DETAILED OFFICE ACTION
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 preliminary amendment filed on 15 May 2023 is acknowledged and entered. Following the amendment, the original claims 5-16 are canceled, and claims 1 and 3 are amended.
Currently, claims 1-4 are pending and under consideration.
Formal Matters:
Information Disclosure Statement
Applicant's IDS submitted on 5/9/2023 and 6/21/2023 are acknowledged and have been considered. A signed copy is attached hereto.
Priority acknowledgement
This application claims benefit of U.S. application 16/319,174 filed 01/18/2019, which is a national stage entry (371) of PCT/IB2017/054333 with the international filing date of 07/18/2017, which claims priority from U.S. provisional application 62/364,007 filed 07/19/2016, which is acknowledged.
Claims
Claims 1 and 4 are objected to for the following informalities, appropriate correction is required:
Claims 1 and 4 recite “administering the patient …”; the following is suggested: “administering to the patient …”.
Rejections Over Prior Art:
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 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 interpretation: claim 4 recites “A method of reducing the number of tissue resident memory cells in the lesional skin of a patient …” in the preamble, and the recitation “reducing the number of tissue resident memory cells in the lesional skin” is not considered a limitation and is of no significance to claim construction in this case because the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations. See MPEP 2111.02. II. As such, claim 4 is interpreted as drawn to a method of treating a patient having moderate to severe new-onset plaque-type psoriasis with secukinumab.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Guettner et al. (US 20130202610, 8/8/2013, provided by applicant; or its patent US 9,717,971, 8/1/2017), and in view of Novartis Media Release (1/19/2015, provided by applicant).
Guettner discloses various therapeutic regimens for treating psoriasis with an IL-17 binding molecule, e.g., IL-17 antibody such as secukinumab antibody, which include, among others, administering to a patient in need thereof four or five weekly doses of about 75 mg-about 300 mg (e.g., about 150 mg-about 300 mg) of IL-17 binding molecule such as secukinumab; and b) thereafter administering about 75 mg-about 300 mg (e.g., about 150 mg-about 300 mg) of secukinumab to the patient monthly (abstract; page 3, [0022]; and page 20, [0117], for example). As an example, Guettner teaches a clinical trial study (CAIN457A2304), which is a randomized, double-blind, multicenter study of subcutaneous secukinumab in patients with moderate to severe chronic plaque-type psoriasis; wherein patients will be randomized to receive secukinumab in one of two different doses (150 mg or 300 mg); secukinumab will be administered at Weeks 0, 1, 2, 3, 4, and 8 during the induction phase; and at the end of the induction phase, patients who have shown a PASI 75 response after twelve weeks of treatment will be randomized to either receive secukinumab every four weeks (two different doses i.e. 150 mg or 300 mg), starting at Week 12, and up until Week 48 (for an overall treatment duration of 52 weeks) (page 29, [0293] and [0294], and Fig. 11; and ‘791 patent, claims 11-14, for example). Additionally, Guettner teaches that the dosage of secukinumab used in the disclosed induction and/or maintenance regimens is based on the patient's weight, the patient is administered about 150 mg s.c. if the patient weighs less than or equal to about 90 kg or about 100 kg; and the patient is administered about 300 mg s.c. if the patient weighs more than about 90 kg or about 100 kg (page 19, [0172]). Further, Guettner teaches that patient to be treated with secukinumab is a naive patient (i.e., has not been previously treated for psoriasis) (page 23, [0222]). Furthermore, Guettner teaches that the disclosed treatment regimens are used in patients having moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy (page 24, [0223], for example). Furthermore, Guettner teaches that secukinumab has a very long half life, i.e., about 4 weeks (i.e., about 30 days), which allows for prolonged periods between administration, an exceptional property when treating chronic life-long disorders, such as psoriasis; and that due to the long half-life, high affinity and fast onset of action of secukinumab, it is possible to treat psoriasis using relatively low doses of secukinumab administered at infrequent intervals (page 1, [0008], last 4 lines to page 2, 1st column, line 4).
Novartis Media Release teaches that Cosentyx™ (secukinumab) receives EU approval for first-line treatment of moderate-to-severe plaque psoriasis patients; and that in clinical studies, 70% or more Cosentyx 300 mg patients achieved clear skin (PASI 100) or almost clear skin (PASI 90) during the first 16 weeks of treatment and importantly, this was maintained with continued treatment in the majority of patients up to Week 52 (1st page, for example).
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 moderate-to-severe plaque psoriasis patients by subcutaneous administration of 150 mg or 300 mg secukinumab based on the patient’s weight following Guettner’s regimen (above), wherein the treatment regimen may comprise four or five weekly doses of about 150 mg or 300 mg secukinumab, and monthly or once every 4 weeks thereafter; and wherein the patient includes a naïve patient and a patient having moderate to severe new-onset plaque-type psoriasis, following the teachings of Guettner and the Novartis Media Release, as a naïve patient can include said “new-onset” psoriasis patient, and a patient receiving first-line treatment of moderate-to-severe psoriasis also indicates the inclusion of said “new-onset” psoriasis patient. The person of ordinary skill in the art would have been motivated to do so for treating moderate to severe psoriasis and for the advantages of secukinumab being fast onset of action, high efficacy, having infrequent administration intervals, and as first-line treatment, and reasonably would have expected success because secukinumab has been used successfully in treating moderate to severe plaque psoriasis.
With respect to the recitation of “reducing the number of tissue resident memory cells in the lesional skin” in the preamble of claim 4, such merely represents the purpose of the invention, rather than any distinct definition of any of the claimed invention’s limitations; i.e., it does not limit the claim scope, as the method of claim 4 uses the same active ingredient, has the same method steps, and is for treating the same patient population as that in claim 1. Therefore, this preamble is not considered a limitation and is of no significance to claim construction; and claim 4 is rejected for the same reasons above.
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 Rejections:
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-14 of U.S. Patent No. 9,717,791, in view of Novartis Media Release (1/19/2015, provided by applicants).
Claims 11-14 of the ‘791 patent are directed to a method of treating moderate to severe plaque psoriasis, comprising subcutaneously administering to a patient about 300 mg or 150 mg of secukinumab at weeks 0, 1, 2, 3, and 4, followed by about 300 mg or 150 mg every four weeks. Additionally, the Novartis Media Release teaches that Cosentyx™ (secukinumab) can be used as a first-line systemic treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy (indicating that the patient has not been previously treated with a systemic therapy), and that secukinumab has high efficacy. Therefore, it would have been obvious to treat moderate-to-severe plaque psoriasis patients with secukinumab following the teachings of claims 11-14 of the ‘791 patent, including a patient who has not been previously treated with a systemic therapy, and a patient having moderate to severe new-onset plaque-type psoriasis, because secukinumab can be used as first-line treatment of moderate-to-severe plaque psoriasis, and a patient receiving first-line treatment of moderate-to-severe psoriasis would include a “new-onset” psoriasis patient having moderate-to-severe psoriasis. Therefore, the conflicting claims are not patentably distinct from each other.
Claims 1-4 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-11, 16, 20 and 26 of U.S. Patent No. 10,583,190, in view of Novartis Media Release (1/19/2015), for the similar reasons above.
Claims 2-11, 16, 20 and 26 of the ‘190 patent are directed to a method of treating psoriasis by subcutaneously administering to a patient a dose of about 150 mg or about 300 mg of an IL-17 antibody or a pharmaceutical formulation thereof, wherein the patient has plaque psoriasis such as moderate to severe plaque psoriasis (claims 2-10, 16 and 20, for example), and has not been previously treated with a systemic agent for psoriasis (claim 11); and wherein the IL-17 antibody is secukinumab (claim 26). The teachings of Novartis Media Release are reviewed above. Thus, claims 2-11, 16, 20 and 26 of the ‘190 patent in view of the teachings of Novartis Media Release render the present claims 1-4 obvious. Therefore, the conflicting claims are not patentably distinct from each other.
Claims 1-4 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34 of U.S. Patent No. 11,534,490, in view of Novartis Media Release (1/19/2015), for the similar reasons above.
Claims 1, 2 and 4 are also rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 7-9, 14, 15 and 21 of Application 18/983,030 (now allowed), in view of Novartis Media Release (1/19/2015), for the similar reasons above.
Claims 1, 2, 7-9, 14, 15 and 21 of the application ‘030 are directed to a method of treating psoriasis by subcutaneously administering to a patient about 150 mg secukinumab at each of weeks 0, 1, 2, 3, and 4; or 4 or 5 times in a month, and every 4 weeks thereafter, wherein the patient has plaque psoriasis such as moderate to severe plaque psoriasis (claims 1, 2, 7-9, 14, 15 and 21). Novartis Media Release teaches that Cosentyx™ (secukinumab) receives EU approval for first-line treatment of moderate-to-severe plaque psoriasis patients. As such, 1, 2, 7-9, 14, 15 and 21 of the application ‘030 in view of the teachings of Novartis Media Release render the present claims 1 and 2 obvious. Therefore, the conflicting claims are not patentably distinct from each other.
Claims 1 and 2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 3, 7-10, 13, 19 and 28-36 of copending Application No. 18/061,227, and in view of Novartis Media Release (1/19/2015), for the similar reasons above.
Claims 2, 3, 7-10, 13, 19 and 28-36 of the ‘227 application are directed to a method of treating psoriasis by subcutaneously administering to a patient a dose of about 150 mg or about 300 mg of an IL-17 antibody or a pharmaceutical formulation thereof, wherein the patient has plaque psoriasis such as moderate to severe plaque psoriasis (claims 2, 7-10, 13, 28-30 and 34-36, for example); wherein, prior to treatment with the IL-17 antibody, the patient has not been previously treated with a systemic agent for psoriasis (claim 3); and wherein the IL-17 antibody is secukinumab (claims 19 and 31-33, for example). The teachings of Novartis Media Release are reviewed above. As such, claims 2, 3, 7-10, 13, 19 and 28-36 of the ‘227 application in view of Novartis Media Release render the present claims 1 and 2 obvious. Therefore, the conflicting claims are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion:
No claim is allowed.
Advisory Information:
Any inquiry concerning this communication should be directed to Examiner DONG JIANG whose telephone number is 571-272-0872. The examiner can normally be reached on Monday - Friday from 9:30 AM to 7:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DONG JIANG/
Primary Examiner, Art Unit 1674
1/6/26
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674