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
Applicant's arguments filed 6/26/2026 regarding the rejection of Independent Claims 1, 13 and 21 under 35 U.S.C. 103 as being unpatentable over US 20190143116 A1 to Mowery et al. (“Mowery”) in view of US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and US 4979508 A to Beck (“Beck”) have been fully considered but they are not persuasive. Applicant argues that because “the amplifier 42 of Beck has a function of delivering the same output voltage to the headset electrodes 22” (Applicant’s 6/26/2026 Remarks at Pg. 13 (emphasis in original)), the combination of Mowery, Greenberg and Beck does not disclose detecting a difference in voltage between first and second sensor electrodes “in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient,” as required by the Independent Claims. The Examiner respectfully disagrees. Applicant’s arguments appear to be that because Beck’s difference is zero, Beck’s amplifier does not determine whether phosphenes are visible to the patient. However, Beck’s differential amplifier ensures that characteristics of the electrical stimulation are such that they are within a range that produces phosphenes, and thereby detects a difference in voltage between first and second sensor electrodes “in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.” However, to the extent that the differential amplifier of the Independent Claims somehow requires a non-zero difference, Claims 1, 13 and 21 are rejected in the alternative in view of Grumet, Andrew Eli, "Electric stimulation parameters for an epi-retinal prosthesis," Thesis (Ph.D.)--Massachusetts Institute of Technology, Dept. of Electrical Engineering and Computer Science, 1999.
Overarchingly, Applicant’s arguments attempt to differentiate the claimed invention from the prior art based on the precisely the detail the Examiner has indicated the written description lacks. Applicant argues that the limitation “a differential amplifier configured to detect a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient” differentiates the claimed invention because (by Applicant’s characterization at Pg. 13 of Applicant’s 6/26/26 Remarks) Beck’s amplifier detects only “a difference in voltage” that is zero. Applicant’s arguments suggest that the above-quoted language somehow precludes such a difference, because Beck’s difference is inadequate as “a characteristic of the electrical stimulation” to indicate “whether phosphenes are visible to the patient.”
The Examiner’s position (see Para. 5 of the Non-Final Office Action dated 3/26/2026) is that the Present Specification does not describe precisely this in manner sufficient to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Applicant’s arguments regarding the rejection of Claims 1 and 13 under 35 USC 112(a) contradict Applicant’s art-based arguments. Applicant acknowledges at Pg. 11 of Applicant’s Remarks that a “differential amplifier” is “a common electronic component typically used to amplify a voltage difference…,” then proceeds to acknowledge that recited “differential amplifier” is used precisely for this “typical” purpose (“In this case, … the differential amplifier is used to detect a difference in voltage….”) (see Grumet at Pg. 94, Sixth Paragraph in support of this interpretation, referencing the amplified voltage differential as a measure of the difference). Applicant does not dispute that Beck’s differential amplifier is also used for this “typical” purpose, but instead highlights the specific output of Beck’s differential amplifier as being different.
This is precisely the issue: the Present Specification provides no guidance as to what particularly makes Beck’s output different, and the claims do not require any such particulars.
There is something specific about the what the differential amplifier detects that facilitates the determination of whether phosphenes are visible. These specifics could likely differentiate the claimed invention from the prior art. However, as it stands, these specifics are not reflected.
The Examiner notes that Para. [0067] of the Present Specification describes “stimulation pulse characteristics” upon which phosphenes depend, including “whether the pulse is biphasic or monophasic and whether the active electrode at the cornea or eyelid is anodic or cathodic,” but appears to describe these “stimulation pulse characteristics” in a generic sense and does not tie in the recited “differential amplifier.” If the Independent Claims intend to reference such “stimulation pulse characteristics” as described at Para. [0067], clarification to this effect would likely resolve several outstanding issues, provided the Specification supports such clarification.
The Examiner further notes that in view of divergent use of the term “characteristics” as elaborated upon below, in view of the fact that Applicant’s 6/26/2026 Remarks make no reference to any details of Para. [0067], and in view of Para. [0067] lack of reference to a “differential amplifier,” it is not clear whether the language of the Independent Claims is intended to reference the “stimulation pulse characteristics” of Para. [0067].
Applicant’s arguments regarding the rejection of dependent Claims 2-12, 14 and 16-20 are based on Applicant’s arguments regarding Independent Claims 1, 13 and 21. Applicant’s arguments have been fully considered but are not persuasive for the same reasons as explained above.
Applicant’s arguments regarding the objection to Claim 21 for minor informalities have been fully considered and are persuasive. The Examiner agrees that the cited informalities have been corrected. The objection is withdrawn.
Applicant’s arguments regarding the rejection of Claim 12 under 35 USC 112(b) have been fully considered and are persuasive. The Examiner agrees that the amendments to Claims 12 have resolved the cited indefiniteness issues. The rejection is withdrawn.
Applicant’s arguments regarding the rejection of Independent Claim 21 under 35 USC 112(b) for lack of antecedent basis for the term “the first eye of the patient” have been fully considered and are persuasive. The Examiner agrees that the lack of antecedent basis has been resolved. The rejection is withdrawn.
Applicant’s arguments regarding the rejection of Claims 1, 8, 12, 13 and 21 under 35 USC 112(a) for failing to comply with the written description requirement have been fully considered but are not persuasive. Applicant argues that “[O]ne of ordinary skill in the art would understand that a controller (e.g., a stimulation controller) may include a ‘differential amplifier,’ which is a common electronic component typically used to amplify a voltage difference between two input signals while suppressing any voltage common to both inputs, thus eliminating noise and interference. In this case, as described above, the differential amplifier is used to detect a difference in voltage between first and second sensor electrodes (e.g., a first sensor electrode 660 and a second sensor electrode 661 depicted in FIG. 6A of the application) in order to determine a characteristic of electrical- stimulation therapy, e.g., whether phosphenes are visible to a patient” (6/26/2026 Remarks at Pg. 12). The Present Specification provides no guidance as to how “a difference in voltage between the first sensor electrode and the second sensor electrode” is related to “a characteristic of the electrical-stimulation therapy.” That is, although the function of a differential amplifier is clear, one of ordinary skill in the art would not understand from the Specification how to “determine a characteristic of the electrical stimulation therapy” from the voltage difference detected by the differential amplifier. Applicant’s arguments are thus unpersuasive.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 8, 12, 13 and 21, and Claims 2-7, 9-11, 14 and 16-20 by dependency, rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Independent Claim 1, Claim 1 recites “wherein the stimulation controller includes a differential amplifier configured to detect a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient” The Present Specification does not relate the “detect[ed] … difference in voltage” to determining “a characteristic of the electrical-stimulation therapy” in manner sufficient to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
The Present Specification lists several “characteristics” determined in the manner of Claim 1. Those characteristics include an indication that phosphenes are visible to the patient (see, e.g., Present Specification at Para. [0105]) and an indication that the patient is experiencing discomfort (see, e.g., Present Specification at Para. [0106]).
It is noted that these same characteristics are additionally recited in dependent Claims 8, 10, 16 and 18.
The Present Specification details a “differential amplifier” only at Paras. [0023] and [0105]. The description at Para. [0105] appears pertinent to the “differential amplifier” recited by Claim 1. However, Para. [0105] does describe how the “differential amplifier “detect[s] a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy.”1 That is, neither Para. [0105] nor the remainder of the Present Specification reasonably convey how “a difference in voltage between the first sensor electrode and the second sensor electrode” is related to “a characteristic of the electrical-stimulation therapy.” One of ordinary skill in the art would therefore not understand from the Present Specification what is contemplated as being done to “detect a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy….”
The Examiner notes that “a characteristic of the electrical-stimulation therapy” is being interpreted to mean either the presence of phosphenes or patient discomfort, as opposed to an electrical characteristic of the stimulation itself. In this light, Paras. [0054] and [0066] through [0070] describe altering stimulation based on patient-reported phosphenes, and Paras. [0083] through [0089] describe various “indication[s] of phosphene visibility.” However, such voltage as recited by Claim 1 is not described as such an indication.
Regarding Claim 8, Claim 8 recites “wherein the characteristic of the electrical-stimulation therapy determined by the stimulation controller includes a first indication that phosphenes are visible to the patient in the first eye during the first treatment session.” For similar reasons to those explained above with respect to Claim 1, the Present Specification does not describe how “the stimulation controller” is configured to determine “the characteristic of the electrical-stimulation therapy” in manner sufficient to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Regarding Claim 12, Claims 12 recites a similar limitation (i.e., Claim 12 recites “wherein the differential amplifier is further configured to detect a difference in voltage between the third sensor electrode and the fourth sensor electrode in order to determine the characteristic of the electrical-stimulation therapy…”) and fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed for the same reasons as explained above with respect to Claim 1
Regarding Independent Claims 13 and 21, Claims 13 and 21 recites a similar limitation (i.e., Claims 13 and 21 both recite “detecting a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy…”) and fail to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed for the same reasons as explained above with respect to Claim 1.
Claims 1, 8, 12, 13 and 21, and Claims 2-7, 9-11, 14 and 16-20 by dependency, are alternatively rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement under an alternative interpretation of the term “… a characteristic of the electrical-stimulation therapy….”
As elaborated upon below, the Present Specification uses the term “characteristic” in two divergent ways: Para. [0067] describes “stimulation pulse characteristics” upon which phosphenes depend, including “whether the pulse is biphasic or monophasic and whether the active electrode at the cornea or eyelid is anodic or cathodic;” and Para. [0105] states “the characteristic includes a first indication that phosphenes are visible to the patient.” Para. [0021] states “As used herein, ‘phosphenes’ are impressions of light (e.g., visual flashes) within the eye that occur without light entering the eye that are caused by stimulation of the retina (e.g., stimulation of specific cells within the retina such as bipolar cells).” Under an interpretation wherein the term “characteristic” is intended to reflect the manner of its use at Para. [0067], the term “characteristic” is a broad genus which encompasses a wide variety of species. However, the Present Specific lists only a single species: “whether the active electrode at the cornea or eyelid is anodic or cathodic.” This single species is not a “representative number of species, as it is not representative of the entire genus. See MPEP 2163(II)(A)(3)(a)(ii).
Claims 1, 8, 12, 13 and 21 recites the term “a characteristic of the electrical-stimulation therapy,” regarding which the Present Specification fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
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 1, 12, 13 and 21, and Claims 2-11, 14, and 16-20 by dependency, 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.
Regarding Independent Claim 1, Claim 1 recites “determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.” It is unclear in what sense “whether phosphenes are visible to the patient” is “a characteristic of … electrical-stimulation therapy.”
The Present Specification does not attribute any special definition to the term “characteristic.” Accordingly, the term is being interpreted consistent with its plain meaning. Meriam-Webster dictionary defines the term “characteristic” as “a distinguishing trait, quality or property” (see Merriam-Webster Dictionary, "characteristic," accessed online 8/23/2026 via https://www.merriam-webster.com/dictionary/characteristic). The Present Specification uses the term “characteristic” in two divergent ways: Para. [0067] describes “stimulation pulse characteristics” upon which phosphenes depend, including “whether the pulse is biphasic or monophasic and whether the active electrode at the cornea or eyelid is anodic or cathodic;” and Para. [0105] states “the characteristic includes a first indication that phosphenes are visible to the patient.” Para. [0021] states “As used herein, ‘phosphenes’ are impressions of light (e.g., visual flashes) within the eye that occur without light entering the eye that are caused by stimulation of the retina (e.g., stimulation of specific cells within the retina such as bipolar cells).”
The limitation “determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient” appears to reference the Para. [0105] description (see Alternative Rejection of Claims 1, 8, 12, 13 and 21 under 35 USC 112(a), above). The description at Para. [0105] is not a “characteristic” (i.e., “a distinguishing trait, quality or property”) but an effect. This is a consequence of the Para. [0021] definition of the term “phosphenes” (Para. [0021], “…‘phosphenes’ are impressions of light (e.g., visual flashes) within the eye that occur without light entering the eye that are caused by stimulation of the retina…” (emphasis added)), and is compounded by claim phrasing (i.e., “to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.”).
For purposes of this Office Action, the term “determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient” is being interpreted to reference Para. [0105], and is being interpreted to mean that it is determined whether the applied stimulation produces phosphenes.
Claims 8, 12, 13 and 21 contain similar recitations to that addressed above with respect to Claim 1, and are indefinite for the same reasons.
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.
Claims 1-2, 8, 10, 12-13, 16-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 20190143116 A1 to Mowery et al. (“Mowery”) in view of previously cited US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and previously cited US 4979508 A to Beck (“Beck”).
Regarding Independent Claim 1, Mowery teaches:
A system for delivering electrical-stimulation therapy to a patient, the system comprising: (Title, Apparatus and method for ocular microcurrent stimulation therapy);
a first electrode substrate that includes: one or more stimulation electrodes on the first electrode substrate that are configured to apply electrical stimulation signals to a first eye of the patient, the first eye having an upper eyelid and a lower eyelid, wherein the first electrode substrate is configured to locate the one or more electrodes on an outer surface of at least one of the upper eyelid and the lower eyelid of the first eye of the patient; (Para. [0061]; Para. [0082]; Figs. 6A and 6B, “linear therapy strips 115,” “electrodes 111;” see Annotated Figs. 6A and 6B, below);
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a first return electrode configured to be placed in a return location on the patient that provides a return path for the electrical stimulation signals applied by the one or more stimulation electrodes such that an electrical current is formed between at least one of the one or more stimulation electrodes and the first return electrode; (Para. [0061]; Para. [0082], “In some embodiments, the therapeutic electrical-stimulation pulses are applied in a sequence (one at a time) to the electrodes 111 on therapy strips 615 surrounding each eye, wherein the return path (i.e., the ground signal) is provided through electrodes 641 (in some embodiments, one or more electrodes 641 is adhesively a coupled to the neck of patient 99; e.g., one to each side of the neck as shown);” Fig. 6A, “electrodes 641;” see Annotated Figs. 6A and 6B, above);
and a stimulation controller operatively coupled to the one or more stimulation electrodes, the plurality of sensor electrodes, and the first return electrode, (Fig. 6A, “controller 661;” Paras. [0082]-[0083]; Figs. 6A and 6B);
wherein the stimulation controller is configured to control the electrical current formed between the at least one of the one or more stimulation electrodes and the first return electrode such that the electrical current passes through a retina of the first eye of the patient and delivers the electrical-stimulation therapy, (Para. [0082], “In some embodiments, uniphasic signals are applied to the eye electrodes (either all positive voltages relative to ground electrode(s) 614, or all negative relative to ground electrode(s) 614) in order to accumulate the desired ionic molecules in or near the retinas of the patient);” Claim 4, “wherein the microcurrent-stimulation controller generates a prescribed microcurrent delivered to each electrode of the plurality of electrodes in a temporal sequence;” Claim 5);
Mowery does not disclose:
a plurality of sensor electrodes configured to detect electrical activity from neural cells of the patient during delivery of the electrical-stimulation therapy, wherein the plurality of sensor electrodes includes a first sensor electrode placed in a first selected location on the patient and a second sensor electrode placed in a second selected location on the patient;
and wherein the stimulation controller includes a differential amplifier configured to detect a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy.
Greenberg describes “a method of automatically adjusting an electrode array to the neural characteristics of an individual patient” (Abstract). Greenberg is analogous art.
Greenberg teaches:
a plurality of sensor electrodes configured to detect electrical activity from neural cells of the patient during delivery of the electrical-stimulation therapy, wherein the plurality of sensor electrodes includes a first sensor electrode placed in a first selected location on the patient and a second sensor electrode placed in a second selected location on the patient; (Para. [0041], “ One or more recording electrodes 162 are placed in near the visual cortex. The recording electrodes may temporary external electrodes, implanted electrodes under the scalp, or electrode implanted within the visual cortex;” Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]).
Greenberg’s “recording electrodes” as such “sensor electrodes as claimed. Greenberg’s “recording electrodes” are placed in the manner claimed. Each of Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]; and Para. [0041] detail alternative such placements.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mowery with the teachings of Greenberg (i.e., to employee such recording electrodes and associated recording components as taught by Greenberg in the device of Mowery) in order to facilitate objective (i.e., as opposed to subjective) assessment of stimulation response (Greenberg at Paras. [0035] through [0037]).
Beck describes an “apparatus and method [to] produce visual sensations by applying low voltages through conductive electrodes to the outside of a person's head, for transmission by natural mechanisms to the nervous system--to entertain or inform a sighted person, or to help a blind person to locate nearby objects” (Abstract). Beck is analogous art.
Beck teaches:
and wherein the stimulation controller includes a differential amplifier configured to detect a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient. (Col. 9, Ln. 63 through Col. 10, Ln. 27 (quotation omitted for brevity)).
As noted above, the term “determine a characteristic of the electrical-stimulation therapy” is being interpreted to reference the appearance of phosphenes. Beck describes using a differential operation amplified to control the generation of phosphenes at Col. 9, Ln. 63 through Col. 10, Ln. 27. Beck’s differential amplifier ensures that characteristics of the electrical stimulation are such that they are within a range that produces phosphenes, and thereby detects a difference in voltage between first and second sensor electrodes “in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery and Greenberg with the teachings of Beck (i.e., to use such a differential amplifier as taught by Beck in the controller of Mowery in conjunction with the sensor electrodes of Greenberg) in order to control the generation of phosphenes (Beck at Col. 3, Ln. 4-33), which may be useful “to entertain or inform a sighted person, or to help a blind person to locate nearby objects” (Beck at Abstract).
Regarding Claim 2, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 1 as explained above.
Greenberg additionally discloses:
wherein the one or more stimulation electrodes also functions as one of the plurality of sensor electrodes. (Para. [0032], “FIG. 2 is a flow chart of the automatic fitting sequence. In the flow chart, the value N is the current (or selected) electrode, X is the neural activity recorded, and L is the level of stimulation. First N is set to 0 40 and them incremented 42. The first electrode, electrode N, is addressed 44. The stimulation level is set to zero 46, and then incremented 48. The neural tissue is stimulated at the minimum level 50. The stimulation is immediately followed by a recording of activity in the neural tissue 52. Alternatively, recording can be done simultaneously by an adjacent electrode.”).
Regarding Claim 8, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 1 as explained above.
Greenberg additionally teaches:
wherein the stimulation controller is further configured to: set a current level of the electrical-stimulation therapy at a first value during a first treatment session, wherein the first value of the current level is below a stimulation threshold of the first eye, and increase the current level from the first value during the first treatment session, (Para. [0021], “A minimum input stimulus is applied to a patient, followed by recording neural response in the vicinity of the input stimulus. By alternating stimulation and recording at gradually increasing levels, one can determine the minimum input that creates a neural response, thereby identifying the threshold stimulation level;” Para. [0032]);
Greenberg’s “gradually increasing levels” of stimulation is an increase in current. See Greenberg at Para. [0032].
wherein the characteristic of the electrical-stimulation therapy determined by the stimulation controller includes a first indication that phosphenes are visible to the patient in the first eye during the first treatment session, (Para. [0004]; Para. [0015]; Para. [0019]; Para. [0021]; Para. [0032]);
Greenberg adjusts current to find the “threshold of perception” (Greenberg at Paras. [0021] and [0032]), stating that “[a]ny stimulation, less than the threshold of perception, is ineffective” (Greenberg at Para. [0015]). Greenberg uses the term “perception” as a shorthand for “electrically elicited visual perception” (Greenberg at Para. [0004]), which is “flashes of light or phosphenes” produced by retinal stimulation (Greenberg at Para. [0004]). Greenberg’s “threshold of perception” is thus the amount of stimulation required to invoke visual perception of phosphenes. Greenberg’s “characteristic of the electrical-stimulation therapy determined by the stimulation controller” thus “includes a first indication that phosphenes are visible to the patient” in the manner claimed.
and wherein the increase of the current level from the first value is stopped at a second value when the first indication is determined. (Para. [0021], “By alternating stimulation and recording at gradually increasing levels, one can determine the minimum input that creates a neural response, thereby identifying the threshold stimulation level. One can further determine a maximum level by increasing stimulus until a predetermined maximum neural response is obtained;” Para. [0019]).
Regarding Claim 10, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 8 as explained above.
Greenberg additionally teaches:
wherein the stimulation controller is further configured to increase the current level from the second value during the first treatment session, wherein the characteristic of the electrical-stimulation therapy includes a second indication that the patient is experiencing discomfort during the first treatment session, and wherein the increase of the current level from the second value is stopped at a third value when the second indication is determined. (Para. [0033], “Once minimum neural activity is recorded, the stimulation level is saved in memory 56. The level is then further increased 58 and stimulation is repeated 60. Again stimulation is immediately followed by recording neural activity 62. If a predetermined maximum level has not been reached, steps 58-64 are repeated until the predetermined maximum stimulation level is obtained. Once the predetermined maximum stimulation level is obtained, steps 42-64 are repeated for the next electrode. The process is continued until a minimum and maximum stimulation level is determined for each electrode 66;” Para. [0004]; Para. [0015]; Para. [0019]; Para. [0021]; Para. [0032]).
Greenberg’s “minimum” stimulation level is perception of phosphenes (see above), and Greenberg’s “maximum stimulation level” is the point where pain begins (see Greenberg at Para. [0019], “The greatest dynamic range is achieved by setting the minimum stimulation at the threshold of perception and the maximum stimulation level approaching the pain threshold.”). Pain is such discomfort as claimed.
Greenberg’s second increase to pain threshold is such an increase as recited by Claim 10.
Greenberg’s “gradually increasing levels” of stimulation is an increase in current. See Greenberg at Para. [0032].
Regarding Claim 12, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 1 as explained above.
Mowery additionally teaches:
further comprising: a second electrode substrate that includes: one or more stimulation electrodes on the second electrode substrate that are configured to apply electrical stimulation signals to a second eye of the patient, the second eye having an upper eyelid and a lower eyelid, wherein the second electrode substrate is configured to locate the one or more electrodes on an outer surface of at least one of the upper eyelid and the lower eyelid of the second eye of the patient; (Para. [0061]; Para. [0082]; Figs. 6A and 6B, “linear therapy strips 115,” “electrodes 111;” see Annotated Figs. 6A and 6B, above at Claim 1);
wherein the first return electrode is further configured to provide a return path for the electrical stimulation signals applied by the one or more stimulation electrodes on the second electrode substrate such that an electrical current is formed between at least one of the one or more stimulation electrodes on the second electrode substrate and the first return electrode; (Para. [0061]; Para. [0082], “In some embodiments, the therapeutic electrical-stimulation pulses are applied in a sequence (one at a time) to the electrodes 111 on therapy strips 615 surrounding each eye, wherein the return path (i.e., the ground signal) is provided through electrodes 641 (in some embodiments, one or more electrodes 641 is adhesively a coupled to the neck of patient 99; e.g., one to each side of the neck as shown);” Fig. 6A, “electrodes 641;” see Annotated Figs. 6A and 6B, above);
wherein the stimulation controller is operatively coupled to the one or more stimulation electrodes on the second electrode substrate, and wherein the stimulation controller is operatively coupled to the third sensor electrode and the fourth sensor electrode; (Fig. 6A, “controller 661;” Paras. [0082]-[0083]; Figs. 6A and 6B);
and wherein the stimulation controller is further configured to control the electrical current formed between the at least one of the one or more stimulation electrodes on the second electrode substrate and the first return electrode such that the electrical current passes through a retina of the second eye of the patient and delivers the electrical-stimulation therapy, (Para. [0082], “In some embodiments, uniphasic signals are applied to the eye electrodes (either all positive voltages relative to ground electrode(s) 614, or all negative relative to ground electrode(s) 614) in order to accumulate the desired ionic molecules in or near the retinas of the patient);” Claim 4, “wherein the microcurrent-stimulation controller generates a prescribed microcurrent delivered to each electrode of the plurality of electrodes in a temporal sequence;” Claim 5);
The combination of Mowery, Greenberg and Beck as contemplated with respect to Claim 1 does not disclose:
wherein the plurality of sensor electrodes includes a third sensor electrode placed in a third selected location on the patient and a fourth sensor electrode placed in a fourth selected location on the patient;
and wherein the differential amplifier is further configured to detect a difference in voltage between the third sensor electrode and the fourth sensor electrode in order to determine the characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient in the second eye..
However, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Mowery, Greenberg and Beck as contemplated with respect to Claim 1 in the same manner as explained above with respect to Claim 1, because such a modification entails a mere duplication of parts, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient (MPEP 2144.04(VI)(B)).
In this light, Greenberg teaches:
wherein the plurality of sensor electrodes includes a third sensor electrode placed in a third selected location on the patient and a fourth sensor electrode placed in a fourth selected location on the patient; (Para. [0041], “ One or more recording electrodes 162 are placed in near the visual cortex. The recording electrodes may temporary external electrodes, implanted electrodes under the scalp, or electrode implanted within the visual cortex;” Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]).
Greenberg’s “recording electrodes” as such “sensor electrodes as claimed. Greenberg’s “recording electrodes” are placed in the manner claimed. Each of Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]; and Para. [0041] detail alternative such placements.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Mowery, Greenberg and Beck with the teachings of Greenberg (i.e., to employee such recording electrodes and associated recording components as taught by Greenberg in the device of Mowery) in order to facilitate objective (i.e., as opposed to subjective) assessment of stimulation response (Greenberg at Paras. [0035] through [0037]).
Beck teaches:
and wherein the differential amplifier is further configured to detect a difference in voltage between the third sensor electrode and the fourth sensor electrode in order to determine the characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient in the second eye. (Col. 9, Ln. 63 through Col. 10, Ln. 27 (quotation omitted for brevity)).
As noted above, the term “determine a characteristic of the electrical-stimulation therapy” is being interpreted to reference the appearance of phosphenes. Beck describes using a differential operation amplified to control the generation of phosphenes at Col. 9, Ln. 63 through Col. 10, Ln. 27. Beck’s differential amplifier ensures that characteristics of the electrical stimulation are such that they are within a range that produces phosphenes, and thereby detects a difference in voltage between first and second sensor electrodes “in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of combined Mowery, Greenberg and Beck with the teachings of Beck (i.e., to use such a differential amplifier as taught by Beck in the controller of Mowery in conjunction with the sensor electrodes of Greenberg) in order to control the generation of phosphenes (Beck at Col. 3, Ln. 4-33), which may be useful “to entertain or inform a sighted person, or to help a blind person to locate nearby objects” (Beck at Abstract).
Regarding Independent Claim 13, Mowery teaches:
A method for delivering electrical-stimulation therapy to a patient, the method comprising: (Title, Apparatus and method for ocular microcurrent stimulation therapy);
providing a first electrode substrate, wherein the first electrode substrate includes: one or more stimulation electrodes on the first electrode substrate that are configured to apply electrical stimulation signals to a first eye of the patient, the first eye having an upper eyelid and a lower eyelid; (Para. [0061]; Para. [0082]; Figs. 6A and 6B, “linear therapy strips 115,” “electrodes 111;” see Annotated Figs. 6A and 6B, above at Claim 1);
attaching the first electrode substrate to the patient's skin such that the one or more stimulation electrodes are on the outer surface of at least one of the upper eyelid and the lower eyelid of the first eye of the patient; (Para. [0061]; Para. [0082]; Figs. 6A and 6B, “linear therapy strips 115,” “electrodes 111;” see Annotated Figs. 6A and 6B, above at Claim 1);
Mowery’s “electrode substrate” is so-attached, as shown in Annotated Figs. 6A and 6B.
providing a first return electrode; placing the first return electrode in a return location on the patient that provides a return path for the electrical stimulation signals applied by the one or more stimulation electrodes such that an electrical current is formed between at least one of the one or more stimulation electrodes and the first return electrode; (Para. [0061]; Para. [0082], “In some embodiments, the therapeutic electrical-stimulation pulses are applied in a sequence (one at a time) to the electrodes 111 on therapy strips 615 surrounding each eye, wherein the return path (i.e., the ground signal) is provided through electrodes 641 (in some embodiments, one or more electrodes 641 is adhesively a coupled to the neck of patient 99; e.g., one to each side of the neck as shown);” Fig. 6A, “electrodes 641;” see Annotated Figs. 6A and 6B, above);
delivering the electrical-stimulation therapy to the first eye, wherein the delivering includes controlling the electrical current formed between the at least one of the one or more stimulation electrodes and the first return electrode such that the electrical current passes through a retina of the first eye of the patient; (Para. [0082], “In some embodiments, uniphasic signals are applied to the eye electrodes (either all positive voltages relative to ground electrode(s) 614, or all negative relative to ground electrode(s) 614) in order to accumulate the desired ionic molecules in or near the retinas of the patient);” Claim 4, “wherein the microcurrent-stimulation controller generates a prescribed microcurrent delivered to each electrode of the plurality of electrodes in a temporal sequence;” Claim 5);
Mowery does not disclose:
providing a plurality of sensor electrodes including a first sensor electrode and a second sensor electrode;
placing the first sensor electrode in a first selected location on the patient, and placing the second sensor electrode in a second selected location on the patient;
and detecting, using the plurality of sensor electrodes, electrical activity from neural cells of the patient during the delivering of the electrical-stimulation therapy to the first eye,
wherein the detecting of the electrical activity includes: detecting a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.
Greenberg describes “a method of automatically adjusting an electrode array to the neural characteristics of an individual patient” (Abstract). Greenberg is analogous art.
Greenberg teaches:
providing a plurality of sensor electrodes including a first sensor electrode and a second sensor electrode; placing the first sensor electrode in a first selected location on the patient, and placing the second sensor electrode in a second selected location on the patient; (Para. [0041], “ One or more recording electrodes 162 are placed in near the visual cortex. The recording electrodes may temporary external electrodes, implanted electrodes under the scalp, or electrode implanted within the visual cortex;” Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]).
Greenberg’s “recording electrodes” as such “sensor electrodes as claimed. Greenberg’s “recording electrodes” are placed in the manner claimed. Each of Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]; and Para. [0041] detail alternative such placements.
and detecting, using the plurality of sensor electrodes, electrical activity from neural cells of the patient during the delivering of the electrical-stimulation therapy to the first eye, (Para. [0032], “The first electrode, electrode N, is addressed 44. The stimulation level is set to zero 46, and then incremented 48. The neural tissue is stimulated at the minimum level 50. The stimulation is immediately followed by a recording of activity in the neural tissue 52. Alternatively, recording can be done simultaneously by an adjacent electrode. … The neural response follows stimulation (see FIG. 4).”);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mowery with the teachings of Greenberg (i.e., to employee such recording electrodes and associated recording components as taught by Greenberg in the device of Mowery and to use those electrodes for Greenberg’s purpose of detecting neural activity) in order to facilitate objective assessment (i.e., as opposed to subjective assessment) of stimulation response (Greenberg at Paras. [0035] through [0037]).
Beck describes an “apparatus and method [to] produce visual sensations by applying low voltages through conductive electrodes to the outside of a person's head, for transmission by natural mechanisms to the nervous system--to entertain or inform a sighted person, or to help a blind person to locate nearby objects” (Abstract). Beck is analogous art.
Beck teaches:
wherein the detecting of the electrical activity includes: detecting a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient. (Col. 9, Ln. 63 through Col. 10, Ln. 27 (quotation omitted for brevity)).
As noted above, the term “determine a characteristic of the electrical-stimulation therapy” is being interpreted to reference the appearance of phosphenes. Beck describes using a differential operation amplified to control the generation of phosphenes at Col. 9, Ln. 63 through Col. 10, Ln. 27. Beck’s differential amplifier ensures that characteristics of the electrical stimulation are such that they are within a range that produces phosphenes, and thereby detects a difference in voltage between first and second sensor electrodes “in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Mowery and Greenberg with the teachings of Beck (i.e., to use such a differential amplifier as taught by Beck in the controller of Mowery in conjunction with the sensor electrodes of Greenberg) in order to control the generation of phosphenes (Beck at Col. 3, Ln. 4-33), which may be useful “to entertain or inform a sighted person, or to help a blind person to locate nearby objects” (Beck at Abstract).
Regarding Claim 16, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 13 as explained above.
Greenberg additionally teaches:
wherein the characteristic of the electrical-stimulation therapy includes a first indication that phosphenes are visible to the patient in the first eye during the first treatment session (Para. [0004]; Para. [0015]; Para. [0019]; Para. [0021]; Para. [0032]; see Rejection Claim 8, above);
the method further comprising: setting a current level of the electrical-stimulation therapy at a first value during a first treatment session, wherein the first value of the current level is below a stimulation threshold of the first eye; increasing the current level from the first value during the first treatment session; and stopping the increasing of the current level from the first value at a second value based on the first indication (Para. [0004]; Para. [0015]; Para. [0019]; Para. [0021]; Para. [0032]; see rejection of Claim 8, above).
Regarding Claim 17, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 13 as explained above.
Greenberg additionally teaches:
further comprising: eliciting and receiving feedback from the patient during the first treatment session, wherein the determining of the first indication is calibrated based at least in part on the received feedback. (Para. [0033], “…perception by the patient is the determining factor;” Paras. [0034] through [0038]; Para. [0015]; Para. [0019]; Para. [0021]; Para. [0033]).
Regarding Claim 18, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 13 as explained above.
Greenberg additionally teaches
further comprising: increasing the current level from the second value during the first treatment session, wherein the characteristic includes a second indication that the patient is experiencing discomfort during the first treatment session; and stopping the increasing of the current level from the second value at a third value based on the second indication. (Para. [0033], “Once minimum neural activity is recorded, the stimulation level is saved in memory 56. The level is then further increased 58 and stimulation is repeated 60. Again stimulation is immediately followed by recording neural activity 62. If a predetermined maximum level has not been reached, steps 58-64 are repeated until the predetermined maximum stimulation level is obtained. Once the predetermined maximum stimulation level is obtained, steps 42-64 are repeated for the next electrode. The process is continued until a minimum and maximum stimulation level is determined for each electrode 66;” Para. [0004]; Para. [0015]; Para. [0019]; Para. [0021]; Para. [0032]).
Greenberg’s “minimum” stimulation level is perception of phosphenes (see above), and Greenberg’s “maximum stimulation level” is the point where pain begins (see Greenberg at Para. [0019], “The greatest dynamic range is achieved by setting the minimum stimulation at the threshold of perception and the maximum stimulation level approaching the pain threshold.”). Pain is such discomfort as claimed.
Greenberg’s second increase to pain threshold is such an increase as recited by Claim 10.
This limitation is being interpreted similarly to Claim 10, above.
Regarding Independent Claim 21, Mowery teaches:
A non-transitory computer-readable medium having instructions stored thereon for causing a suitably programmed control system to execute a method for delivering electrical- stimulation therapy to a patient, wherein the method is executed by the control system on an electrical-stimulation system (Title, Apparatus and method for ocular microcurrent stimulation therapy;” Para. [0063], “…micro-current stimulation controller apparatus 161 includes a microprocessor (μP) operated by a battery, and optionally is controlled and/or programmed by a nearby laptop personal computer, a tablet computer, a desktop computer or the like;” Fig. 6A, “controller 661;” Paras. [0082]-[0083]; Figs. 6A and 6B);
that includes one or more stimulation electrodes on a first electrode substrate, wherein the one or more stimulation electrodes are configured to apply electrical stimulation signals to a first eye of the patient, the first eye having an upper eyelid and a lower eyelid, wherein the first electrode substrate is attached to the patient's skin such that the one or more stimulation electrodes are on the outer surface at least one of the upper eyelid and the lower eyelid of the first eye of the patient, (Para. [0061]; Para. [0082]; Figs. 6A and 6B, “linear therapy strips 115,” “electrodes 111;” see Annotated Figs. 6A and 6B, above at Claim 1);
a first return electrode that is placed in a return location on the patient that provides a return path for the electrical stimulation signals applied by the one or more stimulation electrodes such that an electrical current is formed between at least one of the one or more stimulation electrodes and the first return electrode, (Para. [0061]; Para. [0082], “In some embodiments, the therapeutic electrical-stimulation pulses are applied in a sequence (one at a time) to the electrodes 111 on therapy strips 615 surrounding each eye, wherein the return path (i.e., the ground signal) is provided through electrodes 641 (in some embodiments, one or more electrodes 641 is adhesively a coupled to the neck of patient 99; e.g., one to each side of the neck as shown);” Fig. 6A, “electrodes 641;” see Annotated Figs. 6A and 6B, above);
the method comprising: delivering the electrical-stimulation therapy to the first eye, wherein the delivering includes controlling the electrical current formed between the at least one of the one or more stimulation electrodes and the first return electrode such that the electrical current passes through a retina of the first eye of the patient; (Para. [0082], “In some embodiments, uniphasic signals are applied to the eye electrodes (either all positive voltages relative to ground electrode(s) 614, or all negative relative to ground electrode(s) 614) in order to accumulate the desired ionic molecules in or near the retinas of the patient);” Claim 4, “wherein the microcurrent-stimulation controller generates a prescribed microcurrent delivered to each electrode of the plurality of electrodes in a temporal sequence;” Claim 5);
Mowery does not disclose:
a plurality of sensor electrodes including a first sensor electrode placed in a first selected location on the patient and a second sensor electrode placed in a second selected location on the patient,
and detecting, via the plurality of sensor electrodes, electrical activity from neural cells of the patient during the delivering of the electrical-stimulation therapy to the first eye,
wherein the detecting of the electrical activity includes: detecting a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.
Greenberg describes “a method of automatically adjusting an electrode array to the neural characteristics of an individual patient” (Abstract). Greenberg is analogous art.
Greenberg teaches:
a plurality of sensor electrodes including a first sensor electrode placed in a first selected location on the patient and a second sensor electrode placed in a second selected location on the patient, (Para. [0041], “ One or more recording electrodes 162 are placed in near the visual cortex. The recording electrodes may temporary external electrodes, implanted electrodes under the scalp, or electrode implanted within the visual cortex;” Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]).
Greenberg’s “recording electrodes” as such “sensor electrodes as claimed. Greenberg’s “recording electrodes” are placed in the manner claimed. Each of Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]; and Para. [0041] detail alternative such placements.
and detecting, via the plurality of sensor electrodes, electrical activity from neural cells of the patient during the delivering of the electrical-stimulation therapy to the first eye, (Para. [0032], “The first electrode, electrode N, is addressed 44. The stimulation level is set to zero 46, and then incremented 48. The neural tissue is stimulated at the minimum level 50. The stimulation is immediately followed by a recording of activity in the neural tissue 52. Alternatively, recording can be done simultaneously by an adjacent electrode. … The neural response follows stimulation (see FIG. 4).”);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mowery with the teachings of Greenberg (i.e., to employee such recording electrodes and associated recording components as taught by Greenberg in the device of Mowery and to use those electrodes for Greenberg’s purpose of detecting neural activity) in order to facilitate objective assessment (i.e., as opposed to subjective assessment) of stimulation response (Greenberg at Paras. [0035] through [0037]).
Beck describes an “apparatus and method [to] produce visual sensations by applying low voltages through conductive electrodes to the outside of a person's head, for transmission by natural mechanisms to the nervous system--to entertain or inform a sighted person, or to help a blind person to locate nearby objects” (Abstract). Beck is analogous art.
Beck teaches:
wherein the detecting of the electrical activity includes: detecting a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient. (Col. 9, Ln. 63 through Col. 10, Ln. 27 (quotation omitted for brevity)).
As noted above, the term “determine a characteristic of the electrical-stimulation therapy” is being interpreted to reference the appearance of phosphenes. Beck describes using a differential operation amplified to control the generation of phosphenes at Col. 9, Ln. 63 through Col. 10, Ln. 27. Beck’s differential amplifier ensures that characteristics of the electrical stimulation are such that they are within a range that produces phosphenes, and thereby detects a difference in voltage between first and second sensor electrodes “in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of combined Mowery and Greenberg with the teachings of Beck (i.e., to use such a differential amplifier as taught by Beck in the controller of Mowery in conjunction with the sensor electrodes of Greenberg) in order to control the generation of phosphenes (Beck at Col. 3, Ln. 4-33), which may be useful “to entertain or inform a sighted person, or to help a blind person to locate nearby objects” (Beck at Abstract).
Claims 3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190143116 A1 to Mowery et al. (“Mowery”) in view of US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and US 4979508 A to Beck (“Beck”) as applied to Claims 1 and 13 above, and further in view of V. Wong and S. Graham, “Effect of repeat use and coating defects of gold foil electrodes on electroretinogram recording,” Vision Research, vol. 35, pp. 2795-2799, October 1995, available: http://www.sciencedirect.com/science/article/pii/00426989950004 63 (“Wong”).
Regarding Claim 3, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 1 as explained above.
The combination of Mowery, Greenberg and Beck does not disclose:
wherein the first sensor electrode includes a gold foil electrode configured to contact a conjunctiva of the first eye of the patient
Wong describes “Effect of Repeat Use and Coating Defects of Gold Foil Electrodes on Electroretinogram Recording” (Title). Wong is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Wong teaches:
wherein the first sensor electrode includes a gold foil electrode configured to contact a conjunctiva of the first eye of the patient (Pg. 2795, Right Column, Second Paragraph, “A total of 94 Arden-Carter-Hogg type gold foil electrodes (The Electrode Store, Enumclaw, Wash.) used over an 18 month period were collected;” Pg. 2798, Right Column, First Paragraph, “It provides good contact with corneas of any curvature, does not create optical distortion, produces minimal conjunctival or corneal irritation, is comfortable to the patient, and is useful in prolonged testing sessions.”)
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Wong (i.e., to use such a gold foil electrode configured to contact a conjunctiva of the first eye of the patient as taught by Wong as a sensor electrode) because “[g]old foil electrodes do not interfere with the visual axis and make contact only with the inferior cornea [and] [t]hey are well tolerated and can be used without local anaesthetic in many patients” (Wong at Pg. 2795, Left Column, First Paragraph).
Regarding Claim 20, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 13 as explained above.
The combination of Mowery, Greenberg and Beck does not disclose:
wherein the placing of the first sensor electrode on the patient in the first selected location includes contacting a cornea of the first eye of the patient with at least a portion of the first sensor electrode
Wong describes “Effect of Repeat Use and Coating Defects of Gold Foil Electrodes on Electroretinogram Recording” (Title). Wong is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Wong teaches:
wherein the placing of the first sensor electrode on the patient in the first selected location includes contacting a cornea of the first eye of the patient with at least a portion of the first sensor electrode (Pg. 2795, Left Column, First Paragraph “Since its inception in the late 1970s, the gold foil electrode has gained widespread acceptance as a means of recording electroretinograms (ERGs) (Arden, Carter, Hogg, Siegel & Margolis, 1979; Borda, Gilliam & Coats, 1977). Gold foil electrodes do not interfere with the visual axis and make contact only with the inferior cornea.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Wong (i.e., to place the sensor electrode of combined Mowery, Greenberg and Beck in contact with the cornea in the manner of Wong) in order to facilitate recording electroretinograms (Pg. 2795, Left Column, First Paragraph).
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190143116 A1 to Mowery et al. (“Mowery”) in view of US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and US 4979508 A to Beck (“Beck”) as applied to Claim 1 above, and further in view of US 2013/0066396 A1 to Gekeler et al. (“Gekeler”).
Regarding Claim 4, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 1 as explained above.
The combination of Mowery, Greenberg and Beck does not disclose:
wherein the first sensor electrode includes a Dawson- Trick-Litzkow (DTL) electrode configured to contact a cornea of the first eye of the patient
Gekeler describes a “Method For Treating An Eye” (Title). Gekeler is analogous art.
Gekeler teaches:
wherein the first sensor electrode includes a Dawson- Trick-Litzkow (DTL) electrode configured to contact a cornea of the first eye of the patient (Para. [0069], “For electrical stimulation a sterile single-use DTL electrode (Diagnosys UK Ltd, Cambridge, UK) was used as active electrode as described in the original publication of Dawson et al., "Improved electrode for electroretinography", in Invest Ophthalmol VisSci, 1979; 18: 988-991;” Para. [0111], “The threads which were selected (monofilament, 0.1 mm in diameter) lie securely on the corneal surface or the edge of the lid and engender only the same kind of irritation as that created by an eyelash, for example.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Gekeler (i.e., to use such a Dawson- Trick-Litzkow (DTL) electrode configured to contact a cornea as taught by Gekeler as a sensor electrode) because such DTL electrodes “engender only the same kind of irritation as that created by an eyelash, for example,” (Gekeler at Para. [0111]) and therefore result in a less physically irritating device.
Regarding Claim 9, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 8 as explained above.
Greenberg additionally teaches:
wherein the stimulation controller is calibrated for the determination of the first indication based at least in part on the feedback received by the user interface. (Para. [0033], “…perception by the patient is the determining factor;” Paras. [0034] through [0038]).
The combination of Mowery, Greenberg and Beck does not disclose:
further comprising: a user interface configured to elicit and receive feedback from the patient during the first treatment session,
Gekeler describes a “Method For Treating An Eye” (Title). Gekeler is analogous art.
Gekeler teaches:
further comprising: a user interface configured to elicit and receive feedback from the patient during the first treatment session, (Paras. [0127] through [0129]);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Gekeler (i.e., to include such a user interface for receiving patient feedback as taught by Gekeler) in order to “provide the patient with a treatment designed for him/her alone” (Gekeler at Para. [0127]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 20190143116 A1 to Mowery et al. (“Mowery”) in view of US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and US 4979508 A to Beck (“Beck”) as applied to Claim 1 above, and further in view of Ozaki K, Yoshikawa Y, Ishikawa S, Katsumoto T, Shibuya M, et al. (2019) Electroretinograms recorded with skin electrodes in silicone oil-filled eyes. PLOS ONE 14(5): e0216823 (“Ozaki”).
Regarding Claim 5, the combination of the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 1 as explained above.
The combination of Mowery, Greenberg and Beck does not disclose:
wherein the first selected location of the first sensor electrode is the outer surface of the lower eyelid of the first eye of the patient.
Ozaki describes “Electroretinograms recorded with skin electrodes in silicone oil-filled eyes” (Title). Ozaki is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Ozaki teaches:
wherein the first selected location of the first sensor electrode is the outer surface of the lower eyelid of the first eye of the patient. (Pg. 3 of 11, First Paragraph, “The ERGs were recorded after 20 minutes of dark-adaptation, and the combined rod and cone responses were picked-up by a sensor strip skin electrode affixed to the lower eyelid of both eyes.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Ozaki (i.e., to position the sensors of combined Mowery, Greenberg and Beck on the outer surface of the lower eyelid in the manner of Ozaki) in order to facilitate measurement of rod and cone response (Ozaki at Pg. 3 of 11, First Paragraph).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 20190143116 A1 to Mowery et al. (“Mowery”) in view of US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and US 4979508 A to Beck (“Beck”) as applied to Claim 1 above, and further in view of US 20170319093 A1 to Stewart (“Stewart”).
Regarding Claim 6, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 1 as explained above.
The combination of Mowery, Greenberg and Beck does not disclose:
wherein the second selected location of the second sensor electrode is on a side of the patient's head
Stewart describes a “Mono-Layer Electrode Sensor” (Title) suitable for use in electroretinography (ERG) (Stewart at Para. [0012]). Stewart is reasonable pertinent to the problem faced by the inventor and is thus analogous art.
Stewart teaches:
wherein the second selected location of the second sensor electrode is on a side of the patient's head (Para. [0027], “FIG. 8 is a front plan view of a human face showing placement of curvilinear-shaped electrode sensors over a variety of locations including lower eyelids for active signals, temples for reference signals, and forehead for ground for ERG testing according to an embodiment;” Para. [0062]; Para. [0063], “The curvilinear-shaped electrode sensors 36 placed on the lower eyelids 52 act as the signal sensors for the ERG test, while the electrode sensors 36 placed about the temples 58 and the forehead 60 serve as additional reference and ground sensors, respectively.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Stewart (i.e., to position the second sensor electrode is on a side of the patient's head in the manner of Stewart) in order to facilitate the provision of reference signals during ERG testing (Stewart at Para. [0062]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 20190143116 A1 to Mowery et al. (“Mowery”) in view of US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and US 4979508 A to Beck (“Beck”) as applied to Claim 1 above, and further in view of US 2015/0342495 A1 to Davis et al. (“Davis”).
Regarding Claim 7, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 1 as explained above.
The combination of Mowery, Greenberg and Beck does not disclose:
wherein the plurality of sensors includes a third sensor electrode configured to reduce common-mode interference.
Davis describes “A device providing an indication of visual system function of a patient” (Claim 1). Davis is analogous art.
Davis teaches:
wherein the plurality of sensors includes a third sensor electrode configured to reduce common-mode interference (Para. [0075], “…in one embodiment, the first electrode can be located under the eye, the second electrode can be located near the temple, and the third electrode can be located in between the first electrode and the second electrode. The common-mode attenuation circuit can reduce the common-mode voltage difference between signals on the electrodes and the A/D converter caused, for example, by capacitive coupling between the power lines and the body. By reducing common-mode interference, potential measurements between electrodes can be made more accurately.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Davis (i.e., to include a third sensor electrode configured to reduce common-mode interference in the manner of Davis) in order to increase the accuracy of potential measurements between electrodes (Davis at Para. [0075]).
Claims 11 and 14 is rejected under 35 U.S.C. 103 as being unpatentable over US 20190143116 A1 to Mowery et al. (“Mowery”) in view of US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and US 4979508 A to Beck (“Beck”) as applied to Claims 1 and 13above, and further in view of US 20200101290 A1 to Rockley et al. (“Rockley”).
Regarding Claim 11, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 1 as explained above.
Greenberg additionally teaches:
wherein the stimulation controller is further configured to: set a current level of the electrical-stimulation therapy at a first value during a first treatment session, wherein the first value of the current level is below a stimulation threshold of the first eye, increase the current level from the first value during the first treatment session, and … receive … a first indication that phosphenes are visible to the patient, wherein the increase of the current level from the first value is stopped at a second value when the first indication is received (Para. [0021], “A minimum input stimulus is applied to a patient, followed by recording neural response in the vicinity of the input stimulus. By alternating stimulation and recording at gradually increasing levels, one can determine the minimum input that creates a neural response, thereby identifying the threshold stimulation level;” Para. [0004]; Para. [0015]; Para. [0019]; Para. [0021]; Para. [0032]; Para. [0033]);
Greenberg adjusts current to find the “threshold of perception” (Greenberg at Paras. [0021] and [0032]), stating that “[a]ny stimulation, less than the threshold of perception, is ineffective” (Greenberg at Para. [0015]). Greenberg uses the term “perception” as a shorthand for “electrically elicited visual perception” (Greenberg at Para. [0004]), which is “flashes of light or phosphenes” produced by retinal stimulation (Greenberg at Para. [0004]). Greenberg’s “threshold of perception” is thus the amount of stimulation required to invoke visual perception of phosphenes. Greenberg stops looking for the threshold of perception when reached.
Greenberg’s “gradually increasing levels” of stimulation is an increase in current. See Greenberg at Para. [0032].
Greenberg’s above methodology is based on receipt of patient perception. See Greenberg at Para. [0033] (“…perception by the patient is the determining factor. If neural activity is detected and the patient reports no perception, the minimum level must be set higher. Once minimum neural activity is recorded, the stimulation level is saved in memory 56.”)
Greenberg’s controller does not elicit and receive such information from the patient, however. This deficiency is addressed below
The combination of Mowery, Greenberg and Beck does not disclose:
and elicit and receive, from the patient, a first indication that phosphenes are visible to the patient
That is, Greenberg’s controller does not elicit and receive such information from the patient.
Rockley describes a “System and methods for controlled electrical modulation for vision therapy” (Title). Rockley is analogous art.
Rockley teaches:
and elicit and receive, from the patient, a first indication that phosphenes are visible to the patient (Para. [0064], “Additionally or alternatively, the system comprises a user interface (such as interface 30 or patient controller 220), wherein the threshold test means is configured to perform the phosphene threshold test in a series of iterations (block 324 in FIG. 7) in which: A. a phosphene threshold test signal is issued; and B. the patient is queried via the user interface as to whether a phosphene was observed and a response from the patient is obtained via the user interface; wherein if the patient indicates that no phosphene was observed at B, the phosphene threshold test signal is modified and the iterative analysis returns to A; or if the patient indicates that a phosphene was observed, the system concludes that the last used parameters of the phosphene threshold test signal met the phosphene threshold.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Rockley (i.e., to automate Greenberg’s process of manually soliciting patient response regarding phosphenes in the manner of Rockley’s controller) because such a modification merely entails automating a manual activity, which is a common practice the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient (MPEP 2144.04(III)).
Regarding Claim 14, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 13 as explained above.
The combination of Mowery, Greenberg and Beck does not disclose:
further comprising: generating electroretinogram (ERG) data based at least in part on the detected electrical activity.
Rockley describes a “System and methods for controlled electrical modulation for vision therapy” (Title). Rockley is analogous art.
Rockley teaches:
further comprising: generating electroretinogram (ERG) data based at least in part on the detected electrical activity. (Para. [0026], “In other examples information may include patient entered responses to electrically evoked phosphene thresholds (EPT) that may be correlated with electrical stimulation parameters, visual acuity, patient disease status or other information about the patient or the therapy. Furthermore, data on particular patterns or morphology (snow flakes, stars, lightening bolts) of the evoked phosphenes may be recorded. Information may also be collected from physician administered testing including Early Treatment Diabetic Retinopathy Study Charts (ETDRS Visual Acuity Tester), slit lamp biomicroscopy, fundus examination, tonometry, static and kinetic perimetries, electroretinogram (ERG) readings,…”).
Rockley’s correlation is “generating electroretinogram (ERG) data based at least in part on the detected electrical activity.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Rockley (i.e., to generate electroretinogram (ERG) data based at least in part on the detected electrical activity via such correlation as taught by Rockley) in order to “provid[e] the physician greater access to status and therapy history for a patient” (Rockley at Para. [0027]).
Claim 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20190143116 A1 to Mowery et al. (“Mowery”) in view of US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and US 4979508 A to Beck (“Beck”) as applied to Claim 13 above, and further in view of US 7003355 B1 to Suaning et al. (“Suaning”).
Regarding Claim 19, the combination of Mowery, Greenberg and Beck renders obvious the entirety of Claim 13 as explained above.
The combination of Mowery, Greenberg and Beck does not disclose:
wherein the placing of the first sensor electrode on the patient in the first selected location includes contacting a conjunctiva of the first eye of the patient with at least a portion of the first sensor electrode.
Suaning describes “Vision prosthesis for the blind and method for implementing same” (Title). Suaning is analogous art.
Suaning teaches:
wherein the placing of the first sensor electrode on the patient in the first selected location includes contacting a conjunctiva of the first eye of the patient with at least a portion of the first sensor electrode. (Col. 5, Ln. 4-10, “Other locations for positioning electrodes 50, 60 include, but are not limited to, the vitreous, aqueous, lenticular, iridal, or corneal media, beneath the conjunctiva and in contact with the sclera 74, upon the cornea or beneath the eyelid, and remote to the eye 70 and orbit, e.g., embedded within the temporal bone.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery, Greenberg and Beck with the teachings of Suaning (i.e., to position the sensing electrode in contact with the conjunctiva in the manner of Suaning) in order to “avoid[] unacceptable damage or trauma to the eye” (Suaning at Col. 4, Ln. 58-59).
Independent Claims 1, 13 and 21 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 20190143116 A1 to Mowery et al. (“Mowery”) in view of previously cited US 2006/0271123 A1 to Greenberg et al. (“Greenberg”) and Grumet, Andrew Eli, "Electric stimulation parameters for an epi-retinal prosthesis," Thesis (Ph.D.)--Massachusetts Institute of Technology, Dept. of Electrical Engineering and Computer Science, 1999 (“Grumet”).
Regarding Independent Claim 1, Mowery teaches:
A system for delivering electrical-stimulation therapy to a patient, the system comprising: (Title, Apparatus and method for ocular microcurrent stimulation therapy);
a first electrode substrate that includes: one or more stimulation electrodes on the first electrode substrate that are configured to apply electrical stimulation signals to a first eye of the patient, the first eye having an upper eyelid and a lower eyelid, wherein the first electrode substrate is configured to locate the one or more electrodes on an outer surface of at least one of the upper eyelid and the lower eyelid of the first eye of the patient; (Para. [0061]; Para. [0082]; Figs. 6A and 6B, “linear therapy strips 115,” “electrodes 111;” see Annotated Figs. 6A and 6B, above);
a first return electrode configured to be placed in a return location on the patient that provides a return path for the electrical stimulation signals applied by the one or more stimulation electrodes such that an electrical current is formed between at least one of the one or more stimulation electrodes and the first return electrode; (Para. [0061]; Para. [0082], “In some embodiments, the therapeutic electrical-stimulation pulses are applied in a sequence (one at a time) to the electrodes 111 on therapy strips 615 surrounding each eye, wherein the return path (i.e., the ground signal) is provided through electrodes 641 (in some embodiments, one or more electrodes 641 is adhesively a coupled to the neck of patient 99; e.g., one to each side of the neck as shown);” Fig. 6A, “electrodes 641;” see Annotated Figs. 6A and 6B, above);
and a stimulation controller operatively coupled to the one or more stimulation electrodes, the plurality of sensor electrodes, and the first return electrode, (Fig. 6A, “controller 661;” Paras. [0082]-[0083]; Figs. 6A and 6B);
wherein the stimulation controller is configured to control the electrical current formed between the at least one of the one or more stimulation electrodes and the first return electrode such that the electrical current passes through a retina of the first eye of the patient and delivers the electrical-stimulation therapy, (Para. [0082], “In some embodiments, uniphasic signals are applied to the eye electrodes (either all positive voltages relative to ground electrode(s) 614, or all negative relative to ground electrode(s) 614) in order to accumulate the desired ionic molecules in or near the retinas of the patient);” Claim 4, “wherein the microcurrent-stimulation controller generates a prescribed microcurrent delivered to each electrode of the plurality of electrodes in a temporal sequence;” Claim 5);
Mowery does not disclose:
a plurality of sensor electrodes configured to detect electrical activity from neural cells of the patient during delivery of the electrical-stimulation therapy, wherein the plurality of sensor electrodes includes a first sensor electrode placed in a first selected location on the patient and a second sensor electrode placed in a second selected location on the patient;
and wherein the stimulation controller includes a differential amplifier configured to detect a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.
Greenberg describes “a method of automatically adjusting an electrode array to the neural characteristics of an individual patient” (Abstract). Greenberg is analogous art.
Greenberg teaches:
a plurality of sensor electrodes configured to detect electrical activity from neural cells of the patient during delivery of the electrical-stimulation therapy, wherein the plurality of sensor electrodes includes a first sensor electrode placed in a first selected location on the patient and a second sensor electrode placed in a second selected location on the patient; (Para. [0041], “ One or more recording electrodes 162 are placed in near the visual cortex. The recording electrodes may temporary external electrodes, implanted electrodes under the scalp, or electrode implanted within the visual cortex;” Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]).
Greenberg’s “recording electrodes” as such “sensor electrodes as claimed. Greenberg’s “recording electrodes” are placed in the manner claimed. Each of Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]; and Para. [0041] detail alternative such placements.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Mowery with the teachings of Greenberg (i.e., to employee such recording electrodes and associated recording components as taught by Greenberg in the device of Mowery) in order to facilitate objective (i.e., as opposed to subjective) assessment of stimulation response (Greenberg at Paras. [0035] through [0037]).
Grumet describes an “Electric Stimulation Parameters for an Epi-Retinal Prosthesis” (Title) which prosthesis employs “a large number of individually addressable phosphene elements, conveying the visual scene much in the same way that images are represented on a computer screen” (Grumet at Pg. 13, Second Paragraph). Grumet is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Grumet teaches:
and wherein the stimulation controller includes a differential amplifier (Pg. 95, Second Paragraph, “A schematic diagram of the differential amplifier at the stimulus monitor input is shown in Figure B.9.”);
configured to detect a difference in voltage between the first sensor electrode and the second sensor electrode (Pg. 94, Sixth Paragraph, “Two nearly identical amplifiers were built to monitor stimuli as they were delivered to the array. One of these monitors amplifies the voltage across a 10kf2 resistor in series with the load (labeled RM1 in Figure B.7), providing a measure of the current. The other monitor was usually used to track the voltage output of the current source op-amp (AD711 in Figure 8.7). This voltage is dominated by the drop across the stimulating electrodes. In a few instances (see section 8.5.2) the second monitor was used to measure the voltage drop across RM2 , allowing for simultaneous measurement of both current source branch currents.
in order to determine a characteristic of the electrical-stimulation therapy (Pg. 94, Sixth Paragraph, “Two nearly identical amplifiers were built to monitor stimuli as they were delivered to the array.” (emphasis added));
including whether phosphenes are visible to the patient. (Pg. 85, First Paragraph, “To make the measurements documented in earlier parts of this thesis I designed and built several specialized electronic instruments. These instruments consist of: a current source which delivers stimuli to the retina, a bank of nerve response amplifiers which simultaneously monitor the activity at eight sites on the retina, and a pair of amplifiers which monitor the electrode current delivered (which, in principal, should be equal to that requested of the source) as well as the voltage required for delivery.”).
Grumet describes an “Electric Stimulation Parameters for an Epi-Retinal Prosthesis” (Title) which prosthesis employs “a large number of individually addressable phosphene elements, conveying the visual scene much in the same way that images are represented on a computer screen” (Grumet at Pg. 13, Second Paragraph). Grumet’s differential amplifier is purposed for monitoring voltage to ensure applied voltage is within the range predicted as sufficient for phosphene production.
Grumet thus “determine[s] a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient” via Grumet’s differential amplifiers in that Grumet’s differential amplifiers determine whether applied voltage is within the range predicted as sufficient for phosphene production. If so, Grumet determines that phosphenes are visible.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Mowery and Greenberg with the teachings of Grumet (i.e., to use such a differential amplifier as taught by Grumet in the controller of Mowery in conjunction with the sensor electrodes of Greenberg) in order to monitor delivered stimuli (Grumet at Pg. 94, Sixth Paragraph).
Regarding Independent Claim 13, Mowery teaches:
A method for delivering electrical-stimulation therapy to a patient, the method comprising: (Title, Apparatus and method for ocular microcurrent stimulation therapy);
providing a first electrode substrate, wherein the first electrode substrate includes: one or more stimulation electrodes on the first electrode substrate that are configured to apply electrical stimulation signals to a first eye of the patient, the first eye having an upper eyelid and a lower eyelid; (Para. [0061]; Para. [0082]; Figs. 6A and 6B, “linear therapy strips 115,” “electrodes 111;” see Annotated Figs. 6A and 6B, above at Claim 1);
attaching the first electrode substrate to the patient's skin such that the one or more stimulation electrodes are on the outer surface of at least one of the upper eyelid and the lower eyelid of the first eye of the patient; (Para. [0061]; Para. [0082]; Figs. 6A and 6B, “linear therapy strips 115,” “electrodes 111;” see Annotated Figs. 6A and 6B, above at Claim 1);
Mowery’s “electrode substrate” is so-attached, as shown in Annotated Figs. 6A and 6B.
providing a first return electrode; placing the first return electrode in a return location on the patient that provides a return path for the electrical stimulation signals applied by the one or more stimulation electrodes such that an electrical current is formed between at least one of the one or more stimulation electrodes and the first return electrode; (Para. [0061]; Para. [0082], “In some embodiments, the therapeutic electrical-stimulation pulses are applied in a sequence (one at a time) to the electrodes 111 on therapy strips 615 surrounding each eye, wherein the return path (i.e., the ground signal) is provided through electrodes 641 (in some embodiments, one or more electrodes 641 is adhesively a coupled to the neck of patient 99; e.g., one to each side of the neck as shown);” Fig. 6A, “electrodes 641;” see Annotated Figs. 6A and 6B, above);
delivering the electrical-stimulation therapy to the first eye, wherein the delivering includes controlling the electrical current formed between the at least one of the one or more stimulation electrodes and the first return electrode such that the electrical current passes through a retina of the first eye of the patient; (Para. [0082], “In some embodiments, uniphasic signals are applied to the eye electrodes (either all positive voltages relative to ground electrode(s) 614, or all negative relative to ground electrode(s) 614) in order to accumulate the desired ionic molecules in or near the retinas of the patient);” Claim 4, “wherein the microcurrent-stimulation controller generates a prescribed microcurrent delivered to each electrode of the plurality of electrodes in a temporal sequence;” Claim 5);
Mowery does not disclose:
providing a plurality of sensor electrodes including a first sensor electrode and a second sensor electrode;
placing the first sensor electrode in a first selected location on the patient, and placing the second sensor electrode in a second selected location on the patient;
and detecting, using the plurality of sensor electrodes, electrical activity from neural cells of the patient during the delivering of the electrical-stimulation therapy to the first eye,
wherein the detecting of the electrical activity includes: detecting a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.
Greenberg describes “a method of automatically adjusting an electrode array to the neural characteristics of an individual patient” (Abstract). Greenberg is analogous art.
Greenberg teaches:
providing a plurality of sensor electrodes including a first sensor electrode and a second sensor electrode; placing the first sensor electrode in a first selected location on the patient, and placing the second sensor electrode in a second selected location on the patient; (Para. [0041], “ One or more recording electrodes 162 are placed in near the visual cortex. The recording electrodes may temporary external electrodes, implanted electrodes under the scalp, or electrode implanted within the visual cortex;” Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]).
Greenberg’s “recording electrodes” as such “sensor electrodes as claimed. Greenberg’s “recording electrodes” are placed in the manner claimed. Each of Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]; and Para. [0041] detail alternative such placements.
and detecting, using the plurality of sensor electrodes, electrical activity from neural cells of the patient during the delivering of the electrical-stimulation therapy to the first eye, (Para. [0032], “The first electrode, electrode N, is addressed 44. The stimulation level is set to zero 46, and then incremented 48. The neural tissue is stimulated at the minimum level 50. The stimulation is immediately followed by a recording of activity in the neural tissue 52. Alternatively, recording can be done simultaneously by an adjacent electrode. … The neural response follows stimulation (see FIG. 4).”);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mowery with the teachings of Greenberg (i.e., to employee such recording electrodes and associated recording components as taught by Greenberg in the device of Mowery and to use those electrodes for Greenberg’s purpose of detecting neural activity) in order to facilitate objective assessment (i.e., as opposed to subjective assessment) of stimulation response (Greenberg at Paras. [0035] through [0037]).
Grumet describes an “Electric Stimulation Parameters for an Epi-Retinal Prosthesis” (Title) which prosthesis employs “a large number of individually addressable phosphene elements, conveying the visual scene much in the same way that images are represented on a computer screen” (Grumet at Pg. 13, Second Paragraph). Grumet is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Grumet teaches:
wherein the detecting of the electrical activity includes: detecting a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient. (Pg. 95, Second Paragraph; Pg. 94, Sixth Paragraph; Pg. 94, Sixth Paragraph; Pg. 85, First Paragraph)
This limitation is being interpreted similarly to Claim 1 above, the specifics of which interpretation are reiterated by reference.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify combined Mowery and Greenberg with the teachings of Grumet (i.e., to use such a differential amplifier as taught by Grumet in the controller of Mowery in conjunction with the sensor electrodes of Greenberg) in order to monitor delivered stimuli (Grumet at Pg. 94, Sixth Paragraph).
Regarding Independent Claim 21, Mowery teaches:
A non-transitory computer-readable medium having instructions stored thereon for causing a suitably programmed control system to execute a method for delivering electrical- stimulation therapy to a patient, wherein the method is executed by the control system on an electrical-stimulation system (Title, Apparatus and method for ocular microcurrent stimulation therapy;” Para. [0063], “…micro-current stimulation controller apparatus 161 includes a microprocessor (μP) operated by a battery, and optionally is controlled and/or programmed by a nearby laptop personal computer, a tablet computer, a desktop computer or the like;” Fig. 6A, “controller 661;” Paras. [0082]-[0083]; Figs. 6A and 6B);
that includes one or more stimulation electrodes on a first electrode substrate, wherein the one or more stimulation electrodes are configured to apply electrical stimulation signals to the first eye of the patient, the first eye having an upper eyelid and a lower eyelid, wherein the first electrode substrate is attached to the patient's skin such that the one or more stimulation electrodes are on the outer surface at least one of the upper eyelid and the lower eyelid of the first eye of the patient, (Para. [0061]; Para. [0082]; Figs. 6A and 6B, “linear therapy strips 115,” “electrodes 111;” see Annotated Figs. 6A and 6B, above at Claim 1);
a first return electrode that is placed in a return location on the patient that provides a return path for the electrical stimulation signals applied by the one or more stimulation electrodes such that an electrical current is formed between at least one of the one or more stimulation electrodes and the first return electrode, (Para. [0061]; Para. [0082], “In some embodiments, the therapeutic electrical-stimulation pulses are applied in a sequence (one at a time) to the electrodes 111 on therapy strips 615 surrounding each eye, wherein the return path (i.e., the ground signal) is provided through electrodes 641 (in some embodiments, one or more electrodes 641 is adhesively a coupled to the neck of patient 99; e.g., one to each side of the neck as shown);” Fig. 6A, “electrodes 641;” see Annotated Figs. 6A and 6B, above);
the method comprising: delivering the electrical-stimulation therapy to the first eye, wherein the delivering includes controlling the electrical current formed between the at least one of the one or more stimulation electrodes and the first return electrode such that the electrical current passes through a retina of the first eye of the patient; (Para. [0082], “In some embodiments, uniphasic signals are applied to the eye electrodes (either all positive voltages relative to ground electrode(s) 614, or all negative relative to ground electrode(s) 614) in order to accumulate the desired ionic molecules in or near the retinas of the patient);” Claim 4, “wherein the microcurrent-stimulation controller generates a prescribed microcurrent delivered to each electrode of the plurality of electrodes in a temporal sequence;” Claim 5);
Mowery does not disclose:
a plurality of sensor electrodes including a first sensor electrode placed in a first selected location on the patient and a second sensor electrode placed in a second selected location on the patient,
and detecting, via the plurality of sensor electrodes, electrical activity from neural cells of the patient during the delivering of the electrical-stimulation therapy to the first eye,
wherein the detecting of the electrical activity includes: detecting a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient.
Greenberg describes “a method of automatically adjusting an electrode array to the neural characteristics of an individual patient” (Abstract). Greenberg is analogous art.
Greenberg teaches:
a plurality of sensor electrodes including a first sensor electrode placed in a first selected location on the patient and a second sensor electrode placed in a second selected location on the patient, (Para. [0041], “ One or more recording electrodes 162 are placed in near the visual cortex. The recording electrodes may temporary external electrodes, implanted electrodes under the scalp, or electrode implanted within the visual cortex;” Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]).
Greenberg’s “recording electrodes” as such “sensor electrodes as claimed. Greenberg’s “recording electrodes” are placed in the manner claimed. Each of Para. [0021]; Para. [0032]; Para. [0038]; Para. [0040]; and Para. [0041] detail alternative such placements.
and detecting, via the plurality of sensor electrodes, electrical activity from neural cells of the patient during the delivering of the electrical-stimulation therapy to the first eye, (Para. [0032], “The first electrode, electrode N, is addressed 44. The stimulation level is set to zero 46, and then incremented 48. The neural tissue is stimulated at the minimum level 50. The stimulation is immediately followed by a recording of activity in the neural tissue 52. Alternatively, recording can be done simultaneously by an adjacent electrode. … The neural response follows stimulation (see FIG. 4).”);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mowery with the teachings of Greenberg (i.e., to employee such recording electrodes and associated recording components as taught by Greenberg in the device of Mowery and to use those electrodes for Greenberg’s purpose of detecting neural activity) in order to facilitate objective assessment (i.e., as opposed to subjective assessment) of stimulation response (Greenberg at Paras. [0035] through [0037]).
Grumet describes an “Electric Stimulation Parameters for an Epi-Retinal Prosthesis” (Title) which prosthesis employs “a large number of individually addressable phosphene elements, conveying the visual scene much in the same way that images are represented on a computer screen” (Grumet at Pg. 13, Second Paragraph). Grumet is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
Grumet teaches:
wherein the detecting of the electrical activity includes: detecting a difference in voltage between the first sensor electrode and the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy including whether phosphenes are visible to the patient. (Pg. 95, Second Paragraph; Pg. 94, Sixth Paragraph; Pg. 94, Sixth Paragraph; Pg. 85, First Paragraph)
This limitation is being interpreted similarly to Claim 1 above, the specifics of which interpretation are reiterated by reference.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify combined Mowery and Greenberg with the teachings of Grumet (i.e., to use such a differential amplifier as taught by Grumet in the controller of Mowery in conjunction with the sensor electrodes of Greenberg) in order to monitor delivered stimuli (Grumet at Pg. 94, Sixth Paragraph).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
1 Para. [0105] states only “In some embodiments of the system, the stimulation controller is further configured to compare the active electrical-activity data generated by the first sensor electrode to the reference electrical-activity data generated by the second sensor electrode in order to determine a characteristic of the electrical-stimulation therapy (e.g., in some embodiments, the stimulation controller includes a differential amplifier that detects the difference in voltage between the first sensor electrode and the second sensor electrode).”
Prosecution Insights