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 .
Response to Amendment
The amendment filed 06/05/2025 has been entered. Claims 1-2, 6-7 have been amended. Claims 4-5 are cancelled. Claims 1-3, 6-24 remain pending in this application. Claims 20-24 are withdrawn.
Response to Arguments
The amendment to claim 2 overcomes the 112(b) rejection and such rejection is therefore withdrawn.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on Gutierrez alone for any teaching or matter specifically challenged in the argument. A new grounds of rejection is made over Gutierrez in view of Jow.
Regarding claim 13, applicant argues that Ung does not disclose any configuration related to the treatment of glaucoma. However, as discussed in the rejection below, Gutierrez in view of Jow and further in view of Ung disclose the claimed method steps. Thus, Gutierrez in view of Jow and further in view of Ung relate to the treatment of glaucoma.
Applicant argues that the intraocular pressure sensor of Ung utilizes changes in capacitance. However, as discussed in the rejection below, Gutierrez discloses the claimed strain sensor.
Similarly, applicant argues that Hahn does not disclose any configuration corresponding to a strain sensor. However, Gutierrez discloses the claimed strain sensor. Hahn is relied upon to teach steps of forming a sensor.
Claim Rejections - 35 USC § 101
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 8 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 8 recites “wherein a structure of the strain sensor…entirely or partially surrounds the cornea of an eyeball” which positively recites a portion of the human body. Applicant is recommended to use inferential language (e.g. adapted to, for, configured to, or whereby clause) to avoid positively claiming the human body.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guitierrez (Pub. No.: US 2019/0380871 A1) in view of Jow et al. (Pub. NO.: US 2019/0094570 A1).
Regarding claim 1, Gutierrez discloses (fig. 3-6) a wirelessly driven contact lens (eye-mountable therapy device, ¶ 0036) for monitoring intraocular pressure (¶ 0030) and treating glaucoma in a glaucoma patient (abstract), the wirelessly driven contact lens comprising:
A strain sensor (intraocular pressure sensor 116) which is transparent and measures intraocular pressure of a subject (eye 50 of a patient, ¶ 0040, fig. 4); and
A drug reservoir (plurality of therapeutic agent reservoirs 118a, 118b, ¶ 0050);
Wherein the strain sensor and the drug reservoir are formed on a transparent substrate (flexible substrate 112, fig. 4),
Wherein the strain sensor measures a change in resistance due to a change in intraocular pressure (change in corneal radius and change in intraocular pressure is linearly related, ¶ 0047, change in corneal diameter can be measured through piezoresistive means ¶ 0049), and
Wherein when an abnormality is detected in the change in intraocular pressure (¶ 0047), a drug is released form the drug reservoir (¶ 0050, ¶ 0061),
Wherein the strain sensor includes:
A material layer (see layer forming the inductor loop 126) formed on the transparent substrate (fig. 6B); and
A passivation layer formed on the material layer (see flexible coating 117 formed on the inductor loop 126, ¶ 0040, fig. 6b.
Gutierrez fails to disclose that the material layer is a nanomaterial layer, wherein the nanomaterial layer includes nanowires.
Jow teaches (fig. 1) a wirelessly driven contact lens (ophthalmic device 100, ¶ 0002) and thus in the same field of endeavor, comprising a sensor including a nanomaterial layer, the nanomaterial layer includes nanowires (¶ 0021), wherein such nanowire materials are substantially transparent conductive materials for forming an electrode (¶ 0021).
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 material layer of Gutierrez such that it is a nanomaterial layer, wherein the nanomaterial layer includes nanowires, as taught by Jow, as such nanowire materials are substantially transparent conductive materials for forming an electrode (¶ 0021).
Regarding claim 2, Gutierrez discloses wherein the contact lens 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) (flexible biocompatible material 117 can be silicone elastomer, ¶ 0043).
Regarding claim 3, Gutierrez discloses wherein the transparent substrate includes at least one selected from the group consisting of parylene C, polydimethylsiloxane (PDMS), a silicone elastomer, polyethylene terephthalate (PET), and polyimide (P1) (PET, ¶ 0043).
Regarding claim 6, Gutierrez in view of Jow disclose the nanomaterials, as discussed above in claim 1. Jow further implies wherein the nanomaterials have biocompatibility since the nanomaterials are mounted on or in an eye of a user (Jow abstract, ¶ 0021).
Regarding claim 7, Gutierrez discloses wherein the passivation layer includes at least one selected from the group consisting of parylene C, polydimethylsiloxane (PDMS), a silicone elastomer, polyethylene terephthalate (PET), and polyimide (P1) (¶ 0043).
Regarding claim 8, Gutierrez discloses wherein a structure of the strain sensor comprises a circle (loop, ¶ 0044, fig. 4) or a straight line and is configured to entirely or partially surround the cornea of an eyeball (fig. 6B, ¶ 0046).
Regarding claim 9, Gutierres discloses wherein wherein the drug reservoir includes an electrode pattern (characterized by thin film seals 119a, 119b) which includes gold and is formed on a portion of a surface of the transparent substrate (fig. 6B, ¶ 0051-¶ 0053) and a drug well layer (fig. 6B) which is formed on the electrode pattern and includes one or more drug wells with a shape that is recessed so as to face outward (fig. 6B),
wherein perforations are formed in the transparent substrate, and
wherein the electrode pattern covers the perforations (fig. 6B).
Regarding claim 10, Gutierrez discloses wherein the drug included in the drug well includes a drug for treating glaucoma or includes a drug carrier for releasing a drug and a drug-release-controlling material (¶ 0039).
Regarding claim 11¸ Gutierrez discloses an antenna configured to transmit and receive power and signals to and from the outside through induced current and electromagnetic resonance, wherein the antenna is formed on the transparent substrate (¶ 0043-¶ 0044, fig. 5). Gutierrez in view of Jow fail to disclose wherein the antenna is circular.
Jow further teaches (fig. 2A-2B) an antenna (240) that is circular (fig. 2A-2B), the circular antenna sharing a common plane with the substrate (¶ 0035).
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 antenna of Gutierrez in view of Jow such that it is circular, as taught by Jow, in order to configure the antenna to share a common plane with the substrate (Jow ¶ 0035).
Regarding claim 12, Gutierrez in view of Jow fail to disclose wherein the antenna includes at least one selected from the group consisting of metal thin film materials, zero-dimensional materials that are nanoparticles, one-dimensional nanomaterials that are nanowires, nanofibers, or nanotubes, and two-dimensional nanomaterials that are graphene, MOS2, or nanoflakes.
Jow further teaches wherein the antenna includes at least one selected from the group consisting of metal thin film materials, zero-dimensional materials that are nanoparticles, one-dimensional nanomaterials that are nanowires, nanofibers, or nanotubes, and two-dimensional nanomaterials that are graphene, MOS2, or nanoflakes (¶ 0021), wherein nanowires are suitable for being employed on a substrate (¶ 0021).
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 antenna of Gutierrez in view of Jow such that it antenna includes at least one selected from the group consisting of metal thin film materials, zero-dimensional materials that are nanoparticles, one-dimensional nanomaterials that are nanowires, nanofibers, or nanotubes, and two-dimensional nanomaterials that are graphene, MOS2, or nanoflakes, as taught by Jow, as nanowires are suitable for being employed on a substrate (Jow ¶ 0021).
Claims 13-14 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez in view of Jow, as applied to claim 1 above, and further in view of Ung et al. (KR 20170139300 A).
Regarding claim 13, Gutierrez in view of Jow disclose the wirelessly driven contact lens for monitoring intraocular pressure and treating glaucoma in a glaucoma patient according to claim 1, as discussed above in claim 1.
Gutierrez further discloses a method comprising: Forming a sacrificial layer ('plurality of controllable thin film seals 119a, 119b', fig.6B, ¶ 0050) soluble in water on a handling substrate;
Forming a transparent substrate (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.
Gutierrez in view of Jow fail to disclose 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 discloses 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", ¶ 0011).
Regarding claim 16, Gutierrez discloses 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", ¶ 0053); 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; ¶ 0052).
Regarding claim 17, Gutierrez discloses 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; ¶ 0052) covers the perforations (see 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 discloses the drug well layer (see fig.6B) including the drug wells. Gutierrez in view of Jow and further in view of Ung fail to disclose 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 method of Gutierrez in view of Jow and further in view of Ung 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 discloses 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", ¶ 0043; 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", ¶ 0044).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gutierrez in view of Jow and further in view of Ung, as applied to claim 13 above, and further in view of Hahn et al. (US 2020/0319479 A1).
Regarding claim 15, Gutierrez discloses the forming of the strain sensor (116) on the transparent substrate (112).
Gutierrez in view of Jow and further in view of Ung fail to disclose 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 further 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 method of Gutierrez in view of Jow and further in view of Ung such that it includes forming 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.
Gutierrez in view of Jow and further in view of Ung fail to disclose 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", ¶ 0091).
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 method of Gutierrez in view of Jow and further in view of Ung such that it includes 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 as taught by Hahn, such that a 3D surface can be masked utilizing biocompatible materials such that a foreign body sensation is less.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kamthan et al. (Pub. No.: US 2021/0353145 A1) discloses a sensor including nanowires. Hahn (Pub. No.: US 2018/0036974 A1) discloses a sensor including nanowires.
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 MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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/MEAGAN NGO/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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