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 3/6/2026 wherein claims 1-19, 21-23, and 28-30 were canceled; claim 24 was amended; and claims 31-43 were added.
Note(s): Claims 20, 24-27, and 31-43 are pending.
Priority
This application is a CON of PCT/US2024/059036 filed 12/6/2024;
PCT/US2024/059036 claims benefit to PRO 63/721,990 filed 11/18/2024;
PCT/US2024/059036 claims benefit to PRO 63/650,364 filed 5/21/2024;
PCT/US2024/059036 claims benefit to PRO 63/650,365 filed 5/21/2024;
PCT/US2024/059036 claims benefit to PRO 63/636,076 filed 4/18/2024; and
PCT/US2024/059036 claims benefit to PRO 63/607,988 filed 12/08/2023.
Note(s): The earliest effective filing date is 11/18/2024 as the pending invention is fully supported in provisional application 63/721,990. Support for SEQ ID NO: 267 (see independent claims 20, 42, and 43) was not found in the other provisional applications listed supra.
Claim Interpretation
Independent claim 20 is directed to a composition comprising a polypeptide having an amino acid sequence comprising SEQ ID NO: 267.
Claim 24 is directed to a method of treating cancer comprising administering the composition of claim 36.
Claim 36 is directed to a composition comprising SEQ ID NO: 267, a chelator, linker, and radionuclide.
Claim 42 is directed to a composition comprising a polypeptide having an amino acid sequence comprising SEQ ID NO: 267, wherein the polypeptide is a miniprotein (M) that further comprises a radionuclide (R) chelated to a chelator (C), which chelator is conjugated to the N-terminus of (M) through a linker (L), wherein R is Ac-225, C comprises DOTA, and L comprises PEG4.
Claim 43 is directed to a composition comprising a polypeptide having an amino acid sequence comprising SEQ ID NO: 267, wherein the polypeptide is a miniprotein (M) that further comprises a radionuclide (R) chelated to a chelator (C), which chelator is conjugated to the N-terminus of (M) through a linker (L), wherein R is Cu-64, C comprises DOTA, and L comprises PEG4.
Applicant’s Election
Applicant's election without traverse of Group II (pending claims 20 and 32-43) filed 3/6/2026 is acknowledged.
Amended claim 20 directed to a composition comprising SEQ ID NO: 267 was searched. Since no prior art was found to reject the claims, the restriction requirement mailed 1/7/2026 was withdrawn as indicated below.
Rejoining of Claims
Claim 20 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 24-27 and 31, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 1/7/2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, 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.
Information Disclosure Statement
The information disclosure statement filed 10/31/2025 was considered.
Written Description Rejection
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.
Claim 27 is 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 is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection. The pending application does not sufficiently describe the invention as it relates other childhood kidney tumors that are being referenced in claim 17. The types of cancers listed in claim 27 are not listed as being only directed to those present in a subject’s childhood. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
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 26, 27, 31, 34, 35, 37, 38, and 40-43 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 26: The claim is ambiguous because it reads on claim 24 which is directed to a method of treating cancer while claim 26 is directed to a subject diagnosed as having cancer. If claim 24 is a method of treating cancer, then the subject is not being diagnosed as having cancer, but actually has cancer present because it is being treated.
Claim 27 (line 21) and 31: The claim is ambiguous because it is unclear what ‘other childhood kidney tumors’ diseases/disorders Applicant is referring that should be a part of the claim limitations. Since claim 31 depends upon claim 27 for clarity, the claim is also vague and indefinite.
Claims 34 and 35: According to MPEP 803.02, proper Markush terminology requires ‘closed’ language. The use of the term ‘comprises’ is ‘opened’ language as it allows for unnamed substances to be present in the Markush listing.
Claim 34: According to MPEP 2173.05(s), where possible, claims are to be complete in themselves. Incorporation by reference to specific tables is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplication a table into the claims. For clarity of the claimed invention, that appropriate portions of Tables 2A and 2C should be incorporated into the claim. In addition, the claim is confusing because it is unclear what fragment(s) Applicant is referring to in all the linkers and references to Table 2A and 2C.
Claims 35, 37, 38, and 40-43: Did Applicant intend to replace ‘comprises’ with ‘is’? Specifically, the components (L, C, and R) being referenced in the claims are the actual components (linker, chelator, and radionuclide), not comprises those components.
Allowable Claims
Claims 20, 24, 25, 32, 33, 36, and 39 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 rejections supra. In particular, the prior art neither anticipates nor renders obvious a composition or uses thereof comprising SEQ ID NO: 267. The closest art is that of Abou-Elkacem et al (WO 2020041626) which is directed to similar sequences.
Conclusion
Claims 20, 24, 25, 32, 33, 36, and 39 are allowable over the prior art of record. Claims 26, 27, 31, 34, 35, 37, 38, and 40-43 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.
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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
March 28, 2026