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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 CFR 1.114.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 17 June 2026 has been entered. Applicant’s amendment of the claims filed 17 June 2026 has been entered. Applicant’s remarks filed 17 June 2026 are acknowledged.
Claims 3 and 11-15 are cancelled. Claim 21 has been added. Claims 1-2, 4-10 and 16-21 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 Claims 6-10 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.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, 4-5 and 21 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Claim Rejections Withdrawn
The rejection of claim 4 under 35 U.S.C. 112(b), as being indefinite for depending from claim 4, is withdrawn in response to Applicant’s amendment of the claim to depend from claim 1.
Claim Rejections Maintained / New Grounds of Rejections
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 2 is newly 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.
Claim 2 recites “The method according to claim 1, wherein said statistically significant improvement in disease activity by week 16 of the treatment is …”. However, claim 1 recites “measuring whether the patient has achieved a statistically significant improvement in disease activity at 52 weeks of treatment”. There is insufficient antecedent basis for this limitation in the claim.
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) (“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), nor teaches measuring whether the patient has achieved a statistically significant improvement in disease activity at 52 weeks of treatment by a mean change from baseline in AS QoL, SF-36 PCS, SF-36 MCS, MOS-SS, or EQ-VAS (amended claim 1).
The NPF document describes that FDA has approved IV infusion of golimumab for treatment of 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.
Further, 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 assess whether the patients have achieved statistically significant improvements by measuring a mean change from baseline in AS QoL, SF-36 PCS, or SF-36 MCS at 52 weeks of treatment. One of ordinary skill in the art would have been motivated to do so, because Deodhar teaches measuring these clinical metrics to assess patients’ response to the treatment at Week 16 and Deodhar teaches that the treatment continued through 1 year. By doing so, it provides a reasonable expectation of success in assessing whether the patients have achieved statistically significant improvements by the treatment.
Response to Applicant’s Arguments
In the response received on 17 June 2026, 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 the claims are directed not merely to administering treatment for an extended period of time, but to measuring and determining treatment response based on statistically significant improvements in the specifically recited clinical endpoint measures after 52 weeks of treatment. Applicant argues that Deodhar is entirely silent as to whether the reported Week 16 improvements would be maintained through Week 52. Applicant reiterates the arguments that a person of ordinary skill in the art would not have reasonably expected that efficacy observed at Week 16 would necessarily persist through one year of treatment (referring to previously cited Patel et al. (2017) for support). Applicant argues that Deodhar provides no teaching, suggestion, or reasonable expectation that the claimed long-term efficacy endpoints would be achieved, measured, or maintained at Week 52. 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 furthermore argues that the cited art does not inherently teach the claimed invention and that the existence of improvements at 16 weeks does not inherently or necessarily result in the specific statistically significant improvements after 52 weeks or treatment as required in claim 1.
Applicant’s arguments have been fully considered but have not been found to be persuasive.
As set forth above, Deodhar expressly teaches and renders obvious each and every element of amended claim 1, except for the duration of each IV infusion session (i.e., 30±10 minutes) and the steps of the measuring and determining at 52 weeks of the treatment.
Regarding the duration of each IV infusion session of golimumab (i.e., 30±10 minutes), 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.
Regarding the amended steps b) and c) in claim 1, Deodhar teaches assessing the clinical efficacy by measuring changes from baseline in SF-36 PCS, SF-36 MCS, and AS QoL scores. Deodhar teaches that the patients achieved statistically significant improvements at Week 16, as shown by a change from baseline in SF-36 PCS score (8.5±7.5), a change from baseline in SF-36 MCS score (6.5±9.1), and a change from baseline in AS QoL score (-5.4±5.0). Deodhar teaches that the treatment in this patient population would continue through 1 year. 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 assess the clinical efficacy by using these clinical metrics, i.e., measuring changes from baseline in SF-36 PCS score, SF-36 MCS score, and AS QoL score, after the patients have completed 1 year of treatment. With respect to Applicant’s arguments that Deodhar provides no teaching, suggestion, or reasonable expectation that the claimed long-term efficacy endpoints would be achieved, measured, or maintained at Week 52, however, claim 1, as presently amended, only requires measuring one of the clinical metrics at 52 weeks of treatment and determining that the patient is a responder to the treatment. The cited art renders obvious the recited method steps. With respect to Applicant’s arguments that the existence of improvements at 16 weeks does not inherently or necessarily result in the specific statistically significant improvements after 52 weeks of treatment as required in claim 1, however, amended claim 1 does not require the specific statistically significant improvements after 52 weeks of treatment, and the claim only requires measuring and determining whether the patient has achieved the specific statistically significant improvements after 52 weeks of treatment. Further, Deodhar, in combination with NPF, teach treating the same patient population with the same treatment regimen (the dose, administration route and frequency, and treatment duration), and the results would necessarily be the same.
For reasons set forth above, the rejection is maintained.
Claims 1-2, 4-5 and 21 are newly 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) (“NPF”) (both references provided previously), and further in view of Reveille et al. (Arthritis Rheumatol., 2017, Vol. 69 (suppl 10): Abstract #1531).
Deodhar and NPF teach as set forth above. These references, however, do not teach determining whether the patient has achieved a statistically significant improvement in disease activity at 52 weeks of treatment by measuring a mean change from baseline in EQ-VAS score (claims 1 and 21).
Reveille reports the results of the same clinical study as Deodhar for treating active ankylosing spondylitis (AS) by administration of golimumab (the GO-ALIVE Phase III trial). Reveille teaches that patient-reported outcomes (PRO) of the treatment were evaluated by measuring changes from baseline at Weeks 8, 16, and 28 in SF-36 PCS, SF-36 MCS, EQ-5D VAS (EQ-VAS), and AS QoL (see Table).
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 assess the treatment outcomes at 52 weeks of treatment by including EQ-5D VAS (EQ-VAS) score in the clinical metrics. One of ordinary skill in the art would have been motivated to do so, because Deodhar teaches that the treatment in this patient population continued through 1 year, and Reveille teaches that EQ-5D VAS (EQ-VAS) score, along with SF-36 PCS, SF-36 MCS, and AS QoL scores, are used for evaluating patients’ improvements in physical functioning, mental health functioning, health state, and health-related quality of life (HRQoL). By doing so, it provides a reasonable expectation of success in assessing whether the patients have achieved statistically significant improvements by the treatment.
Double Patenting
Amended and newly added claims 1-2, 4-5 and 21 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 AS QoL. While the claims of the ‘982 and ‘566 patents do not recite administering the treatment “for at least 52 weeks”, and measuring/determining one of the clinical metrics (i.e. AS QoL, SF-36 PCS, SF-36 MCS, MOS-SS, and EQ-VAS scores) at 52 weeks of the treatment, Deodhar and Reveille (cited above) render these elements obvious.
As set forth above, Deodhar teaches that the treatment continues through 1 year, and Reveille teaches that patient-reported outcomes (PRO), including SF-36 PCS, SF-36 MCS, EQ-5D VAS (EQ-VAS), and AS QoL scores, are used to evaluate patients’ improvements by the treatment. 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 and assessing wherein the patient achieves statistically significant improvements in disease activity after the treatment by measuring clinical metrics, including SF-36 PCS, SF-36 MCS, AS QoL, and EQ-5D VAS (EQ-VAS) scores. 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, and Reveille teaches that patient-reported outcomes (PRO), including SF-36 PCS, SF-36 MCS, AS QoL, and EQ-5D VAS (EQ-VAS) scores, are used to evaluate patients’ improvements by the treatment. Therefore, the claims of the ‘982 and ‘566 patents render the instant claims obvious in view of Deodhar and Reveille.
Amended and newly added claims 1-2, 4-5 and 21 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 ‘523 application, 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 further argues that the present application has an effective filing date of December 02, 2021, which pre-dates the effective filing date of the ‘870 application, and thus the rejection on the ground of nonstatutory provisional double patenting in this application should be withdrawn and permit the application to issue as a patent.
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 ‘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). While the claims of the ‘870 and ‘523 applications do not recite administering the treatment “for at least 52 weeks”, and measuring/determining one of the clinical metrics (i.e. AS QoL, SF-36 PCS, SF-36 MCS, MOS-SS, and EQ-VAS scores) at 52 weeks of the treatment, Deodhar and Reveille (cited above) render these elements obvious.
As set forth above, Deodhar teaches that the treatment continues through 1 year, and Reveille teaches that patient-reported outcomes (PRO), including SF-36 PCS, SF-36 MCS, EQ-5D VAS (EQ-VAS), and AS QoL scores, are used to evaluate patients’ improvements by the treatment. 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 and assessing wherein the patient achieves statistically significant improvements in disease activity after the treatment by measuring clinical metrics, including SF-36 PCS, SF-36 MCS, AS QoL, and EQ-5D VAS (EQ-VAS) scores. 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, and Reveille teaches that patient-reported outcomes (PRO), including SF-36 PCS, SF-36 MCS, AS QoL, and EQ-5D VAS (EQ-VAS) scores, are used to evaluate patients’ improvements by the treatment. Therefore, the claims of the ‘870 and ‘523 applications render the instant claims obvious in view of Deodhar and Reveille.
Regarding the ‘870 application, the provisional nonstatutory double patenting rejection is maintained because the provisional nonstatutory double patenting rejection is not the only rejection remaining and the instant claims are subjected to rejections on other grounds (see above). See MPEP § 804(1)(B)(1)(b).
Conclusion
NO CLAIM IS ALLOWED.
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
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