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 Amendment
This office action is in response to the amendment filed on 5/5/2026. Currently claims 1-17 are pending.
Response to Arguments
Applicant’s arguments, see pg. 8, filed 5/5/2026, with respect to the previous rejection of claims 1-17 under nonstatutory double patenting in view of US pat 11007367 in view of Paul have been fully considered and are persuasive based on the terminal disclaimer filed (see below). The previous non-statutory double patenting rejection of claims 1-17 in view of US pat 11007367 in in view of Paul has been withdrawn.
Applicant’s arguments, see pgs. 5-7, filed 5/5/2026, with respect to the rejection(s) of
claim(s) 1-17 under 35 USC 103 as being unpatentable over Paul have been fully considered and are persuasive based applicant’s amendments to claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the additional reference of Jeffery et al (US 20150335876) as outlined below.
Terminal Disclaimer
The terminal disclaimer filed on 5/5/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 11007367 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paul Jr. et al (US 20040176820) hereafter known as Paul in view of Jeffery et al (US 20150335876) hereafter known as Jeffery.
Independent claim
Regarding claim 1:
Paul discloses:
A method of using microcurrent stimulation for the treatment of a visual disease [see abstract… “A method and apparatus for providing microcurrent stimulation (MSC) therapy. In accordance with the present invention, it has been determined that the application of microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves conditions of macular degeneration and other ocular diseases.”], comprising:
generating a hybrid waveform comprising a series of current pulses [see para 28… “current will be provided in a square waveform at a frequency of 292 Hz for 60 seconds. During those 60 seconds the program indicator light (50) is lit, which advises the user that the program is underway. When the current applied at 292 Hz for 60 seconds stops, an audible tone will sound and the next step in the therapy program will begin. Here, program indicator light (51) will light, current will be provided at 30 Hz for 120 seconds. At the conclusion of this step in the therapy program, a tone will sound again. The program indicator light (51) will dim and program indicator light (52) will light. This indicates that current will be provided at 9.1 Hz for 180 seconds. A third tone will sound indicating that step in the therapy program is over.”] having current amplitude between 1 microamp and 1000 microamps [see para 35… “the current can be present at a constant dc current of between, for example, 1.0 and 1,000.00 .mu.A.”],
wherein three or more waveform parameters of the hybrid waveform are varied in accordance with a visual disease treatment protocol, wherein the varied waveform parameters are selected from the group consisting of pulse width, pulse period, pulse position, pulse coding, peak current amplitude, duty cycle, and pulse shape [see para 44… “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal. In accordance with this embodiment, each signal is applied for a longer period of time than the previously applied signal. One particular sequence that has produced excellent results is as follows. A first microcurrent signal having a first modulation frequency more than 200 Hz but less than or equal to 300 Hz is applied for a period from 1 second up to 120 seconds. A second microcurrent signal having a second modulation frequency more than 10 Hz but less than or equal to 200 Hz is then applied for a period from 1 second up to 240 seconds. A third microcurrent signal having a third modulation frequency more than 1 Hz but less than or equal to 10 Hz is then applied for a period from 10 seconds up to 800 seconds.” Discloses at least three waveforms with different pulse width, pulse period and pulse amplitude] and
applying the hybrid waveform to at least one stimulation point within an eye region during the treatment session [see para 44… “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal.”].
However, Paul only discloses current amplitude between 1- 1000 microamps and therefore fails to disclose the hybrid wave as specifically having a peak current amplitude between 1 microamp and 450 microamps or that the hybrid waveform is based on a plurality of pulse modulation techniques” and is selectively varied and thus Paul fails to fully disclose “generating a hybrid waveform based on a plurality of pulse modulation techniques, the hybrid waveform comprising a series of current pulses having a peak current amplitude between 1 microamp and 450 microamps, wherein three or more waveform parameters of the hybrid waveform are selectively varied in accordance with a visual disease treatment protocol, wherein the three or more waveform parameters are varied within the hybrid waveform during a treatment session” as claimed.
Jeffery discloses in the analogous art of neural electrical stimulation [see para 4… “In particular described herein are electrode apparatuses (including cantilever electrode apparatuses) that may be attached to a wearable neurostimulator (neuromodulator) and worn on a user's head and/or neck and used for electrical stimulation to modulate the user's cognitive state.”] selectively modifying parameters using pulse modulation techniques during stimulation for the purpose of adjusting stimulation used to modulate a user’s cognitive state and/or function [see all of paras 219-222 in particular see para 219…. “any waveform described above can be combined in series or in parallel (i.e. concurrently) to create a hybrid waveform, or ensemble waveform. In embodiments, any waveform described above can be added, subtracted, convolved, or otherwise amplitude modulated. Moreover, in embodiments, any waveform above can have its amplitude ramped using linear, exponential, or another ramp shape including by one or more controllers that the user may manually adjust during stimulation” and see para 222… “using alternating current stimulation or pulsed direct current stimulation, pulses can comprise square waves, sine waves, sawtooth waves, triangular waves, rectified (unimodal) waves, pulse-width modulated, amplitude-modulated, frequency-modulated, or other pattern of alternating current waveform” And see para 15… “A cantilever electrode may also be referred to as an electrode assembly, electrode pad, electrode system, or electrode apparatus, may be durable or disposable, and is generally configured to connect to the neuromodulation device and apply energy (e.g., current) from the neuromodulation device to the subject's skin to modulate a subject's cognitive state (e.g., calming, invigorating, etc.) or other cognitive function.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a peak current amplitude of 1-450 microamps because this is a subset of the taught current amplitude of 1-1000 microamps.
Since Paul is directed at treating a visual disease and a vision includes cognitive function and/or states, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Paul by selectively modifying parameters during stimulation for the purpose of further adjusting stimulation similarly to that disclosed by Jeffery (i.e. thereby fully reciting “generating a hybrid waveform based on a plurality of pulse modulation techniques, the hybrid waveform comprising a series of current pulses having a peak current amplitude between 1 microamp and 450 microamps, wherein three or more waveform parameters of the hybrid waveform are selectively varied in accordance with a visual disease treatment protocol, wherein the three or more waveform parameters are varied within the hybrid waveform during a treatment session”), because this would allow for a greater range of variation in stimulation which one of ordinary skill would expect a greater accuracy to fine tune the stimulation to the specific vision condition being treated.
Independent claim
Regarding claim 10:
Paul discloses:
A method of generating a microcurrent waveform for use in the treatment of a visual disease [see abstract… “A method and apparatus for providing microcurrent stimulation (MSC) therapy. In accordance with the present invention, it has been determined that the application of microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves conditions of macular degeneration and other ocular diseases.”], comprising:
generating a hybrid waveform comprising a series of current pulses [see para 28… “current will be provided in a square waveform at a frequency of 292 Hz for 60 seconds. During those 60 seconds the program indicator light (50) is lit, which advises the user that the program is underway. When the current applied at 292 Hz for 60 seconds stops, an audible tone will sound and the next step in the therapy program will begin. Here, program indicator light (51) will light, current will be provided at 30 Hz for 120 seconds. At the conclusion of this step in the therapy program, a tone will sound again. The program indicator light (51) will dim and program indicator light (52) will light. This indicates that current will be provided at 9.1 Hz for 180 seconds. A third tone will sound indicating that step in the therapy program is over.”] having current amplitude between 1 microamp and 1000 microamps [see para 35… “the current can be present at a constant dc current of between, for example, 1.0 and 1,000.00 mu.A.”], wherein three or more waveform parameters of the hybrid waveform are varied in accordance with a visual disease treatment protocol, wherein the varied waveform parameters are selected from the group consisting of pulse width, pulse period, pulse position, pulse coding, peak amplitude, duty cycle, and pulse shape [see para 44… “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal. In accordance with this embodiment, each signal is applied for a longer period of time than the previously applied signal. One particular sequence that has produced excellent results is as follows. A first microcurrent signal having a first modulation frequency more than 200 Hz but less than or equal to 300 Hz is applied for a period from 1 second up to 120 seconds. A second microcurrent signal having a second modulation frequency more than 10 Hz but less than or equal to 200 Hz is then applied for a period from 1 second up to 240 seconds. A third microcurrent signal having a third modulation frequency more than 1 Hz but less than or equal to 10 Hz is then applied for a period from 10 seconds up to 800 seconds.” Discloses at least three waveforms with different pulse width, pulse period and pulse amplitude].
However, Paul only discloses current amplitude between 1- 1000 microamps and therefore fails to disclose the hybrid wave as specifically having a peak current amplitude between 1 microamp and 450 microamps or that the hybrid waveform is based on a plurality of pulse modulation techniques and is selectively varied and thus fails to fully disclose “generating a hybrid waveform based on a plurality of pulse modulation techniques, the hybrid waveform comprising a series of current pulses having a peak current amplitude between 1 microamp and 450 microamps, wherein three or more waveform parameters of the hybrid waveform are selectively varied in accordance with a visual disease treatment protocol, wherein the three or more waveform parameters are varied within the hybrid waveform during a treatment session” as claimed.
Jeffery discloses in the analogous art of neural electrical stimulation [see para 4… “In particular described herein are electrode apparatuses (including cantilever electrode apparatuses) that may be attached to a wearable neurostimulator (neuromodulator) and worn on a user's head and/or neck and used for electrical stimulation to modulate the user's cognitive state.”] selectively modifying parameters using pulse modulation techniques during stimulation for the purpose of adjusting stimulation used to modulate a user’s cognitive state and/or function [see all of paras 219-222 in particular see para 219…. “any waveform described above can be combined in series or in parallel (i.e. concurrently) to create a hybrid waveform, or ensemble waveform. In embodiments, any waveform described above can be added, subtracted, convolved, or otherwise amplitude modulated. Moreover, in embodiments, any waveform above can have its amplitude ramped using linear, exponential, or another ramp shape including by one or more controllers that the user may manually adjust during stimulation” and see para 222… “using alternating current stimulation or pulsed direct current stimulation, pulses can comprise square waves, sine waves, sawtooth waves, triangular waves, rectified (unimodal) waves, pulse-width modulated, amplitude-modulated, frequency-modulated, or other pattern of alternating current waveform” And see para 15… “A cantilever electrode may also be referred to as an electrode assembly, electrode pad, electrode system, or electrode apparatus, may be durable or disposable, and is generally configured to connect to the neuromodulation device and apply energy (e.g., current) from the neuromodulation device to the subject's skin to modulate a subject's cognitive state (e.g., calming, invigorating, etc.) or other cognitive function.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a peak current amplitude of 1-450 microamps because this is a subset of the taught current amplitude of 1-1000 microamps.
Since Paul is directed at treating a visual disease and a vision includes cognitive function and/or states, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Paul by selectively modifying parameters during stimulation for the purpose of further adjusting stimulation similarly to that disclosed by Jeffery (i.e. thereby fully reciting “generating a hybrid waveform based on a plurality of pulse modulation techniques, the hybrid waveform comprising a series of current pulses having a peak current amplitude between 1 microamp and 450 microamps, wherein three or more waveform parameters of the hybrid waveform are selectively varied in accordance with a visual disease treatment protocol, wherein the three or more waveform parameters are varied within the hybrid waveform during a treatment session”) because this would allow for a greater range of variation in stimulation which one of ordinary skill would expect a greater accuracy to fine tune the stimulation to the specific vision condition being treated.
Dependent claims:
Regarding claims 2 and 11, see para 44 of Paul [see “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal. “] with two of the four microcurrent signals being at least a first and second pulse sequence as claimed.
Regarding claims 3 and 12, wherein a polarity of each of the first and second pulse sequences is varied to generate a bipolar waveform [see para 28 of Paul…. “During the therapy program the polarity of the electrodes (22) and (22A) will reverse every two seconds. At this point, a user will remove the electrodes (22) and (22A), turn the on/off switch (40) to off, and the microcurrent nerve stimulation apparatus (10) is ready to begin another treatment program or maybe stored until required for further use” which discloses a bipolar waveform as claimed.]
Regarding claims 4 and 13, see para 28 of Paul [see “current will be provided in a square waveform at a frequency of 292 Hz for 60 seconds. During those 60 seconds the program indicator light (50) is lit, which advises the user that the program is underway. When the current applied at 292 Hz for 60 seconds stops, an audible tone will sound and the next step in the therapy program will begin. Here, program indicator light (51) will light, current will be provided at 30 Hz for 120 seconds. At the conclusion of this step in the therapy program, a tone will sound again. “] which disclose an audible tone sounding each step where the parameters are the same.
Regarding claims 5-7 and 14-16, see para 44 of Paul [see… “at least three, but preferably four different microcurrent signals are applied to the ocular tissue in a particular sequence in which each subsequently applied signal in the sequence is lower in frequency than the previously applied signal. In accordance with this embodiment, each signal is applied for a longer period of time than the previously applied signal. One particular sequence that has produced excellent results is as follows. A first microcurrent signal having a first modulation frequency more than 200 Hz but less than or equal to 300 Hz is applied for a period from 1 second up to 120 seconds. A second microcurrent signal having a second modulation frequency more than 10 Hz but less than or equal to 200 Hz is then applied for a period from 1 second up to 240 seconds. A third microcurrent signal having a third modulation frequency more than 1 Hz but less than or equal to 10 Hz is then applied for a period from 10 seconds up to 800 seconds.”] which disclose different parameters of pulse width, pulse period and pulse amplitude as recited by claims 5 and 14; also interpreted as different parameters of pulse width, pulse period and pulse position (in seconds) as recited by claims 6 and 15; also interpreted as different parameters of pulse width, pulse period and pulse coding (in Hz) as recited by claims 7 and 16.
Regarding claims 8 and 17, see abstract of Paul [see “the application of microcurrent signals at particular frequencies to the eye for particular periods of time stabilizes and even improves conditions of macular degeneration and other ocular diseases.”] and see para 38 of Paul [see “the present invention is not only directed toward stabilizing or improving conditions of macular degeneration, but also to stabilizing or improving other ocular diseases or problems, including, for example, Dry Macular Degeneration, Wet Macular Degeneration Stargardt's, Retinitis Pigmentosa, Glaucoma, CMV-Retinitis, Best's Disease Macular Dystrophy, Optic Neuritis, Diabetic Retinopathy, Ischemic Anterior Optic, Neuritis, Usher's Syndrome, Leber's Congenital Amaurosis, Cone-Rod Dystrophy, Cone Dystrophy, Choroideremia and Gyrate Atrophy, Central Retinal Artery Occlusion, Central Retinal Vein Occlusion, Branch Retinal Artery Occlusion, Branch Retinal Vein Occlusion, Central Serous Chorioretinopathy, Cystoid Macular Edema, Ocular Histoplasmosis, Ocular Toxoplasmosis and Retinopathy of Prematurity”] which discloses treating one or more of the claimed visual diseases
Regarding claim 9:
wherein the applying step comprising using a probe to apply the hybrid waveform to the stimulation point [see Fig. 1 elements 15, 15A and 22, 22A of Paul (i.e. probe to apply waveform) and see para 25 of Paul … “If the polarity of the current is reversed as part of a therapy method, then more than two electrodes may be employed. Electrodes (22) and (22A) connect by means of dual-lead wires (20) and (20A) and probes (15) and (15A) to electrode jacks (14) and (14A) in the front of the box (11). Electrodes (22) and (22A) will be applied to a user completing an electrical circuit, which allows a microcurrent to pass from one electrode through the body of the user to the other electrode to complete the circuit.”]
and further comprising the step of attaching a counter electrode to a body part [see Fig. 3B element 44 of Paul (i.e. counter electrode) and para 34 of Paul … “Ends of the electrodes (44) come into contact with the user's skin at a location in the periorbital region of the face. The electrodes (44) are surrounded by a plastic dielectric material (47) that insulates the electrodes (44). FIG. 3C shows a front view of the goggles (40). The regions (45) and (46) are seen in the front views as groups of very small openings formed in the goggles (40). The electrical circuitry housed in casing (42) may be the same as those contained in housing (11) shown in FIG. 1”]
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.
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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