FINAL ACTION
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 .
Applicant’s amendment and response filed June 9, 2026 are acknowledged. Claims 1-3, 6, 8, 10, 12-16, 18, 20, 22 and 24 and 26 have been amended. Claims 7, 9, 11, 19, 21 and 23 have been canceled. Correction is required in response to this office action. Claims 1-6, 8, 10, 12-18, 20, 22, 24, 25 and 26 are under examination.
Rejections Objections/Withdrawn
The following rejection are withdrawn based on Applicant’s amendments.
Objections to claims 1-3 and 14-16, pages 2-3 of the previous Office action.
Rejection of claims 1-6, 8, 10, 12-18, 20, 22 and 24-26 under 112 (b), pages 3-4 of the previous Office action.
Rejection of claims 1-6, 8, 10, 12-18 and 25 under 35 U.S.C. 102(a)(1), pages 5-6 of the precious Office action.
Rejection of claims 1-6, 8, 10, 12-18 and 25-26 under 35 U.S.C.103(a), pages 6-8 of the precious Office action.
Rejection of claims 1, 2, 4-6, 8, 10, 12-15, 17-18 and 25 under 35 U.S.C. 101, nonstatutory double patenting over U.S. Patent 7,935,344, pages 8-9 of the precious Office action.
Rejection of claims 1, 2, 4-6, 8, 10, 12-15, 17-18 and 25 under 35 U.S.C. 101, nonstatutory double patenting over U.S. Patent 7,993,645, page 9 of the precious Office action.
Rejection of claims 1, 2, 4-6, 8, 10, 12-15, 17-18 and 25 under 35 U.S.C. 101, nonstatutory double patenting over U.S. Patent 9,783,607, page 9 of the precious Office action.
Rejection of claims 1, 2, 4-6, 8, 10, 12-15, 17-18 and 25 under 35 U.S.C. 101, nonstatutory double patenting over 10,030,070 in view of ‘285 Clinical Trial, page 9 of the precious Office action.
Rejection of claims 1, 2, 4-6, 8, 10, 12-15, 17-18 and 25 under 35 U.S.C. 101, nonstatutory double patenting over U.S. Patent 8,221,760 in view of ‘285 Clinical Trial, page 10 of the precious Office action.
Rejection of claims 1, 2, 4-6, 8, 10, 12-15, 17-18 and 25-26 under 35 U.S.C. 101, nonstatutory double patenting over U.S. Patent 12,404,324, page 10-11 of the precious Office action.
Rejection of claims 1, 2, 4-6, 8, 10, 12-15, 17-18 and 25-26 under 35 U.S.C. 101, nonstatutory double patenting over U.S. Patent 19/259,990 in view of ‘285 Clinical Trial, page 11 of the precious Office action.
Provisional rejection of claims 1-5, 8, 10, 12, 13, 25-26 under 35 U.S.C. 101, nonstatutory double patenting over co-pending application 17/691,182, page 11-12 of the precious Office action.
New Grounds of Rejection are Necessitated by Applicant’s Amendments
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 8, 10, 13-18, 20, 22 and 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Deodhar et al (Efficacy and Safety Results of Guselkumab, an Anti-IL23 Monclonal Antibody, in Patients with Active Psoriatic Arthritis over 24 Weeks: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study (Abstract), Arthritis Rheumatol. 2016;68 (suppl 10)) is being referred to in this Office action is Deodhar et al, I.
Claim 1 is a method of treating psoriatic arthritis in a subject in need thereof, wherein the subject has previously received at least one biologic treatment for psoriatic arthritis, the method comprising subcutaneously administering to the subject about 50 mg to about 150 mg of an anti-IL-23 antibody, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising HCDR1-3 comprising the amino acid sequences of SEQ ID NOs:1-3, respectively; and the light chain variable region comprising LCDR1-3 comprising the amino acid sequences of SEQ ID NOs:4-6, respectively, and measuring whether the subject achieves an improvement in disease activity determined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, an improvement in the Leeds enthesitis index (LEI), and/or an improvement in a dactylitis assessment score.
Claim 2 the method of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 7, and the light chain variable region comprises the amino acid sequence of SEQ ID NO: 8.
Claim 3 is the method of claim 1, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 9, and a light chain comprising the amino acid sequence of SEQ ID NO: 10.
Claim 4 the method of claim 1, wherein the antibody is administered at a dose of about 100 mg per administration.
Claim 5 is the method of claim 4, wherein the antibody is administered once every 4 weeks (q4w).
Claim 6 is the method of claim 1, wherein the improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, improvement in the Leeds enthesitis index (LEI), and/or improvement in a dactylitis assessment score is achieved following a treatment period of about 24 to about 52 weeks.
Claim 8 is drawn to the method of claim 1, further comprising measuring whether the subject has achieved an improvement in a disease activity determined by at least one criteria selected from the group consisting of a 50% improvement in the American College of Rheumatology core set disease index (ACR50), a 70% improvement in the American College of Rheumatology core set disease index (ACR70), Health Assessment Questionnaire Disability Index (HAQ-DI), Investigator's Global Assessment (IGA), Disease Activity Score 28 (DAS28) C-reactive protein (CRP), Short Form Health survey (SF-36) in the mental and physical component summary (MCS and PCS), achievement of minimal disease activity (MDA), very low disease activity (VLDA), GRAppa Composite score (GRACE), Psoriatic Arthritis Disease Activity Score (PASDAS), modified Composite Psoriatic Disease Activity Index (mCPDAI), Psoriatic Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Functional Assessment of Chronic Illness Therapy (FACIT), a Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29), and vdH-S score.
Claim 10 is drawn to the method of claim 8 further comprising measuring whether the subject has achieved an improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) and/or Disease Activity Score 28 (DAS28) C-reactive protein (CRP) following a treatment period of about 24 weeks.
Claim 13 is drawn to the method of claim 1, wherein the subject has had inadequate response to a standard therapy for the PsA, and wherein the subject is also administered with the standard therapy during the treatment.
Claim 14 is drawn to a method of treating psoriatic arthritis in a subject in need thereof, wherein the subject has previously received at least one biologic treatment for psoriatic arthritis, the method comprising subcutaneously administering to the subject about 50 mg to about 150 mg of an anti-IL-23 antibody once at week 0, once at week 4, and once every 8 weeks (q8w) thereafter, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising HCDR1-3 comprising the amino acid sequences of SEQ ID NOs:1-3, respectively; and the light chain variable region comprising LCDR1-3 comprising the amino acid sequences of SEQ ID NOs:4-6, respectively a, and wherein the subject has at least one psoriatic plaque of >2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis before the treatment, and measuring whether the subject achieved an improvement in disease activity determined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, an improvement in the Leeds enthesitis index (LEI), and/or an improvement in a dactylitis assessment score.
Claim 15 is drawn to the method of claim 14, wherein the heavy chain variable region of comprises the amino acid sequence of SEQ ID NO: 7, and the light chain variable region of comprises the amino acid sequence of SEQ ID NO: 8.
Claim 16 is drawn to the method of claim 15, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 9, and a light chain comprising the amino acid sequence of SEQ ID NO: 10.
Claim 17 is drawn to the method of claim 14, wherein the antibody is administered at a dose of about 100 mg per administration.
Claim 18 is drawn to the method of claim 17, wherein the improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, improvement in the Leeds enthesitis index (LEI), and/or improvement in a dactylitis assessment score is achieved following a treatment period of about 24 to about 52 weeks.
Claim 20 is drawn to the method of claim 18 further comprising measuring whether the subject has achieved an improvement in a disease activity determined by at least one criteria selected from the group consisting of: a 50% improvement in the American College of Rheumatology core set disease index (ACR50), a 70% improvement in the American College of Rheumatology core set disease index (ACR70), Health Assessment Questionnaire Disability Index (HAQ-DI), Investigator's Global Assessment (IGA), Disease Activity Score 28 (DAS28) C-reactive protein (CRP), Short Form Health survey (SF-36) in the mental and physical component summary (MCS and PCS), achievement of minimal disease activity (MDA), very low disease activity (VLDA), GRAppa Composite score (GRACE), Psoriatic Arthritis Disease Activity Score (PASDAS), modified Composite Psoriatic Disease Activity Index (mCPDAI), Psoriatic Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Functional Assessment of Chronic Illness Therapy (FACIT), Patient-Reported Outcomes Measurement Information System-29 (PROMIS- 29), and vdH-S score.
Claim 22 is drawn to the method of claim 20, further comprising measuring whether the subject has achieved an improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) and/or Disease Activity Score 28 (DAS28) C-reactive protein (CRP) following a treatment period of about 24 weeks.
Claim 25 is drawn to the method of claim 14, wherein the subject has had inadequate response to a standard therapy for the PsA.
Claim 26 is drawn to the method of claim 25, wherein the subject is also administered with the standard therapy during treatment, wherein the standard therapy is at least one selected from the group consisting of non-biological disease-modifying antirheumatic drugs (DMARDs), oral corticosteroid, apremilast, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Deodhar et al, I teach a method of subcutaneous of administration of 100 mg of guselkumab to psoriatic arthritis patients. Deodhar et al, I teach that the psoriatic arthritis patients included patient with current or previous treatment. The patients were evaluated for improvement using Leeds enthesitis index (LEI), ACR20/50, PASI75, dactylitis score and HAQ-DI. The sequences of the antibody are inherent in the teachings of the prior art. The antibody was administered from 4 week through 44 weeks. Deodhar et al, I anticipate the claimed invention.
Claim(s) 1-6, 8, 10, 13-18, 20, 22 and 25-26 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Deodhar et al (Lancet, Vol. 391, June 2, 2018, p. 2213-2224) is being referred to in this Office action is Deodhar et al, II.
Claim 1 is a method of treating psoriatic arthritis in a subject in need thereof, wherein the subject has previously received at least one biologic treatment for psoriatic arthritis, the method comprising subcutaneously administering to the subject about 50 mg to about 150 mg of an anti-IL-23 antibody, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising HCDR1-3 comprising the amino acid sequences of SEQ ID NOs:1-3, respectively; and the light chain variable region comprising LCDR1-3 comprising the amino acid sequences of SEQ ID NOs:4-6, respectively, and measuring whether the subject achieves an improvement in disease activity determined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, an improvement in the Leeds enthesitis index (LEI), and/or an improvement in a dactylitis assessment score.
Claim 2 the method of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 7, and the light chain variable region comprises the amino acid sequence of SEQ ID NO: 8.
Claim 3 is the method of claim 1, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 9, and a light chain comprising the amino acid sequence of SEQ ID NO: 10.
Claim 4 the method of claim 1, wherein the antibody is administered at a dose of about 100 mg per administration.
Claim 5 is the method of claim 4, wherein the antibody is administered once every 4 weeks (q4w).
Claim 6 is the method of claim 1, wherein the improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, improvement in the Leeds enthesitis index (LEI), and/or improvement in a dactylitis assessment score is achieved following a treatment period of about 24 to about 52 weeks.
Claim 8 is drawn to the method of claim 1, further comprising measuring whether the subject has achieved an improvement in a disease activity determined by at least one criteria selected from the group consisting of a 50% improvement in the American College of Rheumatology core set disease index (ACR50), a 70% improvement in the American College of Rheumatology core set disease index (ACR70), Health Assessment Questionnaire Disability Index (HAQ-DI), Investigator's Global Assessment (IGA), Disease Activity Score 28 (DAS28) C-reactive protein (CRP), Short Form Health survey (SF-36) in the mental and physical component summary (MCS and PCS), achievement of minimal disease activity (MDA), very low disease activity (VLDA), GRAppa Composite score (GRACE), Psoriatic Arthritis Disease Activity Score (PASDAS), modified Composite Psoriatic Disease Activity Index (mCPDAI), Psoriatic Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Functional Assessment of Chronic Illness Therapy (FACIT), a Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29), and vdH-S score.
Claim 10 is drawn to the method of claim 8 further comprising measuring whether the subject has achieved an improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) and/or Disease Activity Score 28 (DAS28) C-reactive protein (CRP) following a treatment period of about 24 weeks.
Claim 13 is drawn to the method of claim 1, wherein the subject has had inadequate response to a standard therapy for the PsA, and wherein the subject is also administered with the standard therapy during the treatment.
Claim 14 is drawn to a method of treating psoriatic arthritis in a subject in need thereof, wherein the subject has previously received at least one biologic treatment for psoriatic arthritis, the method comprising subcutaneously administering to the subject about 50 mg to about 150 mg of an anti-IL-23 antibody once at week 0, once at week 4, and once every 8 weeks (q8w) thereafter, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising HCDR1-3 comprising the amino acid sequences of SEQ ID NOs:1-3, respectively; and the light chain variable region comprising LCDR1-3 comprising the amino acid sequences of SEQ ID NOs:4-6, respectively a, and wherein the subject has at least one psoriatic plaque of >2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis before the treatment, and measuring whether the subject achieved an improvement in disease activity determined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, an improvement in the Leeds enthesitis index (LEI), and/or an improvement in a dactylitis assessment score.
Claim 15 is drawn to the method of claim 14, wherein the heavy chain variable region of comprises the amino acid sequence of SEQ ID NO: 7, and the light chain variable region of comprises the amino acid sequence of SEQ ID NO: 8.
Claim 16 is drawn to the method of claim 15, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 9, and a light chain comprising the amino acid sequence of SEQ ID NO: 10.
Claim 17 is drawn to the method of claim 14, wherein the antibody is administered at a dose of about 100 mg per administration.
Claim 18 is drawn to the method of claim 17, wherein the improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, improvement in the Leeds enthesitis index (LEI), and/or improvement in a dactylitis assessment score is achieved following a treatment period of about 24 to about 52 weeks.
Claim 20 is drawn to the method of claim 18 further comprising measuring whether the subject has achieved an improvement in a disease activity determined by at least one criteria selected from the group consisting of: a 50% improvement in the American College of Rheumatology core set disease index (ACR50), a 70% improvement in the American College of Rheumatology core set disease index (ACR70), Health Assessment Questionnaire Disability Index (HAQ-DI), Investigator's Global Assessment (IGA), Disease Activity Score 28 (DAS28) C-reactive protein (CRP), Short Form Health survey (SF-36) in the mental and physical component summary (MCS and PCS), achievement of minimal disease activity (MDA), very low disease activity (VLDA), GRAppa Composite score (GRACE), Psoriatic Arthritis Disease Activity Score (PASDAS), modified Composite Psoriatic Disease Activity Index (mCPDAI), Psoriatic Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Functional Assessment of Chronic Illness Therapy (FACIT), Patient-Reported Outcomes Measurement Information System-29 (PROMIS- 29), and vdH-S score.
Claim 22 is drawn to the method of claim 20, further comprising measuring whether the subject has achieved an improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) and/or Disease Activity Score 28 (DAS28) C-reactive protein (CRP) following a treatment period of about 24 weeks.
Claim 25 is drawn to the method of claim 14, wherein the subject has had inadequate response to a standard therapy for the PsA.
Claim 26 is drawn to the method of claim 25, wherein the subject is also administered with the standard therapy during treatment, wherein the standard therapy is at least one selected from the group consisting of non-biological disease-modifying antirheumatic drugs (DMARDs), oral corticosteroid, apremilast, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Deodhar et al, II teach a randomized, double-blind, placebo-controlled, phase 2a trial at 34 rheumatology and dermatology practices. Eligible participants were aged 18 years or older with active psoriatic arthritis and plaque psoriasis affecting at least 3% of their body surface area, with three or more of 66 tender joints and three or more of 68 swollen joints, who had an inadequate response or intolerance to standard treatments. We randomly assigned patients (2:1) via a central interactive web-response system using computer-generated permuted blocks with a block size of six, stratified by previous anti-tumor necrosis factor-α use, to receive subcutaneous guselkumab 100 mg or placebo at week 0, week 4, and every 8 weeks thereafter for 24 weeks. Patients, investigators, and site staff were masked to treatment assignment until final database locked at week 56. At week 16, patients with less than 5% improvement in swollen and tender joint counts were eligible for early escape to ustekinumab. At week 24, the remaining placebo-treated patients crossed over to receive guselkumab 100 mg at weeks 24, 28, 36, and 44 and guselkumab-treated patients received a placebo injection at week 24, followed by guselkumab injections at weeks 28, 36, and 44. The primary endpoint was the proportion of patients with at least 20% improvement at week 24 in signs and symptoms of psoriatic arthritis according to American College of Rheumatology criteria (ACR20) in the modified intention-to-treat population (i.e., all randomly assigned patients who received at least one dose of study treatment). Safety analyses included patients according to the study drug received.
Deodhar et al, II teach Eligible patients were required to have a screening Creactive protein (CRP) concentration of at least 0·3 mg/dL, with at least 3% of their body surface area affected by plaque psoriasis, and an inadequate response to, or intolerance of, standard therapies. Patients were permitted, but not required, to use stable doses of concomitant methotrexate (≤25 mg per week), oral corticosteroids (≤10 mg per day of prednisone or equivalent), and NSAIDs during the first 24 weeks of the study. Sulfasalazine (≤3 g per day) and leflunomide (≤20 mg per day) were permitted after week 24 (page 2215). Patients exposed to one previous anti-TNFα drug were permitted (page 2215). Deodhar et al teach that the patients were evaluated for improvement using Leeds enthesitis index (LEI), ACR20/50, PASI75, dactylitis score and HAQ-DI. The sequences of the antibody are inherent in the teachings of the prior art. Deodhar et al, II anticipate the claimed invention.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-6, 8, 10, 12-18, 20, 22 and 24-26 is/are rejected under 35 U.S.C. 103 as unpatentable over Deodhar et al (Lancet, Vol. 391, June 2, 2018, p. 2213-2224) is being referred to in this Office action is Deodhar et al, II in view of Clinical Trial (NCT03158285, 5/19/ 2017).
Claim 1 is a method of treating psoriatic arthritis in a subject in need thereof, wherein the subject has previously received at least one biologic treatment for psoriatic arthritis, the method comprising subcutaneously administering to the subject about 50 mg to about 150 mg of an anti-IL-23 antibody, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising HCDR1-3 comprising the amino acid sequences of SEQ ID NOs:1-3, respectively; and the light chain variable region comprising LCDR1-3 comprising the amino acid sequences of SEQ ID NOs:4-6, respectively, and measuring whether the subject achieves an improvement in disease activity determined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, an improvement in the Leeds enthesitis index (LEI), and/or an improvement in a dactylitis assessment score.
Claim 2 the method of claim 1, wherein the heavy chain variable region comprises the amino acid sequence of SEQ ID NO: 7, and the light chain variable region comprises the amino acid sequence of SEQ ID NO: 8.
Claim 3 is the method of claim 1, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 9, and a light chain comprising the amino acid sequence of SEQ ID NO: 10.
Claim 4 the method of claim 1, wherein the antibody is administered at a dose of about 100 mg per administration.
Claim 5 is the method of claim 4, wherein the antibody is administered once every 4 weeks (q4w).
Claim 6 is the method of claim 1, wherein the improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, improvement in the Leeds enthesitis index (LEI), and/or improvement in a dactylitis assessment score is achieved following a treatment period of about 24 to about 52 weeks.
Claim 8 is drawn to the method of claim 1, further comprising measuring whether the subject has achieved an improvement in a disease activity determined by at least one criteria selected from the group consisting of a 50% improvement in the American College of Rheumatology core set disease index (ACR50), a 70% improvement in the American College of Rheumatology core set disease index (ACR70), Health Assessment Questionnaire Disability Index (HAQ-DI), Investigator's Global Assessment (IGA), Disease Activity Score 28 (DAS28) C-reactive protein (CRP), Short Form Health survey (SF-36) in the mental and physical component summary (MCS and PCS), achievement of minimal disease activity (MDA), very low disease activity (VLDA), GRAppa Composite score (GRACE), Psoriatic Arthritis Disease Activity Score (PASDAS), modified Composite Psoriatic Disease Activity Index (mCPDAI), Psoriatic Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Functional Assessment of Chronic Illness Therapy (FACIT), a Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29), and vdH-S score.
Claim 10 is drawn to the method of claim 8 further comprising measuring whether the subject has achieved an improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) and/or Disease Activity Score 28 (DAS28) C-reactive protein (CRP) following a treatment period of about 24 weeks.
Claim 12 is drawn to the method of claim 8, further comprising measuring whether the subject has achieved Investigator's Global Assessment (IGA) of 0 (clear) or 1 (minimal), or 2 or more grade reduction in the IGA, following a treatment period of
Claim 13 is drawn to the method of claim 1, wherein the subject has had inadequate response to a standard therapy for the PsA, and wherein the subject is also administered with the standard therapy during the treatment.
Claim 14 is drawn to a method of treating psoriatic arthritis in a subject in need thereof, wherein the subject has previously received at least one biologic treatment for psoriatic arthritis, the method comprising subcutaneously administering to the subject about 50 mg to about 150 mg of an anti-IL-23 antibody once at week 0, once at week 4, and once every 8 weeks (q8w) thereafter, wherein the antibody comprises a heavy chain variable region and a light chain variable region, the heavy chain variable region comprising HCDR1-3 comprising the amino acid sequences of SEQ ID NOs:1-3, respectively; and the light chain variable region comprising LCDR1-3 comprising the amino acid sequences of SEQ ID NOs:4-6, respectively a, and wherein the subject has at least one psoriatic plaque of >2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis before the treatment, and measuring whether the subject achieved an improvement in disease activity determined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, an improvement in the Leeds enthesitis index (LEI), and/or an improvement in a dactylitis assessment score.
Claim 15 is drawn to the method of claim 14, wherein the heavy chain variable region of comprises the amino acid sequence of SEQ ID NO: 7, and the light chain variable region of comprises the amino acid sequence of SEQ ID NO: 8.
Claim 16 is drawn to the method of claim 15, wherein the antibody comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 9, and a light chain comprising the amino acid sequence of SEQ ID NO: 10.
Claim 17 is drawn to the method of claim 14, wherein the antibody is administered at a dose of about 100 mg per administration.
Claim 18 is drawn to the method of claim 17, wherein the improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), radiographic progression, resolution of enthesitis, resolution of dactylitis, improvement in the Leeds enthesitis index (LEI), and/or improvement in a dactylitis assessment score is achieved following a treatment period of about 24 to about 52 weeks.
Claim 20 is drawn to the method of claim 18 further comprising measuring whether the subject has achieved an improvement in a disease activity determined by at least one criteria selected from the group consisting of: a 50% improvement in the American College of Rheumatology core set disease index (ACR50), a 70% improvement in the American College of Rheumatology core set disease index (ACR70), Health Assessment Questionnaire Disability Index (HAQ-DI), Investigator's Global Assessment (IGA), Disease Activity Score 28 (DAS28) C-reactive protein (CRP), Short Form Health survey (SF-36) in the mental and physical component summary (MCS and PCS), achievement of minimal disease activity (MDA), very low disease activity (VLDA), GRAppa Composite score (GRACE), Psoriatic Arthritis Disease Activity Score (PASDAS), modified Composite Psoriatic Disease Activity Index (mCPDAI), Psoriatic Area and Severity Index (PASI), Dermatology Life Quality Index (DLQI), Functional Assessment of Chronic Illness Therapy (FACIT), Patient-Reported Outcomes Measurement Information System-29 (PROMIS- 29), and vdH-S score.
Claim 22 is drawn to the method of claim 20, further comprising measuring whether the subject has achieved an improvement in the Health Assessment Questionnaire Disability Index (HAQ-DI) and/or Disease Activity Score 28 (DAS28) C-reactive protein (CRP) following a treatment period of about 24 weeks.
Claim 24 is drawn to the method of claim 20, further comprising measuring whether the subject has achieved Investigator's Global Assessment (IGA) of 0 (clear) or 1 (minimal), or 2 or more grade reduction in the IGA, following a treatment period of about 24 weeks, wherein the subject has 3% or more body surface area (BSA) psoriatic involvement and an IGA score of 2 or more at the baseline before the treatment.
Claim 25 is drawn to the method of claim 14, wherein the subject has had inadequate response to a standard therapy for the PsA.
Claim 26 is drawn to the method of claim 25, wherein the subject is also administered with the standard therapy during treatment, wherein the standard therapy is at least one selected from the group consisting of non-biological disease-modifying antirheumatic drugs (DMARDs), oral corticosteroid, apremilast, and nonsteroidal anti-inflammatory drugs (NSAIDs).
Deodhar et al, II teach a randomized, double-blind, placebo-controlled, phase 2a trial at 34 rheumatology and dermatology practices. Eligible participants were aged 18 years or older with active psoriatic arthritis and plaque psoriasis affecting at least 3% of their body surface area, with three or more of 66 tender joints and three or more of 68 swollen joints, who had an inadequate response or intolerance to standard treatments. We randomly assigned patients (2:1) via a central interactive web-response system using computer-generated permuted blocks with a block size of six, stratified by previous anti-tumor necrosis factor-α use, to receive subcutaneous guselkumab 100 mg or placebo at week 0, week 4, and every 8 weeks thereafter for 24 weeks. Patients, investigators, and site staff were masked to treatment assignment until final database locked at week 56. At week 16, patients with less than 5% improvement in swollen and tender joint counts were eligible for early escape to ustekinumab. At week 24, the remaining placebo-treated patients crossed over to receive guselkumab 100 mg at weeks 24, 28, 36, and 44 and guselkumab-treated patients received a placebo injection at week 24, followed by guselkumab injections at weeks 28, 36, and 44. The primary endpoint was the proportion of patients with at least 20% improvement at week 24 in signs and symptoms of psoriatic arthritis according to American College of Rheumatology criteria (ACR20) in the modified intention-to-treat population (i.e. all randomly assigned patients who received at least one dose of study treatment). Safety analyses included patients according to the study drug received.
Deodhar et al, II teach Eligible patients were required to have a screening Creactive protein (CRP) concentration of at least 0·3 mg/dL, with at least 3% of their body surface area affected by plaque psoriasis, and an inadequate response to, or intolerance of, standard therapies. Patients were permitted, but not required, to use stable doses of concomitant methotrexate (≤25 mg per week), oral corticosteroids (≤10 mg per day of prednisone or equivalent), and NSAIDs during the first 24 weeks of the study. Sulfasalazine (≤3 g per day) and leflunomide (≤20 mg per day) were permitted after week 24 (page 2215). Patients exposed to one previous anti-TNFα drug were permitted (page 2215). Deodhar et al, II teach that the patients were evaluated for improvement using Leeds enthesitis index (LEI), ACR20/50, PASI75, dactylitis score and HAQ-DI. The sequences of the antibody are necessarily taught in the teachings of the prior art.
Deodhar et al, II not specifically teach the claim limitations “ the method of claim 8, further comprising measuring whether the subject has achieved Investigator's Global Assessment (IGA) of 0 (clear) or 1 (minimal), or 2 or more grade reduction in the IGA, following a treatment period of about 24 weeks, and an IGA score of 2 or more at the baseline before the treatment and the method of claim 20, further comprising measuring whether the subject has achieved Investigator's Global Assessment (IGA) of 0 (clear) or 1 (minimal), or 2 or more grade reduction in the IGA, following a treatment period of about 24 weeks, and an IGA score of 2 or more at the baseline before the treatment”.
However, Clinical Trials (NCT03158285, 5/19/2017) has demonstrated that the Investigator’s Global Assessment (IGA) can be used to evaluate patients with psoriasis and lesions using a score of 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate) and 4 (severe).
It would have prima facie obvious at the time the invention was made to use (IGA) as taught by Clinical Trial (NCT03158285) in a method of treating psoriasis arthritis as taught by Deodhar et al, II to assess psoriasis lesions because has Clinical Trials (NCT03158285, 5/19/2017) has demonstrated the success in using this evaluation tool on psoriatic arthritis patients. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.). The combination of prior art references renders the invention obvious.
Status of Claims
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Conclusion
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