NON-FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed May 31, 2026.
Claims 1-5 have been amended and incorporate no new matter.
No claims have been canceled, and no new claims have been added.
Claims 8, 10, and 11 stand withdrawn as being drawn to nonelected inventions and/or species.
Thus, claims 1-7 and 9 now represent all claims currently pending and under consideration.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
REQUEST FOR CONTINUED EXAMINATION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 31, 2026 has been entered.
INFORMATION DISCLOSURE STATEMENT
No new Information Disclosure Statements (IDS) have been submitted.
RESPONSE TO ARGUMENTS
Applicant’s amendments overcome the rejection under 35 U.S.C. § 103 over Marineau et al., which has been withdrawn.
However, upon further consideration, a new ground of rejection is set forth below.
NEW REJECTIONS
Claim Rejections - 35 USC § 112(b) - Indefiniteness
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 1-7 and 9 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.
Independent claims 1 and 7 recite compounds of formula (I), or a prodrug thereof. The term "prodrug" is defined in the specification as follows:
The term “prodrug” herein refers to a compound, which produces a compound, salt, or solvate in the present invention resulting from the chemical transformation of a metabolic or chemical process when used in the treatment of an associated disease (p. 25, lines 6-8).
The metabolites of the compounds of the present application and their pharma-ceutically acceptable salts, and prodrugs that can be converted into the compounds of the present application and their pharmaceutically acceptable salts thereof in vivo, are also included in the claims (p. 27, lines 29-32).
The term "prodrug" is generally understood by those skilled in the art as a compound which is therapeutically inactive until administered to a subject and metabolized to its active form. However, the specification fails to define “prodrug” in structurally limiting terms. That is, the term "prodrug" is defined in purely functional terms, and sets no limit on the functional groups or chemical moieties which may be added to a compound of formula (I) to yield a “prodrug” thereof.
Thus, the scope of the compounds encompassed by the term “prodrug,” and the nature of the steps required to prepare them, have no clear boundary, such that substances which might constitute a “prodrug” of the claimed compounds is ambiguous. Therefore, one of ordinary skill in the art could not readily distinguish compounds which are included by the claims, from compounds which are excluded.
Because a skilled artisan would not be reasonably apprised of the scope of the claimed invention, infringing compounds cannot be distinguished from non-infringing compounds, rendering the metes and bounds of the claims indefinite.
This rejection may be overcome by amending the claims to omit the term “prodrug.”
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
WO 2017/050938 (cited on PTO-892; compounds 32-36 (pp. 66-67) are intermediates).
CONCLUSION
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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