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 .
Response to Amendment
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.
The Information Disclosure Statement (IDS) filed 23 December 2025 has been entered. Applicant’s amendment of the claims filed 23 December 2025 has been entered. Applicant’s remarks filed 23 December 2025 are acknowledged.
Claims 3 and 11-15 are cancelled. Claims 1-2, 4-10 and 16-20 are pending. Claims 6-10 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 1-2 and 4-5 are under examination to the extent they read on the elected species: A-a) wherein the method further comprises administering said composition with or without methotrexate (MTX); and B) wherein the method further comprising administering, prior, concurrently, or after said administering, at least one composition comprising an effective amount of a cytokine antagonist.
Claim Rejections Maintained
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.
Claim 4 remains 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.
Applicant argues that claim 4 has been amended to depend from claim 1. However, amended claim 4 now recites “The method according to claim 4”. The metes and bounds of the claim are unclear.
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 of this title, 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.
Amended claims 1-2 and 4-5 remain rejected under 35 U.S.C. 103 as being unpatentable over Deodhar et al. (J. Rheumatol., March 2018, Vol. 45(3) 341-348), in view of National Psoriasis Foundation, Advance Online, “FDA Approves Intravenous Infusion Drug for Psoriatic Arthritis” (Oct. 23, 2017) (hereinafter “NPF”).
Ground of Rejection
Deodhar teaches treating patients with active ankylosing spondylitis (AS) by administration of golimumab (the GO-ALIVE Phase III trial). Golimumab is an anti-TNFa monoclonal antibody comprising a heavy chain and a light chain set forth in SEQ ID NOs: 36 and 37, respectively. Deodhar teaches that the patients with active AS received golimumab by intravenous (IV) infusions at a dose of 2 mg/kg at week 0, 4, 12, and every 8 weeks (see Abstract). Deodhar teaches that the patients included those who had prior anti-TNF therapy, and who were receiving concomitant medication, such as methotrexate (MTX), sulfasalazine (SSZ), and NSAID (see Table 1). Deodhar reported the clinical efficacy which showed that the patients achieved statistically significant improvement (e.g., BASDAI50) by week 8 (Figure 2); at week 16, change from baseline in SF-36 PCS score is 8.5±7.5; change from baseline in SF-36 MCS score is 6.5±9.1; and change from baseline in ASQoL score is -5.4±5.0 (see Table 3). Deodhar teaches that the treatment continued after week 28; in this publication, the results through week 28 are reported herein (p. 342, col 1, top paragraph, and Figure 1). Deodhar further describes that the safety and efficacy of IV GOL 2 mg/kg in this patient population will be reported through 1 year in a subsequent publication (p. 347, col. 1, last paragraph in section “DISCUSSION”).
Deodhar teaches as set forth above. Deodhar, however, does not teach wherein the intravenous (IV) infusions of golimumab are administered over 30±10 minutes (claim 1).
The NPF document describes that FDA has approved IV infusion of golimumab for treating psoriatic arthritis. The NPF document describes that the IV infusion of golimumab (e.g., at a dose of 2 mg/kg of body weight) is performed as a 30-minute infusion (4th paragraph).
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 administer golimumab as 30-minute IV infusions in the treatment method of Deodhar. One of ordinary skill in the art would have been motivated to do so, because Deodhar teaches treating patients with active AS by IV infusions of golimumab at a dose of 2 mg/kg of body weight, and the NPF document describes that the IV infusion of golimumab with the same dose is performed as a 30-minute infusion. Therefore, the combined teachings provide a reasonable expectation of success in treating the patients.
Response to Arguments
In the response received on 23 December 2025, Applicant argues that Deodhar and NPF, alone or in combination, do not teach or suggest each and every element of claim 1. Applicant argues that Deodhar does not teach or suggest the recited prolonged dosing regimen to treat active ankylosing spondylitis or that the prolonged treatment regimen improves disease activity as measured by the clinical metrics (i.e., AS QoL, SF-36 PCS, SF-36 MCS, MOS-SS, and EQ-VAS scores) after 52 weeks of treatment. Applicant argues that the step of achieving, maintaining or improving the recited clinical metrics at 52 weeks of treatment is not an inherent feature of the treatment but provides meaningful limitations to the claimed method. Applicant further cites Billioud et al. (2011), which describes the loss of response to Adalimumab (an anti-TNF antibody), for support. Applicant argues that Deodhar does not provide any reasonable expectation of success as providing data for only 16 weeks does not address whether efficacy would be maintained, improved, diminished, or reversed with longer treatment (referring to previously cited Patel et al. (2017) for support). Applicant further argues that the NPF document does not teach or suggest treatment of ankylosing spondylitis; rather, the NPF document theorizes that golimumab could be used to treat a different disease, i.e., psoriatic arthritis. Applicant argues that a skilled person cannot predict from the NPF document what dosages and infusion times would result in efficacy for treating active ankylosing spondylitis.
Applicant’s arguments have been fully considered but have not been found to be persuasive.
As set forth above, Deodhar teaches each and every element of amended claim 1, except for the duration of each IV infusion session (i.e., 30±10 minutes). Regarding the amended steps b) and c) in claim 1, these “steps” do not require any different treatment other than administering the claimed anti-TNF antibody or antigen-binding fragment according to step a) to achieve a statistically significant improvement in disease activity at 16 weeks of treatment, and maintain or improve the statistically significant improvement in disease activity at 52 weeks of treatment.
Deodhar teaches treating the patients with active AS by administering golimumab via intravenous (IV) infusions at a dose of 2 mg/kg at week 0, 4, 12, and every 8 weeks. Deodhar reported the clinical metrics showing that the patients achieved statistically significant improvement at week 16, e.g., the change from baseline in SF-36 PCS score is 8.5±7.5; the change from baseline in SF-36 MCS score is 6.5±9.1; and the change from baseline in ASQoL score is -5.4±5.0 (see Table 3), which results are the same as claim 2 of the instant application. Deodhar further describes that the safety and efficacy of IV GOL 2 mg/kg in this patient population will be reported through 1 year in a subsequent publication (p. 347, col. 1, last paragraph in section “DISCUSSION”). Thus, contrary to Applicant’s argument that Deodhar does not teach or suggest the prolonged dosing regimen, Deodhar teaches that the same patient population continued the treatment through 1 year. With respect to Applicant’s argument that achieving and maintaining/improving the recited clinical metrics at 52 weeks of treatment is not an inherent feature of the treatment but provides meaningful limitations to the claimed method, however, Deodhar teaches the SAME treatment method, i.e., treating the same patients with the same therapeutic agent using the same dose, administration schedule, and treatment length, as the presently claimed method, the treatment outcomes would necessarily occur in the patients of Deodhar. With respect to Applicant’s argument that Deodhar does not provide any reasonable expectation of success with longer treatment and Billioud et al. (2011) teaches away from doing so, however, Deodhar teaches that the patients were treated with the regimen through 1 year (52 weeks). Further, Billioud et al. (2011) is related to a different antibody (adalimumab) for treatment of a different disease (Crohn’s disease).
The only deficiency in Deodhar’s teachings is the duration of each IV infusion session (i.e., 30±10 minutes), which, however, is cured by NPF. The NPF document describes that the IV infusion of golimumab (e.g., at a dose of 2 mg/kg of body weight) is performed as a 30-minute infusion (4th paragraph). 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 administer golimumab as 30-minute IV infusions in the treatment method of Deodhar. One of ordinary skill in the art would have been motivated to do so and have a reasonable expectation of success, because Deodhar teaches treating patients with active AS by IV infusions of golimumab at a dose of 2 mg/kg of body weight, and the NPF document describes that the IV infusion of golimumab with the same dose is performed as a 30-minute infusion.
Therefore, the combined teachings of Deodhar and NPF render the instant claims obvious.
Double Patenting
Claims 1-2 and 4-5 remain rejected on the ground of nonstatutory double patenting as being unpatentable over:
1) claims 1-10 of U.S. Patent No. 11,014,982; and
2) claims 1-7 of U.S. Patent No. 12,291,566.
Applicant argues that the present claims are distinct from the claims in the cited patents as the present claims are drawn to long-term treatment (at least 52 weeks) and define disease activity by different clinical metrics (i.e. AS QoL, SF-36 PCS, SF-36 MCS, MOS-SS, and EQ- VAS scores).
Applicant’s arguments have been fully considered but have not been found to be persuasive.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the ‘982 and ‘566 patents recite a method of treating active ankylosing spondylitis in a patient comprising administering a composition comprising the anti-TNF antibody of the subject claims using the same dosing regimen, wherein the patient achieves a statistically significant improvement in disease activity at 4 weeks or 2 weeks of treatment, as measured by, e.g., ASDAS, SF-36 PCS, SF-36 MCS, or ASQoL. While the claims of the ‘982 and ‘566 patents do not recite administering the treatment “for at least 52 weeks”, Deodhar et al. (J. Rheumatol., March 2018, Vol. 45(3) 341-348) (reference provided previously) cures this deficiency. Deodhar teaches that such treatment continues through 1 year (p. 347, col. 1, last paragraph in section “DISCUSSION”). It would have been prima facie obvious to one ordinary skill in the art to modify the methods claimed in the ‘982 and ‘566 patents by continuing the treatment through 1 year. One of ordinary skill in the art would have been motivated to do so and have a reasonable expectation of success, because Deodhar teaches that such treatment continues through 1 year in the patients. With respect to Applicant’s argument that the instant claims recite different clinical metrics for measuring disease activity, however, the claims of the ‘982 and ‘566 patents also recite measuring, e.g., SF-36 PCT, at week 16 of the treatment. Further, any treatment outcome(s) would necessarily occur because modifying the methods claimed in the ‘982 and ‘566 patents in view of Deodhar would arrive at the same treatment method.
Therefore, the claims of the ‘982 and ‘566 patents render the instant claims obvious in view of Deodhar.
Claims 1-2 and 4-5 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
3) claims 1, 4-7 and 10-16 of copending Application No. 17/552,870; and
4) claims 11-18 of copending Application No. 18/499,523.
Applicant argues that the present claims are distinct from the claims of the ‘870 and ‘523 applications, because the present claims recite administering the recited antibody for at least 52 weeks and define disease activity by different clinical metrics (i.e. AS QoL, SF-36 PCS, SF-36 MCS, MOS-SS, and EQ-VAS scores).
Applicant’s arguments have been fully considered but have not been found to be persuasive.
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. The claims of the ‘870 and ‘523 applications recite a method of treating active ankylosing spondylitis in a patient comprising administering a composition comprising the anti-TNF antibody of the subject claims using the same dosing regimen (including the dose, administration mode, and administration schedule). Regarding administering the treatment “for at least 52 weeks” as recited in present claim 1, Deodhar et al. (cited above) cures this deficiency. Deodhar teaches that such treatment continues through 1 year (p. 347, col. 1, last paragraph in section “DISCUSSION”). It would have been prima facie obvious to one ordinary skill in the art to modify the methods claimed in the ‘870 and ‘523 applications by continuing the treatment through 1 year. One of ordinary skill in the art would have been motivated to do so and have a reasonable expectation of success, because Deodhar teaches that such treatment continues through 1 year in the patients. With respect to Applicant’s argument that the instant claims recite different clinical metrics for measuring disease activity, however, any treatment outcome(s) would necessarily occur because modifying the methods claimed in the ‘870 and ‘523 applications in view of Deodhar would arrive at the same treatment method.
Therefore, the claims of the ‘870 and ‘523 applications render the instant claims obvious in view of Deodhar.
Conclusion
NO CLAIM IS ALLOWED.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674