,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 .
Information Disclosure Statement
An information disclosure was filed on 01/26/2024.
A Preliminary amendment was filed on 02/09/2024.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 12-19, and 21-28 in the reply filed on 04/10/2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/10/2026.
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.
Claim(s) 1, 12, and 15 – 19, 21-26, and 28 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2018/209155 A1 (Yang et al).
Yang et al disclose intraocular implants comprising TKI inhibitors listed at page 44, second paragraph ; claim 1. Specific TKIs are listed at claim 27. Both page 44 , second paragraph and claim 27 list axitinib as a possible TKI inhibitor. Drug loading occurs at 10-40% ( page 44 , line 30). Administration includes intravitreal at claim 4. The method of administration is set out at page 10 , lines 23-25. An embodiment including both PLA and PLGA is found at page 48, lines 15-22, and claim 14. Different ratios of the polymers re set out in claim 7-11. Administration can occur over 6 months as set out in claim 5.Regarding the burst effect and zero order or near zero order drug release, since Yang et al teaches the same polymers, in overlapping ratios, and releasing the same drug (axitinib) for the same therapeutic purposes, those of ordinary skill would expect similar burst effect and drug release characteristics. Inherent viscosity can be looked up by polymer .Those of ordinary skill would expect similar therapeutic effects from the composition and method of administration as taught by Yang et al. The claims would have been obvious to one of ordinary skill in the art at the time of filing given the teachings of Yang et al.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 19, 21, 24-26, and 28 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2018/0256497 (Johns Hopkins University).
Regarding claim 1, Johns Hopkins University discloses an implant , and pharmaceutical composition of particles for ophthalmic application (see [0078] and [0367]. This comprises a tyrosine kinase inhibitor such as axitinib ([0006] and [0383]) . A biodegradable polyester polymer blend is disclosed at [0119]. The tyrosine kinase inhibitor is present in a range between 5 and about 80 % ([0142}).
With regard to claim 19 , 24-26 , Johns Hopkins University discloses a method of introducing a tyrosine kinase inhibitor into the eye of a subject ([0004]). The compositions comprise a plurality of particles which comprise a receptor kinase inhibitors which are injected as implants into the vitreous humor and posterior segment of the eye ([0083], [0367], [0372]). The method may deliver axitinib ([0383]) particles comprising a bioerodible polyester blend ([0119]). The first polymer is PLA ([0217]) . The tyrosine kinase inhibitor is present at a concentration in an amount of between about 5 and about 80% ([0142]).
Regarding claim 21, Johns Hopkins discloses a TKI concentration in the range of about 40 and about 80%(w/w) ([0142]). Inherent viscosity of the polymer is an inherent property.
With regard to claim 28, the ratio of PLA to PLGA is selected from a range of between 10;1 to about 1:10 ([0128]). These ratios can be any suitable ratio less than or equal to about 50:50.
Claims 1 and 19-28 are anticipated by Johns Hopkins University .
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, 12, 15-19, and 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,883,525 (US’525). Although the claims at issue are not identical, they are not patentably distinct from each other because US’525 claims a tyrosine kinase inhibitor , a bioerodible polyester polymer blend , wherein the tyrosine kinase inhibitor (TKI) is presented in an amount selected from a range of between about 5 and about 80 % (w/w) (claim 1). The TKI is present in an amount selected from a range of between about 40 to about 80% (claim 2) . The TKI maybe selected from a group of agents which includes axitinib (claims 3 and 4). The bioerodible polyester blend comprises an acid or ester end group PLA and an acid or ester end group PLGA , and wherein at least one of the polymers comprises an ester end group (claim 6). Inherent viscosity of PLA is set out in claim 7. PLGA has a lactide to glycolide ratio from between about 50;50 to about 85:15 in claim 8, which further teaches the inherent viscosity of PLGA. These ratios are further refined in claims 9-11. He release rate of TKI is in the range of between 10 ng/day to about 10 mg/day in claim 12. Release of the TKI in the vitreous humor is at least 6 months or a year in claims 13 and 14 , respectively. The burst effect and release rate are set out in claims 15-18. Claim 19 sets out the method of introducing the TKI to the eye. As such, the ordinary practitioner would expected similar therapeutic results from the implant and method of administering TKI to the eye as taught by US’525. The instantl claims would have been obvious to the ordinary practitioner at the time of filing given the claims of US’525.
Conclusion
No claims are allowed.
Correspondence
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
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