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 .
Remarks
This action is in response to the amendments filed 04/04/2024.
Claims 1, 4, 5, 7-11, 13-20, 22-29, 33, and 35-42 are pending.
Response to Arguments
Applicant's arguments filed 04/04/2024 have been fully considered but they are not persuasive.
Rejection of claims 1-5, 7-11, 13-29, 33, and 34 under 35 U.S.C. 103
Claims 2, 3, 21, and 34 have been cancelled. New claims 35-42 have been added. Applicant argues (see Remarks, pages 11-12) that Ackerman’s sensing of the wetness of the eye is not electrical activity produced by nerve tissue. However, this is not found to be persuasive. As explained in par. [0009] of Ackerman, dry eye is treated by stimulating nerves that innervate lacrimal gland tissue. Therefore, the measured wetness of the eye is a product of the electrical activity produced by the lacrimal gland tissue. Further, the argument that the modification of Fig. 16A with the embodiment of Fig. 17 would render the embodiment of Fig. 16A of Ackerman unsatisfactory for its purpose are not found to be persuasive. The purpose of the embodiment of Fig. 16A is to provide stimulation to the eye (par. [0160]-[0162]), which is the same purpose as the embodiment of Fig. 17 ([0163]-[0164]). Therefore, this rejection is maintained.
Claims 4 and 5 now depend on claim 3, which has been cancelled. Therefore, claims 4 and 5 are moot. However, for examination purposes, it will be understood that claim 4 depends on claim 1. Regarding claim 4, the argument that Ackerman does not disclose the electrical activity produced by the nerve tissue (see Remarks, pages 12-13) is not found to be persuasive. Ackerman discloses the claimed limitation of “wherein the electrical stimulation signals are configured to correct, at least in part, the electrical activity produced by the nerve tissue” (e.g. Par. [0164]: sensing a condition (i.e. abnormal signals) based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity; Par. [0159]: treating dry eye by stimulating nerves in lacrimal gland tissue). Therefore, this rejection is maintained.
Regarding claim 5, the argument that Ackerman does not disclose stimulating the ophthalmic nerve (see Remarks, page 13) is not found to be persuasive. Ackerman discloses stimulating nerves of the eye, including the ophthalmic nerve (e.g. Par. [0009]: implanting a microstimulator next to the lacrimal gland; Pars. [0160]-[0161]: microstimulator implemented with a contact lens; Par. [0155]: stimulating one or more nerves in the lacrimal gland; Pars. [0093]-[0094]: structures of the eye that can be stimulated include ophthalmic nerves, “The structures that enter through the superior orbital fissure 33 include the cranial nerves (CN) III, IV, and VI, lacrimal nerve, frontal nerve, nasociliary nerve, orbital branch of middle meningeal artery, recurrent branch of lacrimal artery, superior orbital vein, and the superior ophthalmic vein.”, “The structures entering through the superior orbital fissure 33 and the inferior orbital fissure 35 may be stimulated by the microstimulator 120.” (Emphasis added)). Therefore, this rejection is maintained.
Regarding claim 7, the argument that Ackerman does not disclose “generated electrical stimulation signals applied to one or more tissue areas of the patient to reduce or impede abnormal electrical activity behavior produced by the nerve tissue” (see Remarks, page 14) is not found to be persuasive. Ackerman discloses detecting abnormal electrical activity produced by nerve tissue (e.g. Par. [0164]: sensing a condition (i.e. abnormal signals) based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity), and in response to this determination, generating electrical stimulation signals to reduce or impede abnormal electrical activity (e.g. Par. [0164]: modulating the output signals in response to any abnormal signals, “The device then modulates its output in response to this condition signal to modify its output in tear production”). Therefore, this rejection is maintained.
Regarding claim 16, Applicant simply states that a sensor that senses conductivity is one that is configured to sense the electrical activity produced b nerve tissue, and further states that conductivity is a property of matter (see Remarks, page 14). No argument against the rejection has been provided, therefore this rejection is maintained.
Regarding claim 17, Applicant argues that the blink detector of Ackerman is not the same sensor that senses conductivity (see Remarks, pages 14-15). This is not persuasive. Ackerman discloses that the microstimulator used for sensing conductivity can also include a blink detection mechanism, which is considered to be mechanical stimuli (e.g. Par. [0162]: the microstimulator can be activated by blinking an eye, in which case a blink detection mechanism is used, which is considered to be mechanical stimuli; Par. [0163]: multiple sensors can be used in the microstimulator). Therefore, this rejection is maintained.
Regarding claim 29, Applicant argues (see Remarks, pages 15-16) that Ackerman does not disclose determining conductivity based on activity produced by the nerve tissue, and further argues that Ackerman does not disclose determining severity of dry eye or treatment and prognosis of the condition. This is not persuasive. As explained in par. [0009] of Ackerman, dry eye is treated by stimulating nerves that innervate lacrimal gland tissue. Therefore, the measured wetness of the eye is a product of the electrical activity produced by the lacrimal gland tissue. Further, Ackerman discloses treatment and prognosis of the dry eye condition (e.g. Par. [0164]: detecting a condition based on the sensed impedance, and adjusting stimulation to treat the condition; Par. [0159]: treating dry eye by stimulating nerves in lacrimal gland tissue). Therefore, this rejection is maintained.
Regarding claim 8, Applicant argues (see Remarks, page 16) that Franke does not disclose comparing the measured electrical activity waveforms to a pre-stored baseline data representative of electrical activity waveforms. This is not found to be persuasive. Ackerman was used to disclose the electrical activity signals being representative of measured electrical activity waveforms generated due to nerve firing by at least one nerve (e.g. Par. [0164]: sensing gland conductivity). Franke was used to disclose comparing the measured signals to a baseline (e.g. Par. [0086]: compare the detected characteristics to predetermined values and provide stimulation in response to the characteristics to reduce the effects of the condition). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include comparing the measured signals to a baseline as taught by Franke in order to provide the predictable results of determining when to provide the appropriate therapy.
Regarding claim 9, Applicant argues (see Remarks, pages 16-17) that Ackerman does not disclose continually varying the generated modulating control signals responsive to variations in the measured electrical activity waveforms resulting from earlier modulating control signals. This is not persuasive. While Ackerman discloses in par. [0117] that the input can be user input, Ackerman also discloses that the input can also be generated from logic inside the input module (e.g. Par. [0117]: “The input signals may also be generated from logic inside the input module 138. For example, input module 138 may include logic to apply stimulation to a lacrimal gland periodically, in a ramped fashion, continuously, in a patterned fashion, in response to detecting a condition of low or decreased tear production, or some other condition.”). Therefore, this rejection is maintained.
Regarding claim 27, Applicant argues (see Remarks, page 17) that Franke fails to disclose the pre-stored baseline data representative of the electrical activity waveforms. This is not persuasive. Franke discloses using subject characteristics to develop a model that is used to adjust stimulation to the user (e.g. Par. [0089). Franke further discloses that the subject characteristics can include electrical activity (e.g. Par. [0066]: EMG sensor to detect electrical activity). Therefore, this rejection is maintained.
Regarding claim 10, Applicant argues (see Remarks, page 17) that Rosenbluth is not relevant to the claim because Rosenbluth discloses proprioceptors, which are not recited in the claim. This is not persuasive. As best understood, proprioceptors include mechanoreceptors (e.g. see Wikipedia article: https://en.wikipedia.org/wiki/Proprioception, under section titled Mechanisms: low-threshold mechanoreceptors are considered to be a type of proprioceptor; Note: this article is being used as an evidentiary reference). Therefore, Rosenbluth is relevant to the claim.
Regarding claim 13, Applicant argues (see Remarks, page 18) that the rejection is flawed because the underlying assumption, and points to an example of the mouth, stomach, esophagus, and buccinator. This is not relevant to the claim. As explained in the rejection below, Humphreys discloses a second contact lens that is couplable to a first contact lens (e.g. Par. [0068]: the system includes two contact lenses that are in communication with each other). As taught by Ackerman, the first contact lens has a stimulator. Therefore, the second contact lens of Humphreys would be couplable with the stimulator, since the first contact lens of Ackerman is coupled to the stimulator.
Regarding claim 14, Applicant argues (see Remarks, page 19) Humphreys does not disclose the first and second contact lens being configured to alternately sense electrical activity of a nerve and to stimulate the tissue. This is not persuasive. Humphreys discloses first and second contact lens being configured to alternately sense electrical activity of a nerve and to stimulate the tissue (e.g. Par. [0068]: the system includes two contact lenses that are in communication with each other and include sensors and stimulators such as lens activators; Par. [0037]: the first and second contact lens can alternately communicate with the base device). Therefore, this rejection is maintained.
Regarding claim 18, Applicant argues (see Remarks, page 19) that it is not always the case that a multipurpose device is better than a single purpose device, and therefore, the it would not be obvious to make the contact lens od Ackerman a vision correcting contact lens. This is not persuasive. The vision correction contact lens of Humphreys performs the multipurpose function of vision correction and lens activation (e.g. stimulation). Applicant’s specification at par. [0105] states that the contact lens may also have a vision correcting ability, which would result in a multifunctional/multipurpose device. Therefore, it would be obvious to modify the contact lens of Ackerman to include vision correction as taught by Humphreys, in order to result in a multifunctional device. Therefore, this rejection is maintained.
Regarding claim 19, Applicant argues (see Remarks, pages 19-20) that the stimulation of Bogdanowicz is not based on electrical activity of the nerve tissue, and further argues that there is no reasoning to combine Ackerman and Bogdanowicz. Regarding the argument that the stimulation of Bogdanowicz is not based on electrical activity of the nerve tissue, Ackerman was used to disclose this limitation, as explained in the rejection below. The argument that there is no reasoning to combine Ackerman and Bogdanowicz is not found to be persuasive. Bogdanowicz is in the similar field of ocular stimulation devices, and is used to promote tissue growth and promote blood vessel growth (e.g. Par. [0013]: providing electrical stimulation to stimulate the regrowth of ocular neural tissue) to provide treatment for eye diseases (e.g. Abstract; Par. [0013]). The device of Ackerman is used to provide treatment for the eye disease of dry eye (e.g. Abstract). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include providing electrical stimulation to stimulate the regrowth of ocular neural tissue as taught by Bogdanowicz to provide the results of eye disease treatment.
Regarding claim 20, Applicant argues (see Remarks, pages 20-21) that Manzo discloses controlling delivery of a compound based on measured pH, and not electrical activity, and is therefore not eligible as prior art. This is not persuasive. Manzo at par. [0009] discloses that iontophoretic therapy (e.g. electrical stimulation) is used for ocular treatment, and that the application of the current results in OH- and H+ ions that change the pH. The pH sensor then senses the change, and adjusts the stimulation as required. Further, as explained in the rejection below, Ackerman discloses sensing electrical activity based on nerve tissue. Manzo discloses a reservoir of chemical compound and releasing the compound based on sensed signals. Therefore, Manzo is eligible as prior art.
No arguments have been provided for claims 2, 3, 11, 15, 21-25, 26, 28, 33, and 34. New claims 35-42 are addressed in the rejection below.
Claim Objections
Claims 35 and 36 are objected to because of the following informalities:
Claims 35 and 36 are exactly the same.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 5 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.
Claim 4 depends on claim 3, which has been cancelled. For examination purposes, it will be understood to depend on claim 1.
Claim 5 is rejected based on its dependency on claim 4.
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.
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, 4, 5, 7, 11, 16, 17, 22-25, 29, 33, and 37 are rejected under 35 U.S.C. 103 as being obvious over Ackerman et al. (US Patent Application Publication 2012/0130398), hereinafter Ackerman.
Regarding claim 1, Ackerman discloses an apparatus comprising:
at least one contact lens fittable on an eye of a patient (e.g. Fig. 16A: contact lens positioned over the eye); and
a first stimulator to trigger a response in a body of the patient based, at least in part, on the electrical activity signals (e.g. Pars. [0160]-[0161]: microstimulator implemented with a contact lens; Par. [0155]: stimulating one or more nerves in the lacrimal gland; Par. [0110]: microstimulator with electrodes for applying stimulation to a target such as a lacrimal gland).
The embodiment of Figure 16A, as cited above, does not specifically disclose circuitry for receiving electrical activity signals associated with electrical activity produced by nerve tissue located proximal to the contact lens and a first sensor configured to sense the electrical activity produced by the nerve tissue and to provide the electrical activity signals.
However, the embodiment of Figure 17, as described in pars. [0163]-[0164], discloses a system where sensors are a part of the microstimulator (e.g. Par. [0164]: “A sensing element may be part of an implantable microstimulator”), wherein the system includes circuitry for receiving electrical activity signals associated with electrical activity produced by nerve tissue (e.g. Par. [0163]: the stimulator may have sensors on eyeballs; Par. [0164]: sensing surface impedance based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity), and a first sensor configured to sense the electrical activity produced by the nerve tissue and to provide the electrical activity signals (e.g. Par. [0163]: the stimulator may have sensors on eyeballs; Par. [0164]: sensing surface impedance based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity).
It would therefore be obvious to modify the embodiment of Figure 16A in Ackerman to include the sensing element as disclosed by the embodiment of Figure 17 and as described in pars. [0163]-[0164] in order to provide the predictable results of providing improved control and customized stimulation to the eye of the patient.
Regarding claim 4, Ackerman further discloses wherein the first stimulator is configured to produce the electrical stimulation signals responsive to a determination that the electrical activity signals are abnormal, and wherein the electrical stimulation signals are configured to correct, at least in part, the electrical activity produced by the nerve tissue (e.g. Par. [0164]: sensing a condition (i.e. abnormal signals) based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity; Par. [0159]: treating dry eye by stimulating nerves in lacrimal gland tissue).
Regarding claim 5, Ackerman further discloses wherein the first stimulator is configured to produce the electrical stimulation signals directed at one or more nerves in the body of the patient, including at ophthalmic nerve tissue comprising one or more of an ophthalmic nerve, branches of the ophthalmic nerve, or related parts of the ophthalmic nerve, wherein the related parts comprise cell bodies and synapses associated with nerve branch pathways (e.g. Par. [0009]: implanting a microstimulator next to the lacrimal gland; Pars. [0160]-[0161]: microstimulator implemented with a contact lens; Par. [0155]: stimulating one or more nerves in the lacrimal gland; Pars. [0093]-[0094]: structures of the eye that can be stimulated include ophthalmic nerves).
Regarding claim 7, Ackerman further discloses a controller (e.g. Par. [0078]: stimulation system includes a controller) configured to: determine whether the electrical activity signals are abnormal (e.g. Par. [0164]: sensing a condition (i.e. abnormal signals) based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity); and in response to a determination that the electrical activity signals are abnormal, generate modulating control signals to modulate electrical stimulation signals producible by the first stimulator, the generated electrical stimulation signals applied to one or more tissue areas of the patient to reduce or impede abnormal electrical activity behavior produced by the nerve tissue (e.g. Par. [0164]: modulating the output signals in response to any abnormal signals, “The device then modulates its output in response to this condition signal to modify its output in tear production”).
Regarding claim 11, Ackerman further discloses wherein the contact lens further includes at least one of: the controller and the first sensor (e.g. Pars. [0160]-[0161]: microstimulator implemented with a contact lens).
Regarding claim 16, Ackerman further discloses wherein the first sensor comprises multiple sensors (e.g. Par. [0163]: multiple sensors can be used; Fig. 17: sensors 208), and wherein at least one of the multiple sensors is configured to sense the electrical activity produced by nerve tissue (e.g. Par. [0164]: sensing surface impedance based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity), and another at least one of the multiple sensors is configured to sense at least one of: chemical stimuli produced by the patient, mechanical stimuli, thermal, magnetic stimuli, or optical stimuli (e.g. Par. [0162]: the microstimulator can be activated by blinking an eye, in which case a blink detection mechanism is used, which is considered to be mechanical stimuli).
Regarding claim 17, Ackerman further discloses wherein the first sensor configured to sense electrical activity produced by nerve tissue is further configured to sense at least one of: chemical stimuli produced by the patient, mechanical stimuli, thermal stimuli, magnetic stimuli, or optical stimuli (e.g. Par. [0162]: the microstimulator can be activated by blinking an eye, in which case a blink detection mechanism is used, which is considered to be mechanical stimuli).
Regarding claim 22, Ackerman further discloses a power source comprising one or more of: a charging holding device including at least one of a battery or a capacitor, a mountable power source connectable to an external power supply, or a wireless power receiver module to generate electrical current from wireless transmissions received by the wireless power receiver module with the wireless transmissions comprising one or more of: RF transmissions, or optical radiation (e.g. Par. [0106]: power source can be a battery).
Regarding claim 23, Ackerman discloses a method comprising:
establishing a communication link between circuitry, included in a contact lens fitted on an eye of a patient (e.g. Fig. 16A: contact lens positioned over the eye; Par. [0078]: the controller and the microstimulator can communicate wirelessly or through a wired connection); and
causing activation of a first stimulator to trigger a response in a body of the patient based, at least in part, on the electrical activity signals (e.g. Pars. [0160]-[0161]: microstimulator implemented with a contact lens; Par. [0155]: stimulating one or more nerves in the lacrimal gland; Par. [0110]: microstimulator with electrodes for applying stimulation to a target such as a lacrimal gland).
The embodiment of Figure 16A, as cited above, does not specifically disclose a first sensor configured to sense electrical activity produced by nerve tissue located proximate to the contact lens, and receiving from the first sensor electrical activity signals associated with the electrical activity produced by nerve tissue.
However, the embodiment of Figure 17, as described in pars. [0163]-[0164], discloses a system where sensors are a part of the microstimulator (e.g. Par. [0164]: “A sensing element may be part of an implantable microstimulator”), wherein the system includes a first sensor configured to sense electrical activity produced by nerve tissue located proximate to the contact lens (e.g. Par. [0163]: the stimulator may have sensors on eyeballs; Par. [0164]: sensing surface impedance based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity), and receiving from the first sensor electrical activity signals associated with the electrical activity produced by nerve tissue (e.g. Par. [0163]: the stimulator may have sensors on eyeballs; Par. [0164]: sensing surface impedance based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity).
It would therefore be obvious to modify the embodiment of Figure 16A in Ackerman to include the sensing element as disclosed by the embodiment of Figure 17 and as described in pars. [0163]-[0164] in order to provide the predictable results of providing improved control and customized stimulation to the eye of the patient.
Regarding claim 24, Ackerman further discloses wherein causing activation of the first stimulator to trigger the response in the body of the patient comprises: triggering electrical stimulation directed at one or more nerves in the body of the patient in response to a determination that the sensed electrical activity is abnormal (e.g. Par. [0164]: sensing a condition (i.e. abnormal signals) based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity; Par. [0159]: treating dry eye by stimulating nerves in lacrimal gland tissue).
Regarding claim 25, Ackerman further discloses determining whether the electrical activity signals are abnormal (e.g. Par. [0164]: sensing a condition (i.e. abnormal signals) based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity); and in response to a determination that the electrical activity signals are abnormal, generating modulating control signals to modulate electrical stimulation signals producible by the first stimulator, the generated electrical stimulation signals applied to one or more tissue areas of the patient to reduce or impede abnormal electrical activity behavior produced by the nerve tissue (e.g. Par. [0164]: modulating the output signals in response to any abnormal signals, “The device then modulates its output in response to this condition signal to modify its output in tear production”).
Regarding claim 29, Ackerman further discloses determining a medical condition that the patient is suffering from based on the sensed electrical activity produced by the nerve tissue; and determining one or more of: severity of the medical condition, or treatment and prognosis of the medical condition (e.g. Par. [0164]: detecting a condition based on the sensed impedance, and adjusting stimulation to treat the condition; Par. [0159]: treating dry eye by stimulating nerves in lacrimal gland tissue).
Regarding claim 33, Ackerman discloses a device comprising:
a contact lens fittable on an eye of a patient (e.g. Fig. 16A: contact lens positioned over the eye); and
circuitry included with the contact lens to: establish a communication link (e.g. Fig. 16A: contact lens positioned over the eye; Par. [0078]: the controller and the microstimulator can communicate wirelessly or through a wired connection); and
cause activation of a first stimulator to trigger a response in a body of the patient based, at least in part, on the electrical activity signals received from the first sensor (e.g. Pars. [0160]-[0161]: microstimulator implemented with a contact lens; Par. [0155]: stimulating one or more nerves in the lacrimal gland; Par. [0110]: microstimulator with electrodes for applying stimulation to a target such as a lacrimal gland).
The embodiment of Figure 16A, as cited above, does not specifically disclose a first sensor configured to sense electrical activity produced by nerve tissue located proximate to the contact lens, and receiving from the first sensor electrical activity signals associated with the electrical activity produced by nerve tissue.
However, the embodiment of Figure 17, as described in pars. [0163]-[0164], discloses a system where sensors are a part of the microstimulator (e.g. Par. [0164]: “A sensing element may be part of an implantable microstimulator”), wherein the system includes a first sensor configured to sense electrical activity produced by nerve tissue located proximate to the contact lens (e.g. Par. [0163]: the stimulator may have sensors on eyeballs; Par. [0164]: sensing surface impedance based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity), and receiving from the first sensor electrical activity signals associated with the electrical activity produced by nerve tissue (e.g. Par. [0163]: the stimulator may have sensors on eyeballs; Par. [0164]: sensing surface impedance based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity).
It would therefore be obvious to modify the embodiment of Figure 16A in Ackerman to include the sensing element as disclosed by the embodiment of Figure 17 and as described in pars. [0163]-[0164] in order to provide the predictable results of providing improved control and customized stimulation to the eye of the patient.
Regarding claim 37, Ackerman further discloses wherein the first stimulator is configured to trigger an immune system of the patient to counter a medical condition detected based at least in part on the sensed electrical activity produced by the nerve tissue (e.g. Pars. [0160]-[0161]: microstimulator implemented with a contact lens; Par. [0155]: stimulating one or more nerves in the lacrimal gland; Par. [0110]: microstimulator with electrodes for applying stimulation to a target such as a lacrimal gland; The medical condition is understood to be dry eyes.).
Claims 8, 9, 15, 26-28, and 38-42 are rejected under 35 U.S.C. 103 as being unpatentable over Ackerman et al. (US Patent Application Publication 2012/0130398), hereinafter Ackerman, as applied to claims 1 and 23 above, and further in view of Franke et al. (US Patent Application Publication 2018/0161579), hereinafter Franke.
Regarding claims 8 and 26, Ackerman further discloses wherein the electrical activity signals are representative of measured electrical activity waveforms generated due to nerve firing by at least one nerve (e.g. Par. [0164]: sensing gland conductivity). However, Ackerman fails to disclose wherein the controller configured to determine whether the electrical activity signals are abnormal is configured to compare the measured electrical activity waveforms to a pre-stored baseline data representative of electrical activity waveforms; and wherein the controller configured to generate the modulating control signals is configured to generate the modulating control signals that cause the first stimulator to generate modulating electrical stimulation signals applied to the one or more tissue areas to cause the at least one nerve or related parts of the at least one nerve to vary resultant electrical activity waveforms such that differences between the resultant electrical activity waveforms and at least one baseline waveform is reduced or impeded.
Franke, in a similar field of endeavor, is directed towards a stimulation system for treating a condition such as dry eye. Franke discloses a controller configured to compare the measured electrical activity waveforms to a pre-stored baseline data representative of electrical activity waveforms, and wherein the controller is configured to generate the modulating control signals that cause the first stimulator to generate modulating electrical stimulation signals applied to the one or more tissue areas to cause the at least one nerve or related parts of the at least one nerve to vary resultant electrical activity waveforms such that differences between the resultant electrical activity waveforms and at least one baseline waveform is reduced or impeded (e.g. Par. [0086]: compare the detected characteristics to predetermined values and provide stimulation in response to the characteristics to reduce the effects of the condition).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include a controller configured to compare the measured electrical activity waveforms to a pre-stored baseline data representative of electrical activity waveforms, and wherein the controller is configured to generate the modulating control signals that cause the first stimulator to generate modulating electrical stimulation signals applied to the one or more tissue areas to cause the at least one nerve or related parts of the at least one nerve to vary resultant electrical activity waveforms such that differences between the resultant electrical activity waveforms and at least one baseline waveform is reduced or impeded as taught by Franke in order to provide the predictable results of reducing the effects of a condition, such as reducing the effects of dry eye symptoms.
Regarding claims 9 and 28, Ackerman further discloses wherein the controller is configured to continually vary the generated modulating control signals responsive to variations in the measured electrical activity waveforms resulting from earlier modulating control signals (e.g. Par. [0118]: output signal can be varied based on input).
Regarding claim 15, Ackerman fails to disclose wherein the first stimulator comprises one or more stimulators that each produce a chemical output. Franke, in a similar field of endeavor, is directed towards a stimulation system for treating a condition such as dry eye. Franke discloses a stimulator that produce a chemical output (e.g. Par. [0043]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include the stimulation producing a chemical output as taught by Franke in order to provide the predictable results of providing stimulation to the eye.
Regarding claim 27, Ackerman fails to disclose wherein the pre-stored baseline data representative of the electrical activity waveforms comprises one or more of: a normal electrical activity waveform for a particular nerve, or a disease- caused electrical activity waveform for the particular nerve when a person is suffering from a particular irregular medical condition. Franke, in a similar field of endeavor, is directed towards a stimulation system for treating a condition such as dry eye. Franke discloses wherein the baseline data is a disease- caused electrical activity waveform for the particular nerve when a person is suffering from a particular irregular medical condition (e.g. Par. [0089]: an adaptive algorithm can be trained using current disease caused data, which would be the new baseline data).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman in view of Franke to include the baseline data being disease-caused data as taught by Franke in order to provide the predictable results of improved detection of patient conditions using baseline data.
Regarding claims 38-42, Ackerman fails to disclose wherein the first stimulator comprises a stimulator that produces a mechanical output, a thermal output, a vibratory or tactile output, a magnetic output, and an optical output.
Franke, in a similar field of endeavor, is directed towards a stimulation system for treating a condition such as dry eye. Franke discloses wherein the stimulator comprises a stimulator that produces a mechanical output (e.g. Par. [0061]: vibration), a thermal output (e.g. Par. [0056]: thermal output), a vibratory or tactile output (e.g. Par. [0061]: vibration), a magnetic output (e.g. Par. [0056]: magnetic field generating output), and an optical output (e.g. Par. [0056]: light generating output).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include the stimulation producing a mechanical output, a thermal output, a vibratory or tactile output, a magnetic output, and an optical output as taught by Franke in order to provide the predictable results of providing stimulation to the eye.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ackerman et al. (US Patent Application Publication 2012/0130398), hereinafter Ackerman, and further in view of Franke et al. (US Patent Application Publication 2018/0161579), hereinafter Franke, as applied to claim 8 above, and further in view of Rosenbluth et al. (US Patent Application Publication 2015/0321000), hereinafter Rosenbluth.
Regarding claim 10, Ackerman fails to disclose wherein the controller is further configured to: determine abnormality in electrical activity waveforms associated with patient pain or discomfort resulting from one or more of: stimuli and conditions detected by thermoreceptors, stimuli and conditions detected by mechanoreceptors, or stimuli and conditions detected by polymodal and other nociceptors. Rosenbluth, in a similar field of endeavor, is directed towards nerve stimulation. Rosenbluth discloses determining abnormality in electrical activity waveforms associated with patient pain or discomfort resulting from stimuli and conditions detected by proprioceptors (e.g. Pars. [0116]-[0117]: proprioceptors provides information to the nervous system based on stimuli or conditions applies to the body, such as by application of biomechanical loads).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman in view of Franke to include determining abnormality in electrical activity waveforms associated with patient pain or discomfort resulting from stimuli and conditions detected by proprioceptors as taught by Rosenbluth in order to provide the predictable results of determining abnormalities in the collected data.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ackerman et al. (US Patent Application Publication 2012/0130398), hereinafter Ackerman, as applied to claim 1 above, and further in view of Humphreys et al. (US Patent Application Publication 2020/0096787), hereinafter Humphreys.
Regarding claim 13, Ackerman further discloses wherein the apparatus comprises a first contact lens, wherein the first contact lens is couplable to the first sensor (e.g. Par. [0164]: the sensing element may be a part of the contact lens). However, Ackerman fails to disclose wherein the apparatus comprises a second contact lens, wherein the second contact lens is couplable to the first stimulator.
Humphreys, in a similar field of endeavor, is directed towards ophthalmic devices. Humphreys discloses a second contact lens, wherein the second contact lens is couplable to the first lens (e.g. Par. [0068]: the system includes two contact lenses that are in communication with each other; as taught by Ackerman, the first contact lens has a stimulator and therefore the second contact lens of Humphreys would be couplable with the stimulator).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include the second contact lens, wherein the second contact lens is couplable to the first lens as taught by Humphreys in order to provide the predictable results of providing stimulation therapy to both of the eyes. Further, the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04(VI)(B)).
Regarding claim 14, Ackerman further discloses wherein the apparatus comprises a first contact lens couplable to at least one first sensor and at least one first stimulator (e.g. Pars. [0160]-[0161]: microstimulator implemented with a contact lens; Par. [0164]: sensing surface impedance based on one or more variables such as tear conductivity, tear volume, and gland conductivity, which are being considered to be the electrical activity; Par. [0155]: stimulating one or more nerves in the lacrimal gland; Par. [0110]: microstimulator with electrodes for applying stimulation to a target such as a lacrimal gland). However, Ackerman fails to disclose a second contact lens couplable to at least one second sensor and at least one second stimulator, and wherein each of the first contact lens and the second contact lens is configured to alternately sense electrical activity of a respective at least one nerve and to stimulate respective tissue.
Humphreys, in a similar field of endeavor, is directed towards ophthalmic devices. Humphreys discloses a second contact lens couplable to at least one second sensor and at least one second stimulator, and wherein each of the first contact lens and the second contact lens is configured to alternately sense activity and to stimulate respective tissue (e.g. Par. [0068]: the system includes two contact lenses that are in communication with each other and include sensors and stimulators such as lens activators; Par. [0037]: the first and second contact lens can alternately communicate with the base device).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include the second contact lens couplable to at least one second sensor and at least one second stimulator as taught by Humphreys in order to provide the predictable results of providing the appropriate therapy to both eyes.
Regarding claim 18, Ackerman fails to specifically disclose wherein the at least one contact lens is further configured to correct vision attributes of the eye of the patient. Humphreys, in a similar field of endeavor, is directed towards ophthalmic devices. Humphreys discloses wherein the at least one contact lens is further configured to correct vision attributes of the eye of the patient (e.g. Par. [0024]: an ophthalmic device for vision correction through contact lens).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include the contact lens is further configured to correct vision attributes of the eye of the patient as taught by Humphreys in order to provide the predictable results of a multipurpose ophthalmic device that can be used to correct vision.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ackerman et al. (US Patent Application Publication 2012/0130398), hereinafter Ackerman, as applied to claim 1 above, and further in view of Bogdanowicz (US Patent Application Publication 2005/0010266).
Regarding claim 19, Ackerman fails to disclose wherein the first stimulator is further configured to perform one or more of: promote tissue growth, promote blood vessel growth, or trigger an immune system of the patient to counter a medical condition detected based, at least in part, on the sensed electrical activity produced by the nerve tissue. Bogdanowicz, in a similar field of endeavor, is directed towards an ocular stimulation device. Bogdanowicz discloses wherein the first stimulator is further configured to perform one or more of: promote tissue growth and promote blood vessel growth (e.g. Par. [0013]: providing electrical stimulation to stimulate the regrowth of ocular neural tissue).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include the first stimulator is further configured to perform one or more of: promote tissue growth and promote blood vessel growth as taught by Bogdanowicz in order to provide the predictable results of providing treatment for retinal degenerative diseases.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ackerman et al. (US Patent Application Publication 2012/0130398), hereinafter Ackerman, as applied to claim 1 above, and further in view of Manzo (US Patent Application 2016/0213514).
Regarding claim 20, Ackerman further discloses implantable devices (e.g. Par. [0009]), but fails to specifically disclose wherein the first stimulator includes a device with a reservoir of chemical compound, the device configured to controllably release the chemical compound in the reservoir based, at least in part, on the sensed electrical activity or other measured activity produced by the nerve tissue. Manzo, in a similar field of endeavor, is directed towards contact lenses for ocular therapy. Manzo discloses the first stimulator includes a device with a reservoir of chemical compound, the device configured to controllably release the chemical compound in the reservoir based, at least in part, on the sensed electrical activity or other measured activity produced by the nerve tissue (e.g. Par. [0009]: contact lens with a reservoir for a charged therapeutic compound that is released based on data collected by the sensor).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include the device with a reservoir of chemical compound, the device configured to controllably release the chemical compound in the reservoir based, at least in part, on the sensed electrical activity or other measured activity produced by the nerve tissue as taught by Manzo in order to provide the predictable results of providing a therapeutic compound to the patient as required.
Claims 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Ackerman et al. (US Patent Application Publication 2012/0130398), hereinafter Ackerman, as applied to claims 1 and 23 above, and further in view of Hyeon (International Publication 2011/016626).
Regarding claims 35 and 36, Ackerman fails to disclose wherein the first stimulator is configured to promote blood-vessel growth based at least in part on the sensed electrical activity produced by the nerve tissue. Hyeon is directed towards a stimulation device. Hyeon discloses wherein the first stimulator is configured to promote blood-vessel growth (e.g. Abstract: the stimulation is used to promote the growth of peripheral blood vessels).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Ackerman to include wherein the first stimulator is configured to promote blood-vessel growth based at least in part on the sensed electrical activity produced by the nerve tissue as taught by Hyeon in order to provide the predictable results of facilitating a blood flow through the vessels.
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 extension fee 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 date of this final action.
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