DETAILED 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 .
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 allowance. 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 4/27/2026 has been entered.
Claims 11-18 are pending and under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 4/27/2026 has been considered.
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) 11-12 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by NCT02186873 (IDS of 4/27/2026, study primary completion 12/15/2015).
The instantly claimed invention is broadly drawn to a method for treating a TNF related condition, wherein the TNF related condition is active ankylosing spondylitis, the method comprising: administering a composition comprising a safe and effective amount of at least one isolated mammalian anti- TNF antibody comprising: a) a heavy chain (HC) complementary determining region (CDR) 1 comprising an amino acid sequence of SEQ ID NO: 1;b) a HC CDR2 comprising an amino acid sequence of SEQ ID NO: 2; wherein position 1 of SEQ ID NO: 2 is phenylalanine, position 2 of SEQ ID NO: 2 is methionine, position 3 of SEQ ID NO: 2 is serine, position 4 of SEQ ID NO: 2 is tyrosine, position 10 of SEQ ID NO: 2 is lysine, position 11 of SEQ ID NO: 2 is tyrosine, and position 17 of SEQ ID NO: 2 is glycine; c) a HC CDR3 comprising an amino acid sequence of SEQ ID NO: 3; wherein position 4 of SEQ ID NO: 3 is isoleucine, position 5 of SEQ ID NO: 3 is alanine, and position 9 of SEQ ID NO: 3 is asparagine; d) a light chain (LC) CDR1 comprising an amino acid sequence of SEQ ID NO: 4; wherein position 7 of SEQ ID NO: 4 is tyrosine; e) a LC CDR2 comprising an amino acid sequence of SEQ ID NO: 5; and f) a LC CDR3 comprising an amino acid sequence of SEQ ID NO: 6 (which is antibody golimumab) and at least one pharmaceutically acceptable carrier or diluent, wherein said composition is administered via IV infusion, and wherein at week 16 of treatment patients treated with the anti-TNF antibody achieve a mean change from baseline in BASFI = -2.4 2.1 SD (claims 11-12 and 15-16), and wherein said composition is administered such that said anti-TNF antibody is administered at a dose of 2 mg/kg, administered over 30 + 10 minutes, at Weeks 0 and 4, and then every 8 weeks (q8w) thereafter (claims 13, 17).
It is noted to applicant that the instantly claimed anti-TNF antibody is same as golimumab.
NCT02186873 teaches a method of treating ankylosing spondylitis (AS) comprising administering golimumab 2 mg/Kg by intravenous infusion and the result is compared with placebo at Weeks 0, 4,12 and 20 (see detailed description). It is well known in the art that SIMPONI ARIA golimumab (same product) is administered by IV at 2 mg/Kg over a period of 30 min (IDS, Simponi Aria Label, FDA approved, 7/2013). Therefore, the instantly claimed method is anticipated by the prior art of record.
Claim(s) 11-12, 14-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inman et al. (IDS, Arthritis and Rheum. 58: 3402-3412, 2008).
The instantly claimed invention is broadly drawn to a method for treating a TNF related condition, wherein the TNF related condition is active ankylosing spondylitis, the method comprising: administering a composition comprising a safe and effective amount of at least one isolated mammalian anti- TNF antibody comprising: a) a heavy chain (HC) complementary determining region (CDR) 1 comprising an amino acid sequence of SEQ ID NO: 1;b) a HC CDR2 comprising an amino acid sequence of SEQ ID NO: 2; wherein position 1 of SEQ ID NO: 2 is phenylalanine, position 2 of SEQ ID NO: 2 is methionine, position 3 of SEQ ID NO: 2 is serine, position 4 of SEQ ID NO: 2 is tyrosine, position 10 of SEQ ID NO: 2 is lysine, position 11 of SEQ ID NO: 2 is tyrosine, and position 17 of SEQ ID NO: 2 is glycine; c) a HC CDR3 comprising an amino acid sequence of SEQ ID NO: 3; wherein position 4 of SEQ ID NO: 3 is isoleucine, position 5 of SEQ ID NO: 3 is alanine, and position 9 of SEQ ID NO: 3 is asparagine; d) a light chain (LC) CDR1 comprising an amino acid sequence of SEQ ID NO: 4; wherein position 7 of SEQ ID NO: 4 is tyrosine; e) a LC CDR2 comprising an amino acid sequence of SEQ ID NO: 5; and f) a LC CDR3 comprising an amino acid sequence of SEQ ID NO: 6 (which is antibody golimumab) and at least one pharmaceutically acceptable carrier or diluent, wherein said composition is administered via IV infusion, and wherein at week 16 of treatment patients treated with the anti-TNF antibody achieve a mean change from baseline in BASFI = -2.4 2.1 SD (claims 11-12 and 15-16), and wherein the method further comprises administering said composition with or without methotrexate (MTX), sulfasalazine (SSZ) or hydroxychloroquine (HCQ) (claims 14,18).
Inman et al teach a method for treating ankylosing spondylitis using golimumab antibody and a pharmaceutically acceptable carrier by a subcutaneous injection.
The specification discloses that golimumab comprises a light chain comprising amino acid sequence of SEQ ID NO:37 and a heavy chain comprising amino acid sequence of SEQ ID NO: 36 (also see sequence alignment below). Regarding achieving one or more criteria selected from the group consisting of: HAQ-DI = -0.60, enthesitis = -1.87, dactylitis = -7.8, SF-36 PCS =8.65 and SF-36 MCS= 5.33 after a treatment of 4 weeks, because the reference teaches treating 2 mg/kg or about 100 mg per subject (methods, pg. 3402), the result would be the same, unless evidence to contrary. Regarding the limitation of claims 14 and 18, the reference teaches that patients were allowed to continue treatment with methotrexate (MTX), sulfasalazine or hydroxychloroquine (pg. 3403, left col.). They used two dosages 50 mg or 100 mgs per subject and the determined the ankylosing spondylitis using a Bath Ankylosing spondylitis disease activity index greater than equal or >4 and a week treat that improves in the assessment in AS (ASAS20) criteria at week 14 (Methods, pg. 3402).
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, 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.
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.
Claim(s) 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Inman et al. (IDS, Arthritis and Rheum. 58: 1214-1219, 2013) in view of NCT02186873 (IDS, 4/27/2026).
The instantly claimed invention is broadly drawn to a method for treating a TNF related condition, wherein the TNF related condition is active ankylosing spondylitis, the method comprising: administering a composition comprising a safe and effective amount of at least one isolated mammalian anti- TNF antibody comprising: a) a heavy chain (HC) complementary determining region (CDR) 1 comprising an amino acid sequence of SEQ ID NO: 1;b) a HC CDR2 comprising an amino acid sequence of SEQ ID NO: 2; wherein position 1 of SEQ ID NO: 2 is phenylalanine, position 2 of SEQ ID NO: 2 is methionine, position 3 of SEQ ID NO: 2 is serine, position 4 of SEQ ID NO: 2 is tyrosine, position 10 of SEQ ID NO: 2 is lysine, position 11 of SEQ ID NO: 2 is tyrosine, and position 17 of SEQ ID NO: 2 is glycine; c) a HC CDR3 comprising an amino acid sequence of SEQ ID NO: 3; wherein position 4 of SEQ ID NO: 3 is isoleucine, position 5 of SEQ ID NO: 3 is alanine, and position 9 of SEQ ID NO: 3 is asparagine; d) a light chain (LC) CDR1 comprising an amino acid sequence of SEQ ID NO: 4; wherein position 7 of SEQ ID NO: 4 is tyrosine; e) a LC CDR2 comprising an amino acid sequence of SEQ ID NO: 5; and f) a LC CDR3 comprising an amino acid sequence of SEQ ID NO: 6 (which is antibody golimumab) and at least one pharmaceutically acceptable carrier or diluent, wherein said composition is administered via IV infusion, and wherein at week 16 of treatment patients treated with the anti-TNF antibody achieve a mean change from baseline in BASFI = -2.4 2.1 SD (claims 11-12 and 15-16), and wherein said composition is administered such that said anti-TNF antibody is administered at a dose of 2 mg/kg, administered over 30 + 10 minutes, at Weeks 0 and 4, and then every 8 weeks (q8w) thereafter (claims 13, 17), wherein the method further comprises administering said composition with or without methotrexate (MTX), sulfasalazine (SSZ) or hydroxychloroquine (HCQ).
Inman et al teach a method for treating ankylosing spondylitis using golimumab antibody and a pharmaceutically acceptable carrier by a subcutaneous injection.
The specification discloses that golimumab comprises a light chain comprising amino acid sequence of SEQ ID NO:37 and a heavy chain comprising amino acid sequence of SEQ ID NO: 36 (also see sequence alignment below). Regarding achieving one or more criteria selected from the group consisting of: HAQ-DI = -0.60, enthesitis = -1.87, dactylitis = -7.8, SF-36 PCS =8.65 and SF-36 MCS= 5.33 after a treatment of 4 weeks, because the reference teaches treating 2 mg/kg or about 100 mg per subject (methods, pg. 3402), the result would be the same, unless evidence to contrary. Regarding the limitation of claims 14 and 18, the reference teaches that patients were allowed to continue treatment with methotrexate (MTX), sulfasalazine or hydroxychloroquine (pg. 3403, left col.). They used two dosages 50 mg or 100 mgs per subject and the determined the ankylosing spondylitis using a Bath Ankylosing spondylitis disease activity index greater than equal or >4 and a week treat that improves in the assessment in AS (ASAS20) criteria at week 14 (Methods, pg. 3402). Inman does teach administer golimumab 2.0 mg/kg by intravenous infusion.
NCT02186873 teaches a method of treating ankylosing spondylitis (AS) comprising administering golimumab 2 mg/Kg by intravenous infusion and the result is compared with placebo at Weeks 0, 4,12 and 20 (see detailed description). It is well known in the art that SIMPONI ARIA golimumab (same product) is administered by IV at 2 mg/Kg over a period of 30 min (IDS, Simponi Aria Label, FDA approved, 7/2013 and enclosed: Highlights of Prescribing information, initial US Approval: 2009, updated 9/2020).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of invention to administer the antibody golimumab at 2 mg/Kg intravenously for treating ankylosing spondylitis as taught by Inman et al. Further, one of ordinary skill of the art would have been motivated to administer golimumab by an intravenous infusion because NCT02186873 teaches administering golimumab at 2 mg/Kg for treating Ankylosing spondylitis. One would have a reasonable expectation of success in administering golimumab 2 mg/Kg intravenously NCT02186873 teaches the same for treating AS. Therefore, the invention is obvious over the combined teachings of the prior art.
Conclusion
No claim is allowed.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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