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
Claims 1-4, 10, and 14 are deemed to have an effective filing date of July 11, 2021 as the provisional application does not appear to provide support for an electrode arrangement generating sensing signals indicative of an electrical activity map of the individual’s face; for a local controller operable to activate selected electrode elements while avoiding application of NMES signals outside of the applied region resulting in safety and optimal nerves’ stimulation and muscle contraction; for utilizing operation data of a predetermined time pattern of activation of selected stimulating elements, communicating with a sensing system to provide sensing data indicative of the individual eyes’ condition; for the appliance being glasses wearable by the individual where the device is mounted on the glasses; for the glasses being vision correcting, sunglasses, virtual/augmented-reality glasses; and for an additional stimulation system of a different type .
Claims 6-7, 9, 11-13, and 15-22 are deemed to have an effective filing date of July 10, 2022.
Claims 5 and 8 are deemed to have an effective filing date of December 11, 2023 as the parent application does not appear to provide support for an electrode arrangement generating sensing signals indicative of an electrical activity map of the individual’s face; and the sensing system being integral with the stimulator arrangement providing sensing data of an electrical activity map.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “106” has been used to designate both memory (Fig. 1) and an appliance (Fig. 2).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “102” has been used to designate both a stimulator (Fig. 1) and an appliance (Fig. 5 – unnumbered box).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “SE1” and SE2” has been used to designate both selected sub-arrays for triggering tearing by stimulating the infratrochlear nerve (Figs. 6A-C) and different sub-arrays that stimulate signals stimulating different parts of the nerve circuitry (Figs. 7A and B). The Examiner notes that the instant specification uses reference characters “SA” when describing Figs. 6A-C.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 242, SE.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: SA1, SA2.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0009], line 8, the recitation of “of the sane effectivity” appears to have a misspelling of --same--.
In paragraph [0055], line 3, “bur at” should be --but at--.
In paragraph [0087], line 1, the recitation of “Fig. 4E” should be --Fig. 4F-- to be consistent with the drawings.
In paragraph [0093], line 5, “140” should be –150-- to be consistent with the drawings.
In paragraphs [0099] and [0100], line 3,”138” should be –148-- to be consistent with the drawings.
In paragraph [0124], line 1, “240” should be --220-- to be consistent with the drawings.
Appropriate correction is required.
Claim Objections
Claims 1, 14 and 16 objected to because of the following informalities:
In claim 1, line 1, an article (i.e., an) should be added before “individual’s eye”; and
Line 3, an article (i.e., an) should be added before “individual’s face”.
In claim 14, lines 2-3, “wearable by individual the device” should be replaced by “wearable by an individual, the device”
In claim 16, line 2, there is a misspelling of “within”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 1-22 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 1, lines 4-5, recites “covering a region of interest on the individual’s face in a vicinity of the respective individual’s eye”. It is unclear to what “the respective individual’s eye” refers back. Is there more than one “individual” or “eye”? While most individuals have two eyes, some have only one eye and others may be missing an eye. The Examiner suggest amending claim 1, line 1, to replace “individual’s eye” with -- an individual--; and amending line 5 to replace “the respective individual’s eye” with --an eye of the individual--.
Claim 2, line 3, recites “the individual”, but claim 1 does not recite an individual. Instead, claim 1 refers to an individual’s eye and an individual’s face. However, if claim 1 is amended as suggested above, then the recitation of “the individual” would be definite.
Claim 7, lines 5-6, recites “the individual eyes’ condition”. Claim 1 does not recite an individual eyes’ condition. Thus, there is insufficient antecedent basis for “the individual eyes’ condition.
Claim 8, line 7, recites “said selected sub-array”, but claim 1 does not mention selecting a sub-array or a selected sub-array. Thus, there is insufficient antecedent basis for the recitation of “said selected sub-array of the electrode elements” in the second of four possible characterizations of claim 8.
Claim 8, line 9, recites “the individual eye’s condition”, but claim 1 does not recite a condition, let alone a condition of an eye. Instead, claim 1 refers to eye functions of an individual’s eye. Is the eye condition of the individual referring to the eye functions? Thus, the scope of claim 8 is vague and indefinite.
Claim 9, line 2, recites “the eye activity”, there is insufficient antecedent basis as earlier in claim 1, line 1, “eye functions” were recited. Is an eye activity an “eye function”? The scope of claim 9 is vague and indefinite.
Claim 9, line 2, also recites “stimulation of the eye activity via the selected sub-array of the stimulating elements”. The recitation of “the selected sub-array of the stimulating elements” is confusing as claim 1 does not have a selecting step and claim 8 refers to “said selected sub-array of electrode elements”. Thus, the scope of claim 9 is vague and indefinite.
Claim 9, lines 3-4, the recitation of “the individual eye’s condition” appears to be referring back to “an imaging system providing the sensing data indicative of the individual eye’s condition” in claim 8. However, the imagining system is one of four possible scenarios and thus, is not required to meet the limitations of claim 8. There is insufficient antecedent basis in claim 9 because the imagining system of claim 8 is not required. The Examiner suggest reciting the imaging system of claim 8 in claim 9.
Claim 19, line 5, recites “the individual”, but claim 1 does not recite an individual. Instead, claim 1 refers to an individual’s eye and an individual’s face. However, if claim 1 is amended as suggested above, then the recitation of “the individual” would be definite.
Claim 19, lines 7-9 recites “utility installed in individual’s personal electronic device” and “the stimulation effect embedded in displayed data exposed to individual’s eyes”. It is unclear if the “individual” of lines 7 and 9 is the individual associated with the eye of claim 1, line 1 or face of claim 1, line 3. Further, it is unclear if “the stimulation effect embedded in display data” has antecedent basis from the stimulating effect of claim 1, lines 7 and 17-18, which are not embedded in display data.
Claim 22, lines 3-4 recites “in response to the sensing data, the stimulation effect embedded in display data”, there is a lack of antecedent basis for the recitation of “the sensing data” as clams 1 and 19 do not “sense” or mention “sensing data”. With respect to the recitation of “the stimulation effect embedded in displayed data exposed to individual’s eyes”, it is unclear if “the stimulation effect embedded in display data” has antecedent basis from the stimulating effect of claim 1, lines 7 and 17-18, which are not embedded in display data.
Claim 22, line 5, recites “the sensing system”, but neither claim 1 nor claim 18 recite a sensing system that could be referred back to. Thus, claims 22 is vague and indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 10 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 10,874,858 to Mowery et al. (hereinafter referred to as “Mowery”).
Regarding claim 1, Mowery discloses a device for stimulating one or more eye functions of individual's eye (e.g., title and abstract), said device comprising a stimulator which is configured to be incorporated in or mountable on an appliance attachable to individual's face (e.g., column 16, lines 40-60 and Figs. 3A and 4A, a stimulator comprising a strip 315/365 of electrodes 111, controller apparatus 161, and a cable 114 is mounted/incorporated in each encircling frame member 410 or appliance) and comprises a respective at least one stimulator arrangement, the stimulator arrangement defining an interface region for covering a region of interest on the individual's face in a vicinity of the respective individual's eye (e.g., column 16, lines 46-60; column 17, lines 11-40, and Fig. 4A, strip of electrodes 111 is considered to be a stimulation arrangement as it covers a region of interest on the individual’s face in a vicinity of the individual’s eye), the stimulator comprising a local controller for operating said at least one stimulator arrangement to apply a stimulating effect on one or more nerves in the region of interest (e.g., column 15, lines 38-53: local controller provides a stimulating effect on nerves in the region of interest, which can be sensed to control therapy stimulation signals or determine efficacy of the treatment, and Fig. 4A, controller apparatus 161) to thereby affect at least one predetermined eye function (e.g., column 7, lines 17-22: microcurrent stimulation therapy to key points around the eye treat a number of eye diseases; column 15, lines 48-51: electrodes 111 sense nerve electrical signals from the patient’s eyelid and thus, the stimulation affects at least one eye function); wherein (i) the stimulator arrangement comprises an array of stimulating elements (e.g., Fig. 4A, strip of electrodes 111 is an array of stimulating electrodes), each stimulating element being individually operable by said local controller to generate a stimulating signal at a respective location of said stimulating element within said interface region (e.g., column 6, line 62-column 7, line 8: each one of the plurality of electrodes is configured to be individually activated for microsimulation); and (ii) said local controller is configured and operable to activate a predetermined individual-specific sub-array of the stimulating elements from said array of the of stimulating elements during a stimulation session, wherein locations of the stimulating elements of the sub-array being activated within the interface region provide a desired spatial pattern of the stimulating effect to be applied while avoiding applications of the stimulating effect outside said locations within the interface region (e.g., column 10, lines 57-64: microcurrent electrostimulation therapy of this invention delivers stimulation to a particular designated point of the body; column 11, lines 10-16: present invention allows for a sequence of stimulation in pinpointed areas which improves treatment efficacy and treatment performance; column 26, lines 34-48: advantages of present invention include: determining specific areas of stimulation by the software program, delivering timed or sequenced specific stimulation to different points to the patient; and claim 4/1).
With respect to claim 2, Mowery discloses the device according to claim 1, wherein the local controller is configured and operable to utilize predetermined data indicative of an individual-specific facial nerve's sensitivity map of the individual, predetermined at a calibration stage performed once for said individual, to define the selected sub-array of the stimulating elements for use in stimulation sessions (e.g., column 15, lines 38-53: local controller provides a stimulating effect on nerves in the region of interest, which can be sensed to control therapy stimulation signals or determine efficacy of the treatment; column 26, lines 34-48: advantages of present invention include: determining specific areas of stimulation by the software program, delivering timed or sequenced specific stimulation to different points to the patient).
As to claim 3, Mowery discloses the device according to claim 1, wherein said stimulator arrangement is configured and operable to generate electric stimulating signals (e.g., column 11, lines 28-30: when an electrical signal is applied to a first selected electrode 111 describes the therapy-appliance strip as providing electrical stimulating signals) .
With respect to claim 4, Mowery discloses the device according to claim 3, wherein said stimulator arrangement comprises an electrodes arrangement configured and operable to generate the stimulating effect associated with neuro-muscular electrostimulation (NMES) of said one or more nerves muscle (e.g., column 1, line 62 through column 2, line 5: microcurrent therapy treatment stimulation reestablishes functional neural pathways for muscle and brain; column 7, lines 17-22: microcurrent stimulation therapy to key points around the eye treat a number of eye diseases; column 15, lines 48-51: electrodes 111 sense nerve electrical signals from the patient’s eyelid and thus, the stimulation affects at least one eye function).
As to claim 5, Mowery discloses the device according to claim 4, wherein said electrodes arrangement is configured and operable to generate sensing signals indicative of an electrical activity map of the individual's face within the interface region (e.g., column 15, lines 35-53: electrodes 111 of Fig. 4A are used to sense nerve electrical signals from the patient’s eyelid and to deliver the sensed signals to the controller apparatus [thus generate sensing signals indicative of electrical activity within the interface region).
With respect to claim 6, Mowery discloses the device according to claim 4, wherein: (i) said stimulator arrangement comprises first and second electrodes, wherein the first electrode is configured to be attached to and extend along said interface region and is formed by said array of first electrode elements, each being individually operable by the controller to form an electrode pair with the second electrode to apply NMES signal to a respective location of the first electrode element within said interface region (e.g., column 16, lines 46-60; column 17, lines 11-40, and Fig. 4A, strip of electrodes 111 is considered to be a stimulation arrangement as it covers a region of interest on the individual’s face in a vicinity of the individual’s eye; column 6, line 62-column 7, line 8: each one of the plurality of electrodes is configured to be individually activated for microsimulation); and (ii) said local controller is configured and operable to activate a selected sub-array of said array of the first electrode elements whose locations define a desired spatial pattern of NMES signals to be applied while avoiding applications of NMES signals outside said locations within the interface region, resulting in safety and optimal nerves' stimulation and muscle contraction (e.g., column 7, lines 38-57: delivering microcurrent pulses to each respective electrode of the plurality of electrodes in a temporal sequence; column 15, lines 38-53: local controller provides a stimulating effect on nerves in the region of interest, which can be sensed to control therapy stimulation signals or determine efficacy of the treatment; column 26, lines 29-33: incorporating a safety feature by separately wiring each electrode or sensor to the treatment device that provides electrical stimulation to prevent more than one electrode delivering therapy simultaneous and potentially injuring the patient).
As to claim 7, Mowery discloses the device according to claim 1, wherein the local controller is configured and operable to carry out at least one of the following: utilize operational data indicative of a predetermined time pattern of activation of the selected sub-array of the stimulating elements (e.g., column 7, lines 38-57: controller generates prescribed microcurrent pulses and delivers the microcurrent pulses to each respective electrode in a temporal sequence; column 11, lines 10-16: allows for stimulation to a sequence of “pinpointed” areas; column 13, lines 4-32: In some embodiments, only one selected electrode 111 is activated (driven by a pulsed electrical signal) at any one time, and each of a plurality of the electrodes 111 is sequentially driven by temporally separated pulses. In some embodiments, two or more of a plurality of the electrodes 111 are driven by simultaneous pulses or by pulses that at least partially overlap in time. In some embodiments, each one or a plurality of subsets of the electrodes is tested to determine which are most effective at relieving symptoms and/or which, when driven by pulsed signals, may cause a worsening of symptoms. Based on the empirical results of such testing of subsets of the electrodes, the system (e.g., system 102 of FIG. 1B) selectively activates those set(s) of electrodes 111 and the sequences of pulses that have been determined empirically to be effective and avoids activation of those set(s) of electrodes 111 and the sequences of pulses that have been determined empirically to worsen symptoms); and communicate with a sensing system providing sensing data indicative of the individual eyes' condition (e.g., column 15, lines 35-53: controller senses electrical impedance and/or sensed nerve electrical signals that are used to limit stimulation signals …; column 24, lines 44-53: controller includes software that is programmed to sequence the therapy and level of microcurrent stimulation based on electrical impedance detected from the patient).
With respect to claim 8, Mowery discloses the device according to claim 1, wherein the local controller is configured and operable to communicate with a sensing system providing sensing data indicative of an individual's condition (e.g., column 15, lines 35-53: controller senses electrical impedance and/or sensed nerve electrical signals that are used to limit stimulation signals …; column 24, lines 44-53: controller includes software that is programmed to sequence the therapy and level of microcurrent stimulation based on electrical impedance detected from the patient), the device being characterized by at least one of the following: the sensing system is integral with the appliance carrying the stimulator (e.g., Fig. 4A and column 15, lines 48-53: electrodes 111 that are not being used to deliver therapy are used to sense nerve electrical signals from the patient’s eyelid where the electrodes are mounted on a frame that carries the stimulator); the local controller is configured and operable to communicate with the sensing system and is responsive to sensing data originated in the sensing system, to selectively activate said selected sub-array of the electrode elements (e.g., column 13, lines 4-32); the sensing system is an imaging system providing the sensing data indicative of the individual eye's condition (alternative characterization not required); the sensing system is integral with the stimulator arrangement providing the sensing data indicative of an electrical activity map of the individual's face within the interface region (e.g., column 15, lines 48-53).
As to claim 10, Mowery discloses the device according to claim 1, characterized by one of the following: said appliance comprises glasses wearable by individual (see Fig. 4A); and said appliance is a label (alternative characterization, not required).
With respect to claim 14, Mowery discloses the device according to claim 1, said appliance comprises glasses wearable by individual the device being configured to be mounted on the glasses (e.g., column 16, lines 40-60 and Figs. 3A and 4A, a stimulator comprising a strip 315/365 of electrodes 111, controller apparatus 161, and a cable 114 is mounted/incorporated in each encircling frame member 410 or appliance).
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.
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, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mowery as applied to claim 8 above, and further in view of US Patent No. 9,625,251 to Heaton et al. (hereinafter referred to as “Heaton”).
With respect to claim 9, Mowery discloses the device according to claim 8, wherein the local controller is configured and operable to affect stimulation of the eye activity via the selected sub-array of the stimulating elements upon identifying, from the sensing data, the individual eye's condition (e.g., column 13, lines 4-32; and column 15, lines 35-53: controller senses electrical impedance and/or sensed nerve electrical signals that are used to limit stimulation signals …; column 24, lines 44-53: controller includes software that is programmed to sequence the therapy and level of microcurrent stimulation based on electrical impedance detected from the patient) but does not expressly disclose that the eye’s condition corresponds to absence of said eye activity during a predetermined time interval. However, Heaton, in a related art: stimulating facial area by using glasses with electrodes attached to eyeglasses, teaches that a plurality of radiation sources and detectors for detecting facial movements can be mounted on the eyeglass frame surrounding an eye (e.g., column 5-6 and Figs. 1 and 2 of Heaton) where the sensing data determines where radiation paths are blocked and unblocked and determines the subject’s facial expression where electrodes can induce a complementary response (i.e., produce a similar facial expression) in the other half of the subject’s face (e.g., column 5, lines 15-22 and columns 11-12 and Figs. 13-14 of Heaton - the sensed data corresponds to a missing eye condition of the individual). Accordingly, one of ordinary skill in the art would have recognized the benefits of a device for stimulating eye functions of a patient with Bell’s Palsy in view of the teachings of Heaton (see column 1 for Bels Palsy condition). Consequently, one of ordinary skill in the art would have modified the device of Mowery so that its microstimulation therapy can treat Bell’s Palsy, as mentioned in Mowery’s abstract, to include a controller sensing data that corresponds to absence of eye activity during a predetermined time in view of the teachings of Heaton, and because the combination would have yielded predictable results.
As to claim 11, Mowery discloses the device according to claim 1, wherein said appliance comprises glasses wearable by individual, but does not expressly disclose that said glasses are one of the following types: vision correcting glasses, sunglasses, vision correcting sunglasses, virtual/augmented-reality glasses (e.g., column 1, lines 41-60 of Heaton: systems can be integrated into eyeglass frames, or implemented as an apparatus that can be attached to a user’s existing eyeglasses; column 6, lines 12-19: support structure 120 can be attached to conventional eyeglass frames worn by the user – implies that user’s existing eyeglasses for either vision correction or sun, or gaming can be used as those are conventional eyeglasses). Accordingly, one of ordinary skill in the art would have modified the device of Mowery so that the eyeglasses worn by the user to mount the stimulator/sensing device are one of vision correcting glasses, sunglasses, or virtual/augmented -reality glasses in view of the teachings of Heaton that existing/conventional glasses can be used to mount a stimulator/sensing device.
Referring to claim 15, Mowery discloses glasses wearable by an individual, said glasses comprising the device of claim 1 as discussed above with respect to the rejection of claim 1, but does not expressly teach that the glasses are one of the following types: vision correcting glasses, sunglasses, vision correcting sunglasses, virtual/augmented-reality glasses. However, Heaton teaches that existing/conventional eyeglasses can be used to mount a stimulator/sensing device to treat facial nerve palsy, as does Mowery (Bell’s Palsy). Consequently, one of ordinary skill in the art would have modified the device of Mowery so that the eyeglasses worn by the user to mount the stimulator/sensing device are one of vision correcting glasses, sunglasses, or virtual/augmented -reality glasses in view of the teachings of Heaton that existing/conventional glasses can be used to mount a stimulator/sensing device.
Claims 12-13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Mowery as applied to claims 6 and 15 above, and further in view of US Patent Application Publication No. 2020/0391029 to Mullins et al. (hereinafter referred to as “Mullins”).
With respect to claim 12, Mowery discloses the device according to claim 6, wherein said appliance comprises glasses wearable by individual (e.g., Fig. 4A), but does not expressly disclose that the first electrode is integral with a nose pad of the glasses, and the second electrode is located in temples of the glasses. However, Mullins teaches, in a related art: wearable medical device providing therapy around the head and eyes of an individual, that a frame for eyeglasses has a nosepiece 1130 with nose grips 1132, similar to standard eyeglass fittings upon which are mounted electrodes 1134 to deliver therapy to the individual where therapy delivery may use left or right nosepiece relative to one or the other of the right and/or left ear earpiece electrodes 1404 (e.g., paragraph [0121] and Fig. 11B of Mullins). Accordingly, one of ordinary skill in the art would have recognized the benefits of placing electrodes on a nosepiece/ nose pad and placing electrodes in temples of the glasses (as shown in Figs. 14A and 15A of Mullins) in order to delivery electrical stimulation therapy to the individual in view of the teachings of Mullins. Consequently, one of ordinary skill in the art would have modified the device of Mowery to have a first electrode integral with a nose pad of the glasses and a second electrode located in temples of the glasses in view of the teachings of Mullins that such an arrangement was a well-known arrangement for delivery stimulation therapy to an individual, and because the combination would have yielded a predictable result.
As to claim 13, Mowery in view of Mullins teaches the device according to claim 12, wherein said glasses are one of the following types: vision correcting glasses, sunglasses, vision correcting sunglasses, virtual/augmented-reality glasses (e.g., paragraph [0150] and Figs. 17A-17D: lenses of the eyeglasses can be prescription lenses and/or can carry a tint and be used as sunglasses). Accordingly, one of ordinary skill in the art would have modified the device of Mowery so that the eyeglasses worn by the user to mount the stimulator/sensing device are one of vision correcting glasses, sunglasses, or virtual/augmented -reality glasses in view of the teachings of Mullins that the glasses can have prescription lenses and/or tint to be used as sunglasses.
With respect to claim 16, Mowery discloses the glasses according to claim 15, but does not expressly disclose that the stimulator arrangement is integrated withing (sic) nose pads of the glasses. However, Mullins teaches, in a related art: wearable medical device providing therapy around the head and eyes of an individual, that a frame for eyeglasses has a nosepiece 1130 with nose grips 1132, similar to standard eyeglass fittings upon which are mounted electrodes 1134 to deliver therapy to the individual where therapy delivery may use left or right nosepiece relative to one or the other of the right and/or left ear earpiece electrodes 1404 (e.g., paragraph [0121] and Fig. 11B of Mullins). Accordingly, one of ordinary skill in the art would have recognized the benefits for using electrodes integrated within nose pads of the glasses in view of the teachings of Mullins. Consequently, one of ordinary skill in the art would have modified the glasses of Mowery to have electrodes/stimulation arrangement integrated within nose pads of the glasses as such was a known manner to provide stimulation therapy as taught by Mullins, and because the combination would have yielded a predicable result.
As to claim 17, Mowery in view of Mullins teaches the glasses according to claim 16, wherein the stimulating elements of the stimulator arrangement comprise an array of first electrode elements, each being individually operable by the controller to form an electrode pair with a second electrode to apply the stimulating electrical signal to a respective location of the first electrode element within said interface region (e.g., column 6, line 62-column 7, line 8 of Mowery: each one of the plurality of electrodes is configured to be individually activated for microsimulation of an eyelid; column 19, lines 33-39 of Mowery: electrodes 111 on therapy strip 615 surround each eye and the return path is provided through electrodes 641 attached to the patient’s neck); but, does not expressly teach that the second electrode is located within temples of the glasses. However, Mullins, in a related art, teaches that one or more return electrodes 818 (see Fig. 8A) may be configured to contact the temples or placed on any portion of the patient’s body spaced from the eye area, including in and behind the ear (e.g., paragraphs [0121] of Mullins above and [0122] of Mullins). Accordingly, one of ordinary skill in the art would have recognized the benefits of a return electrode located within temples of the glasses in view of the teachings of Mullins. Consequently, one of ordinary skill in the art would have modified the glasses of Mowery in view of Mullins to have a second electrode integrated within a temple of the glasses in view of the teachings of Mullins that such is a well-known location for return electrodes for electrodes surrounding the eye, and because the combination would have yielded a predictable result.
Claims 18-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Mowery as applied to claim 1 above, and further in view of US Patent No. 11,364,380 to Goodall et al. (EFD: 08/09/2017; hereinafter referred to as “Goodall”).
Regarding claim 18, Mowery discloses an eye function stimulation system comprising the device according to claim 1 (see rejection of claim 1 above), but does not expressly disclose at least one additional stimulator of a different type. However, Goodall, in a related art: nerve stimulation system, teaches a system 2900 for delivering neural stimulation via electrodes 414a and 414b in combination with providing a secondary therapeutic stimulus via digital media to provide cognitive training and therapy (e.g., column 47, line 1 through column 48, line 25 of Goodall). Accordingly, one of ordinary skill in the art would have recognized the benefit of employing a secondary therapeutic stimulus via digital medial with an electrical stimulation therapy in view of the teachings of Goodall. Consequently, one of ordinary skill in the art would have modified the device of Mowery to be used with another stimulator of a different type in view of that teachings of Goodall that such therapy (digital media) together with stimulation therapy was known to provide cognitive training and to control the neural stimulus, and because the combination would have yielded a predictable result.
With respect to claim 19, Mowery in view of Goodall teaches the system according to claim 18, characterized by at least one of the following: said at least one additional stimulator is integral with said appliance (alternative characterization, not required); said at least one additional stimulator is capable of being operable to be responsive to sensing data indicative of individual eyes' condition and generate a stimulation effect to notify the individual that said eye function is to be initiated to thereby induce voluntary conscious eye function (e.g., column 45, lines 4-55 of Goodall: a recommendation relating to the treatment regimen including generating a recommendation based on a predicted response of the subject to the treatment regimen); and said at least one additional stimulator comprises a computerized utility installed in individual's personal electronic device and configured and operable to generate, in response to the sensing data, the stimulation effect embedded in displayed data exposed to individual's eyes (e.g., column 47, lines 39-49 of Goodall: secondary stimulus determination circuitry 2916 – part of personal electronic device in Fig. 29- is used to generate secondary stimulus control signal 2922 which controls delivery of the therapeutic secondary stimulus while the subject is receiving stimulation delivered to pinna 2092) to thereby induce voluntary conscious eye function (e.g., column 45, lines 4-55: generating a recommendation includes generating a recommendation based on a predicted response of the subject to the treatment regimen).
As to claim 22, Mowery in view of Goodall teaches the system according to claim 18, wherein said at least one additional stimulator comprises a computerized utility installed in individual's personal electronic device and capable of being operable to generate, in response to the sensing data, the stimulation effect embedded in displayed data exposed to individual's eyes to thereby induce voluntary conscious eye function, the sensing system being carried by the individual's personal electronic device to which user's eyes are exposed (e.g., column 47, lines 39-49 of Goodall: secondary stimulus determination circuitry 2916 – part of personal electronic device in Fig. 29- is used to generate secondary stimulus control signal 2922 which controls delivery of the therapeutic secondary stimulus while the subject is receiving stimulation delivered to pinna 2092; and column 43, lines 10-33 of Goodall: recommendation 2522 is presented to subject 2508 via a user interface of personal computing device 2034; column 45, lines 52-55: generating a recommendation includes generating a recommendation based on a predicted response of the subject to the treatment regimen).
Claims 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mowery in view of Goodall as applied to claim 18 above, and further in view of US Patent Application Publication No. 2007/0282012 to Kinoshita et al. (hereinafter referred to as “Kinoshita”).
With respect to claim 20, Mowery in view of Kinoshita teaches the system according to claim 18, wherein said at least one additional stimulator is capable of being operable to be responsive to sensing data indicative of individual eyes' condition and generate a stimulation effect to notify the individual that said eye function is to be initiated to thereby induce voluntary conscious eye function (e.g., column 45, lines 4-55 of Goodall: a recommendation relating to the treatment regimen including generating a recommendation based on a predicted response of the subject to the treatment regimen), but does not expressly teach that said at least one additional stimulator including a physical assembly adapted to generate the stimulation effect via a physical contact with individual's body. However, Kinoshita, in a related art: system used for diagnosis and treatment of dry eye, teaches at least one additional stimulator of a different type than that taught by Mowery (e.g., paragraphs [0012]-[0023] of Kinoshita: eye drop stimulation of an eye where the eye drop lubricant container, upon being squeezed, generates the stimulation effect via physical contact of the drop with the individual’s eye). One of ordinary skill in the art would have recognized the benefits of using eye drop stimulation to treat a patient with dry eyes in view of the teachings of Kinoshita. Accordingly, one of ordinary skill in the art would have modified the device of Mowery in view of Goodall to be used with the dry eye stimulation via eye drops of Kinoshita in order to treat a patient with Bell’s Palsy and dry eye, and because the combination would have yielded a predictable result (both diseases would be treated).
As to claim 21, Mowery in view of Goodall and Kinoshita teaches the system according to claim 20, wherein said physical contact has a predetermined contact application pattern (e.g., paragraph [0109] of Kinoshita: the dosage amount of the composition/eye drop is set so that an expected effect can be sufficiently obtained and the dosage frequency/contact application pattern may be 1 to 3 drops). Accordingly, one of ordinary skill in the art would have recognized the benefits of a contact application pattern being predetermined as taught by Kinoshita. Consequently, one of ordinary skill in the art would have modified the system of Mowery in view of Goodall and Kinoshita so that the eye drop additional stimulation has a contact application of 1 to 3 drops as taught by Kinoshita, and because the combination would have yielded a predictable result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2022/0047866 to Masko is directed to an apparatus and method for microstimulation therapy comprising a stimulator (electrode array 210, electrodes 213) mountable onto an appliance (goggle-type device 201) and a visual screen 220 and a display screen frame 221 (e.g. Fig. 1C and Fig. 2 and corresponding paragraphs of Masko).
US Patent Application Publication No. 2020/0360692 to Azar et al. is directed to therapeutic devices for placement underneath the eyelid and associated systems, devices, and methods for treating dry eye.
US Patent Application Publication No. 2018/0161579 to Franke is directed to extranasal stimulation devices and methods where a stimulator may be coupled to eyeglasses and configured to deliver a stimulus to external facial tissue where the stimulator may be disposed on the nose pad of the eyeglasses (e.g., paragraph [0013] of Franke).
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792