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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/06/2025 has been entered.
Status of Claims
Applicant’s amendment filed on 10/06/2025 is acknowledged. Following the amendment, claims 4 and 15 are cancelled. Claims 27-29 are added. Claims 25-26 remain withdrawn due to restriction requirement. Claims 1-3, 5-14, 16-24, and 27-29 are currently pending and under examination.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see pgs. 9-10, filed 10/06/2025, with respect to rejection of claims 2-3, 5-11, 13-4, and 16-24 under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejection of 06/05/2025 has been withdrawn. In addition, applicant’s arguments, see pg. 10, filed 10/06/2025, with respect to rejection of claims 2-3, 5-11, 13-14, and 16-24 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of 06/05/2025 has been withdrawn.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see pgs. 10-11, filed 10/06/2025, with respect to rejection of claims 2-3, 5-11, 13-14, 16-22, and 24 have been fully considered and are persuasive. The rejection of 06/05/2025 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pgs. 11-12, filed 10/06/2025, with respect to the rejection of claims 2-3, 5-11, 13-14, and 16-24 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of applicant’s amendment of claims 1 and 12.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-14, 16-24, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trial NCT03158285 (ver. 31, 02/24/2020) in view of Clinical Trial NCT03162796 (ver. 33, 11/26/2019) and further in view of Deodhar et al. (Lancet, 2020, 395(10230):1115-1125, cited on pg. 2 of IDS filed on 10/06/2025).
As previously discussed in Office Action dated 12/18/2024 (pg. 4), Clinical Trial NCT03158285 ('285) discloses a study evaluating the efficacy and safety of guselkumab (the present application’s anti IL-23 antibody corresponding to the recited SEQ ID NOs) administered subcutaneously in participants with active psoriatic arthritis (PsA) who are biologically naïve and have inadequate response to standard therapies such as non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy (Criteria). Trial '285 teaches study regimens wherein participants received subcutaneous (SC) guselkumab 100 mg at weeks 0 and 4, and then once every 8 weeks (q8w) for an approximate period of 100 weeks (Arms and Interventions, Group 2). Trial '285 measured outcomes at week 16 and week 24 with measures including, among others, ACR 20, HAQ-DI, ACR 50, IGA, and DAS28 (Primary Measures, Secondary Measures 1-14). Trial '285 teaches Investigator's Global Assessment (IGA) at week 24 with percentage of patients who achieved psoriasis response with IGA score of 0 (clear), or 1 (minimal) and 2 more grade reduction from baseline amongst participants with 3% or more body surface area (BSA) psoriatic involvement and an IGA score of 2 or more at baseline before treatment (Secondary Outcome Measures, No. 3). In addition, trial '285 teaches inclusion criteria for participants having active plaque psoriasis, with at least one psoriatic plaque of >= 2 cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis (Inclusion Criteria) thereby anticipating the limitation recited in claim 12 of the instant application. Radiographic progression in response to treatments is measured in the form of modified van der Heijde-Sharp (vdH-S) score at week 24 (Secondary Outcome Measures, No. 5).
Trial NCT03162796 (‘796) teaches the feature added by Applicant’s amendment that the subject had prior exposure to an anti-TNFα agent. In particular, Trial ‘796 discloses a guselkumab Phase 3 PsA study in which approximately 30% of study participants could previously have received one or two TNFα inhibitors (Inclusion Criteria). Furthermore, the study design stratified treatment assignment and efficacy analysis by previous TNF inhibitor use while administering subcutaneous guselkumab 100 mg every 4 weeks or 100 mg at Weeks 0 and 4 and then every 8 weeks, with ACR20 as the primary endpoint (Arms and Intervention, Outcome Measures).
Deodhar, which reports Trial ‘796 (DISCOVER-1 Study Group) results, further confirms that guselkumab was actually administered to active PsA patients who were biologic-naïve or who had previously received TNFα inhibitor treatment (Methods). Deodhar also teaches that patients were stratified by previous TNF inhibitor use, and that the same subcutaneous 100 mg q4w and 100 mg at Weeks 0 and 4 then q8w regimens achieved statistically significant ACR20 responses at Week 24 (Findings).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the long-term guselkumab treatment and monitoring framework taught by Trial ‘285 to the prior anti-TNFα-exposed PsA subgroup expressly taught by Trial ‘796 and confirmed by Deodhar. One would be motivated to do as all three references concern the same drug (guselkumab), the same disease (psoriatic arthritis), and the same clinically used guselkumab regimens. Furthermore, Trial ‘796 shows that prior TNF inhibitor exposure was already recognized in the art as a clinically relevant stratification variable in guselkumab PsA treatment rather than a hindsight-selected subgroup. Thus, a person of ordinary skill would have reasonable expectation that the known guselkumab q4w/q8w regimens used in PsA patients, including those with prior anti-TNFα exposure, could likewise be followed for the longer-term efficacy and radiographic outcomes taught in Trial ‘285 with a reasonable expectation of success. Therefore, claims 1-3, 5-14, 16-24, and 27-29 were clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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.
1. Applicant’s arguments, see pg. 12, filed 10/06/2025, with respect to the rejection of claims 1-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of US Patent No. 7,935,344 in view of Trial ‘285 as evidenced by Bedi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
2. Applicant’s arguments, see pgs. 12-13, filed 10/06/2025, with respect to the rejection of claims 1-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US Patent No. 7,993,645 in view of Trial ‘285 as evidenced by Bedi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
3. Applicant’s arguments, see pg. 13, filed 10/06/2025, with respect to the rejection of claims 1-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US Patent No. 9,783,607 in view of Trial ‘285 as evidenced by Bedi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
4. Applicant’s arguments, see pg. 13, filed 10/06/2025, with respect to the rejection of claims 1-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of US Patent No. 10,030,070 in view of Trial ‘285 as evidenced by Bedi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
5. Applicant’s arguments, see pg. 14, filed 10/06/2025, with respect to the rejection of claims 1-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of US Patent No. 8,221,760 (‘760) in view of Trial ‘285 as evidenced by Bedi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Applicant’s Amendment filed on 10/06/2025.
Claims 1-3, 5-14, 16-24, and 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8221760 in view of Trial ‘285 and further in view of Trial ‘796 and Deodhar (cited above).
Claims 1-8 of Patent '760 are directed to a method for treating an IL-23 related condition by administering a composition comprising an antibody comprising CDRL1-3 of SEQ ID NO:50, 56 and 73, respectively; and CDRH1-3 of SEQ ID NO:5, 20 and 44, respectively (claim 1, for example). Patent '760 recites a composition comprising an antibody with VL of SEQ ID NO:116, and VH of SEQ ID NO:106 (claim 4, for example), wherein the composition can be administered subcutaneously (claims 3 and 6, for example); and wherein the IL-23 related condition includes psoriatic arthritis (claims 1 and 4, for example). The CDRL1-3 of SEQ ID NO:50, 56 and 73, and CDRH1-3 of SEQ ID NO:5, 20 and 44 of patent '760 are 100% identical to the present application's CDRH1-3 SEQ ID NO:1-3 and CDRL1-3 SEQ ID NO:4-6, respectively. Furthermore, Patent '760 VL of SEQ ID NO:116, and the VH of SEQ ID NO:106 are 100% identical to the present application's VL of SEQ ID NO:8 and VH of SEQ ID NO:7. The teachings of Clinical Trials ‘285, ‘796, and Deodhar are reviewed above.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the invention as described in Patent ‘760 and apply the long-term guselkumab treatment and monitoring framework taught by Trial ‘285 to the prior anti-TNFα-exposed PsA subgroup expressly taught by Trial ‘796 and confirmed by Deodhar. One would be motivated to do as all these references concern the same drug (guselkumab), the same disease (psoriatic arthritis), and the same clinically used guselkumab regimens. Furthermore, Trial ‘796 shows that prior TNF inhibitor exposure was already recognized in the art as a clinically relevant stratification variable in guselkumab PsA treatment rather than a hindsight-selected subgroup. Thus, a person of ordinary skill would have reasonable expectation that the known guselkumab q4w/q8w regimens used in PsA patients, including those with prior anti-TNFα exposure, could likewise be followed for the longer-term efficacy and radiographic outcomes taught in Trial ‘285 with a reasonable expectation of success. Therefore, claims 1-3, 5-14, 16-24, and 27-29 were clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made and the conflicting claims are not patentably distinct from each other.
6. Applicant’s arguments, see pgs. 14-15, filed 10/06/2025, with respect to the rejection of claims 1-24 on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 30 of US Patent No. 11,548,941 (‘941) in view of Trial ‘285 as evidenced by Bedi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Applicant’s Amendment filed on 10/06/2025.
Claims 1-3, 5-14, 16-24, and 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15 and 30 of U.S. Patent No. 11548941 in view of Trial ‘285 and further in view of Trial ‘796 and Deodhar (cited above) for the same reasons listed above.
7. Applicant’s arguments, see pg. 15, filed 10/06/2025, with respect to the rejection of claims 1-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18, 20-41, and 43-45 of copending Application No. 17/385,284 (now US. Patent No. 12404324) in view of Trial ‘285 as evidenced by Bedi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Applicant’s Amendment filed on 10/06/2025.
Claims 1-3, 5-14, 16-24, and 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 12404324 in view of Trial ‘285 and further in view of Trial ‘796 and Deodhar (cited above) for the same reasons listed above.
8. Applicant’s arguments, see pgs. 15-16, filed 10/06/2025, with respect to the rejection of claims 1-24 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18, 9-19, and 22-28 of copending Application No. 17/691,219 in view of Trial ‘285 as evidenced by Bedi have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Applicant’s Amendment filed on 10/06/2025.
Claims 1-3, 5-14, 16-24, and 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-19, 22-28, and 31-40 of copending Application No. 17/691,219 in view of Trial ‘285 and further in view of Trial ‘796 and Deodhar (cited above) for the same reasons listed above.
9. Claims 1-3, 5-14, 16-24, and 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 18/166,878 in view of Trial ‘285 and further in view of Trial ‘796 and Deodhar (cited above) for the same reasons listed above.
10. Claims 1-3, 5-14, 16-24, and 27-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19/259,990 in view of Trial ‘285 and further in view of Trial ‘796 and Deodhar (cited above) for the same reasons listed above.
Conclusion
No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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/DENNIS GEORGE/Examiner, Art Unit 1644
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641