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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 19-20 of U.S. Patent No. 10,667,947. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to an ab externo method of placing an intraocular implant into the eye by advancing an injector/needle through the sclera toward the anterior chamber and positioning/releasing the implant within the eye such that it obstructs flow of aqueous humor and permits elution of a drug through a membrane. The instant claims are broader than the ‘947 claims because they do not necessarily require that the needle is advanced through the conjunctiva. Additionally, while the instant claims require that the implant obstructs fluid flow from the anterior chamber, they do not explicitly require that the implant functions as a plug.
Claims 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-18 of U.S. Patent No. 10,667,947. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to an ab externo method of placing a drug-releasing intraocular implant into the eye by advancing an injector/needle through the sclera toward the anterior chamber and delivering a tapered drug delivering implant into the eye, and anchoring/releasing the implant such that the first large end of the tapered implant is superficially within the sclera and the smaller second end of the tapered implant is deep to the first end portion. The instant claims are broader than the ‘947 claims because they do not necessarily require that the implant is released/anchored within the intrascleral space.
Allowable Subject Matter
Claims 1-20 would be allowable upon filing a terminal disclaimer to overcome the double patenting rejection set forth above.
The following is a statement of reasons for the indication of allowable subject matter:
The instant claims are drawn to an ab external method of placing an intraocular implant between the anterior chamber and an intrascleral space. The implant obstructs fluid from the anterior chamber toward the intrascleral space upon the release, while simultaneously delivering a drug to the eye. The implant may have a tapered cross-sectional profile (Claim 16) such that the larger end is disposed in the intrascleral spave and the smaller cross section is disposed in the anterior chamber.
The closest prior art is Horvath (US 2014/0243730), which teaches an ab externo method for implanting a tubular implant between the anterior chamber and intrascleral space (Figure 3; [0008]). Horvath, however, does not teach or suggest that the implant obstructs fluid flow from the anterior chamber to toward the intrascleral space upon release, therefore acting as a plug. Horvath also does not teach or suggest the claimed tapered configuration. It is unclear why one of ordinary skill in the art would have modified Horvath’s implant or implantation method to be a fluid-obstructing plug-type element, as doing so would destroy the intended purpose of transferring fluid out of the anterior chamber.
Haffner (US 10,813,789), Haffner (US 2013/0289467) and Heitzmann (US 11,318,043) teach similar ocular drug delivery devices, but do not teach or suggest the claimed methods for at least the same reasons as discussed above with respect to Horvath.
Conclusion
This is a continuation of applicant's earlier Application No. 16/868,498. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application.
Specifically, instant Claims 1-20 are identical to claims 1-20 of the ‘498 application, and are rejected under identical grounds. See the Non-Final Rejection mailed 4/25/2024 in the ‘498 application.
Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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, Sarah Al-Hashimi can be reached on (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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/PHILIP R WIEST/ Primary Examiner, Art Unit 3781
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