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
The Applicant’s cancellation of Claims 1, 3-8, and 10-11 in the claim set filed 03/05/2026 has been acknowledged. The rejection of these cancelled claims under 35 U.S.C. § 101 has been withdrawn.
Applicant’s arguments, see pages 4-5, filed 03/05/2026, with respect to the rejection of Claim 9 under 35 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 Therefore, the rejection has been withdrawn.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 Hyde, Etzkorn, Gutierrez, and Roholt. The Examiner notes the rejections of all other pending claims under 35 U.S.C. § 103 have been updated accordingly.
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 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al (US 20180031865 A1, cited in applicant’s IDS, hereinafter Hyde) in view of Gutierrez et al (US 20190307399 A1, hereinafter Gutierrez) and Etzkorn et al (US 9298020 B1, hereinafter Etzkorn).
Regarding Claim 9, Hyde discloses a contact lens (Element 1300, Fig. 13; “The ophthalmic device 1300 is a contact lens”, [0135]; “the ophthalmic device 1300 and its materials, components, or elements can be similar to or the same as the ophthalmic devices 100, 300a-b, 400, 500, 600a-b, 700a-b, 800a-b, 900, 1000 (FIGS. 1A-1B and 3-10)”, [0134]) comprising:
an optically transparent or translucent substrate (“the ophthalmic device 1300 can include a soft contact lens (e.g., a hydrogel or silicone hydrogel), gas permeable contact lens (e.g., silicone acrylate, fluorosilicone acrylate) , a hard contact lens, a hybrid contact lens, or another suitable type of contact lens”, [0135]; the examiner notes that to work properly, contact lenses must be optically transparent or translucent); and
a first plurality of electromyography (EMG) electrodes (“the at least one additional sensor 1075 can be substantially similar to the first sensor 1006 and include a plurality of electrodes configured to sense EMG signals”, [0124]; “The ophthalmic device 1000 or its materials, components, or elements can be used in any of the ophthalmic devices or systems disclosed herein”, [0122]) arranged on or within the optically transparent or translucent substrate (“The additional sensor 1075 can be positioned in or on the ophthalmic device 1000 to sense EMG signals…”, [0124]), at least one of the first plurality of electromyography electrodes further arranged to lie adjacent to an iris dilator muscle of a subject's eye when the contact lens is placed on the eye (“The additional sensor 1075 can be…disposed in or on the ophthalmic device 1000 to be closer [to] muscular activity not generated by the ciliary muscle (e.g., the iris) than the first sensor 1006”, [0124]; the Examiner notes that the iris dilator muscle is the outermost muscle of the iris, and therefore will be the closest muscle to sensor 1075);
wherein the contact lens is arranged and disposed to couple to a device (Element 150, Fig. 1A; “The controller 116 is operably (e.g., communicably) coupled to one or more components of the ophthalmic device 100… the controller 116 can include at least one memory storage medium 148, at least one processor 150”, [0054]) configured to correlate EMG measurements from the electromyography electrodes (“one or more EMG signals sensed with the at least one first sensor 106”, [0074]; “the at least one additional sensor 1075 can be substantially similar to the first sensor 1006 and include a plurality of electrodes configured to sense EMG signals”, [0124]) to physiological characteristics of the subject (“Comparing the first and second sensing signals can include comparing the intensity of the EMG signals to the intensity of the characteristics, comparing a change (or lack thereof) in the EMG signals to a change (or lack thereof) in the characteristics… Comparing the first and second sensing signals can also include, with the processor 150, distinguishing the EMG signals associated with the ciliary muscle 110 from the EMG signals associated with other muscular activity”, [0074]).
Hyde discloses the claimed invention except for expressly disclosing at least one of the first plurality of electromyography electrodes arranged on opposing sides of the contact lens along a horizontal axis, and the device configured to correlate EMG measurements from the one or more pairs of electromyography electrodes to a brain state of the subject. However, Gutierrez, which is also directed towards a contact lens ([0002]; “Described herein are embodiments of ophthalmic devices (e.g. eye-mountable devices, smart contact lenses”, [0018]), teaches at least one of the first plurality of electromyography electrodes (Elements 363 and 365, Fig. 3B; “The muscle sensor 351 is an electromyography sensor and includes a plurality of discrete electrodes (including first discrete electrode 363, second discrete electrode 365...”, [0039]; “For example, the iris sensor 235 and or ciliary muscle sensor 240 may be an electromyography sensor”, [0025]) arranged on opposing sides of the contact lens along a horizontal axis (See Fig. 3B). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hyde by arranging at least one of the first plurality of electromyography electrodes on opposing sides of the contact lens along a horizontal axis, as taught by Gutierrez, because multiple electrodes in a bipolar configuration allows for differential measurements, as taught by Gutierrez ([0041]).
Etzkorn, which also discloses a contact lens (see Abstract), teaches the device (Element 214’, Fig. 3; “In some aspects, the analysis component 214 is not included on the contact lens 200 and the information sensed by the one or more sensors 206, 208 is transmitted to an external reader”, 7:47-50) configured to correlate EMG measurements from the one or more pairs of electromyography electrodes (“the sensors 206, 208 can detect neural and/or electromyogram activity of the wearer of the contact lens 200”, 6:10-12) to a brain state of the subject (“method 500 can include sensing, using a contact lens, fatigue of the wearer of the contact lens (e.g., using one or more of the sensors 206, 208). In various aspects, the fatigue can be sensed by sensing neural activity… the sensors 206, 208 can detect the electrical activity from nerve cells in the eye muscles. The electromyogram activity can be the electrical activity from the nerve cells in the eye muscles. If the amount of electrical activity decreases by a predetermined amount over a particular time period, the contact lens 200 can determine that the wearer is fatigued”, 8:30-41). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the device configuration of Etzkorn to the contact lenses of modified Hyde, because there are many applications and/or environments in which it is useful to determine fatigue or an emotional state of a person (Hyde, 1:10-12), and adding this capability to the contact lenses of Hyde expands their usefulness.
Regarding Claim 14, modified Hyde discloses the contact lens of claim 9, wherein a plurality of electromyography electrodes are further arranged to lie adjacent to an iris dilator muscle of a subject's eye when the contact lens is placed on the eye (“The additional sensor 1075 can be…disposed in or on the ophthalmic device 1000 to be closer [to] muscular activity not generated by the ciliary muscle (e.g., the iris) than the first sensor 1006”, [0124]; the Examiner notes that the iris dilator muscle is the outermost muscle of the iris, and therefore will be the closest muscle to sensor 1075). Modified Hyde discloses the claimed invention except for expressly disclosing the contact lens further comprising: a second plurality of electromyography electrodes arranged on or within the optically transparent or translucent substrate, at least one pair of the second plurality of electromyography (EMG) electrodes arranged on opposing sides of the contact lens along a vertical axis. However, Gutierrez teaches a second plurality of electromyography electrodes (Elements 361, Fig. 3B) arranged on or within the optically transparent or translucent substrate (“As illustrated in FIG. 3, the ophthalmic device 300-B includes an enclosure (e.g., first material 302 encapsulating second material 304), controller 225, dynamic optic 230, and muscle sensor 351... The first material 302 may be a soft lens material (e.g., silicone or silicone-based hydrogels) that encapsulated the second material 304”, [0039]), at least one pair of the second plurality of electromyography (EMG) electrodes arranged on opposing sides of the contact lens along a vertical axis (See Fig. 3B; a pair of electrodes 361 are arranged on opposing sides of the contact lens along a vertical axis). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the second plurality of electromyography electrodes arranged on opposing sides of the contact lens along a vertical axis to the contact lens of Hyde (and further arranged to lie adjacent to an iris dilator muscle of a subject's eye when the contact lens is placed on the eye as already taught by Hyde), because multiple pairs of electrodes in a bipolar configuration allows for differential measurements, as taught by Gutierrez ([0041]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde in view of Gutierrez and Etzkorn, and further in view of Annoni et al (US 20190167176 A1, hereinafter Annoni).
Regarding Claim 12, modified Hyde discloses the contact lens of claim 9, further comprising:
an implantable device paired to the contact lens (“The controller 116 can include the at least one transceiver 152 … The transceiver 152 can be configured to communicate with an entity ... The entity can include one or more of a computer, a mobile device, a network, another device implanted or implantable into the individual”, [0065]), the contact lens and paired implantable device forming a closed-loop system (“the entity can at least partially control the operation of one or more components of the ophthalmic device 100. For example, the entity can relay one or more instructions, one or more programs, or other information to the controller 116. In an embodiment, the controller 116 can relay information (e.g., the first or second sensing signals, status of the ophthalmic device 100, status of one or more individual components of the ophthalmic device 100, etc.) to the entity”, [0066]).
Modified Hyde discloses the claimed invention except for expressly disclosing wherein the closed-loop system is arranged and disposed to automatically respond to brain state changes with therapeutic intervention. However, Annoni, which also discloses a contact lens (“monitoring device(s) 321 can include sensors integrated with minimally invasive or borderline invasive devices such as … contact lens…”, [0116]), teaches an implantable device paired to the contact lens, the contact lens and paired implantable device (Element 323, Fig. 3; “system 320 can include an implantable medical device that includes an implantable drug pump and/or a neuromodulation device (e.g., for delivering vagus nerve stimulation…”, [0100]) forming a closed-loop system (“Control circuit 322 can be implemented in portable device 542 and/or therapy device 323. In various embodiments, system 320 is implemented in system 620 as a closed-loop system…”, [0109]);
wherein the closed-loop system is arranged and disposed to automatically respond to brain state changes (Step 432, Fig. 4; “Asthma and COPD are associated with impairment in the autonomic balance … This imbalance, as demonstrated in COPD patients, manifests as an elevation in sympathetic activity and a withdrawal of parasympathetic activity resulting in decreased BRS. In studies with asthma patients, the imbalance in the autonomic nervous system results from the hyperactivity of the parasympathetic branch”, [0060]; therefore, the presence of asthma is indicative of imbalance in nervous system activity; nervous system activity is correlated to brain state) with therapeutic intervention (“If the state of the respiratory distress exceeds the threshold at 433, an alert is produced to notify the patient and/or the user, and/or one or more therapies treating the respiratory distress are delivered, at 434”, [0107]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the closed-loop system of Hyde with the therapeutic intervention of Annoni, because therapeutic intervention to decrease adverse symptoms is beneficial to a patient’s quality of life.
Regarding Claim 13, modified Hyde discloses the contact lens of claim 12. Modified Hyde discloses the claimed invention except for expressly disclosing wherein the implantable device comprises a vagus nerve stimulator or deep brain stimulator. However, Annoni teaches wherein the implantable device comprises a vagus nerve stimulator (Element 323, Fig. 3; “system 320 can include an implantable medical device that includes an implantable drug pump and/or a neuromodulation device (e.g., for delivering vagus nerve stimulation…”, [0100]) or deep brain stimulator. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the implantable device of Hyde to comprise a vagus nerve stimulator, because modulating vagus nerve activity can help to modify respiratory distress, as suggested by Annoni ([0059], [0063]).
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde in view of Gutierrez and Etzkorn, and further in view of Roholt et al (US 20170079771 A1, cited in applicant’s IDS, hereinafter Roholt).
Regarding Claim 15, modified Hyde discloses the contact lens of claim 9. Modified Hyde discloses the claimed invention except for expressly disclosing the contact lens further comprising: a second plurality of electromyography electrodes arranged on or within the optically transparent or translucent substrate, the second plurality of electromyography (EMG) electrodes arranged in a circle around the center of the contact lens, and further arranged to lie adjacent to an iris sphincter muscle of a subject's eye when the contact lens is placed on the eye.
However, Gutierrez teaches a second plurality of electromyography electrodes (Elements 361 arranged in the top, bottom, top right, and bottom left areas of element 300B, Fig. 3B) arranged on or within the optically transparent or translucent substrate (“As illustrated in FIG. 3, the ophthalmic device 300-B includes an enclosure (e.g., first material 302 encapsulating second material 304), controller 225, dynamic optic 230, and muscle sensor 351... The first material 302 may be a soft lens material (e.g., silicone or silicone-based hydrogels) that encapsulated the second material 304”, [0039]), the second plurality of electromyography (EMG) electrodes arranged in a circle around the center of the contact lens (See Fig. 3B; elements 361 are all arranges along a circle configuration around the center of ophthalmic device 300-B). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the second plurality of electromyography electrodes to the contact lens of Hyde, because multiple pairs of electrodes in a bipolar configuration allows for differential measurements, as taught by Gutierrez ([0041]).
Roholt, which is also directed towards a contact lens (Fig. 8, [0016]), teaches a plurality of electromyography (EMG) electrodes (“FIG. 8 shows a contact lens EMG sensor, with a multiplicity of sensors 820”, [0095]) arranged to lie adjacent to an iris sphincter muscle of a subject's eye when the contact lens is placed on the eye (“In addition, other EMG sensors may be positioned more centrally to capture the [action potential] of the iris sphincter muscle, so as to use the iris [action potential] concurrently with the [ciliary muscle action potential] in algorithms appropriate to driving an [electro-active intra-ocular lens]”, [0106]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the second plurality of electromyography electrodes of Hyde with the EMG electrode arrangement of Roholt for the advantage of driving an intraocular lens, which can be used to improve impaired vision ([0039] of Roholt).
Regarding Claim 16, modified Hyde discloses the contact lens of claim 15. Modified Hyde discloses the claimed invention except for expressly disclosing the contact lens further comprising: a third plurality of electromyography electrodes arranged on or within the optically transparent or translucent substrate, the third plurality of electromyography (EMG) electrodes arranged in a circle around the center of the contact lens and concentric with the second plurality of electrodes, and further arranged to lie adjacent to an iris sphincter muscle of a subject's eye when the contact lens is placed on the eye.
However, Gutierrez teaches a third plurality of electromyography electrodes (Elements 361 arranged in the top left and bottom right areas of element 300B, Fig. 3B) arranged on or within the optically transparent or translucent substrate (“As illustrated in FIG. 3, the ophthalmic device 300-B includes an enclosure (e.g., first material 302 encapsulating second material 304), controller 225, dynamic optic 230, and muscle sensor 351... The first material 302 may be a soft lens material (e.g., silicone or silicone-based hydrogels) that encapsulated the second material 304”, [0039]), the third plurality of electromyography (EMG) electrodes arranged in a circle around the center of the contact lens (See Fig. 3B; elements 361 are all arranges along a circle configuration around the center of ophthalmic device 300-B). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the third plurality of electromyography electrodes to the contact lens of Hyde, because multiple pairs of electrodes in a bipolar configuration allows for differential measurements, as taught by Gutierrez ([0041]).
Roholt teaches a plurality of electromyography (EMG) electrodes (“FIG. 8 shows a contact lens EMG sensor, with a multiplicity of sensors 820”, [0095]) arranged to lie adjacent to an iris sphincter muscle of a subject's eye when the contact lens is placed on the eye (“In addition, other EMG sensors may be positioned more centrally to capture the [action potential] of the iris sphincter muscle, so as to use the iris [action potential] concurrently with the [ciliary muscle action potential] in algorithms appropriate to driving an [electro-active intra-ocular lens]”, [0106]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the third plurality of electromyography electrodes of Hyde with the EMG electrode arrangement of Roholt (the Examiner notes that if the third plurality of electromyography (EMG) electrodes is arranged adjacent to an iris sphincter muscle of a subject’s eye, then they also must be concentric with the second plurality of electrodes arranged to lie adjacent to an iris dilator muscle, which is a concentric muscle to the iris sphincter muscle), for the advantage of driving an intraocular lens, which can be used to improve impaired vision ([0039] of Roholt).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Ward et al (US 11484217 B2).
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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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791