 and 35 USC § 101 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. 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. Claims 22-23 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. Claim 22 is drawn to use of the codon optimized synthetic nucleotide sequence as claimed in claim 1, for production of insect resistant transgenic plants. Claim 23 is drawn to use of the codon optimized synthetic nucleotide sequence as claimed in claim 1 for production of insecticidal composition, wherein the composition comprises Bacillus thuringiensis cells comprising the said nucleotide sequences. Because the claims do not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Claims 22-23 are also rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966). Allowable Subject Matter Claims 1, 3, 6, 8-9, 11-15 and 20 are allowed. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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. Remarks Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA E COLLINS whose telephone number is (571)272-0794. The examiner can normally be reached M-F 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, Shubo (Joe) Zhou can be reached at 571-272-0724. 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. /CYNTHIA E COLLINS/Primary Examiner, Art Unit 1662
Read full office action

Prosecution Timeline

Sep 21, 2022
Application Filed
Oct 22, 2021
Response after Non-Final Action
Apr 19, 2025
Non-Final Rejection — §101, §103, §112
Aug 14, 2025
Applicant Interview (Telephonic)
Aug 20, 2025
Examiner Interview Summary
Aug 22, 2025
Response Filed
Dec 12, 2025
Final Rejection — §101, §103, §112
Dec 12, 2025
Examiner Interview (Telephonic)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
82%
Grant Probability
92%
With Interview (+9.1%)
2y 5m
Median Time to Grant
Moderate
PTA Risk
Based on 1309 resolved cases by this examiner. Grant probability derived from career allow rate.

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