DETAILED ACTION
The amendment submitted on February 6, 2026 has been entered. Claims 1, 7-14, 18, 123, 125, 127, 129, 133, 136, 138, 230, 233, 239, and 269-291 are pending in the application. 1, 7-14, 18, 129, 133, 136, 138, 269-273, and 275-278 are allowed. Claims 123, 125, 127, 230, 276, 233, 239, 274, and 279-291 are rejected for the reasons set forth below.
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a solid form of a compound of Formula (I),a salt thereof, or a process for preparing it, in the reply filed on February 6, 2026 is acknowledged. All of the pending claims correspond to the elected invention, with claims drawn to the other inventions having been cancelled by amendment.
Allowable Subject Matter
Claims 1, 7-14, 18, 129, 133, 136, 138, 269-273, and 275-278 are allowed.
Claim Rejections – 35 USC § 112
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.
Claim 276 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The phrase “the camsylate” lacks antecedent basis, although it appears to be applicant’s intention that claim 276 should depend from claim 275.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 123, 125, 127, 230, 233, 239, 274, and 279-291 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/226269 A1 by Horan et al.
Horan (cited in applicant’s IDS1) discloses the compound of Formula (I). See Example 73 at p. 358. The reference also discloses pharmaceutically acceptable addition salts (pp. 109-10), including the chloride salt (p. 110, l. 1), i.e., the hydrochloride salt within the meaning of claim 123. Although the reference does not specifically disclose the hydrochloride salt of Example 73, it nevertheless would have been viewed as being a matter of reduction to practice of subject matter well known in the pharmaceutical arts and therefore prima facie obvious. Claims 125 and 127, and 233 appear to represent applicant’s discovery that these salt forms are crystalline solids. The discovery of such inherent properties does not render the old composition patentably new to the discoverer. See MPEP 2112(I) (something which is old does not become patentable upon the discovery of a new property). The reference discloses a method of making the compounds using intramolecular ring closure using potassium pivalate (pp. 115-20), so one would have viewed claims 230, 233, and 274 as being a simple matter of reduction to practice of the subject generally disclosed in the reference. Horan discloses (pp. 100-10) pharmaceutical compositions according to claim 239. An example lubricant in the pharmaceutical composition is magnesium stearate (p. 103, l. 21), which meets the limitations of claim 279. The concentrations referred to in claims 280-291 would have been prima facie obvious over the general teachings of the reference (see, e.g., p. 107, ll. 18-20) for the reasons discussed in MPEP 2144.05.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 123, 125, 127, 230, 233, 239, 274, and 279-291 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 11,667,649 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 8 of the ‘649 Patent (cited in applicant’s IDS) is directed to the same compound recited in instant claim 123 “or a pharmaceutically acceptable salt thereof.” The written description (col. 151, l. 137 – col. 152, l. 5) of the specification defines “pharmaceutically acceptable salt” as encompassing the subject matter of claim 123. As explained in MPEP 2112(I), the mere observation that these salt forms are crystalline solids does not entitle applicant to a new patent, specifically, claims 125 and 127, on old subject matter. The process of instant claims 230 and 274 would have been prima facie obvious over the disclosure in the reference Patent of the same synthesis (see, e.g., col. 152-67) for substantially the same reasons discussed above. The pharmaceutical compositions of claims 239 and 279-291 would likewise have been prima facie obvious over the disclosure of such compositions in the Patent (see, e.g., col. Col. 144, l. 53 et seq.).
Claims 123, 125, 127, 230, 233, 239, 274, and 279-291 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 12,275,742 B2. Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Note that the ‘742 Patent is a division of the ‘649 Patent, discussed above. See claims 14-15 of the ‘742 Patent, which are drawn to the same compound of the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
March 7, 2026
1 See the information disclosure statement (IDS) submitted on July 12, 2023.