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
Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 13th, 2025.
Applicant’s election without traverse of Invention I (Claims 1-10) in the reply filed on October 13th, 2025 is acknowledged.
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 5 and 7-8 are objected to because of the following informalities:
Claim 5 currently recites “elastomer, polyethylene PET” in line 3, but should read “elastomer, PET”
Claim 7 currently recites “holes are formed” in line 6, but should read “holes formed”
Claim 7 currently recites “the electrode pattern surrounds the holes” in line 7, but should read “wherein the electrode pattern surrounds the holes”, “the electrode pattern surrounding the holes”, or something of the like
Claim 8 currently recites “wherein drug contained in the drug well is drug capable of treating glaucoma” in lines 1-2, but should read “wherein a drug contained in the one or more drug wells is a drug capable of treating glaucoma”, “wherein each drug well contains a drug capable of treating glaucoma”, or something of the like
Appropriate correction is required.
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.
Claims 2, 4-5, and 7-10 are 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 claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim 2 recites “wherein the contact lens is based on” in line 1. It is unclear as to what this limitation entails. Examiner will interpret the limitation “wherein the contact lens is based on one or more” as “wherein the contact lens is composed of one or more materials” for examination purposes.
Claim 4 recites “a gold hollow nanowire layer” in line 3. It is unclear as to whether this limitation is referring to the previously introduced “gold hollow nanowires” from line 4 of Claim 1, or a separate element.
Claim 4 recites the limitation “the transparent substrate” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the transparent substrate” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “one or more drug wells formed to be inserted toward the outside” in lines 4-5. It is unclear as to what exactly this limitation entails, as there seem to be grammatical and/or idiomatic errors present. Clarification is requested.
Claim 7 recites the limitation “the outside” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites “holes” in line 6. It is unclear as to whether these “holes” are supposed to serve as the “one or more drug wells” previously introduced in lines 4-5, or if they are referring to a completely separate element. Clarification is requested.
Claim 9 recites the limitation “the outside” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation “the transparent substrate” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the transparent substrate” in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 6-7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hahn et al (KR20200106582A; the machine translation, provided herewith, is referred to below) in view of Siddique et al (U.S. Publication No. 2021/0223571 A1) and NPL Sun et al (Sun, Y., Mayers, B., & Xia, Y. (2003). Metal nanostructures with hollow interiors. Advanced Materials, 15(7‐8), 641-646.).
Regarding Claim 1, Hahn teaches a contact lens for measuring intraocular pressure or treating glaucoma in glaucoma patients the contact lens (Smart Contact Lens for Intraocular Pressure Monitoring and Therapy; Abstract) comprising an intraocular pressure sensor (strain sensor) and a drug reservoir (drug reservoir), wherein the intraocular pressure sensor includes nanowires (the strain sensor includes a nanomaterial layer formed on a transparent substrate…the nanomaterial may include silver (Ag), and more specifically, may be silver nanowires (Ag NW); [0046-0047]) and measures a change in curvature of an eyeball caused by a change in intraocular pressure (The strain sensor measures the change in the curvature of the eyeball due to the change in intraocular pressure; [0037]).
Hahn fails to teach wherein the nanowires are gold.
In a similar technical field, Siddique teaches a smart contact lens (Abstract), comprising gold nanowires (Connector 103 may be a nanowire and may connect sensor layer 102 to smart module 104, or may connect smart module 104 to additional smart modules (not shown). In another embodiment, connector 103 may be part of smart module 104 or sensor layer 102. Connector 103 may be a metal such as gold; [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the gold teachings of Siddique into the invention of Hahn due to its high biocompatibility, corrosion resistance, and excellent electrical conductivity.
Hahn and Siddique fail to teach wherein the nanowires are hollow.
In a similar technical field, NPL Sun teaches wherein the nanowires are hollow (nanostructures with hollow interiors; Pages 641-645).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the hollow interior teachings of NPL Sun into those of Hahn and Siddique as nanostructures with hollow interiors offer advantages over their solid counterparts in terms of being lighter weight, saving material, reduction in cost, and their usefulness in drug delivery and release purposes (NPL Sun Page 641).
Regarding Claim 2, Hahn teaches wherein the contact lens is based on one or more selected from a group consisting of an elastomer such as a silicone elastomer, silicone hydrogel, and polymer hydrogel such as poly(2-hydroxyethyl methacrylate) (PHEMA), polyvinylpyrrolidone (PVP), poly(lactic acid-glycolic acid) (PLGA), or polyvinyl alcohol (PVA) (The wirelessly driven contact lens of the present invention comprises an elastomer of a silicone elastomer; Silicone hydrogel; And a polymer hydrogel of poly(2-hydroxyethyl methacrylate) (PHEMA), polyvinylpyrrolidone (PVP), poly(lactic acid-glycolic acid) (PLGA) or polyvinyl alcohol (PVA); It may be based on one or more polymers selected from; [0042]).
Regarding Claim 3, Hahn teaches wherein the intraocular pressure sensor and the drug reservoir are formed on a transparent substrate (a transparent substrate is formed inside the wireless driving contact lens, and a strain sensor and a drug reservoir are formed on the transparent substrate; [0043]), and the transparent substrate includes one or more selected from a group consisting of parylene C polydimethyloxane (PDMS), a silicone elastomer, polyethylene terephthalate (PET), and polyimide (PI) (The transparent substrate has excellent light transmittance, flexibility and flexibility, and excellent biocompatibility. Such a transparent substrate may include one or more selected from the group consisting of Parylene C PDMS, silicone elastomer, polyethylene terephthalate (PET), and polyimide (PI); [0044]).
Regarding Claim 6, Hahn teaches wherein the intraocular pressure sensor has a circular structure or a straight-line structure and entirely or partially surrounds a cornea of the eyeball (the structure of the strain sensor is not particularly limited, and may include a circle or a straight line. Specifically, the strain sensor may have a structure that entirely or partially surrounds the cornea of the eyeball; [0049]).
Regarding Claim 7, Hahn teaches wherein the drug reservoir includes: an electrode pattern containing gold formed on a portion of a surface of the transparent substrate; and a drug well layer formed on the electrode pattern and including one or more drug wells formed to be inserted toward the outside, holes are formed in the transparent substrate, and the electrode pattern surrounds the holes (the drug reservoir includes an electrode pattern including gold formed on a partial surface of the transparent substrate; And a drug well layer formed on the electrode pattern and including one or more drug wells in a shape drawn toward the outside. In this case, a perforation may be formed in the transparent substrate, and the electrode pattern may surround the perforation; [0051]).
Regarding Claim 9, Hahn teaches a circular antenna configured to transmit or receive power and signals to or from the outside through induced current and electromagnetic resonance (an antenna may be additionally formed on the transparent substrate…the antenna may transmit and receive power and signals to the outside through induced current and electromagnetic resonance…the antenna may be a circular antenna having a circular structure; [0053-0055]), wherein the circular antenna is formed on the transparent substrate (a circular antenna for transmitting and receiving power and signals to the outside through induced current and electromagnetic resonance, the circular antenna is formed on a transparent substrate to measure intraocular pressure of a glaucoma patient or a wireless driving contact lens for glaucoma treatment; Claim 11).
Regarding Claim 10, Hahn teaches an application specific integrated circuit (ASIC) chip, wherein the ASIC chip is formed on the transparent substrate (the strain sensor and the drug reservoir may be connected to an ASIC chip to enable wireless communication. The strain sensor and drug storage can be driven by receiving electrical signals transmitted from an external system through an ASIC chip, and the result detected by the strain sensor is transmitted to an external system to store and process data, and a drug delivery system the drive of the can be adjusted; [0097]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Hahn, Siddique, and NPL Sun as applied to claim 1 above, and further in view of Lamrani et al (U.S. Publication No. 2019/0282094).
Regarding Claim 4, Hahn teaches wherein the intraocular pressure sensor includes a nanowire layer formed on the transparent substrate (the strain sensor includes a nanomaterial layer formed on a transparent substrate; [0046]); and a passivation layer formed on the nanowire layer (a passivation layer formed on the nanomaterial layer; [0046]).
Hahn fails to teach wherein the nanowires are gold.
In a similar technical field, Siddique teaches a smart contact lens (Abstract), comprising gold nanowires (Connector 103 may be a nanowire and may connect sensor layer 102 to smart module 104, or may connect smart module 104 to additional smart modules (not shown). In another embodiment, connector 103 may be part of smart module 104 or sensor layer 102. Connector 103 may be a metal such as gold; [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the gold teachings of Siddique into the invention of Hahn due to its high biocompatibility, corrosion resistance, and excellent electrical conductivity.
Hahn and Siddique fail to teach wherein the nanowires are hollow.
In a similar technical field, NPL Sun teaches wherein the nanowires are hollow (nanostructures with hollow interiors; Pages 641-645).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the hollow interior teachings of NPL Sun into those of Hahn and Siddique as nanostructures with hollow interiors offer advantages over their solid counterparts in terms of being lighter weight, saving material, reduction in cost, and their usefulness in drug delivery and release purposes (NPL Sun Page 641).
Hahn, Siddique, and NPL Sun fail to teach a D-poly(3,4-ethylenedioxythiophene) (D-PEDOT) layer formed on the nanowire layer; and wherein a passivation layer is formed on the D-PEDOT layer.
In a similar technical field, Lamrani teaches a wireless smart contact lens for intraocular pressure measurement (Abstract), comprising a D-poly(3,4-ethylenedioxythiophene) (D-PEDOT) layer formed on the nanowire layer (One or more of the conductive layers can include a polymer, a metal, a microcomposite material, a nanocomposite material, any appropriate material, or combinations thereof. For example, the conductive layers can be transparent polymer layers and can include, for example, poly(3,4-ethylenedioxythiophene) polystyrene sulfonate; [0056]); and wherein a passivation layer is formed on the D-PEDOT layer (The dielectric layer can be a transparent polymer layer and can include, for example, polydimethylsiloxane; [0056]; Examiner’s Note: the passivation layer can be composed of PDMS).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the D-poly(3,4-ethylenedioxythiophene) teachings of Lamrani into those of Hahn, Siddique, and NPL Sun as D-poly(3,4-ethylenedioxythiophene) offers high electrical conductivity, excellent optical transparency, and good chemical and thermal stability, making it useful in flexible electronics and biosensors.
Regarding Claim 5, Hahn teaches wherein the passivation layer includes one or more selected from a group consisting of thermoplastic polyurethane (TPU), parylene C PDMS, a silicone elastomer, polyethylene PET, and PI (the passivation layer is excellent in elasticity and flexibility, and may contain a component having biocompatibility, and specifically, Parylene C PDMS, silicone elastomer, polyethylene terephthalate (PET), and polyimide It may include one or more selected from the group consisting of (PI); [0048]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hahn, Siddique, and NPL Sun as applied to claim 7 above, and further in view of Gutierrez (U.S. Publication No. 2019/0380871; cited by Applicant).
Regarding Claim 8, Hahn teaches wherein drug contained in the drug well is drug capable of treating glaucoma (The degree of drug release was measured by loading a drug (timolol or latanoprost) into a drug reservoir in the contact lens prepared in Preparation Example 3; [0140]).
Hahn, Siddique, and NPL Sun fail to disclose wherein the drug is made in a form of powder.
In a similar technical field, Gutierrez teaches eye-mountable therapeutic devices, and associated systems and methods (Abstract), wherein the drug is made in a form of powder (The reservoirs 118 a, 118 b can be compatible with various physical forms of drug including aqueous solutions, gel, suspensions, microemulsions, nanoparticles, liposomes, dry (powder) or combinations thereof; [0050]; Other formulations such as beta-blockers (e.g., betaxolol and timolol maleate) are formulated as salts with onset of action generally noted within about 30 minutes and the maximum effect can usually be detected about 2 hours after topical administration; [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the powder teachings of Gutierrez into those of Hahn, Siddique, and NPL Sun in order to enable the reservoirs to be compatible with various physical forms of drug including aqueous solutions, gel, suspensions, microemulsions, nanoparticles, liposomes, dry (powder) or combinations thereof, to 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 (Gutierrez [0050]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J JHIN whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J JHIN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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