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 Group I, claims 1-19, in the reply filed on 11/22/2024 is acknowledged.
Claims 20-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/22/2024.Thus, claims 1-19 are presently under consideration for examination.
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 2 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.
The term “such as” in claim 2 is a relative term which renders the claim indefinite. The term “such as” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gutierrez (US 20190380871 A1).
Regarding Claim 1, Gutierrez teaches a wirelessly driven contact lens ('system 100 for closed-loop intraocular therapy' including 'device 110', figs.3 and 6B, ¶ 36; "wireless communication device", ¶ 36) for monitoring intraocular pressure ("intraocular therapy", ¶ 36; "intraocular pressure", ¶ 40) and treating glaucoma ("glaucoma", ¶ 5) in a glaucoma patient, the wirelessly driven contact lens 100 comprising:
a strain sensor ('intraocular pressure sensor 116', fig.4, ¶ 40) which is transparent and measures intraocular pressure of a subject ('eye 50 of a patient', fig.4, ¶ 40); and
a drug reservoir ('therapeutic agent reservoirs 118a, 118b', fig.6B, ¶ 50; "delivery system...drug administration", ¶ 31; "programmable drug delivery", ¶ 32),
wherein the strain sensor 116 and the drug reservoir (118a, 118b) are formed on a transparent substrate ('polymer substrate 112' formed of " Parylene, PET", fig.4, ¶ 43; NOTE: see fig.4 in which the iris and pupil are clearly visible while the lens is inserted, thus the device is transparent),
wherein the strain sensor 116 measures a change in resistance due to a change in intraocular pressure (“As the IOP of the patient's eye changes, the geometry of the eye (e.g., shape, corneal diameter, size, etc.) also changes”, ¶ 46; "the change in corneal diameter is measured in a contact lens through a variety of mechanisms which includes piezoresistive, electrochemical impedance, or capacitive means", ¶ 49), and
wherein when an abnormality is detected in the change in intraocular pressure ("change in corneal diameter", ¶ 49), a drug is released from the drug reservoir ("The reservoir(s) 118a, 118b provide a means for sterile storage of a drug to allow for on-demand release and delivery at a programmed time thereby providing a therapeutic effect on the eye via targeted transcorneal absorption", ¶ 50; "a drug delivery schedule of the temporal model may be created and/or updated according to IOP measurements obtained over a period of time, such as a day, several days, weeks, or months", ¶ 61).
Regarding Claim 2, Gutierrez teaches the contact lens ('device 110', fig.6B, ¶ 63) is based on at least one selected from the group consisting of an elastomer such as a silicone elastomer, a silicone hydrogel, and a polymer hydrogel of poly(2- hydroxyethyl methacrylate) (PHEMA), polyvinylpyrrolidone (PVP), poly(lactic acid- glycolic acid) (PLGA), or polyvinyl alcohol (PVA) ("The device 110 comprises standard contact lens materials such as silicone, silicone hydrogels, rigid gas permeable polymers, PMMA, polyurethane, Parylene, PET, polyimide or combinations thereof", ¶ 50).
Regarding Claim 3, Gutierrez teaches the transparent substrate 112 includes at least one selected from the group consisting of parylene C, polydimethylsiloxane (PDMS), a silicone elastomer, polyethylene terephthalate (PET), and polyimide (PI) ("The electronics are disposed on a polymer substrate 112, which includes at least one of PMMA, Parylene, PET, polyurethane, polyimide, rigid gas permeable fluorosilicone acrylate, liquid crystal polymer, silicon-based polymers, silicone acrylate and the like", ¶ 43).
Regarding Claim 4, Gutierrez teaches the strain sensor 116 includes:
a nanomaterial layer ('plurality of controllable thin film seals 119a, 119b', fig.6B, ¶ 50) formed on the transparent substrate 112; and
a passivation layer ('soft flexible biocompatible material 117', fig.6B, ¶ 43) formed on the nanomaterial layer (119a, 119b).
Regarding Claim 5, Gutierrez teaches nanomaterials included in the nanomaterial layer include zero-dimensional materials that are nanoparticles ("nanoparticles", ¶ 50).
Regarding Claim 6, Gutierrez teaches the nanomaterials have biocompatibility (NOTE: if the thin film seals 119a, 119b are placed in the eye then they would have to be biocompatible in order to be safe for patient use).
Regarding Claim 7, Gutierrez teaches the passivation layer 117 includes at least one selected from the group consisting of parylene C, polydimethylsiloxane (PDMS), a silicone elastomer ("a soft flexible biocompatible material 117 suitable for ocular wear, such as...silicone elastomer", ¶ 43), polyethylene terephthalate (PET), and polyimide (PI).
Regarding Claim 8, Gutierrez teaches a structure of the strain sensor 116 comprises a circle or a straight line and entirely or partially surrounds the cornea of an eyeball ("the geometry of the IOP sensor 116 can also be described in terms of radius, such as a corneal radius", ¶ 46; see fig.6A).
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Annotated Figure 6B of Gutierrez
Regarding Claim 9, Gutierrez teaches the drug reservoir (118a, 118b) includes an electrode pattern (contained within "metallic film" 119a and 119b; ¶ 52) which includes gold ("Gold is chosen as a membrane material", ¶ 53) and is formed on a portion of a surface of the transparent substrate 112 (see fig.6B) and a drug well layer which is formed on the electrode pattern (contained within "metallic film" 119a and 119b; ¶ 52) and includes one or more drug wells with a shape that is recessed so as to face outward (see fig.6B),
wherein perforations are formed in the transparent substrate 112, and wherein the electrode pattern covers the perforations (see annotated figure 6B).
Regarding Claim 10, Gutierrez teaches the drug included in the drug well includes a drug for treating glaucoma (¶ 39).
Regarding Claim 11, Gutierrez teaches a circular antenna configured to transmit and receive power and signals to and from the outside through induced current and electromagnetic resonance ("The device 110 also comprises an antenna coupled to the processor 114 for communication, programming, and/or power transfer purposes", ¶ 43; see fig.5; "The processor 114 can measure or detect changes in the resonance of the IOP sensor 116 formed by the inductor loop 126 and the matching capacitor", ¶ 44),
wherein the circular antenna is formed on the transparent substrate 112 ("an antenna coupled to the processor 114", which is on the transparent substrate ¶ 43; see fig.5).
Regarding Claim 12, Gutierrez teaches the antenna ("an antenna coupled to the processor 114", ¶ 43; see fig.5) includes at least metal thin film materials ("metallic film", ¶ 52).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13-14 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez in view of Ung et al. (KR 20170139300 A).
Regarding Claim 13, Gutierrez teaches forming a sacrificial layer ('plurality of controllable thin film seals 119a, 119b', fig.6B, ¶ 50) soluble in water on a handling substrate; forming a transparent substrate 112 on the sacrificial layer (119a, 119b); forming a strain sensor 116 and a drug reservoir (118a, 118b) on the transparent substrate 112; transferring the transparent substrate 112, on which the strain sensor 116 and the drug reservoir (118a, 118b) are formed, into a contact lens 110, but fails to teach a method of manufacturing the wirelessly driven contact lens for monitoring intraocular pressure and treating glaucoma in a glaucoma patient.
Ung teaches a method of manufacturing the wirelessly driven contact lens for monitoring intraocular pressure and treating glaucoma ("intraocular pressure sensor using a change in capacitance according to an intraocular pressure, a contact lens including the same, and a method of manufacturing the same", Background) in a glaucoma patient.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Gutierrez to perform a method of manufacturing the wirelessly driven contact lens for monitoring intraocular pressure and treating glaucoma in a glaucoma patient as taught by Ung, such that a foreign body sensation is less when being worn on the eyes since the device is thin, such that elasticity is high, and wireless communication is possible outside the system.
Regarding Claim 14, Gutierrez teaches the sacrificial layer (119a, 119b) includes at least one selected from the group consisting of polyvinyl alcohol (PVA) and dextran ("The thin film is controlled by the processor and operable to dissolve to release a therapeutic agent to the eye of the patient", ¶ 11).
Regarding Claim 16, Gutierrez teaches the forming of the drug reservoir (118a, 118b) on the transparent substrate 112 includes:
forming an electrode pattern including gold on a portion of a surface of the transparent substrate 112 ("Gold is chosen as a membrane material...Gold is chosen as a membrane material because it is easily deposited and patterned", ¶ 53); and
forming a drug well layer (see fig.6B) including one or more drug wells on the electrode pattern (contained within "metallic film" 119a and 119b; ¶ 52).
Regarding Claim 17, Gutierrez teaches one or more perforations (see annotated figure 6B) are formed in the transparent substrate 112 on which the drug reservoir (118a, 118b) is formed,
wherein the electrode pattern (contained within "metallic film" 119a and 119b; ¶ 52) covers the perforations (see annotated figure 6B), and
wherein the perforations (see annotated figure 6B) are formed before or after the electrode pattern (contained within "metallic film" 119a and 119b; ¶ 52) is formed on the transparent substrate 112.
Regarding Claim 18, Gutierrez teaches the drug well layer (see fig.6B) including the drug wells, but fails to teach the drug well layer including the drug wells includes at least one selected from the group consisting of polydimethylsiloxane (PDMS), a silicone elastomer, polyurethane acrylate (PUA), and an SU8. Ung teaches polydimethylsiloxane (PDMS) ("As the dielectric material, a transparent elastomer such as ecoflex, PDMS or the like may be used").
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Gutierrez such that the drug well layer including the drug wells includes at least polydimethylsiloxane (PDMS) as taught by Ung, in order to allow high oxygen permeability, allowing for better corneal health compared to traditional materials due to increased oxygen transmission to the eye.
Regarding Claim 19, Gutierrez teaches forming an antenna on the transparent substrate 112 ("The device 110 also comprises an antenna coupled to the processor 114 for communication, programming, and/or power transfer purposes", ¶ 43; see fig.5; "The processor 114 can measure or detect changes in the resonance of the IOP sensor 116 formed by the inductor loop 126 and the matching capacitor", ¶ 44).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez in view of Ung and Hahn et al. (US 20200319479 A1).
Regarding Claim 15, Gutierrez teaches the forming of the strain sensor 116 on the transparent substrate 112, but fails to teach forming a mask material for patterning on the transparent substrate; patterning a sensor and a circuit by coating nanomaterials on the transparent substrate, on which the mask material is formed, through a lift-off process; and forming a passivation layer on the sensor and circuit that are patterned. Ung teaches forming a mask material ("mask aligner") for patterning on the transparent substrate ("positive photoresist is spin-coated, patterned using a mask aligner, and developed using a developer"); and forming a passivation layer on the sensor and circuit that are patterned ("the passivation layer 20 is a layer formed by coating the upper electrode 18 with parylene. The passivation layer 20 is exemplified by parylene").
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Gutierrez to form a mask material for patterning on the transparent substrate; and forming a passivation layer on the sensor and circuit that are patterned as taught by Ung, such that a foreign body sensation is less when being worn on the eyes since the device is thin, such that elasticity is high, and wireless communication is possible outside the system.
Ung fails to teach patterning a sensor and a circuit by coating nanomaterials on the transparent substrate, on which the mask material is formed, through a lift-off process. Hahn teaches patterning a sensor and a circuit by coating nanomaterials on the transparent substrate through a lift-off process ("A sapphire substrate was removed using a laser lift-off (LLO) technique", ¶ 91).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Gutierrez to pattern a sensor and a circuit by coating nanomaterials on the transparent substrate, on which the mask material is formed, through a lift-off process as taught by Hahn, such that a 3D surface can be masked utilizing biocompatible materials such that a foreign body sensation is less.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel O'Connell whose telephone number is (571)272-7583. The examiner can normally be reached Monday - Friday, 7:30 am - 3:30 pm.
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/RACHEL O'CONNELL/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
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