Office Action Predictor
Last updated: April 16, 2026
Application No. 19/327,141

HEPTAMETHINE CYANINE NEAR-INFRARED FLUORESCENT DYE, PREPARATION METHOD THEREFOR AND USE THEREOF

Final Rejection §112
Filed
Sep 12, 2025
Examiner
JONES, DAMERON LEVEST
Art Unit
1618
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Nanjing Nuoyuan Medical Devices Co., LTD
OA Round
2 (Final)
68%
Grant Probability
Favorable
3-4
OA Rounds
3y 5m
To Grant
83%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allow Rate
721 granted / 1068 resolved
+7.5% vs TC avg
Strong +16% interview lift
Without
With
+15.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 5m
Avg Prosecution
44 currently pending
Career history
1112
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
28.7%
-11.3% vs TC avg
§102
5.6%
-34.4% vs TC avg
§112
25.7%
-14.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1068 resolved cases

Office Action

§112
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 . Acknowledgements and Claim Status The Examiner acknowledges receipt of the amendment filed 2/1/2026 wherein claims 1-10 were amended. Note(s): Claims 1-10 are pending. Priority & Priority Document This application is a CON of PCT/CN2024/105429 filed 7/15/2024 which claims benefit to China CN202410451606.0 filed 4/16/2024. Once again, acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). The certified copy was filed in the pending application on 9/12/2025. While the certified copy of the prior document was non-English, an English translation was submitted on 2/1/2026. Note(s): The earliest effective filing date is 4/16/2024 because the English translation of the priority document indicates that the pending invention is fully supported therein. Claim Interpretation Independent claim 1 is directed to a heptamethine cyanine near infrared fluorescent dye having Formula I, PNG media_image1.png 192 280 media_image1.png Greyscale , wherein X and Y are independently hydrogen or a salifiable positive ion comprising a positive alkali metal ion and/or NH4±; m and n are independently 3 or 4; and g is an integer selected from 0-20. Claim 3 is directed to a method of preparing the heptamethine cyanine near infrared fluorescent dye of independent claim 1 as set forth therein. Claim 9 is directed to a method of fluorescent contrast imaging as set forth in claim 9. Claim 10 is directed to a method of diagnosing a tumor as set forth in claim 10. Response to Applicant’s Amendment and/or Arguments The Applicant's arguments and/or amendment filed 2/1/2026 to the rejection of claims 1-10 made by the Examiner under 35 USC 112 and/or 101 have been fully considered and deemed persuasive because Applicant amended the claims to overcome the rejections. Therefore, the said rejections are hereby WITHDRAWN. NEW GROUNDS OF REJECTIONS 112 Second Paragraph Rejections 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 9 and 10 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. Claim 9: The claim is incomplete as it does not indicate what happens after administering the contrast agent to the subject. How is the imaging obtained. Did Applicant intend to in the step of “and generating an image of the subject”? Claim 10: The claim is ambiguous because it is unclear what happens after administering the fluorescent dye to a subject. In particular, it is unclear what steps result in one diagnosing the presence or absence of a tumor in a subject. Allowable Claims Claims 1-8 are allowable over the prior art of record. Comments/Notes It should be noted that no prior art is cited against the pending invention. However, Applicant must address and overcome the 112 second paragraph rejections supra. In particular, the claims are distinguished over the art because the prior art neither anticipates nor renders obvious the specific heptamethine cyanine near infrared fluorescent dyes as set forth in independent claim 1. The Examiner attempted to resolve all outstanding issues in the application. However, due to Applicant’s not being available, Applicant’s Representative requested that the Examiner generate a written communication of the issue. Conclusion Claims 1-10 are rejected. 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. Future Correspondences Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F. 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, Michael G. Hartley can be reached at (571)272-0616. 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. /D. L. Jones/ Primary Patent Examiner Art Unit 1618 February 21, 2026
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Prosecution Timeline

Sep 12, 2025
Application Filed
Oct 30, 2025
Non-Final Rejection — §112
Jan 31, 2026
Response Filed
Feb 20, 2026
Examiner Interview (Telephonic)
Feb 20, 2026
Final Rejection — §112
Mar 30, 2026
Response after Non-Final Action

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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
68%
Grant Probability
83%
With Interview (+15.9%)
3y 5m
Median Time to Grant
Moderate
PTA Risk
Based on 1068 resolved cases by this examiner. Grant probability derived from career allow rate.

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