The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Priority
As an initial matter, it is noted that a review of provisional application 63/332,520 does not illustrate the claimed subject matter of the instant application. Specifically, this provisional application only teaches the use of monophasic rectangular, biphasic rectangular, and biphasic sine waveforms for stimulation of the eye.
Additionally, a review of provisional application 63/336,234 does not illustrate the claimed subject matter of the instant application either. It is noted that the copies of the specification furnished by the Office are of poor quality and to the best ability of the examiner, it does not appear that this document specifically teaches the use of ramp functions for electrical stimulation of the eyes.
Due to the above, priority is not granted to either of these documents, and the effective filing date of this application is December 1, 2022.
Claim Objections
Claims 13 and 16 are objected to because of the following informalities:
Claim 13 is objected to because it is missing a comma between “at least three days” and “at least four days”.
Claim 16 is objected to because it is missing a comma between “17 minutes” and “16 minutes”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Second Paragraph
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 17 and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 is rejected because “amplitude priority stimulation” is unclear and indefinite, as this term is not an ordinary term of art, nor does the specification define what is meant by this term. Any stimulation system or method in which there is amplitude delivered will be considered to be “amplitude priority stimulation”.
Claim 23 is rejected because ERG, or electroretinography, is the “a method known in the art for assessing photoreceptor function and neural responses…“ and “methods of the disclosure can be assessed using ERG” (see paragraph 79 of the PGPUB 2025/0256100, representative of the specification). According to the specification, “Retinal and visual functions were evaluated by electroretinogram (ERG) and optomotor response (OMR) weekly” (see paragraph 124). “Further, ES also maintained rod photoreceptors functioning in I/R mice over time, as demonstrated in the quantification of scotopic electroretinogram (ERG) a wave analysis respectively” (see paragraph 126). Therefore, it would appear that the “preserving visual function” (as claimed) would be the preserving or maintaining “rod photoreceptors functioning in I/R mice over time” which can be “demonstrated in the quantification of scotopic electroretinogram (ERG) a wave analysis” (according to paragraph 126). However, claim 23 recites that “the preserving visual function … comprises preserving an ERG a wave”, which is unclear.
Fourth Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 24 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 24 is rejected because it depends from canceled claim 6.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 8, 12-17 and 21-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jarding et al. (US Patent No. 6,275,735).
Regarding claim 1, Jarding discloses a method of treating macular degeneration… comprising delivering electrical stimulation in a ramp waveform to the eye of the subject (e.g., “The present invention relates generally to… methods and apparatus for providing electrical microcurrent stimulation around an eye to combat visual system diseases, such as macular degeneration” – see column 1, lines 14-19; “FIG. 12 is an embodiment of a ramp waveform” – see column 4, line 12).
Specifically, in regard to claim 4, it is noted that treating macular degeneration will result in “preserving visual function in a diseased eye”.
Regarding claim 8, “FIG. 4a illustrates eight therapy points around an eyelid to which microcurrent stimulation therapy may be applied” (see column 3, lines 38-40).
Regarding claims 12-13, Jarding teaches that “In accordance with a preferred method for treating macular degeneration, patients initially are treated twice a day for 4 days and 3 times a week thereafter” (see column 13, lines 38-40), which is “every day” and also teaches “at least three days…” and “at least four days … per week”, at least for the first week with regard to “at least four days”, and then three days per week after the first week.
Regarding claim 14, it is re-iterated that Jarding teaches that “In accordance with a preferred method for treating macular degeneration, patients initially are treated twice a day for 4 days and 3 times a week thereafter” (see column 13, lines 38-40). Therefore, when treatment is “4 days and 3 times a week thereafter”, there will inherently be at least one day per week in which no electrical stimulation is delivered, since there are 7 days within a week.
Regarding claims 15-16, Jarding teaches that “In accordance with a preferred embodiment of the present invention, each point around the eye is stimulated for about 8 to about 60 seconds, and more preferably for about 30 seconds” (see column 12, lines 26-29). As shown in Figure 4A, there are eight (8) points around each eye. Therefore, if stimulation were applied for 60 seconds per point, this would amount to a total of eight (8) minutes of stimulation per treatment. Based on the teaching that “In accordance with a preferred method for treating macular degeneration, patients initially are treated twice a day for 4 days and 3 times a week thereafter” (see column 13, lines 38-40), if this were delivered twice a day then that would amount to a total of 16 minutes of stimulation per day of treatment. Regarding claim 16, it is noted that 16 minutes is “not more than 30 minutes”.
Regarding claim 17, it is noted that based on the rejection of claim 17 under 35 USC 112(b) above, Jarding teaches that “sweep wave signal generator 12 preferably is configured to generate one or more sweep wave signals having various … amplitude characteristics” (see column 5, lines 30-35), which therefore teaches that the amplitude may be adjusted and therefore reading on claim 17.
Regarding claim 21, it is inherent that macular degeneration reduces visual acuity. Therefore, the treatment of macular degeneration will assist in preserving visual acuity.
Regarding claims 21-23, it is noted that each of these claims recites the effect of treatment, with no additional limitations that define the treatment. The treatment is recited in claim 4 as “delivering electrical stimulation in a ramp waveform to the eye of the subject”, which is taught by Jarding. Therefore, if the only requirement to produce these results is applying electrical stimulation to the eye in the form of a ramp waveform, which is the requirements of claims 21-23, then Jarding inherently will result in these outcomes.
Regarding claim 24, initially, see the rejection of claim 24 under 35 USC 112(d). It is noted that the treatment of the eye in claim 1 is the application of a ramp waveform, which is taught by Jarding. No other specifics are recited in claim 1 or any other claim. Therefore, the results of applying the claimed ramp function of claim 1 having the results of recited in claim 24 would be inherent based on the methods of Jarding, absent additional limitations provided by the claims.
Claims 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Franke et al. (US Patent Pub. No. 2016/0022992).
Franke discloses a method of treating… dry eye syndrome… comprising delivering electrical stimulation in a ramp waveform to the eye of the subject (e.g., “electrical stimulation patterns and methods of use thereof for treating dry eye disease” – see Abstract; “the stimulation amplitude may be ramped from a low amplitude to a higher amplitude over a period of time” – see column 12, line 27-42).
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 9-10 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jarding in view of Enayati et al. (article titled “Electrical Stimulation Induces Retinal Müller Cell Proliferation and Their Progenitor Cell Potential”, Published: 23 March 2020 in Cells).
Jarding is described above with respect to claim 1. However, Jarding fails to teach the use of a pulse duration of 100 ms.
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Regarding claims 10 and 18-20, Enayati teaches that “Non-invasive electrical stimulation (ES) is increasingly applied to improve vision in untreatable eye conditions, such as retinitis pigmentosa and age-related macular degeneration… Here, we showed that ES with a ramp waveform of 20 Hz and 300 µA of current was effective at inducing mouse Müller cells (MCs) proliferation and enhancing their expression of progenitor cell markers” (see Abstract). Figure 2D illustrates “Changes in MC proliferation with ES of fixed 300 µA current and ramp waveform at various frequencies. Note that 20 PPS yielded significantly increased MC proliferation (see caption of Figure 2). As can be seen to the right, both 20 pulses per second (PPS, or Hz) and 50 PPS are documented as being equally as effective (i.e., relative fold change). Additionally, Figure 2C (left) illustrates “Changes in MC proliferation when stimulated with ramp waveforms of ES at 20 PPS and different current levels” (see caption of Figure 2), from which it can be seen that 100 and 300 µA current are both documented as the most effective.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize the specific parameters taught by Enayati within the system and methods of Jarding, since these parameters have been tested and shown experimentally to be the “Optimal conditions of ES with a ramp waveform” (see caption of Figure 2 of Enayati).
Regarding claim 9, it is noted that the specification of the instant application (see paragraph 69 of the PGPUB 2025/0256100) states the following:
… In some embodiments, the ramp waveform is at a pulse duration of between 0.5 millisecond to 500 millisecond…. In some embodiments, the pulse duration of a ramp waveform is between 0.5 ms and 500 ms, in some cases 50 ms. In some embodiments, the ramp waveform is divided into two phases, for example a 100 ms ramp waveform can be divided into one 50 ms negative and one 50 ms positive ramp waveform phases…
Claim 9 recites that “the ramp waveform is approximately 100ms in duration”. However, as illustrated by the discussion in paragraph 69 of the PGPUB, there is no criticality given specifically to a 100ms duration, and the duration could be as low as 0.5ms, or as high as 500ms, with emphasis in this paragraph on 50ms without any disclosed reason for this emphasis. With the use of 20 PPS, a new pulse would initiate every 50ms, and with the use of 10 PPS, a new pulse would initiate every 100ms. It is noted that Figure 2D of Enayati illustrates that a frequency of 10 PPS is still an improvement over the control. Additionally, if 10 PPS were utilized and the duty cycle of the pulse were around 90-100%, then the pulse duration would be approximately 100ms. As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to utilize a pulse duration of approximately 100ms, since this would approximately be the pulse duration at 10 PPS, which is shown to be more effective than the control in Figure 2D, and it has been held that discovering the optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPC 215 (CCPA 1980).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jarding in view of Musallam (US Patent Pub. No. 2021/0022948).
Jarding is described above with respect to claim 1. However, Jarding fails to teach a rectangular and ramped waveform.
Musallam teaches devices, systems and methods for non-invasive neuromodulation system for treating inherited or acquired retinal, choroidal and optic nerve disorders (see Abstract). Musallam teaches that “Ramping up and/or ramping down: In some instances, the waveforms described herein may be delivered during the whole session of stimulation without any change in its features as shown in FIG. 10C… For example, the stimulation amplitude may be ramped from low amplitude 1020 to higher amplitude 1022 over a period of time. In other variations, the stimulation amplitude may be ramped from high amplitude 1022 to lower amplitude 1024 over a period of time” (see paragraph 151).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to ramp up and/or down with a steady period in between, as illustrated in Figure 10C, and to utilize this within the system and methods of Jarding, because the use of either waveform to perform the method taught Jarding would amount to choosing from a finite number of stimulation waveforms available in the art at the time of the invention, which has previously been held as unpatentable (KSR v. Teleflex).
Conclusion
Additional prior art is made of record as considered pertinent to applicant's disclosure, but not relied upon in the rejections above, as identified on the PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES KISH whose telephone number is (571)272-5554. The examiner can normally be reached M-F 10:00a - 6p EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES KISH/Primary Examiner, Art Unit 3792
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