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 .
DETAILED ACTION
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election of group I, drawn to compounds of the formula I and simple compositions thereof and elected species of example 20 in the disclosure in the reply filed on 11/28/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-26 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claim 27, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 10/24/2025 is hereby withdrawn.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 continuation or 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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Priority
This specification claims the benefit of priority to U.S. Provisional Patent
Application No. 63/366,700 (filed 21 June 2022).
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statement filed of record.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Pursuant to In re Wands, 858 F.2d 731,737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Some experimentation is not fatal; the issue is whether the amount of experimentation is "undue"; see In re Vaeck, 20 USPQ2d 1438, 1444. Analysis is described below:
(A) Breadth of claims: The claims cover the treatment and even prevention of FAP-mediated conditions using the compounds of claim 1. Scope of claims embrace conditions known in the art and those yet discovered. These claims are known as "reach-through" claims, i.e. claims directed to a chemical compound (or the use of that compound) defined only in functional terms with regard to the technical effect it exerts on one of the above molecules. Therefore, the number of diseases/conditions embraced by the claims is indeed expansive.
(B) The nature of the invention:
(C),(F),(G) State of the Prior Art/Direction/Working Examples:
The limited information provided in the disclosure could not possibly enable one skilled in the art to use the compounds of formula I in the manner currently recited at the time the invention was achieved.
In reference to working examples, claimed compounds are, so far as the examiner is aware have not been successfully used as drugs for the prevention or treatment of FAP-mediated disorders. The specification appears to have adequate support for the in vitro inhibition of FAP as described at page 154. No other information is provided regarding how to extrapolate this limited information for treating or preventing the scope of disorders encompassed by the claims. There is no evidence shown in the disclosure or art that the provided assay/model correlates to the treatment of the full scope of claimed diseases (those known and even unknown as mentioned previously).
In this regard, the issue of "correlation" is also dependent on the state of the prior art as mentioned previously. In other words, if the art is such that a particular model is recognized as correlating to a specific condition, then it should be accepted as correlating unless the examiner has evidence that the model does not correlate. Even with such evidence, the examiner must weigh the evidence for and against correlation and decide whether one skilled in the art would accept the model as reasonably correlating to the condition. In re Brana, 51 F.3d 1560, 1566, 34 USPQ2d 1436, 1441. A (Fed. Cir. 1995) (reversing a USPTO decision based on finding that in vitro data did not support in vivo applications). See MPEP 2164.02.
Furthermore, the art teaches that the use of FAP inhibitors in clinical use (e.g. metabolic, thrombolytic therapy, etc.) is limited and are still under exploration (see Simkova et al. Molecular recognition of fibroblast activation protein for diagnostic and therapeutic applications, Biochimica et Biophysica Acta (BBA,) - Proteins and Proteomics Volume 1868, Issue 7, July 2020, 140409, see page 11, upper right column, and conclusion section at page 12). Thus the ability of the claimed compounds to be used in the manner recited in claim 27 is highly questionable.
(D) Skill of those in the art: The level of skill in the art is high and one would possess a Ph.D. in synthetic organic chemistry.
(E) Level of predictability in the art: It is well established that "the scope of enablement varies inversely with the degree of unpredictability of the factors involved," and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(H) The quantity of experimentation needed: Since there are very limited working examples as described above, the amount of experimentation is expected to be high and burdensome. Applicant fails to provide guidance and supporting information for making the thousands of other compounds which are encompassed by the claims, therefore undue experimentation would be expected.
Due to the level of unpredictability in the art, the very limited guidance provided, and the lack of working examples, the applicant has shown lack of enablement. MPEP 2164.01(a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)." That conclusion is clearly justified here.
Conclusion
Claims 1-26 are allowable. Claim 27 is rejected. There is no relevant art to be cited by the examiner in reference to the novelty of the compounds of formula I.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624