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 .
Election/Restrictions
Applicant’s election without traverse of Species A, claims 1-4 and 8-17, in the reply filed on 06/15/2026 is acknowledged.
Claims 5-7 and 18-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/15/2026.
Claims 1-4 and 8-17 are examined on the merits.
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 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 17/971871 (reference application) in view of Farra (US 20120130339 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because
Regarding claim 1, the reference claim 1 substantially teaches the instant claim except for the ophthalmic device comprising a sacrificial barrier layer, and a second drug; and wherein the second drug is released upon sacrifice of the sacrificial barrier layer.
In the same field of endeavor, namely a multi-dose drug delivery device, Farra teaches a sacrificial barrier layer and a second drug (figure 1d, discrete does unit 120 and timing member 122); and wherein the second drug is released upon sacrifice of the sacrificial barrier layer (figure 1d and [0041], discrete dose units 120 releases upon timing member 122 degrades).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reference application to incorporate the teachings of Farra and provides the ophthalmic device as claimed for the purpose of delivering drug over an extended period and obtain complex release profiles as taught by Farrah ([0002 and 0031]).
Regarding claim 13, the reference claim 8 substantially teaches the instant claim except for sacrificing a sacrificial barrier layer holding a second drug in the reservoir; and releasing the second drug from the opening of the reservoir
In the same field of endeavor, namely a multi-dose drug delivery device, Farra teaches sacrificing a sacrificial barrier layer holding a second drug in the reservoir (figure 12 and [0041], degrading discrete timing member 122 holding second dose unit 120 stored in the middle); and
releasing the second drug from the opening of the reservoir (figure 1d and [0041] release the second dose unit).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reference application to incorporate the teachings of Farra and provides the method as claimed for the purpose of delivering drug over an extended period and obtain complex release profiles as taught by Farrah ([0002 and 0031]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 and 8-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez (US 20200214887 A1) in view of Farra (US 20120130339 A1).
Regarding claim 1, Gutierrez substantially teaches applicant’s claimed invention, and specifically discloses a device with every structural limitation of applicant’s claimed invention (except for the limitations shown in italics and grayed-out) including:
An ophthalmic device (figure 2, device 200) comprising:
a reservoir (figures 2 and [0069-0070], one or more reservoirs 215) having an interior, wherein the interior comprises a first drug (figure 2c, therapeutic agent 240), a sacrificial barrier layer ([0069-0070] passive polymer device, e.g., polymeric matrix or hydrogel, between one or more reservoirs 215), and a second drug ([0057] different drug stored in another reservoir); and
a metal electrode (figure 2c and [0069-0070], active controlled release mechanism 280/295, e.g., a metallic thin film 295 configured to cover an opening of the one or more reservoirs 215) configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode ([0067-0068] the metallic film is configured to be electrodissolves upon receives electric signal, i.e., applying electrical potential between 0.8 and 1.2v enables dissolution of the film),
wherein the first drug is released upon electrodissolution of the metal electrode ([0070]) and the second drug is released upon sacrifice of the sacrificial barrier layer.
Gutierrez does not expressly teach the second drug is released upon sacrifice of the sacrificial barrier layer.
In the same field of endeavor, namely a multi-dose drug delivery device, Farra teaches the second drug is released upon sacrifice of the sacrificial barrier layer (figure 1d and [0041], discrete dose units 120 releases upon timing member 122 degrades).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gutierrez to incorporate the teachings of Farra and provides the ophthalmic device as claimed for the purpose of delivering drug over an extended period and obtain complex release profiles as taught by Farrah ([0002 and 0031]).
Regarding claim 2, Gutierrez, as modified by Farrah, teaches the ophthalmic device of claim 1.
The combination further teaches wherein the sacrificial barrier layer is sacrificed a predetermined time after the electrodissolution of the metal electrode (Farrah; [0035] the discrete timing members 122 degrades after a prescribed timeframe).
Regarding claim 3, Gutierrez, as modified by Farrah, teaches the ophthalmic device of claim 1.
The combination further teaches wherein the sacrificial barrier layer is a water soluble material to facilitate the sacrifice (Farrah; [[0030 and 0034] the discrete timing member dissolves in response to an environment conditions include water).
Regarding claim 4, Gutierrez, as modified by Farrah, teaches the ophthalmic device of claim 3.
The combination further teaches wherein the water soluble material comprises a polymer and/or a salt (Farrah; [0035] the discrete timing members are formed of a polymer).
Regarding claim 8, Gutierrez, as modified by Farrah, teaches the ophthalmic device of claim 1.
The combination further teaches further comprising a body comprising a hydrogel-based material configured to encapsulate the reservoir and the metal electrode (Gutierrez; [0007 and 0055] and figure 2c, device 200 made of polymeric substrate 205, e.g., hydrogel, encapsulating the reservoir 215 and 280/295).
Regarding claim 9, Gutierrez, as modified by Farrah, teaches the ophthalmic device of claim 1.
The combination does not teach wherein the interior further comprises a second sacrificial barrier layer and a third drug,
wherein the third drug is released upon sacrifice of the second sacrificial barrier layer.
In the same field of endeavor, namely a multi-dose drug delivery device, Farra teaches wherein the interior further comprises a second sacrificial barrier layer and a third drug (figure 1d, second timing member 122 and third drug 120 stored between 122 and 116),
wherein the third drug is released upon sacrifice of the second sacrificial barrier layer ([0035] the third drug release upon second timing member 122 degrades).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gutierrez, to incorporate the teachings of Farrah, to incorporate the teachings of Farra and provides the ophthalmic device as claimed for the purpose of delivering drug over an extended period and obtain complex release profiles as taught by Farrah ([0002 and 0031]).
Regarding claim 10, Gutierrez, as modified by Farrah, teaches the ophthalmic device of claim 9.
The combination further teaches wherein the second sacrificial barrier layer is sacrificed at a second predetermined time after the sacrificial barrier layer is sacrificed (Farrah; figure 1d [0035 and 0037] the discrete timing members may each have a prescribed timeframe different from that of the fist timing member, the second sacrificial layer sacrificed after the sacrificial barrier layer).
Regarding claim 11, Gutierrez, as modified by Farrah, teaches the ophthalmic device of claim 10
The combination further teaches wherein the second sacrificial barrier layer is sacrificed at a second predetermined time after the sacrificial barrier layer is sacrificed (Farrah; figure 1d and [0035 and 0037] the second barrier sacrificed at a prescribed timeframe after the sacrificial barrier layer is dissolved)
Regarding claim 12, Gutierrez, as modified by Farrah, teaches the ophthalmic device of claim 1.
The combination further teaches wherein a release profile of the second drug is based on a thickness of the sacrificial barrier layer (Farrah; [0035 and 0037]).
Regarding claim 13, Gutierrez teaches a method comprising:
electrodissolving a metal electrode (figure 2c and [0069-0070], active controlled release mechanism 280/295, e.g., metallic thin film 295, configured to cover an opening of the one or more reservoir) covering an opening of a reservoir of an ophthalmic device;
releasing a drug from the opening of the reservoir ([0070]);
sacrificing a sacrificial barrier layer holding a second drug in the reservoir; and
releasing the second drug from the opening of the reservoir.
Gutierrez does not expressly teach sacrificing a sacrificial barrier layer holding a second drug in the reservoir; and
releasing the second drug from the opening of the reservoir.
In the same field of endeavor, namely a multi-dose drug delivery device, Farra teaches sacrificing a sacrificial barrier layer holding a second drug in the reservoir (figure 12 and [0041], degrading discrete timing member 122 holding second dose unit 120 stored in the middle); and
releasing the second drug from the opening of the reservoir (figure 1d and [0041] release the second dose unit).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gutierrez to incorporate the teachings of Farra and provides the method as claimed for the purpose of delivering drug over an extended period and obtain complex release profiles as taught by Farrah ([0002 and 0031]).
Regarding claim 14, Gutierrez, as modified by Farrah, teaches the method of claim 13.
The combination further teaches wherein a release profile of the second drug is based on a thickness of the sacrificial barrier layer (Farrah; [0035 and 0037]).
Regarding claim 15, Gutierrez, as modified by Farrah, teaches the method of claim 13.
The combination further teaches wherein the sacrificial barrier layer is sacrificed a predetermined time after the electrodissolution of the metal electrode (Farrah; [0037 and 0041] the timing member 122 degrades a prescribed time after the end pieces 118 degrades).
Regarding claim 16, Gutierrez, as modified by Farrah, teaches the method of claim 13.
The combination further teaches wherein the sacrificial barrier layer is a water soluble material to facilitate the sacrifice (Farrah; [[0030 and 0034] the discrete timing member dissolves in response to an environment conditions include water).
Regarding claim 17, Gutierrez, as modified by Farrah, teaches the method of claim 16.
The combination further teaches wherein the water soluble material comprises a polymer and/or a salt (Farrah; [0035] the discrete timing members are formed of a polymer).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kim et al (US 20190232584 A1) and Blaskovich et al (US 20130296833 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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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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/SETH HAN/ Examiner, Art Unit 3781
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