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 .
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 21-28 and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 8 of U.S. Patent No.11,925,580 to Ianchulev in view of claims 1, 2, 9, 14 of U.S. Patent No. 12,558,259 to Ianchulev. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to claims 21, 22 patented claim 5 (’580) sets forth a system for ocular implantation comprising a delivery instrument with an elongate tubular member, an implant made of biologically derived material that necessarily comprises a length and a thickness, wherein the implant material fills an internal dimension of the elongate member of the delivery member. ’580 does not disclose ab interno insertion, however, claim 1 of the ’259 patent discloses ab interno insertion, teaching the limitations of the claims. With regard to the limitations regarding structural reinforcement, such limitations are a statement of the intended result of implantation, and does not set forth any patentably distinguishable structural limitations to the claims.
With regard to claims 23 and 24, see (’259) patented claim 9
With regard to claims 25-28 and 30, the limitations do not confer structural limitations to the claimed device. However, ’259 patented claims 1, 2, 14 set forth the limitations of claims 25-28 and 30.
With regard to claim 38, see ’580 patented claim 8.
Claims 31-37, 39, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10, 14, 18, of U.S. Patent No. 12,558,259 to Ianchulev. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to claims 31, 32, 39, ’259 patented claim 18 discloses a method of treating an eye comprising a inserting an implant (which necessarily comprises a length and a thickness) formed of a biologically-derived tissue between eye tissue layers into the anterior chamber (therefore near the anterior angle), structurally reinforcing the implant, and increasing aqueous outflow through the implant
With regard to claims 33-37, see ’259 patented claims 9, 14, 10, respectively.
Claim 29 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 8 of U.S. Patent No.11,925,580 to Ianchulev in view of claims 1, 2, 9, 14 of U.S. Patent No. 12,558,259 to Ianchulev, further in view of US 2015/0342875 to Haffner. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The Ianchulev references claim the system of claim 28, but do not set forth a therapeutic anti-proliferative, anti-fibrotic, or anti-inflammatory effect. Haffner discloses an ocular implant with a therapeutic effect including anti-proliferative, anti-fibrotic, and anti-inflammatory effects (see Haffner ¶0234, 0514, 0516). It would have been obvious to a person having ordinary skill in the art at the time of filing to use the agents disclosed by Haffner in the apparatus claimed by Ianchulev in order to provide desired therapeutic effects.
Claim 38 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 10, 14, 18, of U.S. Patent No. 12,558,259 to Ianchulev in view of US 2015/0342875 to Haffner. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
The Ianchulev reference claims the method of claim 31, but do not set forth a therapeutic anti-proliferative, anti-fibrotic, or anti-inflammatory effect. Haffner discloses an ocular implant with a therapeutic effect including anti-proliferative, anti-fibrotic, and anti-inflammatory effects (see Haffner ¶0234, 0514, 0516). It would have been obvious to a person having ordinary skill in the art at the time of filing to use the agents disclosed by Haffner in the method claimed by Ianchulev in order to provide desired therapeutic effects.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 4 March 2026