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 .
Priority
Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), based on an application filed in Taiwan on 11/20/2024. The Applicant has filed a certified copy of the TW113144551 application as required by 37 CFR 1.55, which has been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/29/2026 and 9/2/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 01/08/2025 are accepted to by the Examiner.
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.
Claims 1 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (US 2019/0060602) in view of Ackermann et al. (US 2019/0290922).
Regarding claim 1, Tran teaches a contact lens (refer to US 2019/0060602; FIG. 16A illustrates a microstimulator implemented with a contact lens, [0076], contact lens 11, [0112], Fig. 1D), comprising: a glasses body configured to be worn on an eyeball (device 100 of the present disclosure may be a contact lens, patient's eye 110; Fig. 2A, [0173]; Fig. 16A, 17; lacrimal gland 10. When stimulated by one or more signals, tears may be produced under upper eye lid 20 and may travel over an iris 200 of the patient's eye assembly. [0164]; active optical layer 100 is aligned by treated surface layers 101… The electrical stimulus is applied to the electrically active optical layer 100 via optically transparent, conductive Indium Tin Oxide (ITO) .. standard glass substrate is the ITO, [0304]), wherein the glasses body includes an optical portion (optical zone 175, [0174]) and a circular wearing portion (Fig. 1D shows contact lens 11 is formed on a circular transparent substrate 12, [0112]), the optical portion is surrounded by the circular wearing portion (Figs. 1D and 2A, optical zone 175 is surrounded by the circular wearing portion, [0174]), and the circular wearing portion has a lower eyelid layout region in a C-shape (Figs. 1D and 2A; ophthalmic device 11 has a lower eyelid layout region is a C-shaped lower region); and an electronic component disposed on the glasses body (see Figs. 1D and 2A), wherein the electronic component is configured to move with the eyeball through the glasses body (electronic component: display drive circuit 16 to refresh pixels in the display 17, [0119]; energy transfer antenna 20, Fig. 1D; Fig. 2A, elements 105, including electronic and electromechanical elements, [0174], Fig. 2A), and the electronic component includes: a stimulation unit (electrical stimulus is applied to the electrically active optical layer 100, [0304]). and a power supply unit electrically coupled to the stimulation unit (radio frequency (RF) power supply 14 powers the active contact lens 11 through a base antenna, [0116]).
Tran doesn’t explicitly teach an electrode module arranged in the lower eyelid layout region, wherein the electrode module is configured to contact a body fluid around the eyeball; and a boost control module electrically coupled to the electrode module, wherein the boost control module is configured to emit a pulse voltage signal through the electrode module, and the pulse voltage signal is conducted by the body fluid to a lower eyelid located on a side of the eyeball; and a power supply unit electrically coupled to the stimulation unit. The circular wearing portion has a lower eyelid layout region in a C-shape.
Tran and Ackermann are related as contact lens.
Ackermann teaches a stimulation unit (one or more stimulation electrodes, [0160]) including: an electrode module arranged in the lower eyelid layout region (contact lens positioned over an iris 200 and having electrodes 113., [0161]; electrodes 113 maybe positioned at the outer edge 204 of the contact lens. The device contains two or more electrodes 113 and delivers electrical current to the surface of the eye in order to activate affluent flows, Activation of these fibers results in reflex lacrimation. A patient's upper eyelid 20 and lower eye lid 22 may both close over the contact lens, [0162]; contact lens stimulator may have a battery/energy storage unit. The stimulator may be powered by a magnet placed within the eyelids, [0163]) arranged in the lower eyelid layout region, wherein the electrode module is configured to contact a body fluid around the eyeball (one or more stimulation electrodes may be positioned adjacent to or in the lacrimal gland. Stimulation may be applied to the lacrimal gland, wherein the one or more electrodes are electrically coupled to a pulse generator. The pulse generator may be implantable in proximity to the one or more stimulation electrodes, to the temporal bone, in the subclavicular pocket, and in a subcutaneous abdominal pocket. A controller may be positioned in proximity to the pulse generator, [0160], Fig. 16A shows electrodes 113 positioned at the outer edge 204 of the contact lens arranged in the lower eyelid layout region, [0162]); and a boost control module electrically coupled to the electrode module, wherein the boost control module is configured to emit a pulse voltage signal through the electrode module, and the pulse voltage signal is conducted by the body fluid to a lower eyelid located on a side of the eyeball; and a power supply unit electrically coupled to the stimulation unit (The microstimulator may be fully implanted within the orbit of the eye. The one or more electrodes are electrically coupled to a pulse generator, which may be implantable. The pulse generator may be implantable in proximity to the one or more stimulation electrodes. The pulse generator may be implantable in proximity to the temporal bone, a subclavicular pocket, and a subcutaneous abdominal pocket. The method may further include positioning a controller in proximity to the pulse generator, [0015]; Battery 170 may provide power to microstimulator 168. Microstimulator 168 may receive power from battery 170, generate a signal, and transmit the signal over leads to electrodes 113, [0107]; FIG. 16A illustrates a microstimulator implemented with a contact lens. The embodiment of FIG. 16A includes a contact lens positioned over an iris 200 and having electrodes 113. The contact lens stimulator is in contact with the cornea, and its inner surface conforms to the shape of the cornea and/or the conjunctiva, [0161]; one or more electrodes 113 maybe positioned at the outer edge 204 of the contact lens. The device contains two or more electrodes 113 and delivers electrical current to the surface of the eye in order to activate affluent flows. Activation of these fibers results in reflex lacrimation. A patient's upper eyelid 20 and lower eye lid 22 may both close over the contact lens, [0162]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the contact lens of Trans to include an electrode module arranged in the lower eyelid layout region, wherein the electrode module is configured to contact a body fluid around the eyeball; and a boost control module electrically coupled to the electrode module, wherein the boost control module is configured to emit a pulse voltage signal through the electrode module, and the pulse voltage signal is conducted by the body fluid to a lower eyelid located on a side of the eyeball; and a power supply unit electrically coupled to the stimulation unit. The circular wearing portion has a lower eyelid layout region in a C-shape, as taught by Ackermann for the predictable advantage of treating dry eye by stimulating one or more nerves that innervate lacrimal gland tissue includes implanting a microstimulator adjacent to the lacrimal gland and applying stimulation to the lacrimal gland and the microstimulator may be fully implanted within the orbit of the eye, as taught by Ackermann in [0009].
Regarding claim 7, the modified Trans teaches the contact lens according to claim 1 (see above), Ackermann teaches, wherein the electrode module includes two coils, and the two coils are respectively arranged on two sides of the boost control module, (microstimulator may include a coil, [0016]; microstimulator may further include a second coil, a second rectifying and tuning circuit, [0019], FIG. 16B is an enlarged view of inductive coils for use with the microstimulator of FIG. 16A. [0077], see [0119-0120] and [Figs. 9K,M]).
Regarding claim 8, the modified Trans teaches the contact lens according to claim 1 (see above), Ackermann teaches, wherein the electrode module includes a plurality of electrode pads spaced apart from each other, and the boost control module is configured to separately emit the pulse voltage signal through the electrode pads. (Microstimulator 120 of FIG. 9E may include four electrodes separated by a body segments. The electrodes may be implemented as part of a pulse generation circuit for stimulating one or more anatomical targets, [0132], here each electrode corresponds to an electrode pad).
Regarding claim 9, the modified Trans teaches the contact lens according to claim 1 (see above), wherein the electronic component is covered by the glasses body (Fig. 2A shows the electronic elements 105 is covered by the glasses body in device 100) , and the glasses body includes a plurality of micro-pore structures; wherein the micro-pore structures correspond in position to the lower eyelid layout region, and the micro-pore structures penetrate the circular wearing portion, so that the body fluid is configured to pass through the micro-pore structures and contact the electrode module (insert 150 can be used and can be fully encapsulated to protect and contain the electronic components, the encapsulating material may be semi-permeable, for example, to prevent specific substances, such as water, from entering the media insert and to allow specific substances, such as ambient gasses, fluid samples, and/or the byproducts of reactions within energization elements, to penetrate and/or escape from the media insert, [0176]; here semipermeable means letting some small bits or water pass through while blocking bigger parts. It acts like a very tiny strainer for liquids and gases. Ackermann teaches one or more electrodes 113 maybe positioned at the outer edge 204 of the contact lens. The device contains two or more electrodes 113 and delivers electrical current to the surface of the eye in order to activate affluent flows. Activation of these fibers results in reflex lacrimation. A patient's upper eyelid 20 and lower eye lid 22 may both close over the contact lens, [0162]).
Regarding claim 10, the modified Trans teaches the contact lens according to claim 1 (see above), wherein the electronic component is covered by the glasses body, and the glasses body includes a hollow portion; wherein the hollow portion is disposed in the lower eyelid layout region of the circular wearing portion, and the electrode module is configured to be exposed to an outside of the glasses body through the hollow portion and contact the body fluid (insert 150 can be used and can be fully encapsulated to protect and contain the electronic components, the encapsulating material may be semi-permeable, for example, to prevent specific substances, such as water, from entering the media insert and to allow specific substances, such as ambient gasses, fluid samples, and/or the byproducts of reactions within energization elements, to penetrate and/or escape from the media insert, [0176]; here semipermeable means letting some small bits or water pass through while blocking bigger parts. It acts like a very tiny strainer for liquids and gases. a microstimulator may include a coil, a housing, and a pair of electrodes. The coil may be formed from a wire having a length turned into a plurality of windings and responsive to an induced field to produce an output signal. The microstimulator may be electrically coupled to receive the output from the coil and produce a signal responsive to the output. The housing may encompass the circuit and the coil, and may be adapted and configured for placement within an orbit and adjacent an eye within the orbit. The pair of electrodes may extend from the housing and be configured to receive the signal, [0016])
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. in view of Ackermann et al. as applied to claim 1 and further in view of Lee et al. (US 2023/0011432).
Regarding claim 2, the modified Trans teaches the contact lens according to claim 1 (see above), Ackermann further teaches, wherein the electrode module includes two fingertip electrodes, (FIG. 4B is an enlarged view of the stimulation system components of FIG. 4A near the eye of the patient. The stimulation system components of FIG. 4A include electrodes 113 and lead 111. Electrodes 113 are attached to lead 111 to form a multi-electrode lead. The multi-electrode lead is positioned such that the electrodes may be adjacent to or in the lacrimal gland. Each of electrodes 113 may be selectively activated to stimulate one or more desired anatomical targets. For example, electrodes 1, 3 and 4 may be activated to stimulate a first anatomical target and electrodes 2 and 5 may be activated to stimulate a second anatomical target. The one or more anatomical targets may be stimulated by different combinations of electrodes to produce tears in the patient's eye, or to produce vasodilation in the lacrimal gland, [0105]; Battery 170 may provide power to microstimulator 168. Microstimulator 168 may receive power from battery 170, generate a signal, and transmit the signal over leads to electrodes 113. Pulse generator 172 of FIG. 6B may include a power source and be implanted within a mastoid region 72 of the patient's temporal bone. Pulse generator 172 may generate a signal for stimulating anatomical targets and transmit the signal to one or more electrodes 113 over leads 111, [0108]; stimulation system of FIG. 7 includes controller 110 and microstimulator 120 which receives a waveform 112 and outputs a signal 114 for stimulating one or more anatomical targets of a patient, such as a lacrimal gland, [0109], Fig. shoes electrode module 113 includes two fingertip electrodes, and the two fingertip electrodes 113 are respectively arranged on two sides of the boost control module).
The modified Trans doesn’t explicitly teach the two fingertip electrodes are respectively arranged on two sides of the boost control module.
Tran and Lee are related as ophthalmic device.
Lee teaches the two fingertip electrodes (110, 120, Fig. 1) are respectively arranged on two sides of the boost control module (device 100 includes a first electrode 110 and a second electrode 120 disposed on a substrate 102. Electronic components 130 are also attached to the substrate 102, [0034]; device 100 includes a plurality of vias 118, 128, 129, which provide points of electrical connection between the electrodes 110, 120, and the electronic components 130 and/or the antenna 140, [0042]; electronic components 130 may include electronic control components to selectively activate one or both of the electrodes 110, 120., [0043]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the contact lens of modified Trans wherein the two fingertip electrodes are respectively arranged on two sides of the boost control module, electronic control component 130, as taught by Lee for the predictable advantage of to selectively activate one or both of the electrodes, as taught by Lee in [0043].
Regarding claim 3, the modified Trans teaches the contact lens according to claim 2 (see above), Lee further teaches, wherein each of the two fingertip electrodes has a plurality of conductors arranged in a comb shape (Figs. 1 and 3, two fingertip electrodes 120 and 110 has a plurality of conductors arranged in a comb shape), a width of each of the conductors is within a range from 1 micron to 20 microns, and a gap between two adjacent ones of the conductors is within a range from 10 nanometers to 100 micron (device 100 includes a width 162 and a height 164. The width 162 height 164 and shape of the device 100 may define or determine the size, area, or footprint of the device. In this regard, the width 162, height 164, shape, and overall footprint of the device 100 is suitable for positioning under the patient's eyelid and within the fornix. For example, the width 162 of the device 100 may range between 5 mm and 25 mm, and the height 164 of the device 100 may range between 2 mm and 15 mm. In this regard, the area or footprint of the device 100 may range between 10 mm.sup.2 and 400 mm.sup.2. Further, the electrodes 110, 120 may occupy, in the aggregate, a substantial portion of the area or footprint of the device 100. For example, the electrodes 110, 120, taken together, may occupy more than 50 percent of the total area or footprint of the device. In the illustrated embodiment, the overall size or footprint of the device 100 substantially corresponds to the size of footprint of the antenna trace 140, the device 100 may include a width 162, height 164, or other dimension greater or smaller than what is explicitly stated herein, [0049]; including the slots in the electrodes, the size or footprint of the electrode surfaces can be increased to substantially or entirely overlap with the antenna region, with less interference with the antenna's harnessing of the EM energy, [0067]; the electrodes 310, 320 may be described as being relatively spaced apart from one another with respect to the central axis of the device 300. In some embodiments, the spacing between the electrodes 310, 320 may be between 10% and 200% of the width of each electrode 310, 320, [0059]). Lee disclosed other dimension greater or smaller than what is explicitly stated herein can be selected, and since it has been held that where the general conditions of a claim are disclosed in the prior art and no criticality has been established on the record, discovering the optimum or workable ranges involves only routine skill in the art, In re Aller, 105 USPQ 233 (C.C.P.A. 1955). Benefits of adjusting is to control the EM energy. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the width of each of the conductors is within a range from 1 micron to 20 microns, and a gap between two adjacent ones of the conductors is within a range from 10 nanometers to 100 micron to control the EM energy.
Regarding claim 4, the modified Trans teaches the contact lens according to claim 1 (see above), the modified Trans doesn’t explicitly teach, wherein the boost control module is a voltage doubler circuit, and the boost control module is configured to adjust a frequency of the pulse voltage signal to adjust within a range from 1Hz to 1MHz.
Tran and Lee are related as ophthalmic device.
Lee teaches devices disclosed herein to have relatively small footprints to fit within the confined spaces available within the eyelid, to be flexible and thin to enhance patient comfort, and to generate sufficient voltage and/or current to stimulate the patient's nerve and achieve a desired physiological response, [0032]; The device 100 allows for larger electrodes to be used without degrading the radiofrequency (RF) coupling, [0044]; The electrical pulse pattern may include a variety of characteristics, such as a pulse, a pulse intensity, a pulse frequency, electrode polarity, or any other suitable characteristic, [0066], the electrodes may be pulsed at 20 Hz initially, and then increase linearly from 20 Hz to 640 Hz, decrease linearly to 20 Hz, and then increase linearly again to 640 Hz, However, it will be understood that these values are merely exemplary, and that any suitable values may be used [0074]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the contact lens of modified Trans wherein the boost control module is a voltage doubler circuit, and the boost control module is configured to adjust a frequency of the pulse voltage signal to adjust within a range from 1Hz to 1MHz, as taught by Lee for the predictable advantage of to selectively activate one or both of the electrodes, as taught by Lee in [0043].
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. in view of Ackermann et al. as applied to claim 1, and further in view of Irazoqui et al. (US 2019/0275326, of record).
Regarding claim 5, the modified Trans teaches the contact lens according to claim 1 (see above), the modified Trans doesn’t explicitly teach, wherein the power supply unit is configured to provide a basic voltage, and the boost control module is configured to increase the basic voltage by a factor within a range from 2 times to 100 times, so as to form the pulse voltage signal.
Tran and Irazoqui are related as ophthalmic device.
Irazoqui teaches the power supply unit is configured to provide a basic voltage, and the boost control module is configured to increase the basic voltage by a factor within a range from 2 times to 100 times, so as to form the pulse voltage signal (improved pulse generator 220 is shown as a block diagram, which is similar to the prior pulse generator except that the digital potentiometer block used in the previous design has now been replaced with a switch/resistor bank block. This circuit block change occurred because there are no digital potentiometers that can handle 55 V. Therefore, in the new circuit, the 5V from the battery is boosted to 55V using a new boost converter. This voltage is then down regulated to the desired value by using an adjustable low drop out (LDO) voltage regulator, [0062]). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the contact lens of modified Trans wherein the power supply unit is configured to provide a basic voltage, and the boost control module is configured to increase the basic voltage by a factor within a range from 2 times to 100 times, so as to form the pulse voltage signal, as taught by Irazoqui for the predictable advantage of the improved stimulus coil may be used alone or in combination with a contact lens for placement adjacent to the exterior of an eye of a mammalian patient. The improved stimulus coil may also be implanted in the eye of a mammalian subject, as taught by Irazoqui in [0001].
Regarding claim 6, the modified Trans teaches the contact lens according to claim 5 (see above), Irazoqui further teaches, wherein the basic voltage is within a range from 1 volt to 5 volts, (in the new circuit, the 5V from the battery is boosted to 55V using a new boost converter. This voltage is then down regulated to the desired value by using an adjustable low drop out (LDO) voltage regulator and a switch/resistor bank, which determined the output of the LDO. The output voltage from the LDO is then fed to the H-bridge, which was used to drive the primary coil 222. The primary coil 222, in turn, transmits the signal to the improved serpentine stimulus coil 200 (Coil S4) to reduce IOP in the patient as described above, [0062]; therefore the basic voltage is 5v, which is boosted afterward). It would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the contact lens of modified Trans wherein the basic voltage is within a range from 1 volt to 5 volts, as taught by Irazoqui for the predictable advantage of the improved stimulus coil may be used alone or in combination with a contact lens for placement adjacent to the exterior of an eye of a mammalian patient. The improved stimulus coil may also be implanted in the eye of a mammalian subject, as taught by Irazoqui in [0001].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Huang et al. (US 2023/0400712), Deering et al. (US 9,858,901), Lee (US 2019/0227345) and Gutierrez (US 2020/0306537) disclose eye worn devices, such as contact lenses, of a user that includes a plurality of electrodes.
Although, the prior art in record teaches electrodes, the prior art doesn’t explicitly teach “the electrode module is located directly below the pupil of the eyeball when viewed from the front, and is situated between the eyeball and the lower edge of the orbital bone, approximately 2.3 cm below the pupil”, as recited in paragraph [0030] of the detailed description of the instant application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAHMAN ABDUR whose telephone number is (571)270-0438. The examiner can normally be reached 8:30 am to 5:30 pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bumsuk Won can be reached at (571) 272-2713. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.A/Examiner, Art Unit 2872
/BUMSUK WON/Supervisory Patent Examiner, Art Unit 2872
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