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 .
Claim of Foreign Priority
Applicant has not claimed foreign priority.
Status of the Claims
Claims 1-4, 6-9, 11-17, 19, and 22-32 are pending and examined.
NOTE: The examiner did not apply duplicative references in this matter. For example, the patents applied in Double Patenting Rejections could have been used as prior art in a non-Double Patenting rejection because they each qualify as prior art.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-9, 11-17, 19, 22-24, 26-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kansara et al., (WO2021168218A1).
Kansara teaches treating nAMD, CNV, NAMD associated with CNV. The treatment can be administration of one or more TKIs, including axitinib. See par. 6. Further, in some embodiments a TKI can be used as an inhibitor of VEGF. The method can include administering a formulation comprising axitinib to the suprachoroidal space of an eye of a subject in need thereof. See par. 7. An amount of axitinib includes 0.01 to 3 mg, including discreet amounts listed to include about 0.5 mg and about 1.0 mg. See par. 7. In some instances minimal vision loss is noted to be less than 2 letters. See par. 9. In some instances, no loss of vision will result. See par. 9. A subject can experience improvement in BCVA of more than 10, 15 or 25 letters. See par. 9. Further, no loss or minimal vision loss can occur for 2, 3, 4, 5, or 6 months after axitinib treatment. Further, a patient can experience greater than a 5%, 10%, 15%, or more decrease in retinal thickness as measured by SD-OCT. In some embodiments a decrease in thickness occurs for 2-6 months after administration. See par. 10. A decrease in retinal thickness can be at least 200 pm. See par 36. The VEFG agent can be aflibercept, ziv-aflibercept, bevacizumab, pegaptanib sodium, and ranibizumab, among others. See par. 48. Administration with a VEGF antagonist including aflibercept was done with an intravitreal (IVT) injection. See par. 106. The dose of aflibercept was 2 mg. See par. 107. This falls within the claimed 1-3 mg. In some embodiments, a patient does not experience an increase in retinal thickness for 2, 3, 4, 5, 6, or longer months. See par. 10. A first dose can be administered and then a second dose that can be spaced apart by at least 1, 2, 3, 4, and up to 12 months. See par. 8. Improvement after initial axitinib can last up to 48 weeks or longer after the initial dose. See par. 42. Axitinib can be administered at a dose of 1 mg/ml. See par. 7. In some embodiments, the effectiveness or durability of VEGF treatment results in viewer VEGF administrations and allows for longer times between administrations. This implies that VEGF administration before and/or after are contemplated. One study tested more than 3 injections of IVT anti-VEGF in the preceding 5 months. See par. 105. This is the scenario claimed in claim 32.
With respect to claim 30, polysorbate 80 is taught in a concentrations of about 0.05% or about 0.1%; 0.5% w/v carboxymethylcellulose sodium; about 0.79% w/v sodium chloride; about 0.079% w/v sodium phosphate (dibasic, anhydrous)- rather than about 0.08% claimed; and about 0.059% w/v sodium phosphate (monobasic monohydrate)- rather than about 0.06% claimed. See par. 11.
As such, claims 1-4, 6-9, 11-17, 19, 22-24, 26-32 are anticipated by the prior art.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6-9, 11-17, 19, 22-32 are rejected under 35 U.S.C. 103 as being unpatentable over Kansara et al., (WO2021168218A1), in view of VABYSMO FDA Label Approval faricimab, Revised 1/2022.
Kansara teaches treating nAMD, CNV, NAMD associated with CNV. The treatment can be administration of one or more TKIs, including axitinib. See par. 6. Further, in some embodiments a TKI can be used as an inhibitor of VEGF. The method can include administering a formulation comprising axitinib to the suprachoroidal space of an eye of a subject in need thereof. See par. 7. An amount of axitinib includes 0.01 to 3 mg, including discreet amounts listed to include about 0.5 mg and about 1.0 mg. See par. 7. In some instances minimal vision loss is noted to be less than 2 letters. See par. 9. In some instances, no loss of vision will result. See par. 9. A subject can experience improvement in BCVA of more than 10, 15 or 25 letters. See par. 9. Further, no loss or minimal vision loss can occur for 2, 3, 4, 5, or 6 months after axitinib treatment. Further, a patient can experience greater than a 5%, 10%, 15%, or more decrease in retinal thickness as measured by SD-OCT. In some embodiments a decrease in thickness occurs for 2-6 months after administration. See par. 10. A decrease in retinal thickness can be at least 200 pm. See par 36. The VEFG agent can be aflibercept, ziv-aflibercept, bevacizumab, pegaptanib sodium, and ranibizumab, among others. See par. 48. Administration with a VEGF antagonist including aflibercept was done with an intravitreal (IVT) injection. See par. 106. The dose of aflibercept was 2 mg. See par. 107. This falls within the claimed 1-3 mg. In some embodiments, a patient does not experience an increase in retinal thickness for 2, 3, 4, 5, 6, or longer months. See par. 10. A first dose can be administered and then a second dose that can be spaced apart by at least 1, 2, 3, 4, and up to 12 months. See par. 8. Improvement after initial axitinib can last up to 48 weeks or longer after the initial dose. See par. 42. Axitinib can be administered at a dose of 1 mg/ml. See par. 7. In some embodiments, the effectiveness or durability of VEGF treatment results in viewer VEGF administrations and allows for longer times between administrations. This implies that VEGF administration before and/or after are contemplated. One study tested more than 3 injections of IVT anti-VEGF in the preceding 5 months. See par. 105. This is the scenario claimed in claim 32.
With respect to claim 30, polysorbate 80 is taught in a concentrations of about 0.05% or about 0.1%; 0.5% w/v carboxymethylcellulose sodium; about 0.79% w/v sodium chloride; about 0.079% w/v sodium phosphate (dibasic, anhydrous)- rather than about 0.08% claimed; and about 0.059% w/v sodium phosphate (monobasic monohydrate)- rather than about 0.06% claimed. See par. 11.
Kansara does not teach faricimab.
VABYSMO was approved by the FDA as an IVT injection for use in treating nAMD at a dose of 6 mg.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to use faricimab as a VEGF and Ang-2 inhibitor in patients with nAMD, e.g., in the method taught by Kansara. One would be motivated to do so because faricimab is taught to be of a category of agents that can be used to treat claimed conditions and the FDA label independently teaches treating the same subject population through the same route of administration and approved dosage. Thus, a POSA would immediately understand that faricimab can be used as claimed in the methods described by Kansara and the FDA label for treating nAMD. Even further, timing for administration and dosing amounts are readily optimizable by a POSA as the claimed agents are known therapeutic agents and result-effective variables. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
As such, no claim is allowed.
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 1-4, 6-9, 11-17, 19, 22-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,572,800, in view of Kansara et al., (WO2021168218A1), in view of VABYSMO FDA Label Approval faricimab, Revised 1/2022.
The ‘800 patent is directed towards administering axitinib to the SCS to treat an ocular disorder including CNV and nAMD, e.g., See claims 1-4 of the ‘800 patent. If the references above are applied as secondary references, the regimen and secondary agent is taught. It would therefore be obvious to use the method taught by Kansara in view of the ‘800 claims to arrive at the claimed method because they treat the same subject with the same primary agent administered through the same route of administration. Adding anti-VEGF therapy would be obvious with a reasonable expectation of success in view of the cited prior art.
Claims 1-4, 6-9, 11-17, 19, 22-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12/350,261, in view of Kansara et al., (WO2021168218A1), in view of VABYSMO FDA Label Approval faricimab, Revised 1/2022.
The ‘261 patent is directed towards administering axitinib to the SCS to treat an ocular disorder including AMD, e.g., See claims 10 and 15, e.g., of the ‘261 patent. Additionally, a secondary agent taught for use is an anti-VEGF antibody. See claims 18-20. The agents even include aflibercept, bevacizumab, ranibizumab, and others. It would therefore be obvious to use the method taught by Kansara in view of the ‘261 claims to arrive at the claimed method because they treat the same subject with the same primary agent administered through the same route of administration. Adding anti-VEGF therapy would be obvious with a reasonable expectation of success in view of the cited prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. 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.
/JARED BARSKY/Primary Examiner, Art Unit 1628
Prosecution Insights