DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims Status
Claims 1-16 and 23-24 are pending and are examined on the merits.
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.
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 3 and 10 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.
Each of Claims 3 and 10 recite “the secukinumab dose”, which lacks antecedent basis. The Claims depend from Claims 1 and 2 which do not establish the term “dose”, and it is therefore unclear to what “the secukinumab dose” refers. This rejection can be overcome, for example, by amending the Claim 3 to read “wherein about 150 mg is administered to the patient”, or the like. Claim 10 can be similarly amended.
Claims 4-6, 11-13, and 17-22 depend from Claim 3 or 10 and are rejected for the same reasons.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-16 and 23-24 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-16 and 23-24 of prior U.S. Patent No. 11,534,491 (PTO-892). This is a statutory double patenting rejection.
The scope of instant Claims 1-16 and 23-24 are identical to each of claims 1-16 and 23-24, respectively.
Claims 2, 4-16 and 23-24 are duplicated verbatim.
Instant Claim 1 differs from ‘491 claim 1 only in that instant Claim 1 recites “variable heavy (VH) domain” and “variable light (VL) domain” instead of “heavy chain variable (VH) domain” and “light chain variable (VL) domain” as recited in patent ‘491. Nevertheless, the same sequences are required and the language is interpreted to encompass an identical structure.
Instant Claims 3 and 10 differ slightly in language from the corresponding claims in patent ‘491. For example, instant Claim 3 recites “...the secukinumab dose is about 150 mg” whereas ‘491 claim 3 recites “...about 150 mg secukinumab is administered to the patient”. However, the claims are interpreted to be drawn to identical subject matter with identical scope – namely specifying 150mg or 300mg as the amount of secukinumab that a patient receives – and are therefore not patentably distinct.
Nonstatutory 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 1-6 and 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, 5-7 and 10 of U.S. Patent No. 9,744,234 (IDS dated 01/03/2024). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 2, 3, 5-7 and 10 of patent ‘234 are drawn to a method of treating AS or active AS by subcutaneously administering five doses of about 150 mg of an IL-17 antibody weekly; and monthly or every 4 weeks thereafter; wherein the antibody comprises the same VH/VL or CDRs (claim 2) as that recited in the present claim 1, or the antibody is secukinumab (claims 3, 5, 6 and 10, for example); wherein the patient has active or moderate to severe active AS (claims 5 and 6); or wherein the method further comprises administering an NSAID, methotrexate, sulphasalazine, or prednisolone to the patient (claim 7). Thus, claims 3, 5-7, 10 and 12 of ‘234 patent and the present claims share the same inventive concept: treating AS with the same antibody (secukinumab) using same or similar regimens (though different in scope of the claims). Therefore, the claims at issue are not patentably distinct from each other.
Claims 1-3, 10, and 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 9, 11, 13, and 16-18 of U.S. Patent No. 12,465,635 (PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-3, 6, 9, 11, 13, and 16-18 of patent ‘635 are drawn to a method of treating inflammatory arthritis including ankylosing spondylitis (‘635 claim 3) comprising subcutaneous administration of 150 mg (‘635 claims 6 and 11) or 300 mg (‘635 claims 6 and 13) secukinumab every 4 weeks (‘635 claims 9, 11, 13, and 17-18). Thus, claims 1-3, 6, 9, 11, 13, and 16-18 of patent ‘635 and the present claims share the same inventive concept: treating AS with the same antibody (secukinumab) using same or similar regimens (though different in scope of the claims). Therefore, the claims at issue are not patentably distinct from each other.
Claims 1-3, 8-9, and 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-9 of U.S. Patent No. 12,594,333 (PTO-892). Note, Patent No. 12,594,333 was issued 4/7/2026 but has not yet been published. Reference below is made to claims 1-4 and 7-9 in the claims set filed 11/21/2025 of the corresponding application 19/061,831 as allowed on 1/13/2026. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Application ‘831 claims 1-4 and 7-9 are drawn to a method of treating inflammatory arthritis, including ankylosing spondylitis (‘831 claim 4), comprising subcutaneous administration of 150 mg secukinumab every 4 weeks (‘831 claim 1). ‘831 claims 7-9 are further drawn to patient populations with intolerant, failed, or inadequate response to a DMARD or TNF alpha antagonist. Thus, claims 1-4 and 7-9 of patent ‘333 (application ‘831) and the present claims share the same inventive concept: treating AS with the same antibody (secukinumab) using same or similar regimens (though different in scope of the claims), and wherein the patient population had inadequate response to DMARD or TNF alpha antagonists. Therefore, the claims at issue are not patentably distinct from each other.
Conclusion
No claim is allowed.
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/BRYAN WILLIAM HECK/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
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