DETAILED ACTION
Claims 1-9, submitted on August 2, 2024, are pending in the application. Claims 1-3, 5-6, and 8 are rejected for the reasons set forth below. No claim is allowed, although claims 4, 7, and 9 would be allowable if rewritten in independent form.
Allowable Subject Matter
Claims 4, 7, and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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 explained in MPEP1 2141 et seq. They 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 1-3, 5-6, and 8 are rejected under 35 U.S.C. 103 as being prima facie obvious over US 2013/0116235 A1 by Crawford et al.
Crawford (cited in applicant’s IDS2) discloses the compound3 of structure (I) as a free base (see Example 130 at pp. 130-32), as well as pharmaceutically acceptable acid addition salts thereof with methanesulfonic acid, hydrochloric acid, and sulfuric acid (para. 0082-84), which suggests the salt forms instant claims 3, 6, and 8. Although the reference does not specifically disclose the mesylate, chloride, or sulfate salt of the compound of Example 130, one would nevertheless have viewed this subject matter as being a matter of reduction to practice of the general teachings of the reference, by nothing more than routine experimentations, and there-fore prima facie obvious. It is implicit in the teachings of the reference (see, e.g., para. 0082-84) that the use of pharmaceutically acceptable salts, including the salt forms referred to in the claims, is routine in the pharmaceutical arts.
Claims 2, 5, and 7 appear to represent applicant’s discovery that the foregoing salts are crystalline or have certain dissolution properties. The discovery, however, of previously unappreciated properties of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. The claiming of a new function or unknown property inherently present in the prior art does not necessarily make the instant claims patentable. See MPEP 2112.
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 possi-ble 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 provi-sions 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 accompa-nied 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 1-3, 5-6, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over US Patent Nos. 8,716,274 B2; 8,921,353 B2; 9,238,655 B2; 9,782,405 B2; and 10,045,983 B2. The ‘274 Patent (cited in applicant’s IDS) claims fenebrutinib and pharmaceutically acceptable salts thereof (col. 624, II. 13-18; col. 612, ll. 17-18; see also col. 16, ll. 10-31 for the definition of “pharmaceutically acceptable salt”). The instant claims are therefore prima facie obvious over the corresponding claims of the ‘274 Patent. The functional properties recited in the instant claims are inherent for substantially the same reasons discussed above. The ‘353 Patent (col. 639, II. 13-18), the ‘655 Patent (col. 624, II. 13-18); ‘405 Patent (col. 621, II. 57-61); and the ‘983 Patent (col. 600, ll. 33-37) are cited for the same reasons (each of these Patents was also cited in applicant’s IDS).
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 exam-iner 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
September 16, 2026
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
2 See the information disclosure statement (IDS) submitted on December 20, 2024.
3 Known in the prior art as “fenebrutinib,” CAS Reg. No. 1434048-34-6.
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