DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of the invention restriction of 12 February 2026 in the reply filed on 11 May 2026 is acknowledged. Claims 17-35 are pending, with Groups I, II, and III (claims 17-21) being withdrawn from consideration.
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 22-26 and 29-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21, 23, 25-26, 30, and 36-37 of U.S. Patent No. 11,786,396 in view of Breegi et al (US 2004/0230183). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate the instant claims as detailed below:
Instant
Patent
22. A method
for injecting a therapeutic agent into an ocular implant at least partially implanted in an eye of a patient, the method comprising:
advancing at least one needle into the eye, the at least one needle comprising:
an injection lumen;
an outlet lumen surrounding at least a portion of the injection lumen; and
a receiver chamber fluidly coupled to the outlet lumen;
injecting a therapeutic agent into the ocular implant through the injection lumen; and
displacing pre-existing fluid in the ocular implant through the outlet lumen into the receiver chamber as therapeutic agent is injected into the ocular implant through the injection lumen.
20. An injector
for injecting a therapeutic agent into an ocular implant at least partially implanted in an eye, the injector comprising:
an injection lumen having a first opening, the injection lumen configured to provide a pathway for injecting a therapeutic agent from the injection lumen through the first opening into the ocular implant using positive pressure applied through the injection lumen;
an outlet lumen configured to provide a pathway through which a first amount of pre-existing liquid in the ocular implant exits the ocular implant as therapeutic agent is injected into the ocular implant through the first opening from the injection lumen, wherein the injection lumen is in a fixed position relative to the outlet lumen such that the first opening from the injection lumen is located distal to the outlet lumen;
a receiver chamber fluidly coupled to the outlet lumen, the receiver chamber comprises a vent to pass air that is fluidly coupled to the outlet lumen so as to define a vent path,
wherein injection of the therapeutic agent into the ocular implant via the injection lumen through the distal opening upon application of the positive pressure through the injection lumen
displaces the first amount of pre-existing liquid in the ocular implant into the receiver chamber via the outlet lumen,
wherein the vent path comprises no substantial resistance to flow as the therapeutic agent is injected into the ocular implant through the injection lumen.
The patent claim discloses all of the elements of the claim but is silent regarding “advancing at least one needle into the eye.” However, Breegi teaches an ocular injector (31, Fig. 3), thus being in the same field of endeavor, which advances a needle (¶0045) to reach the therapeutic target area. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the patent claims to incorporate a step of advancing an ocular needle as taught by Breegi in order to provide a sufficient way of reaching a target therapeutic area.
22. A method
for injecting a therapeutic agent into an ocular implant at least partially implanted in an eye of a patient, the method comprising:
advancing at least one needle into the eye,
the at least one needle comprising:
an injection lumen;
an outlet lumen surrounding at least a portion of the injection lumen; and
a receiver chamber fluidly coupled to the outlet lumen;
injecting a therapeutic agent into the ocular implant through the injection lumen; and
displacing pre-existing fluid in the ocular implant through the outlet lumen into the receiver chamber as therapeutic agent is injected into the ocular implant through the injection lumen.
37. An injector
for injecting a therapeutic agent into an ocular implant at least partially implanted in an eye, the injector comprising:
a cartridge having
at least one needle defining
an injection lumen, the injection lumen having a first opening, the injection lumen configured to provide a pathway for injecting a therapeutic agent from the injection lumen through the first opening into the ocular implant using positive pressure applied through the injection lumen;
an outlet lumen configured to provide a pathway through which a first amount of pre-existing liquid in the ocular implant exits the ocular implant as therapeutic agent is injected into the ocular implant through the first opening from the injection lumen, wherein the injection lumen is in a fixed position relative to the outlet lumen such that the first opening from the injection lumen is located distal to the outlet lumen;
a receiver chamber fluidly coupled to the outlet lumen,
wherein injection of the therapeutic agent into the ocular implant via the injection lumen through the distal opening upon application of the positive pressure through the injection lumen
displaces the first amount of pre-existing liquid in the ocular implant into the receiver chamber via the outlet lumen.
The patent claim discloses all of the elements of the claim but is silent regarding “advancing at least one needle into the eye.” However, Breegi teaches an ocular injector (31, Fig. 3), thus being in the same field of endeavor, which advances a needle (¶0045) to reach the therapeutic target area. It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the patent claims to incorporate a step of advancing an ocular needle as taught by Breegi in order to provide a sufficient way of reaching a target therapeutic area.
Instant
23
24
25
26
29
30
Patent
21
25
26
30
36
23
Allowable Subject Matter
Claims 27-28 and 31-35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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