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 .
The preliminary amendment filed 10/9/24 is acknowledged. Claims 1, 3-5, 7, 9-11, 13-21, and 28 have been amended. Claims 2, and 22-27 have been canceled. Claims 1, 3-21, and 28 are pending and under examination.
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.
Claims 1, 3-21, and 28 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 1 is indefinite for the recitation "treating a patient having non-radiographic axial spondyloarthritis (nr-axSpA), comprising administering secukinumab to a patient in need thereof” because it is unclear whether "a patient in need thereof" is the same as "a patient having nr-axSpA" set forth in the preamble, or whether "a patient in need thereof' represents a subpopulation of "a patient having nr-axSpA", and if so, what the term "a patient in need thereof" is meant or encompasses. The metes and bounds of the claim, therefore, cannot be determined. The following is suggested: "treating a patient having non-radiographic axial spondyloarthritis (nr-axSpA), comprising administering secukinumab to the patient", if intended. The dependent claims do not cure the deficiencies of claim 1, and thus, are included in the rejection.
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.
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, 9-11, 13-21, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mpofu et al. (US 20130209480, 8/15/2013; or its patent US9,744,234, 8/29/2017) in view of in view of Poddubnyy, D. (Ther Adv Musculoskelet Dis. 2013 Feb. 5(1): 45-54).
The instant claims are drawn to a method of treating a patient having non-radiographic axial spondyloarthirtis comprising administering secukinumab to a patient in need thereof.
Mpofu teaches of treating an inflammatory arthritis, e.g., AS, RA and PsA, using a therapeutically effective amount of an IL-17 antagonist, such as an IL-17 antibody secukinumab (See paragraph 0010). Mpofu teaches AS or ankylosing spondylitis refer to inflammatory arthridities characterized by chronic inflammation of joints, which can include the spine and the sacroilium in the pelvis, and which can cause eventual fusion of the spine, thus, is an axial spondyloarthritis (axSpA) and is known as radiographic axial spondyloarthritis (See paragraph 0091). Additionally, Mpofu teaches preferred dosing regimens for treating these inflammatory arthritis, which include a regimen comprising the induction regimen comprising S.C. administration of 150 or 300 mg weekly for 5 doses, followed by a maintenance regimen at week 8 (See paragraphs 0236-0238 and Table 5). Further, Mpofu teaches that secukinumab may be administered in accordance with the method of the disclosure either alone or in combination with other therapies, such as, e.g., in combination with additional therapies for inflammation, including, among others, a NSAID (See paragraph 0155 and 0256).
Mpofu does not specifically teach the use of secukinumab for treating non-radiographic axial spondyloarthritis (nr-axSpA).
Poddubnyy teaches that axial SpA (axSpA) is characterized by predominant involvement of the spine and/or sacroiliac joints: ankylosing spondy-litis (AS), nonradiographic axial Spa (nr-axSpa, without definite sacroiliitis on X-ray), certain forms of psoriatic arthritis and reactive arthritis with axial involvement, and arthritis associated with inflammatory bowel disease; and that importantly, nr-axSpA and AS are considered nowadays as two stages of one disease (axSpA) (See abstract and page 45). Additionally, Poddubnyy teaches that nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective against the major symptoms of axSpA (pain and stiffness); and that beyond NSAIDs, only TNF α blockers are effective and approved for the treatment of active axSpA; and several novel drugs (i.e. monoclonal antibodies targeting interleukin-17, interleukin-12/23, …), which might be effective in axSpA, are currently under investigation (See abstract). Further, Poddubnyy teaches that so far, clinical trials demonstrating clinical efficacy of NSAIDs in axSpA were performed in patients with AS only, however, it can be expected that NSAIDs are also effective in patients with nr-axSpA, who did not develop radiographic sacroiliitis yet, that is also being confirmed by daily practice; and that considering nr-axSpA and AS as two stages of axSpA, it is reasonable to extrapolate data on treatment efficacy from AS to the early stage of the disease; therefore, nr-axSpA patients should generally be treated in the same way as patients with AS (See page 46). Furthermore, Poddubnyy teaches that recently, results of the first phase III trial inves-tigating efficacy of a TNF α blocker (adali-mumab) in nr-axSpA were presented, wherein higher treatment response was seen in patients with short dis-ease duration (less than 5 years: 49% of the adal-imumab-treated patients achieved an ASAS40 response), elevated CRP (55%) and presence of active inflammation on MRI of the sacroiliac joints (49%). As a result, adalimumab became the first TNF α blocker to receive a positive opinion from the CHMP of the European Medicines Agency (EMA) for the treatment of adults with severe axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to or are intolerant to NSAIDs; and that it can be expected that all currently available TNF α blockers will extend their official labels to nr-axSpA in the next 2 years (See page 49).
Therefore, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat a patient having nr-axSpA with secukinumab according to Mpofu’s regimen for treating inflammatory arthritis such as AS (axSpA), or secukinumab plus an NSAID, wherein the patient has objective signs of inflammation as indicated by CRP and/or MRI, following the teachings of Mpofu and Poddubnyy (nr-axSpA is widely considered as an early stage of AS (axSpA), and had been treated with the same regimens as that for axSpA). The person of ordinary skill in the art would have been motivated to do so for disease treatment, and reasonably would have expected success because nr-axSpA and AS are considered as two stages of one disease, i.e., nr-axSpA is considered as an early stage of axSpA (indicating similar pathological factors), and it has been demonstrated that same therapies, such as NSAIDs and TNF α blockers, are effective for both axSpA and nr-axSpA (with objective signs of inflammation such as elevated CRP, osteitis on MRI) (by Poddubnyy).
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". The combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Therefore, the invention as a whole would have been 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.
Claims 1, 13, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 8,119,131 in view of in view of Poddubnyy, D. (Ther Adv Musculoskelet Dis. 2013 Feb. 5(1): 45-54).
Claim 14 of ‘131 patent is drawn to a method for treating an IL-17 mediated inflammatory condition or IL-17 mediated autoimmune disease with an IL-17 antibody comprising a VH and VL of SEQ ID NO:8 and 10, respectively, wherein the inflammatory and autoimmune disease includes ankylosing spondylitis (AS). SEQ ID NO:8 and 10 in the patent are 100% identical to the present SEQ ID NO:8 and 10, respectively, which are the heavy and light chain sequences for secukinumab.
The ‘131 claims do not specifically teach treating nr-axSpA.
Poddubnyy teaches that axial SpA (axSpA) is characterized by predominant involvement of the spine and/or sacroiliac joints: ankylosing spondy-litis (AS), nonradiographic axial Spa (nr-axSpa, without definite sacroiliitis on X-ray), certain forms of psoriatic arthritis and reactive arthritis with axial involvement, and arthritis associated with inflammatory bowel disease; and that importantly, nr-axSpA and AS are considered nowadays as two stages of one disease (axSpA) (See abstract and page 45). Additionally, Poddubnyy teaches that nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective against the major symptoms of axSpA (pain and stiffness); and that beyond NSAIDs, only TNF α blockers are effective and approved for the treatment of active axSpA; and several novel drugs (i.e. monoclonal antibodies targeting interleukin-17, interleukin-12/23, …), which might be effective in axSpA, are currently under investigation (See abstract). Further, Poddubnyy teaches that so far, clinical trials demonstrating clinical efficacy of NSAIDs in axSpA were performed in patients with AS only, however, it can be expected that NSAIDs are also effective in patients with nr-axSpA, who did not develop radiographic sacroiliitis yet, that is also being confirmed by daily practice; and that considering nr-axSpA and AS as two stages of axSpA, it is reasonable to extrapolate data on treatment efficacy from AS to the early stage of the disease; therefore, nr-axSpA patients should generally be treated in the same way as patients with AS (See page 46). Furthermore, Poddubnyy teaches that recently, results of the first phase III trial inves-tigating efficacy of a TNF α blocker (adali-mumab) in nr-axSpA were presented, wherein higher treatment response was seen in patients with short dis-ease duration (less than 5 years: 49% of the adal-imumab-treated patients achieved an ASAS40 response), elevated CRP (55%) and presence of active inflammation on MRI of the sacroiliac joints (49%). As a result, adalimumab became the first TNF α blocker to receive a positive opinion from the CHMP of the European Medicines Agency (EMA) for the treatment of adults with severe axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to or are intolerant to NSAIDs; and that it can be expected that all currently available TNF α blockers will extend their official labels to nr-axSpA in the next 2 years (See page 49).
Therefore, it would have been obvious to the person of ordinary skill in the art to treat a patient having nr-axSpA with the IL-17 antibody of the patent (for treating AS (axSpA)), or further in combination with an NSAID, in view of claim 14 of the patent and the teachings of Poddubnyy that nr-axSpA patients should be treated with the same way as patients with AS. As such, the conflicting claims are not patentably distinct from each other.
Claims 1, 13, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9,765,140, in view of Poddubnyy, D. (Ther Adv Musculoskelet Dis. 2013 Feb. 5(1): 45-54).
Claim 1 of the ‘140 patent is drawn to a method of treating a patient having an interleukin 17 (IL-17)-mediated disease or disorder, comprising administering a therapeutically effective amount of an anti-IL-17 antibody to the patient, wherein the anti-IL-17 antibody is capable of inhibiting by 50% the activity of 1 nM human IL-17, at a concentration of less than 5nM, wherein said inhibiting is measured using an assay employing human IL-17 to induce production of interleukin 6 (IL-6) from human dermal fibroblasts, wherein said anti-IL-17antibody is capable of inhibiting the binding of IL-17 to the IL-17 receptor to the same extent as an antibody comprising a VH comprising the amino acid sequence set forth as SEQ ID NO:8 and a VL comprising the amino acid sequence set forth as SEQ ID NO:10, wherein the anti-IL-17 antibody has the three CDRs of the variable heavy chain domain of SEQ ID NO:8 and the three CDRs of the variable light chain domain of SEQ ID NO: 10, and further wherein the disease or disorder is psoriasis, psoriatic arthritis, ankylosing spondylitis, uveitis, juvenile diabetes, asthma, myasthenia gravis, an inflammatory disease of the skin, tumor, or multiple sclerosis. It should be noted that SEQ ID NO:8 and 10 in the patent correspond to the heavy and light chain sequences for secukinumab.
The ‘140 claims do not specifically teach treating nr-axSpA.
Poddubnyy teaches that axial SpA (axSpA) is characterized by predominant involvement of the spine and/or sacroiliac joints: ankylosing spondy-litis (AS), nonradiographic axial Spa (nr-axSpa, without definite sacroiliitis on X-ray), certain forms of psoriatic arthritis and reactive arthritis with axial involvement, and arthritis associated with inflammatory bowel disease; and that importantly, nr-axSpA and AS are considered nowadays as two stages of one disease (axSpA) (See abstract and page 45). Additionally, Poddubnyy teaches that nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective against the major symptoms of axSpA (pain and stiffness); and that beyond NSAIDs, only TNF α blockers are effective and approved for the treatment of active axSpA; and several novel drugs (i.e. monoclonal antibodies targeting interleukin-17, interleukin-12/23, …), which might be effective in axSpA, are currently under investigation (See abstract). Further, Poddubnyy teaches that so far, clinical trials demonstrating clinical efficacy of NSAIDs in axSpA were performed in patients with AS only, however, it can be expected that NSAIDs are also effective in patients with nr-axSpA, who did not develop radiographic sacroiliitis yet, that is also being confirmed by daily practice; and that considering nr-axSpA and AS as two stages of axSpA, it is reasonable to extrapolate data on treatment efficacy from AS to the early stage of the disease; therefore, nr-axSpA patients should generally be treated in the same way as patients with AS (See page 46). Furthermore, Poddubnyy teaches that recently, results of the first phase III trial inves-tigating efficacy of a TNF α blocker (adali-mumab) in nr-axSpA were presented, wherein higher treatment response was seen in patients with short dis-ease duration (less than 5 years: 49% of the adal-imumab-treated patients achieved an ASAS40 response), elevated CRP (55%) and presence of active inflammation on MRI of the sacroiliac joints (49%). As a result, adalimumab became the first TNF α blocker to receive a positive opinion from the CHMP of the European Medicines Agency (EMA) for the treatment of adults with severe axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to or are intolerant to NSAIDs; and that it can be expected that all currently available TNF α blockers will extend their official labels to nr-axSpA in the next 2 years (See page 49).
Therefore, it would have been obvious to the person of ordinary skill in the art to treat a patient having nr-axSpA with the IL-17 antibody of the patent (for treating AS (axSpA)), or further in combination with an NSAID, in view of claims 1-2 of the patent and the teachings of Poddubnyy that nr-axSpA patients should be treated with the same way as patients with AS. As such, the conflicting claims are not patentably distinct from each other.
Claims 1, 13-15, 17-21, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3 and 5-11 of U.S. Patent No. 9,744,234, in view of Poddubnyy, D. (Ther Adv Musculoskelet Dis. 2013 Feb. 5(1): 45-54; provided by applicants).
Claims 2, 3 and 5-11 of ‘234 patent is drawn to a method of treating AS by subcutaneously administering five doses of about 150 mg of an IL-17 antibody weekly; and monthly thereafter; wherein the IL-17 antibody comprises a VH and VL of SEQ ID NO:8 and 10, respectively (claim 2, part i), for example); or is secukinumab (claims 3, 5, 10 and 11, for example); and wherein the method further comprises administering an additional agent such as an NSAID (claim 7, for example). It should be noted that SEQ ID NO:8 and 10 in the patent correspond to the heavy and light chain sequences for secukinumab.
The ‘234 claims do not specifically teach treating nr-axSpA.
Poddubnyy teaches that axial SpA (axSpA) is characterized by predominant involvement of the spine and/or sacroiliac joints: ankylosing spondy-litis (AS), nonradiographic axial Spa (nr-axSpa, without definite sacroiliitis on X-ray), certain forms of psoriatic arthritis and reactive arthritis with axial involvement, and arthritis associated with inflammatory bowel disease; and that importantly, nr-axSpA and AS are considered nowadays as two stages of one disease (axSpA) (See abstract and page 45). Additionally, Poddubnyy teaches that nonsteroidal anti-inflammatory drugs (NSAIDs) are highly effective against the major symptoms of axSpA (pain and stiffness); and that beyond NSAIDs, only TNF α blockers are effective and approved for the treatment of active axSpA; and several novel drugs (i.e. monoclonal antibodies targeting interleukin-17, interleukin-12/23, …), which might be effective in axSpA, are currently under investigation (See abstract). Further, Poddubnyy teaches that so far, clinical trials demonstrating clinical efficacy of NSAIDs in axSpA were performed in patients with AS only, however, it can be expected that NSAIDs are also effective in patients with nr-axSpA, who did not develop radiographic sacroiliitis yet, that is also being confirmed by daily practice; and that considering nr-axSpA and AS as two stages of axSpA, it is reasonable to extrapolate data on treatment efficacy from AS to the early stage of the disease; therefore, nr-axSpA patients should generally be treated in the same way as patients with AS (See page 46). Furthermore, Poddubnyy teaches that recently, results of the first phase III trial inves-tigating efficacy of a TNF α blocker (adali-mumab) in nr-axSpA were presented, wherein higher treatment response was seen in patients with short dis-ease duration (less than 5 years: 49% of the adal-imumab-treated patients achieved an ASAS40 response), elevated CRP (55%) and presence of active inflammation on MRI of the sacroiliac joints (49%). As a result, adalimumab became the first TNF α blocker to receive a positive opinion from the CHMP of the European Medicines Agency (EMA) for the treatment of adults with severe axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to or are intolerant to NSAIDs; and that it can be expected that all currently available TNF α blockers will extend their official labels to nr-axSpA in the next 2 years (See page 49).
Therefore, it would have been obvious to the person of ordinary skill in the art to treat a patient having nr-axSpA using the IL-17 antibody regimes for treating AS (axSpA) in claims 2, 3 and 5-11 of ‘234 patent, or in combination with an NSAID, in view of the teachings of Poddubnyy that nr-axSpA patients should be treated with the same way as patients with AS. As such, the conflicting claims are not patentably distinct from each other.
Claims 1, 5, and 7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-16 and 34-37 of U.S. Patent No. 12,497,449. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treating a patient having non-radiographic axial spondyloarthirtis comprising administering secukinumab to a patient in need thereof.
The ‘449 claims are drawn to a method of treating active psoriatic arthritis (PsA) or active axial spondyloarthritis (axSpA) comprising intravenously administering to a patient in need thereof a dose of about 6 mg/kg secukinumab, followed by intravenously administering a dose of about 2 mg/kg secukinumab every 4 weeks. The ‘449 claims teach wherein the patient has active axSpA, wherein the active axSpA in the patient is active non-radiographic axial spondyloarthritis (nr-axSpA). The ‘449 claims teach wherein wherein the patient achieves ASAS 40 by week 16 of treatment. The ‘449 claims teach wherein the patient achieves ASAS 20 by week 16 of treatment. The ‘449 claims teach wherein the patient achieves an ASDAS-CRP major improvement response by week 16 of treatment.
Claims 1, 5, and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 66-69 of copending Application No. 19/304,006 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treating a patient having non-radiographic axial spondyloarthirtis comprising administering secukinumab to a patient in need thereof.
The ’006 claims are drawn to a method of treating active PsA or active axial spondyloarthritis (axSpA) comprising intravenously administering to a patient in need thereof a dose of 2 mg/kg +/- 10% secukinumab every 4 weeks, wherein the active PsA or active axSpA is active axSpA, wherein the axSpA in the patient is active non- radiographic axial spondyloarthritis (nr-axSpA). The ‘006 claims teach wherein the patient achieves ASAS 40 by week 16 of treatment. The ‘006 claims teach wherein the patient achieves an ASDAS-CRP major improvement response by week 16 of treatment. The ‘006 claims teach wherein the patient achieves ASAS 20 by week 16 of treatment.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Status
No claims are allowed.
Conclusion
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/SANDRA CARTER/ Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674
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