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 .
Status of the Claims
The Claim filed 08/21/2026 has been entered. Claims 1-20 are pending in the application. Claims 5-7 and 18-20 remain withdrawn.
Response to Arguments
In response to the applicant’s argument with respect to double patenting rejection have been fully considered and are persuasive. Accordingly, the rejection has been withdrawn.
In response to the applicant’s argument with respect to 35 USC 103 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation of Farrah and Gutierrez as present below.
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 Farrah (US 20120130339 A1) in view of Gutierrez (US 20200214887 A1)
Regarding claim 1, Farrah 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 comprising:
a reservoir (figures 1a-d, plurality of housing units 124) having an interior (figures 1a-d, interior of the housing 118), wherein the interior comprises a first drug (figure 1d [0040], the housing unit 124 closest to the second end 118 comprises first dose unit 120), a sacrificial barrier layer (figure 1d, degradable timing members 122), and a second drug (figure 1d, second does unit 120 stored in middle housing unit 124) different than the first drug, wherein the sacrificial barrier is positioned between and separates the first drug and the second drug (figure 1d and [0040], the timing members 112 separates the dose units 120 from one another); and
a metal electrode configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode,
wherein the first drug is released upon electrodissolution of the metal electrode and the second drug is released upon sacrifice of the sacrificial barrier layer ([0035 and 0041] the second drug released upon rupture of the timing member 112 defining the middle housing unit).
Farrah does not teach the second drug different than the first drug; and
a metal electrode configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode,
wherein the first drug is released upon electrodissolution of the electrode; though
Farrah teaches a single device may include a single drug or a combination of two or more drugs ([0029]), and the discrete timing members or seal member may be made of different materials for the purpose of controlling release profile ([0037])
In the same field of endeavor, namely devices and systems for targeted and controlled delivery of a therapeutic agent, Gutierrez teaches the second drug different than the first drug [[0057] a device 100 comprises one or more reservoirs 215, and each reservoir holds a single type of therapeutic agent different from other reservoirs); and
a metal electrode (figure 2c and [0067-0070] active controlled release mechanism 280, e.g., metallic thin film 295, configured to cover an opening of the reservoir 215 and configured to electrodissolves upon receiving an electrical signal) configured to cover an opening of the reservoir and to receive an electrical signal that electrodissolves the metal electrode,
wherein the first drug is released upon electrodissolution of the electrode ([0070] the drug contained within the reservoir released upon electrodissolution of the release mechanism 280).
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 Farrah, to incorporate the teachings of Gutierrez and provides the second drug and substitutes the second end piece (figure 1d 118) of Farrah with metal electrode as claimed for the purpose of administering therapeutic agents requiring remain separated prior to administration, and an active drug release mechanism as taught by Gutierrez ([0049]). For instance, Farrah relies on passive drug release, i.e., drug release initiated by degradation of the end piece upon exposure to the environment outside the device ([0032-0037]), while Gutierrez teaches an active, electronically controlled drug-release mechanism in which the release mechanism degrades upon receiving an electrical signal. Incorporating the active release mechanism of Gutierrez into Farrah would provide a controllable and customizable drug-release profile, allowing drug release to be selectively initiated or delayed at a desired time, regardless of the surrounding environment as taught by Gutierrez ([0049]).
Regarding claim 2, Farrah, as modified by Gutierrez, 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 and Gutierrez; figure 1d and [0035] the discrete timing member 122 degrades after a prescribed timeframe after the electrodissolution of the metal electrode substitutes second end 118).
Regarding claim 3, Farrah, as modified by Gutierrez, 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, Farrah, as modified by Gutierrez, teaches the ophthalmic device of claim 1.
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, Farrah, as modified by Gutierrez, teaches the ophthalmic device of claim 1.
The combination does not teach further comprising a body comprising a hydrogel-based material configured to encapsulate the reservoir and the metal electrode.
In the same field of endeavor, namely devices and systems for targeted and controlled delivery of a therapeutic agent, Gutierrez teaches 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).
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 Farrah, as modified by Gutierrez, to incorporate the teachings of Gutierrez and provide the body as claimed for the purpose of providing delivery devices designed to be placed on a surface of the eye and controlled delivery of a therapeutic agent to a treatment site of eye as taught by Gutierrez ([0049]).
Regarding claim 9, Farrah, as modified by Gutierrez, teaches the ophthalmic device of claim 1.
The combination further teaches wherein the interior further comprises a second sacrificial barrier layer and a third drug (Farrah; figure 1d, second timing member 122 and third drug 120 disposed between first end piece 116 and the middle housing unit 124),
wherein the third drug is released upon sacrifice of the second sacrificial barrier layer (Farrah; [0035] the third drug release upon second timing member 122 degrades).
Regarding claim 10, Farrah, as modified by Gutierrez, 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, 0037 and 0041] the discrete timing member may each have a prescribed timeframe different from that of the first timing member, the second timing member degrades after first timing member degrades).
Regarding claim 11, Farrah, as modified by Gutierrez, teaches the ophthalmic device of claim 10.
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] the discrete timing member having thickness designed to degrade in a prescribed timeframe, releasing the drug ).
Regarding claim 12, Farrah, as modified by Gutierrez, teaches the ophthalmic device of claim 10.
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] the discrete timing member having thickness designed to degrade in a prescribed timeframe, releasing the).
Regarding claim 13, Farrah teaches a method comprising:
electrodissolving a metal electrode covering an opening of a reservoir of an ophthalmic device;
releasing a first drug from the opening of the reservoir (figure 1d and [0041] releasing a discrete dose unit 120 closest to a second end piece 118 from the housing 124 following rupture of the second end piece 118);
sacrificing a sacrificial barrier layer (figure 1d and [0040], degradable timing member 122 positioned between the first housing unit 124 and the middle housing unit 124 separates the second dose unit 120 in the middle housing from the first dose unit 120) holding a second drug different than the first drug in the reservoir, wherein the sacrificial barrier is positioned between and separates the first drug and the second drug; and
releasing the second drug from the opening of the reservoir (figure 1d and [0041], releasing the second drug upon rupture of the second timing member 122).
Farrah does not teach electrodissolving a metal electrode covering an opening of a reservoir of an ophthalmic device; and
the second drug different than the first drug in the reservoir; though
Farrah teaches a single device may include a single drug or a combination of two or more drugs ([0029]), and the discrete timing members or seal member may be made of different materials for the purpose of controlling release profile ([0037])
In the same field of endeavor, namely devices and systems for targeted and controlled delivery of a therapeutic agent, Gutierrez teaches electrodissolving a metal electrode covering an opening of a reservoir of an ophthalmic device (figure 2c and [0067-0070] electrodissolving active controlled release mechanism 280, e.g., metallic thin film 295 covering an opening of a reservoir 215); and
the second drug different than the first drug in the reservoir ([0057] device 100 comprises one or more reservoirs 215, and each reservoir hold a single type of therapeutic agent different from other reservoirs).
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 Farrah to incorporate the teachings of Gutierrez and provides the method as claimed for the purpose of administering therapeutic agents requiring remain separated prior to administration, and an active drug release mechanism as taught by Gutierrez ([0049]). For instance, Farrah relies on passive drug release, i.e., drug release initiated by degradation of the end piece upon exposure to the environment outside the device ([0032-0037]), while Gutierrez teaches an active, electronically controlled, drug-release mechanism in which the release mechanism degrades upon receiving an electrical signal. Incorporating the active release mechanism of Gutierrez into Farrah would provide a controllable and customizable drug-release profile, allowing drug release to be selectively initiated or delayed at a desired time, regardless of the surrounding environment as taught by Gutierrez ([0049]).
Regarding claim 14, Farrah, as modified by Gutierrez, 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] the discrete timing member having thickness designed to degrade in a prescribed timeframe, releasing the drug).
Regarding claim 15, Farrah, as modified by Gutierrez, 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; figure 1d and [0035] the discrete timing member 122 degrades after a prescribed timeframe after the electrodissolution of the metal electrode at second end 118).
Regarding claim 16, Farrah, as modified by Gutierrez, teaches the method of claim 13.
The combination further teaches wherein the sacrificial barrier layer is a water soluble material to facilitate the sacrifice (Ferrah; Farrah; [0030 and 0034] the discrete timing member dissolves in response to an environment conditions include water).
Regarding claim 17, Farrah, as modified by Gutierrez, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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 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
