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 6/18/2024 wherein the specification and claims 1-14 were amended and claims 15-17 were added. In addition, the Examiner acknowledges the substitute specification filed 10/21/2025
Note(s): Claims 1-17 are pending.
Priority and Priority Document
This application is a 371 of PCT/EP2022/087067 filed 12/20/2022 which claims benefit to GERMANY DE10 2021 133 942.1 filed 12/20/2021.
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 6/18/2024.
While a certified copy of the prior document was submitted, an English language translation is not of record. Should Applicant desire to obtain the benefit of foreign priority under 35 USC 119 (a) – (d) prior to declaration of an interference, a certified English language translation of the foreign application should be submitted. 37 CFR 41.154(b) and 41.202(e). Failure to provide the certified translation may result in no benefit being accorded for the non-English document.
Note(s): The earliest effective filing date is 12/20/2022 as the invention is fully supported in the PCT application.
Claim Interpretation
Independent claim 1 is directed to pharmaceutical compounds having a formula FAPi-R1-FAPs-CT as set forth therein.
Information Disclosure Statement
The information disclosure statement filed 6/19/2024 was considered.
Specification
The disclosure is objected to because of the following informalities: the structures and/or text appearing on the following pages are not readable: (1) page 25, the structures and text on the top half of the page are not readable; (2) page 28, structures on the lower half of the page are not readable; (3) page 50, it is difficult to read the third structure; and (4) page 53, the first two structures on the page are not readable.
Appropriate correction is required.
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.
Claims 1, 2, 5-15, and 17 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.
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 to MG labeling groups for a radioisotope other than chelators and derivatives thereof selected from H4pypa, EDTA, EDTMP, DTPA, NOTA, NODAGA, TRAP, NOPO, DOTA, DOTAGA, TRITA, TETA, PEPA, HEHA, HBED, HBED-CC, DEDPA, H2dedpa, H4octapa, DFO, THP, H3THP-Ac, H3THP-mal, TEAP, AAZTA, AAZTA5, DATA, DATA5m', SAR, (NH2)2SAR, N4, PnAO, BMS181321, MAG2, MAG3, N3S adipate, MAS3, MAMA, EC, DMSA, DADT, DADS, N2S2, aminothiol, HYNIC, and hydrazine nicotinamide.
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 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 1-17 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 1-17: Independent claim 1 is ambiguous for the following reasons. (1) The claim recites the limitation "the structure" in lines 2, 8-9, and 40-41. There is insufficient antecedent basis for this limitation in the claim. (2) The claim recites the limitation "the fibroblast activation protein" in lines 8 and 40. There is insufficient antecedent basis for this limitation in the claim. (3) Throughout the claims Applicant has brackets (for example, see lines 9, 10-29, and 41-67) appear to indicate deleted subject matter; thus, for clarity of the claims, one may want to consider replacing the bracket with parentheses. (4) For the variable MG (see line 6), it is unclear what labeling group for a radioisotope Applicant is referring to that is compatible with the pending invention. (5) The claim is ambiguous because of the phrase ‘derivatives thereof’. In particular, it is unclear what portion of the parent structures Applicant is referencing that present in the derivative. In other words, it is unclear what are the metes and bounds of derivatives of alcohol, amidine, amine, amide, carboxamide...and silyl ether radicals (see claim 1, lines 35-38; see also the last five line of claim 1). (6) The hashmarks appearing throughout the claims (e.g., claim 1, line 40) are confusing. According to MPEP 608.01(i), claims that set forth a plurality of elements or steps should incorporate each element or step of the claim on a separate line with the designated indentation.
Since claims 2-17 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claim 2: The claim is ambiguous because it is unclear what antimetabolites, alkylating cytotoxins, mitosis inhibitors, antibiotics, enzyme inhibitors PARP inhibitors tubulin inhibitors, tyrosine kinase inhibitors, angiogenesis inhibitors, hedgehog signaling pathway inhibitors, VEGFR inhibitors, and SERCA ATPase inhibitors Applicant is referencing that is Applicable with FAPi-R1-FAPs. (2) The hashmarks appearing throughout the claims (e.g., claim 1, line 40) is confusing. According to MPEP 608.01(i), claims that set forth a plurality of elements or steps should incorporate each element or step of the claim on a separate line with the designated indentation.
Claim 3: The phase ‘derivatives thereof’ appearing throughout the claim is ambiguous. In particular, it is unclear what portion of the parent structure Applicant is referencing is as a derivative is a variation of any portion of a species. Thus, the metes and bounds of the remaining species or what species Applicant intends to claim is vague and indefinite.
Claim 5: The claim is ambiguous because for the variable MG (see line 2) it is unclear what labeling group for a radioisotope Applicant is referring to that is compatible with the pending invention.
Claim 8: The claim is indefinite because the structures and text are not readable.
Claim 11: The claim is ambiguous for the following reasons. (1) The variable ‘n’ is not defined. (2) The hashmarks appearing throughout the claims (e.g., claim 11, line 9) are confusing. According to MPEP 608.01(i), claims that set forth a plurality of elements or steps should incorporate each element or step of the claim on a separate line with the designated indentation. (3) The claim is ambiguous because of the phrase ‘derivatives thereof’. In particular, it is unclear what portion of the parent structures Applicant is referencing that present in the derivative. In other words, it is unclear what are the metes and bounds of derivatives of benzene, phenol, cyclopentane...purine radical. In addition, it is unclear if the phrase ‘derivatives thereof’ read on lines 22-40 or 31-40. (4) Throughout the claims Applicant has brackets (for example, see lines 9, 10-29, and 41-67) appear to indicate deleted subject matter; thus, for clarity of the claims, one may want to consider replacing the bracket with parentheses.
Claim 12: The claim is ambiguous because of the brackets appearing throughout the claim. Brackets tend to indicate deleted subject matter; thus, for clarity of the claims, one may want to consider replacing the bracket with parentheses. In addition, did Applicant intend to insert ‘and’ before the last structure appearing in the claim to conclude the Markush grouping?
Claim 15: According to MPEP 2173.05(u), if the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claims does not comply with the requirements of 35 USC 112(b) or pre-AIA 35USC 112, second paragraph. Thus, Applicant is respectfully requested to make the necessary correction(s).
Trade Name, Trademark, and Other Marks Used in Commerce
Regarding claim 15, Applicant is respectfully reminded that the use of the term ‘Neovastat’ (see specification, page 22, line 15), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Comments/Notes
For clarity of the claimed invention, the following suggestions are respectfully made: (1) throughout the claims, replace ‘denotes’ with ‘is’ or ‘is selected from’; (2) in claim 1, lines 4 and 33, replace ‘with’ with ‘wherein’; (3) in claim 1, line 31, replace ‘where’ with ‘wherein’; (4) replace ‘chosen’ with ‘selected’ throughout the claims (e.g., claim 1, line 35); (4) in claim 11, replace ‘where’ with ‘wherein’; and (5) replace ‘represents’ with ‘is’ for consistency and clarity of throughout the claims (e.g., claim 11, line 25).
It should be noted that no prior art is cited in the pending invention. However, Applicant must address and overcome the 112 rejections above. In particular, the claims are distinguished over the prior art of record because the prior art neither anticipates nor renders obvious the compound of independent claim 1 comprising both a FAPi and FAPs component in combination with R1 and CT. The closest art is that of Biancofiore et al (WO 2021/160825) and Low et al (US Patent No. 12,397,069), both of which lack a FAPs component.
Conclusion
Claims 1-17 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.
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
August 22, 2026
Prosecution Insights