DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 38-40 are cancelled. Claims 1-37 as filed on 15 February 2023 are pending and under examination.
Information Disclosure Statement
The information disclosure statement filed 11/03/2024 and 05/09/2023 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because references in 11/03/2024 all but two of the NPL clinical trials are not attached and while NCT00669916 and NCT01107457 are attached in parent applications the IDS does not have a publication year, regarding 05/09/2023 NPLs 17-62 and 137-208 are not attached, NPL 73 is not attached and does not have a year associated. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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 1-10, 12, 19-25, and 28-37 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9717791 B2 (PTO-892) (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-2, 7-8,19, and 37, the reference patent recites a method of treating psoriasis comprising the administration of about 150 mg to about 300 mg of an anti-IL17 antibody including one comprising VH of SEQ ID NO: 8 and VL of SEQ ID NO: 10 which matches instant SEQ ID NO: 8 and 10 or secukinumab. The patent recites doses every 4 weeks (claim 1).
Regarding claim 3, the reference patent recites the patient has not previously been treated with a systemic agent for psoriasis (claim 7).
Regarding claims 4-6, the reference patent recites the patient has previously been treated with a systemic agent for psoriasis (claim 8) where the systemic agent is methotrexate (claim 9).
Regarding claims 9-10, the reference patent recites the treatment of moderate to severe plaque psoriasis (claims 5 and 11-14).
Regarding claim 12, the reference application recites adult patients (claims 13-14).
Regarding claims 20-24, the reference patent recites the antibody being administered under the conditions of the independent claim and would inherently have the biological effects of claims 20-24.
Regarding claim 25, secukinumab is a fully human monoclonal antibody as disclosed by the instant specification (page 3 in par 2 in lines 3-6) making the recitation of secukinumab meeting the requirements of instant claim 25.
Regarding claims 28-36, the patent recites flat dosing of 150 mg to 300 mg of anti-IL17 antibodies including secukinumab which would then include the doses of instant claims 28-36 (claim 1).
Claims 1-2, 10-11, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9717791 B2 (PTO-892) (Reference Patent) in view of Farhi et. al. Journal of Investigative Dermatology. 128(9):2198-2203. 2008. (PTO-892) and Langley & Ellis. Journal of the American Academy of Dermatology. 51(4):563-569. (2004) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of about 150 mg to about 300 mg of an anti-IL17 antibody including one comprising VH of SEQ ID NO: 8 and VL of SEQ ID NO: 10 which matches instant SEQ ID NO: 8 and 10 or secukinumab. The patent recites doses every 4 weeks (claim 1).
Regarding claims 10, the reference patent recites the treatment of moderate to severe plaque psoriasis (claims 5 and 11-14).
The reference patent does not recite face psoriasis or the IGA score of equal or greater than 3.
This deficiency is filled by Farhi and Langley.
Farhi teaches assessment of psoriasis showing a score higher than 3 in multiple regions of the body including the face (abstract, Table 1, and Figure 2).
Langley teaches the PGA and IGA are the same measurement (page 564 in col 1 in par 1). Langley teaches the higher the rating value the more severe the psoriasis (Tables I and II).
It would have been obvious at the time the application was filed to substitute the generic moderate to severe plaque psoriasis of the reference patent with the specific IGA score of 3 or more face psoriasis in view of Farhi and Langley. One of skill in the art would have been motivated to use the new treatment of the reference patent in patients with more severe psoriasis taught in Farhi and Langley as patients in need of effective treatment. There would have been a reasonable expectation of success as the reference patent recites a method of treating generic moderate to severe plaque psoriasis and the substitution would be from generic to a more specific type of psoriasis.
Claims 1-2 and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9717791 B2 (PTO-892) (Reference Patent) in view of Harris et. al. Drug Development Resarch. 61:137-154. (2004) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of about 150 mg to about 300 mg of an anti-IL17 antibody including one comprising VH of SEQ ID NO: 8 and VL of SEQ ID NO: 10 which matches instant SEQ ID NO: 8 and 10 or secukinumab. The patent recites doses every 4 weeks (claim 1).
By reciting a therapeutic to be administered into a patient this would inherently be a pharmaceutical composition recited by the reference patent.
The reference patent does not recite the specifics of a pharmaceutical compositions as required by the claims.
This deficiency is filled by Harris.
Regarding claims 13-15, Harris teaches antibody therapies as liquid or lyophilized compositions depending on dose to be used (abstract). Harris teaches the use of buffers and stabilizers in pharmaceutical compositions to improve stability and shelf life (page 137 in col 2 in par 1, page 139 in col 1 in par 1 and col 2 in par 1, page 140 in col 1 in par 2, page 145 in col 1 in last paragraph).
Regarding claim 16, Harris teaches the antibody composition in vials (Figure 5).
Regarding claims 17-18, Harris teaches the use of autoinjectors (page 151 in col 1 in par 4).
It would have been obvious at the time the application was filed to combine the pharmaceutical composition for use in the method of treatment with the anti-IL-17 antibodies of the reference patent with the pharmaceutical compositions that are liquid or lyophilized taught by Harris to produce shelf stable pharmaceutical compositions. One of skill in the art would have been motivated to optimize the pharmaceutical composition of the reference claims with known in the art methods of producing shelf stable pharmaceutical compositions. There would have been a reasonable expectation of success as Harris teaches the use of their pharmaceutical compositions with varying therapeutic antibodies.
Regarding the requirement of a kit and instructions required by claims 17-18, the reference patent and Harris teach pharmaceutical compositions comprising antibodies a kit and instructions do not change the physical characteristics of the pharmaceutical composition of the claims making a kit and instructions prima facie obvious (see MPEP 2112.01 and 2183.
Claims 1-2 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9717791 B2 (PTO-892) (Reference Patent) in view of Jefferies. Expert Opinion on Biological Therapy, 7(9): 1401–1413. (2007) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of about 150 mg to about 300 mg of an anti-IL17 antibody including one comprising VH of SEQ ID NO: 8 and VL of SEQ ID NO: 10 which matches instant SEQ ID NO: 8 and 10 or secukinumab. The patent recites doses every 4 weeks (claim 1).
The reference patent does not recite the antibody is the IgG1/kappa isotype.
This deficiency is filled by Jefferies.
Jefferies teaches antibodies for use in therapies for use in neutralization of cytokines in chronic diseases (abstract). Jefferies teaches maximal antibody-dependent cell-mediated cytotoxicity activity using IgG1 format (abstract). Jefferies teaches approved recombinant antibodies predominantly use IgG1 (page 1402 in col 1 in lines 20-25). Jefferies teaches IgG1 subclass antibodies as an obvious choice for antibody development given the accumulated knowledge in the field and effective us in treatment (page 1404 in col 1 in par 1) Jefferies further teaches the effective use of the kappa light chain in therapeutic antibodies (page 1408 in col 2 in par 3).
It would have been obvious at the time the application was filed to combine the anti-IL-17 antibody of the reference application with the teachings of IgG1/kappa isotype taught by Jefferies. One of skill in the art would have been motivated to use known in the art antibody isotypes including the known in the art effective IgG1/kappa taught by Jefferies. There would have been a reasonable expectation of success as Jefferies teaches the widespread effective use of IgG1/kappa in therapeutic antibodies.
Claims 1-37 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10583190 B2 (PTO-892) (reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-2, 7-8,19, and 37, the reference patent recites a method of treating psoriasis comprising the administration of about 150 mg to about 300 mg of an anti-IL17 antibody including one comprising VH of SEQ ID NO: 8 and VL of SEQ ID NO: 10 which matches instant SEQ ID NO: 8 and 10 or secukinumab. The patent recites doses every 4 weeks (claims 1 and 26).
Regarding claim 3, the reference patent recites the patient has not previously been treated with a systemic agent for psoriasis (claim 11).
Regarding claims 4-6, the reference patent recites the patient has previously been treated with a systemic agent for psoriasis (claim 8) where the systemic agent is methotrexate (claims 12-14).
Regarding claims 9-10, the reference patent recites the treatment of moderate to severe plaque psoriasis (claim 16).
Regarding claim 11, the reference patent recites palm psoriasis (claim 19).
Regarding claim 12, the reference patent recites adult patients (claims 13-14).
Regarding claims 13-18, the reference patent recites pharmaceutical compositions comprising a buffer and stabilizer, in liquid form, and lyophilizate formulation (claims 20-22). The reference patent recites a pre-filed syringe, autoinjector, and vial and instructions for use in a kit (claims 23-24).
Regarding claims 20-24, the reference patent recites the antibody having a Tmax of 7-8 days, absolute bioavailability of about 60-80%, and a steady state between 5 µg/ml and 50 µg/ml (claims 31-32).
Regarding claim 25, secukinumab is a fully human monoclonal antibody as disclosed by the instant specification (page 3 in par 2 in lines 3-6) making the recitation of secukinumab meeting the requirements of instant claim 25.
Regarding claim 26, the patent recites the antibody is the IgG1 /lappa isotype (claim 28).
Regarding claim 27, the patent recites the patient has an IGA score of ≥3 prior to treatment (claim 17).
Regarding claims 28-36, the patent recites flat dosing of 150 mg to 300 mg of anti-IL17 antibodies including secukinumab which would then include the doses of instant claims 28-36 (claim 1).
Claims 1-37 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 11534490 B2 (PTO-892).
Regarding claims 1-2, 7-8,19, and 37, the reference patent recites a method of treating psoriasis comprising the administration of about 150 mg to about 300 mg of an anti-IL17 antibody including one comprising VH of SEQ ID NO: 8 and VL of SEQ ID NO: 10 which matches instant SEQ ID NO: 8 and 10 or secukinumab. The patent recites doses every 2 weeks (claims 1 and 19-23).
Regarding claim 3, the reference patent recites the patient has not previously been treated with a systemic agent for psoriasis (claim 10).
Regarding claims 4-6, the reference patent recites the patient has previously been treated with a systemic agent for psoriasis (claim 11) where the systemic agent is methotrexate (claims 12-13).
Regarding claims 9-10, the reference patent recites the treatment of moderate to severe plaque psoriasis (claim 6).
Regarding claim 11, the reference patent recites palm psoriasis (claim 9).
Regarding claim 12, the reference patent recites adult patients (claim 7).
Regarding claims 13-18, the reference patent recites pharmaceutical compositions comprising a buffer and stabilizer, in liquid form, and lyophilizate formulation (claims 27-29) The reference patent recites a pre-filed syringe, autoinjector, and vial and instructions for use in a kit (claims 29-30).
Regarding claims 20-24, the reference patent recites the antibody having a Tmax of 7-8 days, absolute bioavailability of about 60-80%, and a steady state between 5 µg/ml and 50 µg/ml (claims 13-14) and the reference patent recites the antibody being administered under the conditions of the independent claim and would inherently have the biological effects of claims 20-24.
Regarding claim 25, secukinumab is a fully human monoclonal antibody as disclosed by the instant specification (page 3 in par 2 in lines 3-6) making the recitation of secukinumab meeting the requirements of instant claim 25.
Regarding claim 26, the patent recites the antibody is the IgG1 /lappa isotype (claim 17).
Regarding claim 27, the patent recites the patient has an IGA score of ≥3 prior to treatment (claim 8).
Regarding claims 28-36, the patent recites flat dosing of 150 mg to 300 mg of anti-IL17 antibodies including secukinumab which would then include the doses of instant claims 28-36 (claim 1).
The patent does not recite administration every 4 weeks.
In regards to the specific dosage and interval amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are recited, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the recited claims and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (ie dosage and intervals) optimization is obvious.
Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 150 to 300 mg ever 4 weeks rather than every 2 weeks would have been obvious.
Claims 1-2, 7-10, 19-25, and 28-37 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12594331 B2 (PTO-892).
Regarding claims 1-2, 7-8,19, and 37, the reference patent recites a method of treating psoriasis comprising the administration of 75 mg of an anti-IL17 antibody including secukinumab and the patent recites doses every 4 weeks (claims 1 and 16).
Regarding claims 9-10, the reference patent recites the treatment of moderate to severe plaque psoriasis (claims 3 and 7-10).
Regarding claims 20-24, by reciting the treatment of the patient populations
the reference patent recites the antibody having a Tmax of 7-8 days, absolute bioavailability of about 60-80%, and a steady state between 5 µg/ml and 50 µg/ml (claims 13-14) and the reference patent recites the antibody being administered under the conditions of the independent claim and would inherently have the biological effects of claims 20-24.
Regarding claim 25, secukinumab is a fully human monoclonal antibody as disclosed by the instant specification (page 3 in par 2 in lines 3-6) making the recitation of secukinumab meeting the requirements of instant claim 25.
Regarding claims 28-36, the patent recites flat dosing of anti-IL17 antibodies including secukinumab (claims 1 and 6-11).
The patent does not recite administration of 150 to 300 mg.
In regards to the specific dosage and interval amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are recited, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the recited claims and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (ie dosage and intervals) optimization is obvious.
Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 150 to 300 mg ever 4 weeks rather than 75 mg every 4 weeks would have been obvious.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12594331 B2 (PTO-892) in view of Warren & Griffiths. Clinics in Dermatology. 26(5):438-447. (2008) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of 75 mg of an anti-IL17 antibody including secukinumab and the patent recites doses every 4 weeks (claims 1 and 16).
The reference patent does not recite if the patient has received systemic therapy for psoriasis or the use of methotrexate as systemic therapy.
This deficiency is filled by Warren.
Warren recites the development of alternative therapies for psoriasis and further teaches the continued use of traditional systemic therapies. Warren teaches that methotrexate is a cost-effective and life changing therapy option for many patients with psoriasis (abstract). Warren teaches methotrexate can be used in combination with other therapies of psoriasis (page 440 in col 2 in pars 3-4). Warren teaches there are a number of serious side effects form the use of methotrexate including risk of liver function (page 441 in col 1 in par 1).
The dose optimization would be obvious as previously explained in the rejection of claims 1-2. Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 150 to 300 mg ever 4 weeks rather than 75 mg every 4 weeks would have been obvious.
It would have been obvious at the time the application was filed to combine the new method of treating psoriasis with the anti-IL-17 antibody of the reference patent with the teachings of Warren to have a method where patients either could not tolerate the side effects of methotrexate, patients who had previously received systemic treatment as required by claim 4, or for patients that are concerned about or at greater risk for side effects and not a candidate for systemic treatment, as required by claim 3. One of skill in the art would have been motivated by the known serious side effects of systemic treatment with methotrexate to use a method without risk of damaging liver function. There would have been a reasonable expectation of success as the risks of methotrexate were well known in the art and the patent and Warren are teaching the same patient population.
Claims 1-2, 9-12, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12594331 B2 (PTO-892) in view of Farhi et. al. Journal of Investigative Dermatology. 128(9):2198-2203. 2008. (PTO-892) and Langley & Ellis. Journal of the American Academy of Dermatology. 51(4):563-569. (2004) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of 75 mg of an anti-IL17 antibody including secukinumab and the patent recites doses every 4 weeks (claims 1 and 16).
Regarding claims 9-10, the reference patent recites the treatment of moderate to severe plaque psoriasis (claims 3 and 7-10).
The reference patent does not recite face psoriasis or the IGA score of equal or greater than 3 or the treatment of adult patients.
These deficiencies are filled by Farhi and Langley.
Farhi teaches assessment of psoriasis showing a score higher than 3 in multiple regions of the body including the face and adult patients (abstract, Table 1, and Figure 2).
Langley teaches the PGA and IGA are the same measurement (page 564 in col 1 in par 1). Langley teaches the higher the rating value the more severe the psoriasis (Tables I and II).
The dose optimization would be obvious as previously explained in the rejection of claims 1-2 and 9-10. Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 150 to 300 mg ever 4 weeks rather than 75 mg every 4 weeks would have been obvious.
It would have been obvious at the time the application was filed to substitute the generic moderate to severe plaque psoriasis of the reference patent with the adult patient with a specific IGA score of 3 or more face psoriasis in view of Farhi and Langley. One of skill in the art would have been motivated to use the new treatment of the reference patent in patients with more severe psoriasis taught in Farhi and Langley as patients in need of effective treatment. There would have been a reasonable expectation of success as the reference patent recites a method of treating generic moderate to severe plaque psoriasis and the substitution would be from generic to a more specific type of psoriasis.
Claims 1-2 and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12594331 B2 (PTO-892) in view of Harris et. al. Drug Development Resarch. 61:137-154. (2004) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of 75 mg of an anti-IL17 antibody including secukinumab and the patent recites doses every 4 weeks (claims 1 and 16).
The reference patent does not recite the specifics of a pharmaceutical compositions as required by the claims.
This deficiency is filled by Harris.
Regarding claims 13-15, Harris teaches antibody therapies as liquid or lyophilized compositions depending on dose to be used (abstract). Harris teaches the use of buffers and stabilizers in pharmaceutical compositions to improve stability and shelf life (page 137 in col 2 in par 1, page 139 in col 1 in par 1 and col 2 in par 1, page 140 in col 1 in par 2, page 145 in col 1 in last paragraph).
Regarding claim 16, Harris teaches the antibody composition in vials (Figure 5).
Regarding claims 17-18, Harris teaches the use of autoinjectors (page 151 in col 1 in par 4).
The dose optimization would be obvious as previously explained in the rejection of claims 1-2. Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 150 to 300 mg ever 4 weeks rather than 75 mg every 4 weeks would have been obvious.
It would have been obvious at the time the application was filed to combine the pharmaceutical composition for use in the method of treatment with the anti-IL-17 antibodies of the reference patent with the pharmaceutical compositions that are liquid or lyophilized taught by Harris to produce shelf stable pharmaceutical compositions. One of skill in the art would have been motivated to optimize the pharmaceutical composition of the reference claims with known in the art methods of producing shelf stable pharmaceutical compositions. There would have been a reasonable expectation of success as Harris teaches the use of their pharmaceutical compositions with varying therapeutic antibodies.
Regarding the requirement of a kit and instructions required by claims 17-18, the reference patent and Harris teach pharmaceutical compositions comprising antibodies a kit and instructions do not change the physical characteristics of the pharmaceutical composition of the claims making a kit and instructions prima facie obvious (see MPEP 2112.01 and 2183.
Claims 1-2 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12594331 B2 (PTO-892) in view of Jefferies. Expert Opinion on Biological Therapy, 7(9): 1401–1413. (2007) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of 75 mg of an anti-IL17 antibody including secukinumab and the patent recites doses every 4 weeks (claims 1 and 16).
Regarding claim 25, secukinumab is a fully human monoclonal antibody as disclosed by the instant specification (page 3 in par 2 in lines 3-6) making the recitation of secukinumab meeting the requirements of instant claim 25.
The reference patent does not recite the antibody is the IgG1/kappa isotype.
This deficiency is filled by Jefferies.
Jefferies teaches antibodies for use in therapies for use in neutralization of cytokines in chronic diseases (abstract). Jefferies teaches maximal antibody-dependent cell-mediated cytotoxicity activity using IgG1 format (abstract). Jefferies teaches approved recombinant antibodies predominantly use IgG1 (page 1402 in col 1 in lines 20-25). Jefferies teaches IgG1 subclass antibodies as an obvious choice for antibody development given the accumulated knowledge in the field and effective us in treatment (page 1404 in col 1 in par 1) Jefferies further teaches the effective use of the kappa light chain in therapeutic antibodies (page 1408 in col 2 in par 3).
The dose optimization would be obvious as previously explained in the rejection of claims 1-2 and 25. Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 150 to 300 mg ever 4 weeks rather than 75 mg every 4 weeks would have been obvious.
It would have been obvious at the time the application was filed to combine the anti-IL-17 antibody of the reference application with the teachings of IgG1/kappa isotype taught by Jefferies. One of skill in the art would have been motivated to use known in the art antibody isotypes including the known in the art effective IgG1/kappa taught by Jefferies. There would have been a reasonable expectation of success as Jefferies teaches the widespread effective use of IgG1/kappa in therapeutic antibodies.
Claims 1-2, 8-10, 19-25, and 34-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12594332 B2 (reference patent) (PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1-2, 8,19, and 37, the reference patent recites a method of treating psoriasis comprising the administration of 150 mg of an anti-IL17 antibody including secukinumab. The patent recites doses every 4 weeks (claims 1 and 7).
Regarding claims 9-10, the reference patent recites the treatment of moderate to severe plaque psoriasis (claims 8-9).
Regarding claims 20-24, by teaching the administration of secukinumab at the dose and schedule of instant claims 1-2 the reference claims would recite the outcomes of dosing required by these claims.
Regarding claim 25, secukinumab is a fully human monoclonal antibody as disclosed by the instant specification (page 3 in par 2 in lines 3-6) making the recitation of secukinumab meeting the requirements of instant claim 25.
Regarding claims 34-36, by reciting static dose of 150 mg the reference claims recite the dosing for the patients of the instant claims 34-36.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12594332 B2 (PTO-892) (reference patent) in view of Warren & Griffiths. Clinics in Dermatology. 26(5):438-447. (2008) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of 150 mg of an anti-IL17 antibody including secukinumab. The patent recites doses every 4 weeks (claims 1 and 7).
Regarding claims 3-6, the reference patent recites the patient is a candidate for systemic therapy or phototherapy (claims 3 and 10).
The reference patent does not recite if the patient has received systemic therapy for psoriasis or the use of methotrexate as systemic therapy.
This deficiency is filled by Warren.
Warren recites the development of alternative therapies for psoriasis and further teaches the continued use of traditional systemic therapies. Warren teaches that methotrexate is a cost-effective and life changing therapy option for many patients with psoriasis (abstract). Warren teaches methotrexate can be used in combination with other therapies of psoriasis (page 440 in col 2 in pars 3-4). Warren teaches there are a number of serious side effects form the use of methotrexate including risk of liver function (page 441 in col 1 in par 1).
It would have been obvious at the time the application was filed to combine the new method of treating psoriasis with the anti-IL-17 antibody of the reference patent with the teachings of Warren to have a method where patients either could not tolerate the side effects of methotrexate, patients who had previously received systemic treatment as required by claim 4, or for patients that are concerned about or at greater risk for side effects and not a candidate for systemic treatment, as required by claim 3. One of skill in the art would have been motivated by the known serious side effects of systemic treatment with methotrexate to use a method without risk of damaging liver function. There would have been a reasonable expectation of success as the risks of methotrexate were well known in the art and the patent and Warren are teaching the same patient population.
Claims 1-2, 9-12, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12594332 B2(PTO-892) (reference patent) in view of Farhi et. al. Journal of Investigative Dermatology. 128(9):2198-2203. 2008. (PTO-892) and Langley & Ellis. Journal of the American Academy of Dermatology. 51(4):563-569. (2004) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of 150 mg of an anti-IL17 antibody including secukinumab. The patent recites doses every 4 weeks (claims 1 and 7).
The reference patent does not recite face psoriasis or the IGA score of equal or greater than 3 or the treatment of adult patients.
These deficiencies are filled by Farhi and Langley.
Farhi teaches assessment of psoriasis showing a score higher than 3 in multiple regions of the body including the face and adult patients (abstract, Table 1, and Figure 2).
Langley teaches the PGA and IGA are the same measurement (page 564 in col 1 in par 1). Langley teaches the higher the rating value the more severe the psoriasis (Tables I and II).
It would have been obvious at the time the application was filed to substitute the generic moderate to severe plaque psoriasis of the reference patent with the adult patient with a specific IGA score of 3 or more face psoriasis in view of Farhi and Langley. One of skill in the art would have been motivated to use the new treatment of the reference patent in patients with more severe psoriasis taught in Farhi and Langley as patients in need of effective treatment. There would have been a reasonable expectation of success as the reference patent recites a method of treating generic moderate to severe plaque psoriasis and the substitution would be from generic to a more specific type of psoriasis.
Claims 1-2, 7, and 28-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12594332 B2 (PTO-892) (reference patent).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of 150 mg of an anti-IL17 antibody including secukinumab. The patent recites doses every 4 weeks (claims 1 and 7).
The reference patent does not recite a dose of 300 mg every 4 weeks.
In regards to the specific dosage and interval amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are recited, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the recited claims and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (ie dosage and intervals) optimization is obvious.
Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 300 mg ever 4 weeks rather than 150 mg every 4 weeks would have been obvious.
Claims 1-2 and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12594332 B2 (PTO-892) (reference patent) in view of Harris et. al. Drug Development Resarch. 61:137-154. (2004) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of 150 mg of an anti-IL17 antibody including secukinumab. The patent recites doses every 4 weeks (claims 1 and 7).
The reference patent recites the subcutaneous administration of the therapeutic (claim 7). This would inherently be a pharmaceutical composition.
The reference patent does not recite the specifics of a pharmaceutical compositions as required by the claims.
This deficiency is filled by Harris.
Regarding claims 13-15, Harris teaches antibody therapies as liquid or lyophilized compositions depending on dose to be used (abstract). Harris teaches the use of buffers and stabilizers in pharmaceutical compositions to improve stability and shelf life (page 137 in col 2 in par 1, page 139 in col 1 in par 1 and col 2 in par 1, page 140 in col 1 in par 2, page 145 in col 1 in last paragraph).
Regarding claim 16, Harris teaches the antibody composition in vials (Figure 5).
Regarding claims 17-18, Harris teaches the use of autoinjectors (page 151 in col 1 in par 4).
It would have been obvious at the time the application was filed to combine the pharmaceutical composition for use in the method of treatment with the anti-IL-17 antibodies of the reference patent with the pharmaceutical compositions that are liquid or lyophilized taught by Harris to produce shelf stable pharmaceutical compositions. One of skill in the art would have been motivated to optimize the pharmaceutical composition of the reference claims with known in the art methods of producing shelf stable pharmaceutical compositions. There would have been a reasonable expectation of success as Harris teaches the use of their pharmaceutical compositions with varying therapeutic antibodies.
Regarding the requirement of a kit and instructions required by claims 17-18, the reference patent and Harris teach pharmaceutical compositions comprising antibodies a kit and instructions do not change the physical characteristics of the pharmaceutical composition of the claims making a kit and instructions prima facie obvious (see MPEP 2112.01 and 2183.
Regarding the dose of 300 mg required by claim 17, in regards to the specific dosage and interval amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are recited, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the recited claims and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (ie dosage and intervals) optimization is obvious.
Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 300 mg ever 4 weeks rather than 150 mg every 4 weeks would have been obvious.
Claims 1-2 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12594332 B2 (PTO-892) (reference patent) in view of Jefferies. Expert Opinion on Biological Therapy, 7(9): 1401–1413. (2007) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating psoriasis comprising the administration of 150 mg of an anti-IL17 antibody including secukinumab. The patent recites doses every 4 weeks (claims 1 and 7).
Regarding claim 25, secukinumab is a fully human monoclonal antibody as disclosed by the instant specification (page 3 in par 2 in lines 3-6) making the recitation of secukinumab meeting the requirements of instant claim 25.
The reference patent does not recite the antibody is the IgG1/kappa isotype.
This deficiency is filled by Jefferies.
Jefferies teaches antibodies for use in therapies for use in neutralization of cytokines in chronic diseases (abstract). Jefferies teaches maximal antibody-dependent cell-mediated cytotoxicity activity using IgG1 format (abstract). Jefferies teaches approved recombinant antibodies predominantly use IgG1 (page 1402 in col 1 in lines 20-25). Jefferies teaches IgG1 subclass antibodies as an obvious choice for antibody development given the accumulated knowledge in the field and effective us in treatment (page 1404 in col 1 in par 1) Jefferies further teaches the effective use of the kappa light chain in therapeutic antibodies (page 1408 in col 2 in par 3).
It would have been obvious at the time the application was filed to combine the anti-IL-17 antibody of the reference application with the teachings of IgG1/kappa isotype taught by Jefferies. One of skill in the art would have been motivated to use known in the art antibody isotypes including the known in the art effective IgG1/kappa taught by Jefferies. There would have been a reasonable expectation of success as Jefferies teaches the widespread effective use of IgG1/kappa in therapeutic antibodies.
Claims 1-2, 7-9, 11, 19-25, 28-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12551554 B2(reference patent) (PTO-892) in view of Peric et. al. The Journal of Immunology. 181(12):5836-5845. (2008) (PTO-892).
Regarding claim 1-2, 7, the reference patent recites a method of treating a chronic inflammatory diseases mediated by IL-17A by administering about 300 mg of secukinumab by subcutaneous injections every 4 weeks (claims 1-3).
Regarding claims 20-24, as the reference patent recites the active method steps of instant claim 2 of administering secukinumab at a dose of about 300 mg it would have the biological effects required by these claims.
Regarding claim 25, secukinumab is a fully human monoclonal antibody as disclosed by the instant specification (page 3 in par 2 in lines 3-6) making the recitation of secukinumab meeting the requirements of instant claim 25.
Regarding claims 28-33, by reciting static dose of 300 mg the reference claims recite the dosing for the patients of the instant claims 34-36.
The reference patent does not recite the treatment of psoriasis as the chronic inflammatory disease or the administration of 150 mg.
These deficiencies are filled by Peric.
Regarding claims 1, 9, and 37, Peric teaches psoriasis is a chronic inflammatory disease and that IL-17A is found in psoriasis legions and its increased presence leads to increased symptoms as part of the cathelicidin-regulating system and the targeting go this system for therapeutics in this chronic inflammatory disease (abstract and Figures 1-2).
Regarding claim 9, Peric teaches it is plaque psoriasis (page 8506 in col 1 in par 2).
Regarding claim 11, Peric teaches the patients including those with rosacea, which is inflammatory skin disease of the face (page 8510 in col 2 in par 1 in lines 13-19).
It would have been obvious at the time the application was filed to substitute the generic chronic inflammatory disease mediated by IL-17A of the method of treatment of the reference patent with the psoriasis Peric teaches is a chronic inflammatory disease mediated by IL-17A. One of skill in the art would have been motivated by the teachings of Peric to use a method of treatment for a generic chronic inflammatory diseases mediated by IL-17A with the specific psoriasis as Peric explicitly teaches the use of therapeutics that target IL-17A. There would have been a reasonable expectation of success as it is the substitution of a generic chronic inflammatory disease with a specific type of chronic inflammatory disease and Peric specifically teaches the targeting of IL-17A for treating psoriasis.
Regarding the dose of 150 mg required by claims 8 and 34-36, in regards to the specific dosage and interval amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are recited, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the recited claims and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (ie dosage and intervals) optimization is obvious.
Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 150 mg ever 4 weeks rather than 300 mg every 4 weeks would have been obvious.
Claims 1-6, and 9-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12551554 (reference patent) (PTO-892) in view of Peric et. al. The Journal of Immunology. 181(12):5836-5845. (2008) (PTO-892) and Warren & Griffiths. Clinics in Dermatology. 26(5):438-447. (2008) (PTO-892).
Regarding claim 1-2, the reference patent recites a method of treating a chronic inflammatory diseases mediated by IL-17A by administering about 300 mg of secukinumab by subcutaneous injections every 4 weeks (claims 1-3).
The reference patent does not recite the treatment of psoriasis as the chronic inflammatory disease and does not recite if the patient has received systemic therapy for psoriasis or the use of methotrexate as systemic therapy.
These deficiencies are filled by Peric and Warren.
Peric teaches psoriasis is a chronic inflammatory disease and that IL-17A is found in psoriasis legions and its increased presence leads to increased symptoms as part of the cathelicidin-regulating system and the targeting go this system for therapeutics in this chronic inflammatory disease (abstract and Figures 1-2).
Warren recites the development of alternative therapies for psoriasis and further teaches the continued use of traditional systemic therapies. Warren teaches that methotrexate is a cost-effective and life changing therapy option for many patients with psoriasis (abstract). Warren teaches methotrexate can be used in combination with other therapies of psoriasis (page 440 in col 2 in pars 3-4). Warren teaches there are a number of serious side effects form the use of methotrexate including risk of liver function (page 441 in col 1 in par 1). Warren teaches the treatment of moderate to sever psoriasis (page 440 in col 2 in lines 9-12).
It would have been obvious at the time the application was filed to combine the new method of treating a chronic inflammatory disease that is mediated by IL-17A as recited by the reference patent with the method of treating the specific IL-17A mediated chronic inflammatory disease of psoriasis and patients of Warren to have a method where patients either could not tolerate the side effects of methotrexate, patients who had previously received systemic treatment as required by claim 4, or for patients that are concerned about or at greater risk for side effects and not a candidate for systemic treatment, as required by claim 3. One of skill in the art would have been motivated by the known serious side effects of systemic treatment with methotrexate to use a method without risk of damaging liver function. There would have been a reasonable expectation of success as the risks of methotrexate were well known in the art and the patent and Warren are teaching the same patient population.
Claims 1-6, 9-10, 12, and 27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12551554 (reference patent) (PTO-892) in view of Peric et. al. The Journal of Immunology. 181(12):5836-5845. (2008) (PTO-892), Farhi et. al. Journal of Investigative Dermatology. 128(9):2198-2203. 2008. (PTO-892) and Langley & Ellis. Journal of the American Academy of Dermatology. 51(4):563-569. (2004) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating a chronic inflammatory diseases mediated by IL-17A by administering about 300 mg of secukinumab by subcutaneous injections every 4 weeks (claims 1-3).
The reference patent does not recite the treatment of psoriasis as the chronic inflammatory disease and does not recite the IGA score of equal or greater than 3 or the treatment of adult patients.
These deficiencies are filled by Peric, Farhi, and Langley.
Peric teaches psoriasis is a chronic inflammatory disease and that IL-17A is found in psoriasis legions and its increased presence leads to increased symptoms as part of the cathelicidin-regulating system and the targeting go this system for therapeutics in this chronic inflammatory disease (abstract and Figures 1-2).
Farhi teaches assessment of psoriasis showing a score higher than 3 in multiple regions of the body including the face and adult patients (abstract, Table 1, and Figure 2).
Langley teaches the PGA and IGA are the same measurement (page 564 in col 1 in par 1). Langley teaches the higher the rating value the more severe the psoriasis (Tables I and II).
It would have been obvious at the time the application was filed to substitute the generic chronic inflammatory disease that is mediated by IL-17A as recited by the reference patent with the method of treating the specific IL-17A mediated chronic inflammatory disease of psoriasis and patients of the adult patient with a specific IGA score of 3 or more face psoriasis in view of Farhi and Langley. One of skill in the art would have been motivated to use the new treatment of the reference patent in patients with more severe psoriasis taught in Farhi and Langley as patients in need of effective treatment. There would have been a reasonable expectation of success as the reference patent recites a method of treating generic moderate to severe plaque psoriasis and the substitution would be from generic to a specific type of psoriasis.
Claims 1-2 and 13-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12551554 (reference patent) (PTO-892) in view of Peric et. al. The Journal of Immunology. 181(12):5836-5845. (2008) (PTO-892) and Harris et. al. Drug Development Resarch. 61:137-154. (2004) (PTO-892).
Regarding claims 1-2, the reference patent recites a method of treating a chronic inflammatory diseases mediated by IL-17A by administering about 300 mg of secukinumab by subcutaneous injections every 4 weeks (claims 1-3).
The reference patent does not recite the treatment of psoriasis as the chronic inflammatory disease and specifics of a pharmaceutical compositions as required by the claims.
These deficiencies are filled by Peric and Harris.
Peric teaches psoriasis is a chronic inflammatory disease and that IL-17A is found in psoriasis legions and its increased presence leads to increased symptoms as part of the cathelicidin-regulating system and the targeting go this system for therapeutics in this chronic inflammatory disease (abstract and Figures 1-2).
Regarding claims 13-15, Harris teaches antibody therapies as liquid or lyophilized compositions depending on dose to be used (abstract). Harris teaches the use of buffers and stabilizers in pharmaceutical compositions to improve stability and shelf life (page 137 in col 2 in par 1, page 139 in col 1 in par 1 and col 2 in par 1, page 140 in col 1 in par 2, page 145 in col 1 in last paragraph).
Regarding claim 16, Harris teaches the antibody composition in vials (Figure 5).
Regarding claims 17-18, Harris teaches the use of autoinjectors (page 151 in col 1 in par 4).
It would have been obvious at the time the application was filed to combine the pharmaceutical composition for use in the method of treatment with the anti-IL-17 antibodies of the reference patent with the pharmaceutical compositions that are liquid or lyophilized taught by Harris to produce shelf stable pharmaceutical compositions. One of skill in the art would have been motivated to optimize the pharmaceutical composition of the reference claims with known in the art methods of producing shelf stable pharmaceutical compositions. There would have been a reasonable expectation of success as Harris teaches the use of their pharmaceutical compositions with varying therapeutic antibodies.
Regarding the requirement of a kit and instructions required by claims 17-18, the reference patent and Harris teach pharmaceutical compositions comprising antibodies a kit and instructions do not change the physical characteristics of the pharmaceutical composition of the claims making a kit and instructions prima facie obvious (see MPEP 2112.01 and 2183.
Regarding the dose of 150 mg required by claim 18, in regards to the specific dosage and interval amounts recited in the instant claims "[w]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and see M.P.E.P. § 2144.05 II.A. Moreover, it is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804,809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989). This because, as is made clear from the prior art, the determination of the dosage regimen of a known drug is well within the purview of one of ordinary skill in the art at the time the invention was made, and it would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal intervals of treatment because optimal intervals is an art-recognized result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Therefore, it would be conventional and within the skill of the art to identify the optimal dosages administered and optimal intervals to achieve target levels and therapeutically effective doses. Further, it has been held that where the general conditions of a claim are recited, discovering the optimum or workable ranges involves only routine skill in the art. It is clear that both the recited claims and claimed method perform the same protocol to achieve the same results. It would be conventional and within the skill of the art to determine the optimal treatment regimens. Accordingly, one can see that the courts, over a period of over 50 years, have consistently held that treatment (ie dosage and intervals) optimization is obvious.
Thus to one of skill in the art the optimization of administering the antibodies of the reference patent at 150 mg ever 4 weeks rather than 300 mg every 4 weeks would have been obvious.
Claims 1-2 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12551554 (reference patent) (PTO-892) in view of Peric et. al. The Journal of Immunology. 181(12):5836-5845. (2008) (PTO-892) and Jefferies. Expert Opinion on Biological Therapy, 7(9): 1401–1413. (2007) (PTO-892).
Regarding claim 1-2, the reference patent recites a method of treating a chronic inflammatory diseases mediated by IL-17A by administering about 300 mg of secukinumab by subcutaneous injections every 4 weeks (claims 1-3).
Regarding claim 25, secukinumab is a fully human monoclonal antibody as disclosed by the instant specification (page 3 in par 2 in lines 3-6) making the recitation of secukinumab meeting the requirements of instant claim 25.
The reference patent does not recite the treatment of psoriasis and the antibody is the IgG1/kappa isotype.
These deficiencies are filled by Peric and Jefferies.
Peric teaches psoriasis is a chronic inflammatory disease and that IL-17A is found in psoriasis legions and its increased presence leads to increased symptoms as part of the cathelicidin-regulating system and the targeting go this system for therapeutics in this chronic inflammatory disease (abstract and Figures 1-2).
Jefferies teaches antibodies for use in therapies for use in neutralization of cytokines in chronic diseases (abstract). Jefferies teaches maximal antibody-dependent cell-mediated cytotoxicity activity using IgG1 format (abstract). Jefferies teaches approved recombinant antibodies predominantly use IgG1 (page 1402 in col 1 in lines 20-25). Jefferies teaches IgG1 subclass antibodies as an obvious choice for antibody development given the accumulated knowledge in the field and effective us in treatment (page 1404 in col 1 in par 1) Jefferies further teaches the effective use of the kappa light chain in therapeutic antibodies (page 1408 in col 2 in par 3).
It would have been obvious at the time the application was filed to combine the anti-IL-17 antibody of the reference application with the teachings of IgG1/kappa isotype taught by Jefferies to arrive at a method of treating the chronic inflammatory mediated by IL-17A of psoriasis with an anti-IL-17 antibody of IgG1/kappa isotype. One of skill in the art would have been motivated to use known in the art antibody isotypes including the known in the art effective IgG1/kappa taught by Jefferies. There would have been a reasonable expectation of success as Jefferies teaches the widespread effective use of IgG1/kappa in therapeutic antibodies.
Conclusion
No claims allowable.
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/F.E./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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