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 .
The amendment filed on October 10, 2025 has been received and considered. By this amendment, claims 1, 3, 6, and 8 are amended, claim 2 is cancelled, claims 11 and 12 are added, and claims 1 and 3-12 are now pending in the application.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/10/2025 has/have been acknowledged and is/are being considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification is not found to be enabling for the limitations “A method of driving an electroceutical system to treat a disease”, “wherein the disease is a brain disease, a metabolic disease, an infection, an inflammatory disease” (claim 11) and “wherein the disease is Alzheimer's disease, Parkinson's disease, diabetes, obesity, hypertension, or arthritis” (claim 12). The specification fails to satisfy one or more of the Wands factors such that one of ordinary skill in the art is not enabled to make and/or use the invention. The nature of the invention is a method including a contact lens that emits light which is received by a light receiver, converted into an electric signal, and the electric signal is applied to stimulate a nerve, where the method is used to treat a disease. The specification fails to discuss specifically how the invention as claimed, which includes a contact lens comprising a light source, is used to treat the diseases required by claims 11 and 12. How is a system that includes a contact lens used to treat a brain disease, a metabolic disease, an infection, an inflammatory disease, Alzheimer's disease, Parkinson's disease, diabetes, obesity, hypertension, or arthritis? There is a distinction between treating a disease and treating symptoms of a disease. While it may be clear to one skilled in the art how to treat diabetic retinopathy using the device and method of the present application, one would not be enabled to treat diabetes. While the level of skill in the art is high, to include scientists, doctors, and biomedical engineers, the predictability of the art with respect to treating diseases using nerve stimulation with a contact lens device is quite low. One of ordinary skill in the art would require an extensive amount of experimentation to determine how to utilize the claimed invention to treat a disease through nerve stimulation, to include Alzheimer’s, Parkinson’s, diabetes, obesity, hypertension, arthritis, infections, inflammatory diabetes, and optic nerve diseases. The specification fails to provide any working examples, provides very little direction as to how to arrive at the claimed invention, and would require an extensive amount of experimentation to make and/or use the invention based on the content of the disclosure.
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.
Claims 1 and 3-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (U.S. Patent No. 10,117,740). Regarding claim 1, Lee discloses an electroceutical system comprising: a contact lens 110/210/310/410/510 comprising a light-emitting diode (LED) light source (see col. 4, ln. 23-28); and an electroceutical device 150/250/350/450/550, wherein, the electroceutical device comprises, a light receiver (“ the power could be transmitted as optical energy, e.g., from a light-emitting diode (LED) or other light-emitting element(s) of the contact lens to a photovoltaic cell or other light-receiving element(s) of the implanted device”, col. 4, ln. 24-28), a photoelectric element (“such properties of the eye-mountable device could be specified such that a beam of light emitted from the eye-mountable device is directed toward a power-receiving element (e.g., a photovoltaic cell) of the implanted device 150 when the eye-mountable device 110 is mounted to the eye 10.”, col. 8, ln. 46-51), an electrode for optic nerve stimulation (“one or more further elements implanted on or within the eye, e.g., to an array of stimulating electrode disposed on the retina”, col. 14, ln. 36-38), the photoelectric element converts light emitted from the LED light source into an electric signal, the electrode is configured to be connected to sub-retinal optic nerve tissue to stimulate the nerve with an electric current generated in the photoelectric element (see Figures 1c and 6, col. 4, ln. 23-28, col. 8, ln. 46-51, col. 9, ln. 61-67, col. 11, ln. 1-24, and col. 11, ln. 40-col. 12, ln. 27).
Regarding claim 3, Lee discloses that the contact lens is made from one or more selected from the group consisting of silicone elastomers; silicone hydrogels; polydimethylsiloxane (PDMS); poly(2-hydroxyethylmethacrylate) (PHEMA); and poly(ethylene glycol) methacrylate (PEGMA) (see col. 4, ln. 65-col. 5, ln. 7).
Regarding claim 4, Lee discloses that the LED light source is formed on a transparent substrate, and the transparent substrate contains one or more selected from the group consisting of Parylene C, PDMS, silicone elastomers, polyethylene terephthalate (PET), and polyimide (PI) (see col. 4, ln. 65-col. 5, ln. 7).
Regarding claim 5, Lee discloses that the contact lens further comprises one or more selected from the group consisting of an application-specific integrated circuit (see col. 17, ln. 24), an antenna (see col. 4, ln. 20), and a battery (see Abstract).
Regarding claim 6, it is respectfully submitted that the recitation “a bump located on a line extending from an electrode of the photoelectric element is configured to connect to the optic nerve tissue” fails to further define the electroceutical system over that of the prior art because it fails to include any additional elements to the system. The bump is not recited as being part of the system.
Regarding claim 7, Lee discloses smart glasses, wherein the electroceutical system is driven through an electrical signal transmitted from the smart glasses (see Figure 5 and col. 17, ln. 39-62).
Regarding claim 8, Lee discloses a method of driving an electroceutical system to treat a disease, the method comprising: causing a light-emitting diode (LED) light source in a contact lens to emit light to an electroceutical device within a predetermined time period (see col. 4, ln. 23-28); and causing a photoelectric element of the electroceutical device to convert the emitted light into an electric signal, generate an electric current, such that the electric current could stimulate an optic nerve, the electroceutical device comprises, a light receiver (“the power could be transmitted as optical energy, e.g., from a light-emitting diode (LED) or other light-emitting element(s) of the contact lens to a photovoltaic cell or other light-receiving element(s) of the implanted device”, col. 4, ln. 24-28), a photoelectric element (“such properties of the eye-mountable device could be specified such that a beam of light emitted from the eye-mountable device is directed toward a power-receiving element (e.g., a photovoltaic cell) of the implanted device 150 when the eye-mountable device 110 is mounted to the eye 10.”, col. 8, ln. 46-51), an electrode for optic nerve stimulation (“one or more further elements implanted on or within the eye, e.g., to an array of stimulating electrode disposed on the retina”, col. 14, ln. 36-38), the photoelectric element converts light emitted from the LED light source into an electric signal, the electrode is configured to be connected to sub-retinal optic nerve tissue to stimulate the nerve with an electric current generated in the photoelectric element (see Figure 6, col. 4, ln. 23-28, col. 8, ln. 46-51, col. 9, ln. 61-67, col. 11, ln. 1-24, and col. 11, ln. 40-col. 12, ln. 27).
Regarding claim 9, Lee discloses that the driving of the LED light source in the contact lens is controlled by an application-specific integrated circuit (see col. 17, ln. 24).
Regarding claim 10, Lee discloses that the electroceutical system further comprises smart glasses, wireless power generated in a wireless electric coil of the smart glasses is received by an antenna of the contact lens, and power received through control of an application-specific integrated circuit is used for driving the LED light source (see Figure 5 and col. 17, ln. 39-62).
Regarding claim 11, Lee discloses that the disease is a brain disease, a metabolic disease, an infection, an inflammatory disease, or an optic nerve disease (“an intraocular device implanted within the eye (e.g., a retinal implant configured to stimulate the retina to restore vision”, col. 1, ln. 35-37).
Response to Arguments
Applicant's arguments filed October 10, 2025 have been fully considered but they are not persuasive. Regarding the rejection of the claims under 35 USC 112(a) as failing to comply with the enablement requirement, the Applicant submits evidence of the state of the art that support the correlation between light and/or nerve stimulation and diseases. However, the Applicant fails to tie this “state of the art” back to Applicant’s disclosure and claims. A few examples, Applicant cites Johnstone et al. and the disclosure of “Here we propose NIr therapy as a neuroprotective or disease-modifying treatment for Alzheimer’s and Parkinson’s patients.” However, Applicant’s invention does not apply NIr therapy, so this disclosure does not seem particularly relevant in showing that one skilled in the art could make and use Applicant’s invention. Applicant’s citation of Danilenko et al. and the disclosure “Morning bright light treatment reduces body fat and appetite in overweight women” does not seem particular relevant to an electroceutical device including contact lens with an LED. Applicant’s citation of AbuBakr et al. and the disclosure of “Low-level laser therapy is a treatment modality that has been used as an alternative to the traditional [corticosteroid] treatment” and “Both laser and cortisone showed reparative and formative effects, as evidenced by the increases in the proteoglycan content. However, [low-level laser] was superior in its anti-apoptotic effects” does not seem particular relevant because Applicant’s invention does not provide laser therapy, and the laser therapy applied by AbuBakr is applied to the temporomandibular joint of mice and not to an eye, as in the present invention. For at least the reasons given above, the rejection as it applies to the amended claims stands.
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 TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796