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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 5/20/2026 wherein claims 1-30, 32, 33, and 42 were canceled.
Note(s): Claims 31, 34-41, and 43-45 are pending.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/20/2026 has been entered.
Priority and Priority Document
This application is a 371 of PCT/EP2020/062950 filed 5/8/2020 and claims priority to PCT/EP2019/061882 filed 5/8/2019.
Note(s): The earliest effective filing date is 5/8/2019 as the parent applications fully support the claimed invention.
Once again, receipt of the certified priority document filed 11/4/2021 is acknowledged as required by 37 CFR 1.55.
Response to Applicant’s Amendment and/or Arguments
Applicant's amendment filed 3/9/2026 regarding withdrawn claims 15-28 is duly noted.
Clarification of the Record
While no prior art is cited against the pending claims, clarification of the claimed invention is necessary as the pending invention (see independent claim 31) is somewhat vague. The Examiner is respectfully requesting that Applicant consider amending the claim to clarify what is actually being claim. A suggestion of how one may clarify the invention is found below as a starting point to assist Applicant.
NEW GROUNDS OF REJECTION
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 31, 34-41, and 43-45 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.
Claims 31, 34-41, and 43-45: Independent claim 31 is ambiguous because the manner in which the claim is written does not clearly set forth the claimed method. Since claims 34-41, and 43-45 depend upon independent claim 31 for clarity, those claims are also indefinite.
Below is a suggestion of how one may consider clarifying the pending invention.
Suggestion: A method of reducing nephrotoxicity of a radiopharmaceutical in a subject comprising:
administering a pharmaceutical composition comprising para-amino hippuric acid (PAH) or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient, diluent, carrier, or a combination thereof, to the subject prior to, during, or after imaging or therapy;
wherein the radiopharmaceutical in said subject is a radionuclide-containing conjugate molecule comprising a carrier molecule, a chelator, and a radionuclide.
Information Disclosure Statement
The information disclosure statement filed 5/20/2026 was considered.
Allowable Claims
Claims 31, 34-41, and 43-45 are allowable over the prior art of record. In particular, the prior art neither anticipates nor renders obvious a method of nephrotoxicity reduction wherein a subject is administered a pharmaceutical composition comprising para-amino hippuric acid (PAH) or a pharmaceutically acceptable salt as set forth in independent claim 31.
Conclusion
Claims 31, 34-41, and 43-45 are rejected.
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.
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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
June 27, 2026
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