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 7-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-14 of U.S. Patent No. 12,440,378 to Buxton et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
With regard to claims 7-10, patented claim 1 recites a method of treating an eye comprising the step of inserting a tissue-based implant into an eye, and deploying the implant within internal eye tissue layers. With regard to the limitations drawn to the results of implantation (facilitating or increasing flow, reinforcing, or treating), such limitations are drawn to the intended result of the implantation. When a method as claimed is already known in another reference, it follows naturally that the same effects would result from the instantly claimed method.
With regard to claims 11, 12, 13 see patented claims 14, 13, 12, respectively.
With regard to claims 14-15, see patented claim 11.
Claims 16, 17, 28, 29, 31-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,440,378 to Buxton et al in view of several claims of US 10,695,218 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 16, 17, Buxton sets forth all the limitations of claim 7 (see rejections above), but does not set forth that the implant is formed from donor tissue or eludes a therapeutic agent. Ianchulev claims a method of treating an eye with an ocular implant, wherein the implant may comprise donor tissue (claim 14) or therapeutic agents (claim 16).
With regard to claims 28 and 29, see Ianchulev claim 25.
With regard to claim 31, 32-35, see Ianchulev claims 28, 26, respectively.
Claims 40-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 9-10 of U.S. Patent No. US 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 30, 44, Ianchulev claims a method of treating an eye with an biologically derived ocular implant of corneal or scleral tissue, wherein the implant may comprise a length greater than its width and is placed in a delivery instrument with an elongate tubular member for ab interno insertion into the eye (Ianchulev claim 1). The method claimed by Ianchulev requires all the elements of the instantly claimed system, thereby anticipating the claimed system.
With regard to claims 40, 43, Applicant is claiming the intended use of the claimed apparatus, which is not patentably distinguishable over the claimed apparatus. Nonetheless, see Ianchulev claim 3-4.
With regard to claim 41-42, see Ianchulev claim 5-6.
With regard to claims 45-46, see Ianchulev claims 9-10.
Claims 34 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,440,378 to Buxton et al in view of several claims of US 10,695,218 to Ianchulev, further in view of claims 23 and 30 of US 11,045,355 to Ianchulev. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
While the Buxton and Ianchulev ‘218 references set forth the method as claimed by Applicant, they fail to set forth an actuator comprising a wheel, slide, or button, or that the incision is self-sealing. However, such actuation mechanisms and incisions are set forth in Ianchulev ‘355, claims 23 and 30.
Claim 38 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,440,378 to Buxton et al in view of several claims of US 10,695,218 to Ianchulev, further in view of claim 4 of US 12,318,328 to Ianchulev et al. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
While the Buxton and Ianchulev ‘218 references set forth the method as claimed by Applicant, they fail to set forth delivery of a viscous material. However, such delivery is set forth in Ianchulev ‘328, claim 4.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 16 June 2026
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