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 Arguments
1. Applicant’s arguments and amendments, filed 11/24/2025, with respect to the rejection(s) of claim(s) under 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 Therefore, the rejection has been withdrawn.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 Ackermann (US 20120130398 A1).
Regarding the amendment “configured for directing stimulation from underneath an eyelid of the patient into a conjunctiva of the patient to stimulate”, the art of Glasser would teach this limitation. Glasser teaches an eye stimulation device that is configured as a contact lens to be placed on the eye. This configuration would allow stimulation to be directed from under the eyelid to into a conjunctiva. Further, this amendment is considered intended use. Intended use/functional language does not require that reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
2. Claim(s) 1-2, 3-5, 9-12, 21-24, and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mowery (US 20190143116 A1) in view of Ackermann (US 20120130398 A1) and in further view of Glasser (US 20140371565 A1).
In regards to claim 1, 21, and 22, Mowery discloses a device configured to be worn on an eye of a patient for stimulating nerves in and around a patient's eye (Abstract discloses a device for stimulating the nerves of the eye), the device comprising:
an annular body (Fig 3A-3B and Par. 0105 teach embodiments wherein the device is circular, i.e. annular); and
the device comprising:
a substrate comprising an electronic circuitry portion and one or more electrode portions (Par. 0068 teaches that there is a substrate [112] that extends over the surface [see also Fig 1A-B and G] with electrodes [111] and circuitry/microprocessor [160/161]);
electronic circuitry attached to the electronic circuitry portion of the substrate (Fig 1B and 1G show the circuitry/microprocessor [161] being attached to the substrate [112]); and
one or more electrodes bonded to the substrate at the one or more electrode portions and electrically coupled to the electronic circuitry (Fig 1B and 1G show the electrodes [111] bonded to the substrate [112] and attached to the circuitry/microprocessor [161]),
wherein an orientation around the annular body of each of the one or more electrodes is based on a position on the substrate of a respective electrode portion of the one or more electrode portions (the electrodes are disposed on the substrate so it would be inherent that if the substrate orientation moves, so would the electrodes).
While Mowery does disclose the device comprising the substrate, electrodes, and circuitry (microprocessor), they do not teach wherein these elements are mounted on a flex circuit or wherein the one or more electrodes being separated from the position of the electronic circuitry on the substrate by an angular distance along the annular body and relative to the central axis, the one or more electrodes being electrically coupled to the electronic circuitry by one or more electrical leads extending the angular distance along the annular body.
However, in the same field of endeavor, Ackermann teaches a stimulation device for the eye (Abstract) wherein the device has a flex substrate for holding the circuity/control components (Par. 0101) and wherein the electrodes [113] are separated from the circuity [172] and connected via a lead [111] to the circuitry (Par. 0007 and 0104 and Fig 4a-b) in order to stimulate different anatomical targets using different combinations of electrodes (Par. 0104).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Mowery and modified them by having the device comprise a flex circuit as well as have the electrodes connected via a lead, as taught and suggested by Ackermann, in order to stimulate different anatomical targets using different combinations of electrodes (Par. 0104 of Ackermann)
The combined teachings of Mowery and Ackermann do not disclose wherein the stimulation device is placed directly on the surface of the eyeball without extending over the iris and stimulates the surface of the eyeball, configured for directing stimulation from underneath an eyelid of the patient into a conjunctiva of the patient to stimulate (While Mowery teaches the stimulation device placed on the retinal portion of the eyeball, they do not necessarily teach it being placed on the surface of the eyeball without extending over the iris).
However, in the same field of endeavor, Glasser teaches an eye stimulation device (Abstract) wherein the stimulation embodiment is formed in a ring shape (See Fig 3) and is adapted to directly contact the eyeball, being positioned between the eyelid and the eyeball (Par. 0054; per the Applicant’s drawings and specification, the iris is avoided by having a ring-shaped stimulation system with no inner portion. This is shown and taught by Glasser. Par. 0014 and 0060 traches the device can be shaped as a contact lens and exist between the eyelid and the eyeball, a contact lens would be configured to direct stimulation from under the eyelid to the conjunctiva) in order to deliver electrostimulation in a non-invasive fashion
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Mowery and Ackermann and modified them by having the device comprise a ring shape that contacts the eyeball directly, as taught and suggested by Glasser, in order to deliver electrostimulation in a non-invasive fashion.
In regards to claim 2, the combined teachings of Mowery, Ackermann, and Glasser disclose the device of claim 1, wherein one or more of the electrodes are bonded to the electronic circuitry portion of the substrate (Par. 0101 of Ackermann teaches a substrate – see above rejection).
In regards to claims 3-5, the combined teachings of Mowery, Ackermann, and Glasser disclose the device of claim 1, except for wherein the annular body comprises a toroidal shape such that a first electrode is positioned on an inward-facing portion of the toroidal shape, and wherein a second electrode is positioned on an outward-facing portion of the toroidal shape and wherein there is tubular circumference with electrodes on different surfaces
However, Glasser does go on to teach that stimulation embodiment is annular with a circumference (See Fig 3) and there is an outer and inner ring, each with their own electrode (Par. 0013-0014) in order to contact all portions of the contact region.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Mowery, Ackermann, and Glasser and modified them by having the device use an annular circumference, as further taught by Glasser, in order to contact all portions of the contact region.
In regards to claim 9-10, the combined teachings of Mowery, Ackermann, and Glasser disclose the device of claim 1, except for where each of the one or more electrodes comprise a conductive film deposited on the substrate, and wherein each of the one or more electrodes comprises a metallic foil bonded to the substrate.
However, Ackermann does go on to disclose that there are conductive metal layers on the substrate (Par. 0112 and 0134) in order to allow for efficient electrical flow. Therefore, it would have been obvious to further modify the teachings to have a metal conductive layer, as further taught by Ackermann, in order to allow for efficient electrical flow.
In regards to claim 11, the combined teachings of Mowery, Ackermann, and Glasser disclose the device of claim 1, where the substrate is attached to the annular body to define a circumferential path, and wherein a first electrode and a second electrode are misaligned with respect to the circumferential path (Fig 3a of Mowery shows the electrodes [111] along the annular body and misaligned with respect to the path)
In regards to claim 12, the combined teachings of Mowery, Ackermann, and Glasser disclose the device of claim 1, wherein the flex circuit comprises: a first electrode is mounted at a first electrode portion of the substrate, the first electrode portion corresponding to a first angular position around the annular body; and a second electrode is mounted at a different second electrode portion of the substrate, the second electrode portion corresponding to a second angular position around the annular body (Fig 3A of Mowery shows the electrodes on the top portion over the eye which are the first angular positioned and the electrodes on the bottom potion under the eye are the second angular positioned electrodes),
wherein the annular body comprises a filament comprising an annular shape (Par. 0076 or Mowery teaches cables or fibers, i.e. filaments, which are also annular).
In regards to claim 23-24, the combined teachings of Mowery, Ackermann, and Glasser disclose the device of claim 21, wherein the substrate comprises: an elongate portion; a first electrode portion corresponding to a first widened portion; and a second electrode portion corresponding to a second widened portion spaced from the first widened portion, wherein the elongate portion extends between the first widened portion and the second widened portion, and wherein a first electrode is disposed on the first widened portion, and a second electrode is disposed on the second widened portion, wherein the first widened portion and the second widened portion comprise a width, and wherein the width is less than a tubular circumference of the annular body (Fig 1B of Mowery and 3 of Glasser shows there being a top and bottom portions having first and second electrodes [111] disposed on widened potions that have widths)
In regards to claim 27 the combined teachings of Mowery, Ackermann, and Glasser disclose the device of claim 21, further comprising a housing, wherein the electronic circuitry is contained within the housing, wherein the housing projects inward toward a center of the annular body, and wherein the device comprises a circular outer profile (Par. 0012 of Mowery discloses that the electronics are within a housing).
In regards to claim 28 the combined teachings of Mowery, Ackermann, and Glasser disclose the method for stimulating the nerves in or around the eyeball of the patient of claim 22, further comprising wirelessly connecting a remote-control device to the device, the remote-control device being configured to actuate the one or more electrodes (Par. 0068 of Mowery discloses wireless control).
3. Claim(s) 6 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mowery, Ackermann, and Glasser in view of Mullins (US 20200391029 A1).
In regards to claim 6 and 25, the combined teachings of Mowery, Ackermann, and Glasser disclose the device of claim 1 and 21, except for the device further comprising an antenna extending along the annular body, where the antenna is configured to receive electromagnetic energy and provide an electrical current to the one or more electrodes.
However, in the same field of endeavor, Mullins teaches an electrode powered treatment device applied to the eye (Abstract) wherein the device comprises an antenna (Par. 0143) in order to drive the circuitry and power the corresponding circuit.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Mowery, Ackermann, and Glasser and modified them by having the device comprise an antenna, as taught and suggested by Mullins, in order to drive the circuitry and power the corresponding circuit (Par. 0143 of Mullins)
4. Claim(s) 7, 8, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mowery, Ackermann, and Glasser in view of Neysmith (US 20080288037 A1)
In regards to claim 7 and 26, the combined teachings of Mowery, Ackermann, Glasser and Mullins disclose the device of claim 6 and 25, except for where the flex circuit comprises: a first conductive trace disposed in the substrate, wherein the first conductive trace electrically couples the electronic circuitry to at least one of the one or more electrodes; and a second conductive trace disposed in the substrate, wherein the second conductive trace electrically couples the antenna to the electronic circuitry.
However, in the same field of endeavor, Neysmith teaches a stimulation device for the eye (Abstract) wherein there are several conductive traces thoughout the device (Par. 0150 and 0157-0160) in order to increase the conducting intensity (Par. 0157).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Mowery, Ackermann, and Glasser and modified them by having the system include multiple traces, as taught and suggested by Neysmith, in order to increase the conducting intensity (Par. 0157 of Neysmith).
In regards to claim 8, the combined teachings of Mowery, Ackermann, and Glasser disclose the device of claim 1, except for it further comprising a tubing positioned over the flex circuit, wherein the tubing comprises one or more openings, wherein each of the one or more openings are positioned over each of the one or more electrodes such that the one or more electrodes are exposed through the one or more openings.
However, in the same field of endeavor, Neysmith discloses an eye stimulation device (Abstract) wherein the system has tubing with openings for the electrodes (Par. 0109-0110 and 114) in order to provide a protective sleeve or coating (Par. 0110)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have taken the teachings of Mowery, Ackermann, and Glasser and modified them by having the system include tubing, as taught and suggested by Neysmith, in order to provide a protective sleeve or coating (Par. 0110 of Neysmith)
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.
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/S.L.C./Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796