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 .
Receipt is acknowledged of the request for reconsideration filed 08/18/2026.
Claim Status
Claims 111- 136 are pending in the application.
Withdrawn Rejection(s)
The rejection under 35 USC 103 over WO 2019/093818 A1 is withdrawn given the arguments presented in the remarks of 08/18/2026.
Maintained Rejection(s)
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 111-136 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,439,592 (US’592). Although the claims at issue are not identical, they are not patentably distinct from each other because US’592 claims a sustained release biodegradable ocular cylindrical implant comprising 150 ug to about 1200 ug axitinib (claim 1) . The weight of the implants is found in claims 2-4.The hydrated state is in PBS at a pH of 7.2 at 37 C and sets out the implant dimensions and weight in claims 5- 7, and claim 28. Claim 8 sets out a rate of release of 30 days, Claim 9 specifies an intravitreal implant. Claims 10-11 set out a period of release from 3 to 38 months, and 6 to 9 months, respectively. Claims 12-16 set out of PEG, the molecular weight, number of arms and structure. Th d90 of the particle is set out in claim 17. The percentage of PEG is set out in claim 20-21. Claims 23-24 and 27 set out specific embodiments of the hydrogel ocular implants. Claims 25-26 state that the implant is administered by injection as a solid in room temperature. Applicant is claiming the same hydrogel implant of axitinib for the same therapeutic purpose, and the ordinary practitioner would expect similar in vitro release rates from these implants. Dry and wet mass rations would be expected to be similar or overlapping. As such, the instantly claims would have been obvious to one of ordinary skill in the art at the time of filing. The instant claims would have been obvious to the ordinary practitioner given the teachings of US’592.
Claims 111-136 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 103 -132 of copending Application No. 19/330,246 (US’246)(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because US’246 claims a sustained release biodegradable ocular implant comprising a hydrogel and axitinib polymorph IV in an amount of from about 400 ug to about 500 ug (claim 103). The impant is suitable for intravitreal injection (claim 105). The hydrogel comprises crosslinked polyethylene glycol units (claim 111-115). Claims 116 , 119, 120 , and 122 set out an implant in its dry state. Claims 123 -126 set out the implant in its hydrated state. While the ratio of axitinib to polymer in the wet or dry state, or size in the wet and dry state would be expected to be similar or overlapping values since US’246 claims the same drug, with the same polymer for sustained release from the same hydrogel Those of ordinary skill would have expected similar release characteristics , and similar therapeutic results. The instant claims would have been obvious to one of ordinary skill in the art given the claims set out in US’246.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 08/18/2026have been fully considered but they are not persuasive.
It is noted that applicant only argues the merits of the obviousness-type double patenting rejection of US’592, and not of US’246. However since it assumed the same issue pertains to both, the arguments put forth here will pertain to both, and will be referred to as “the references”.
Applicant argues that the references do not set out “axitinib with a solubility of 0.3 ug/mL or greater”. First, unlike the rejection under 35 USC 103 over WO 2019/093818 A1 where applicant rightly argues that the broad disclosure of that patent which includes any active agent useful for ophthalmic delivery, both of the references set out that axitinib as the only bioactive. Further applicant set out the pH and temperature. As such, the solubility of axitinib is easily determined by any ordinary skilled artisan in the chemical arts without undue experimentation. As such, the claims of the references would make the instantly claimed invention obvious given their teachings since those of ordinary skill would easily determine the solubility of axitinib given the temperature and pH. The instant claims would be considered obvious given the teachings of the references,
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARLOS A AZPURU whose telephone number is (571)272-0588. The examiner can normally be reached 9 am- 3 pm, 4 pm-8pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz
Prosecution Insights