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 Claims
Claims 1-20 are pending, of which Claims 14-15 & 17 are amended. All claims are examined on the merits.
Response to Arguments
Applicant’s arguments, filed 7/21/2025, with respect to the rejection(s) of claim(s) under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gutierrez (US 2019/0380871).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites the limitation "wherein dissolving the boost layer further comprises…" There is insufficient antecedent basis for this limitation in the claim because Claim 10, from which Claim 17 depends, merely mentions a boost layer being present but does not mention dissolving the boost layer. Examiner believes that Claim 17 should depend from Claim 11 to have proper antecedent basis.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 8-9, 15, 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gutierrez (US 2019/0380871).
Re Claim 1, Gutierrez discloses an ophthalmic device comprising:
a reservoir (e.g., 118a or 118b, see [0050]) having an interior configured to hold a therapeutic ([0050]);
a metal electrode (thin film seal 119a or 119b) configured to cover an opening of the reservoir ([0050] “a plurality of controllable thin film seals 119a, 119b positioned over the reservoirs 118a, 118b”) and to receive an electrical signal that electrodissolves the metal electrode to release the therapeutic from the reservoir ([0051] “the processor 114 is configured to cause each of the seals 119a, 119b to undergo electrodissolution by applying a voltage to the thin film seals 119a, 119b); and
a body (flexible coating 117) comprising a hydrogel-based material ([0040]) configured to encapsulate the reservoir and the metal electrode ([0040] & FIG. 6B),
wherein electrodissolution is enhanced by chloride ions ([0052] “The metallic film undergoes electrodissolution when a potential is applied in presence of chloride-containing solutions (e.g., tear film).”).
Re Claim 2, Gutierrez discloses claim 1, wherein the hydrogel-based material is permeable to the chloride ions ([0043] of Gutierrez discloses the same materials as those found in [0039] of the current Application’s Specification; therefore the reference’s hydrogel-based material must also be permeable to chloride ions).
Re Claim 8, Gutierrez discloses a method comprising: positioning an ophthalmic device on an eye of a subject, wherein the ophthalmic device comprises:
a reservoir (118a, 118b) having an interior configured to hold a therapeutic;
a metal electrode (119a, 119b) configured to cover an opening of the reservoir and to electrodissolve to release the therapeutic from the reservoir (e.g., [0050]); and
a body (117) comprising a hydrogel-based material ([0040]) configured to encapsulate the reservoir and the metal electrode; and
applying an electrical signal ([0052]) to the electrode so that the electrode undergoes electrodissolution to release the therapeutic,
wherein the electrodissolution is enhanced by chloride ions ([0052]).
Re Claim 9, Gutierrez discloses claim 8, wherein the hydrogel-based material is permeable to the chloride ions ([0043] of Gutierrez discloses the same materials as those found in the current Application).
Re Claim 15, Gutierrez discloses claim 8 and further discloses:
applying an electrical signal ([0052]) to the metal electrode to begin electrodissolution;
dissolving ([0051]-[0052]) the metal electrode by electrodissolution; and
releasing the therapeutic from the reservoir ([0051]) to diffuse across the hydrogel body into the eye.
Re Claim 18, Gutierrez discloses claim 8 and also implies that wherein the applying electrical signal further comprises starting the electrodissolution once a charge transfer limit is reached ([0053] discloses holding the anode potential at a particular voltage to enable gold dissolution, thus implying that once the right conditions are met, such as reaching a particular voltage, electrodissolution will naturally start).
Re Claim 19, Gutierrez discloses claim 8 and also discloses treating an eye disease with the therapeutic (e.g., Abstract).
Re Claim 20, Guterrez discloses claim 19 and also disclosing wherein the eye disease is one of glaucoma (e.g., Abstract) and dry eye.
Allowable Subject Matter
Claims 3-7, 10-14, 16 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.
Claim 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Re Claims 3, 10 & 16, no prior art is found to disclose placing a boost layer next to a metal electrode that gates a drug reservoir, wherein the boost layer is configured to supply the chloride ions to enhance the electrodissolution.
Claims 4-7 and 11-14, 17 are allowable at least for being dependent from Claim 3 or 10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5,797,898 discloses a microchip drug delivery device where the drug reservoirs on the chip are capped by gold that can electrodissolve upon application of an electric potential.
WO 97/11744 discloses an iontophoretic device wherein the anode is substantially copper and the cathode is silver-coated carbon, and both the anode and cathode are in an electrolyte solution.
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/SUSAN S SU/Primary Examiner, Art Unit 3781 25 September 2026
