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 .
Continuity Data
The claimed subject matter in dependent claims 4-11, 13, and 14 appears to be original to this CIP as the parent application 18/754,919 does not appear to support this subject matter. Thus, the examiner is giving this subject matter an effective filing date of 7/2/2025.
Response to Arguments
Applicant's arguments filed 6/10/2026 have been fully considered but they are not persuasive.
Applicant 1st argues against the combination of Maschino with Craig, on pages 7-8 that Craig fails to teach “burst having a frequency of about 1 to about 100 bursts per second”, going on to state that Craig teaches that the interburst period should be at least 100 ms, and teaches that conventional VNS at 20-30Hz causes the benefit of the stimulation of Craig to “virtually disappear”.
It’s noted that the examiner is not modifying the stimulation of Craig to incorporate teachings from Maschino, but rather modifying the stimulation of Maschino with beneficial parameters and benefits from Craig.
Maschino teaches the claimed frequency in [0094] (Note: Maschino discloses “the signal repetition frequency may be programmed to be in a range of about 20-250 Hz”. The examiner understands 1 burst per second to be the same as 1 Hz) (Note: The applicant using “about” allows the examiner to interpret the ranges more broadly).
Furthermore, in [0067] Craig does teach that stimulation in the claimed ranges maintains the positive benefit of eVEP (emphasis added): microbursts according to the present invention, by contrast, can have a microburst duration from about 1 msec to no more than 1 second. Further, each microburst comprises at least 2 and about 25 pulses, with each of the pulses separated from an adjacent pulse by an interpulse interval of from about 1 to about 50 milliseconds, more typically from about 2 to about 10 milliseconds. While the individual pulses in a microburst according to this aspect of the invention may resemble conventional VNS signal pulses in pulse width and pulse current, the number of pulses in a microburst is markedly smaller than in a pulse burst in conventional VNS therapy. Consequently, microbursts are also much shorter in duration (less than 1 second and typically less than 100 msec, such as from about 10 msec to about 80 msec) than pulse bursts in conventional neurostimulation therapy (at least 7 seconds and typically 20-60 seconds). Moreover, in most cases, the interpulse interval separating the pulses is shorter than in conventional neurostimulation (typically 2-10 msec for microbursts compared to 30-50 msec for conventional VNS).
Applicant 3rd argues on page 8 that Craig fails to teach each pulse has a duration of about 50 to about 1000 microseconds in duration. Maschino teaches the duration in [0094] (Note: Maschino discloses “the width of each signal may be set to a value not greater than about 1 msec, such as about 250-500 .mu.sec”. The examiner understands the pulse duration in the claim to be the pulse width in Maschino). Regarding Craig, Craig teaches in [0016] “More particularly, in one embodiment, a microburst may comprise at least two but no more than about 25 electrical pulses, preferably from 2 to about 20 pulses per burst, more preferably from 2 to about 15 pulses per burst. In one embodiment, a microburst may last for no more than 1 second, typically less than 100 milliseconds, and preferably from about 10 msec to about 80 msec.”. Thus, 2 to 20 pulses in 10 milliseconds to 80 milliseconds would fall within the range of “about 50 to about 1000 microseconds in duration” (Note: The applicant using “about” allows the examiner to interpret the ranges more broadly). Furthermore, Craig is concerned with obtaining a benefit from pulses that are shorter than conventional stimulation, as noted with the disclosure in [0067] above. Therefore, PHOSITA would have a reasonable expectation of success in the proposed modification, applying the benefits of Craig to even shorter pulses.
Applicant 4th argues on pages 9-10 that Maschino does not establish a reasonable expectation of success of modifying stimulation parameters with respect to enhancing sleep, and therefore modifying the parameters of Maschino with teachings of Craig would not have had a reasonable expectation of success. Applicant goes on to explain that the modification would not be obvious because Craig is implanted and not an external stimulator.
Maschino, Lesser, and Craig are all directed towards electrical vagus nerve stimulation. Therefore, the teachings in Maschino of “the precise stimulation parameters that would energize particular pathways that affect the particular disorder likewise are difficult to predict” is not applicable in the instant case, because all of the cited references teach energizing the same neural pathways with stimulation parameters known in the art. Additionally, [0038] of Craig states that sleep disorders are one of the medical conditions treated by the method of Craig. Therefore, Craig is directed towards a vagus nerve stimulator that is used in sleep applications, directed to the same neural pathways as Maschino, and the modification in view of Craig would have had a reasonable expectation of success to PHOSITA.
Applicant 6th argues on pages 11-12 that there is no teaching that PHOSITA would have had a reasonable expectation of success for modifying nerve parameters for transcutaneous stimulation (taught by Maschino) with implantable stimulator parameters (taught by Craig) due to experimental factors such as signal attenuation, electrode-nerve distance, current recruitment patterns. However, Craig does address these factors with a disclosure in [0080] (emphasis added):
Another activation modality for stimulation is to program the output of the IMD 100 to the maximum amplitude which the patient may tolerate. The stimulation may be cycled on and off for a predetermined period of time followed by a relatively long interval without stimulation. Where the cranial nerve stimulation system is completely external to the patient's body, higher current amplitudes may be needed to overcome the attenuation resulting from the absence of direct contact with the cranial nerve, such as vagus nerve 127, and the additional impedance of the skin of the patient. Although external systems typically require greater power consumption than implantable ones, they have an advantage in that their batteries may be replaced without surgery.
Craig teaches that the modifications for using external stimulation are limited to amplitude changes. Therefore, the other parameters taught by Craig and relied upon in the rejection below would remain predictable, or having a reasonable expectation of success in the field of endeavor for sleep enhancement.
On p. 11, Applicant argues that none of the cited references links specifically microburst parameters to sleep enhancement. As stated above, [0038] of Craig states that sleep disorders are one of the medical conditions treated by the method of Craig.
Applicant 7th argues on page 12 that the combination of references are drawn from different fields which underscores hindsight reasoning. Maschino, Lesser, and Craig are all directed towards the same field, electrical vagus nerve stimulation, see citations in the rejections below. As noted above, the examiner’s position is that the teachings in Maschino, Lesser, and Craig are sufficient to suggest that PHOSITA would have had a reasonable expectation of success in combining these three references for improving stimulation for enhancing sleep. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant 8th argues on pages 13-14 argues that the examiner’s rationale for combining Malchano with Maschino, Lesser, and Craig is flawed. The motivation is found in the Malchano reference as [0032] discloses determining whether the external stimuli were effective in entraining the brain of the subject to the particular frequency and in improving the cognitive states or functions of the brain. This seems to be similar to the applicant’s invention’s goals as the applicant’s abstract states “The systems and methods may also be useful for improving a cognitive performance of the user by maintaining cognitive function during sleep deprivation and/or temporarily or permanently improving intelligence, learning capacity, memory retention, recall, mood and/or alertness”. Thus, Malchano is being cited for the improving cognitive states or function in the brain rather than the sleep application.
Applicant 9th argues on page 14 that Malchano’s entrainment is not directed towards sleep enhancement in combination with nerve stimulation. In response to the argument, Malchano discloses in [0032] determining whether the external stimuli were effective in entraining the brain of the subject to the particular frequency and in improving the cognitive states or functions of the brain. This seems to be similar to the applicant’s invention’s goals as the applicant’s abstract states “The systems and methods may also be useful for improving a cognitive performance of the user by maintaining cognitive function during sleep deprivation and/or temporarily or permanently improving intelligence, learning capacity, memory retention, recall, mood and/or alertness”. Thus, Malchano is being cited for the improving cognitive states or function in the brain rather than the sleep application.
Applicant 10th argues on pages 15-16 “Poltorak's disclosure of improved sleep quality does not supply a motivation to combine entrainment-to-deep-sleep with the specific transcutaneous microburst vagus nerve stimulation system assembled from the other four references”. The primary reference, Maschino, discloses in [0041] that sleep disorders are one of the conditions that are appropriate for cranial nerve stimulation, of which Maschino and the applicant’s invention focus on Vagus nerve stimulation. Therefore, the use of entrainment to achieve deep sleep as taught by Poltorak ([0066]-[0072]) would contribute a benefit independent of vagus stimulation, which the examiner considers would motivate PHOSITA to combine Poltorak with Maschino as modified for the purpose of improved sleep quality and a decrease in sleep requirements (e.g. see [0092]).
Applicant 11th traverses the rejection for claim 10 by arguing “Claim 10 requires binaural tones having "a beat frequency of about 0.5 to about 4 Hz." This range corresponds to the delta brainwave band associated with deep sleep.”. Poltorak discloses binaural tones in [0090]-[0094] and delta brainwave band in [0034], [0039]. Therefore, the beat frequencies taught by Poltorak contribute a benefit independent of vagus stimulation, which the examiner considers would motivate PHOSITA to combine Poltorak with Maschino as modified for the purpose of improved sleep quality and a decrease in sleep requirements (e.g. see [0092]).
Applicant 12th argues on pages 16-17 that the combination of references are drawn from different fields as Kara is directed towards implanted stimulation, not transcutaneous. In response to applicant's argument that Kara is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the prior art reference is in the field of the inventor’s endeavor as Kara is directed towards electrical vagus nerve stimulation. The examiner was very intentional to cite vagus nerve stimulation prior art as it is of particular relevance. Additionally, [0036], [0038], and [0039] of Kara state that sleep disorders are one of the medical conditions treated by the method of Kara. Therefore, Kara is a vagus nerve stimulator that is used in sleep applications and thus is in the field of the inventor’s endeavor and is reasonably pertinent to the particular problem with which the inventor was concerned.
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.
Claim(s) 1-3, 12, and 18-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino et al. (Pub. No.: US 2007/0179557 A1); hereinafter referred to as “Maschino”, in view of Lesser et al. (Pub. No.: US 2008/0208266 A1); hereinafter referred to as Lesser, and Craig (Pub. No.: US 2007/0233193 A1).
Regarding claim 1, Maschino discloses a system for enhancing sleep (e.g. see [0041]), the system comprising: a nerve stimulator (e.g. see figure 1A element 125, [0051]. Note: Per dependent claim 18 of the current application and [0051] of the Maschino reference, the applicant and Maschino are both stimulating the vagus nerve), with electrical impulses comprising bursts of pulses (e.g. see [0093]-[0094], “pulse burst”), with each burst having a frequency of about 1 to about 100 bursts per second and each pulse has a duration of about 50 to about 1000 microseconds in duration (e.g. see [0094]. Note: Maschino discloses “the width of each signal may be set to a value not greater than about 1 msec, such as about 250-500 .mu.sec, and the signal repetition frequency may be programmed to be in a range of about 20-250 Hz”. The examiner understands 1 burst per second to be the same as 1 Hz and the pulse duration in the claim to be the pulse width in Maschino) and a sensory stimulator configured to deliver one or more stimuli to a sense organ or a brain of a user (e.g. see figures 2, 9, and 10, “external evoking signal”, [0046], [0107] explicitly disclose sensory stimulus).
Maschino discloses the claimed invention but is silent as to an electrode configured for contacting the outer skin surface at, or near a target location and an energy source coupled to the stimulator and wherein the energy source is configured to generate at least one electrical impulse and to transmit the at least one electrical impulse transcutaneously from the electrode through the outer skin surface of the user to a selected nerve in the user adjacent to, or near, the target location. Lesser teaches that it is known to use such a modification as set forth in figure 2 elements 40, 42, [0046]-[0047] to locate a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery operated device (e.g. see [0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use non-invasive, skin electrodes capable of vagus nerve stimulation as taught by Lesser in the system of Maschino, since said modification would provide the predictable results of a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery-operated device.
Maschino and Lesser disclose the claimed invention except for the bursts each
comprise about 2 to 20 pulses and the bursts are separated by an inter-burst period that comprises zero pulses. Craig teaches that it is known to use such a modification as set forth in [0039], figure 4A to produce enhanced vagal evoked potentials (eVEP) in therapeutically significant areas of the brain (e.g. see [0015]) to treat sleep disorders (e.g. see [0038]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use 2 to 20 pulses and the bursts are separated by an inter-burst period that comprises zero pulses as taught by Craig in the system of Maschino and Lesser, since said modification would provide the predictable results of enhanced vagal evoked potentials (eVEP) in therapeutically significant areas of the brain.
Regarding claim 2, Maschino discloses the sensory stimulator comprises one or more of a visual stimulator, an auditory stimulator, a tactile stimulator or a combination thereof (e.g. see figures 2, 9, and 10, “external evoking signal”, [0046], [0107]. Maschino discloses “electrical, chemical, auditory, visual, and/or mechanical signals”. Note: “mechanical signals” will read on “tactile”).
Regarding claim 3, Maschino discloses the sensory stimulator comprises an auditory stimulator and a visual stimulator (e.g. see figures 2, 9, and 10, “external evoking signal”, [0046], [0107]. Maschino discloses “electrical, chemical, auditory, visual, and/or mechanical signals”).
Regarding claim 12, Maschino discloses the nerve stimulator comprises a housing, wherein the electrode is coupled to the housing (e.g. see [0050], figure 1A elements 112, 121).
Regarding claim 13, Maschino discloses the energy source is disposed within the housing (e.g. see figure 8 element 830, [0098]).
Regarding claim 14, Maschino discloses a signal generator disposed within the housing and electrically coupled to the energy source and the electrode (e.g. see [0050], figure 1A element 110).
Regarding claim 18, Maschino discloses the nerve is a vagus nerve (e.g. see [0051]).
Regarding claim 19, Maschino discloses the claimed invention but is silent as to the electrode is configured for contacting an outer skin surface of the neck of the user. Lesser teaches that it is known to use such a modification as set forth in figure 2 elements 40, 42, [0046]-[0047] to locate a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery operated device (e.g. see [0010]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use non-invasive, skin electrodes capable of vagus nerve stimulation as taught by Lesser in the system of Maschino, since said modification would provide the predictable results of a current source for such methods and systems outside the body, for patients who do not need or desire an implanted power supply or battery operated device.
Regarding claim 20, Maschino discloses the energy source is configured to transmit a plurality of electrical impulses to the selected nerve according to a treatment paradigm (e.g. see [0045]-[0048], figures 2, 9, and 10).
Regarding claims 21-25, the prior art establishes the structure and treatment parameters in the rejection for claim 20 above. Claims 21-25 add no structure or stimulation parameters. Applicant is reminded these are system/device claims, not method claims. The prior art is capable of and/or configured to meet the intended use and intended results limitations of claims 21-25 as the structure and treatment parameters are taught by the rejection for claim 20 above.
Claim(s) 4-7 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino and Lesser as applied to claims 1 and 3 above, and further in view of Malchano (Pub. No.: US 2018/0133507 A1).
Regarding claim 4, Maschino and Lesser disclose the claimed invention except for the auditory stimulator is configured to deliver binaural tones to the brain of the user. Malchano teaches that it is known to use such a modification as set forth in figure 11A, [0416]-[0419] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use binaural tones as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 5, Maschino and Lesser disclose the claimed invention except for a wearable device comprising one or more sensors for measuring brainwave activity and a processor configured to compute an effective brainwave frequency based on the brainwave activity. Malchano teaches that it is known to use such a modification as set forth in [0113] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a brainwave sensor and processor as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 6, Maschino and Lesser disclose the claimed invention except for the binaural tones are synchronized with the effective brainwave frequency. Malchano teaches that it is known to use such a modification as set forth in figure 11A, [0416]-[0419] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use binaural tones synchronized with brainwave frequency as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 7, Maschino and Lesser disclose the claimed invention except for the visual stimulator is configured to deliver light patterns synchronized with the binaural tones. Malchano teaches that it is known to use such a modification as set forth in figure 11A, [0416]-[0419] and [0045]-[0046] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the visual stimulator is configured to deliver light patterns synchronized with the binaural tones as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 11, Maschino and Lesser disclose the claimed invention except for the light patterns comprise light waves have a wavelength of about 600 nm to about 720 nm. Malchano teaches that it is known to use such a modification as set forth in [0249] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the light patterns comprising light waves have a wavelength of about 600 nm to about 720 nm as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Claim(s) 8-10, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino, Lesser, and Malchano as applied to claims 4 and 7 above, and further in view of Poltorak (Pub. No.: US 2019/0321583 A1).
Regarding claim 8, Maschino, Lesser, and Malchano disclose the processor is configured to adjust the binaural tones and the light patterns to entrain the brain of the user (e.g. see [0019]) but are silent as to achieving deep sleep through entrainment. Poltorak teaches that it is known to use such a modification as set forth in [0066]-[0072] to provide improved sleep quality and a decrease in sleep requirements (e.g. see [0092]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use entrainment to achieve deep sleep as taught by Poltorak in the system of Maschino, Lesser, and Malchano, since said modification would provide the predictable results of improved sleep quality and a decrease in sleep requirements.
Regarding claim 9, Maschino and Lesser disclose the claimed invention except for the binaural tones have frequencies of about 10 Hz to about 100 Hz. Malchano teaches that it is known to use such a modification as set forth in [0395]-[0400] to entrain the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain (e.g. see [0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the binaural tones having frequencies of about 10 Hz to about 100 Hz as taught by Malchano in the system of Maschino and Lesser, since said modification would provide the predictable results of entraining the brain of the subject to the particular frequency and improve the cognitive states or functions of the brain.
Regarding claim 10, Maschino, Lesser, and Malchano disclose the claimed invention except for the binaural tones have a beat frequency of about 0.5 to about 4 Hz. Poltorak teaches that it is known to use such a modification as set forth in [0090]-[0094] to provide improved sleep quality and a decrease in sleep requirements (e.g. see [0092]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use binaural tones having a beat frequency of about 0.5 to about 4 Hz as taught by Poltorak in the system of Maschino, Lesser, and Malchano, since said modification would provide the predictable results of improved sleep quality and a decrease in sleep requirements.
Regarding claim 13, Maschino discloses the energy source is disposed within the housing (e.g. see figure 8 element 830, [0098]).
Regarding claim 14, Maschino discloses a signal generator disposed within the housing and electrically coupled to the energy source and the electrode (e.g. see [0050], figure 1A element 110).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschino and Lesser as applied to claim 1, and further in view of Kara et al. (Pub. No.: US 2004/0260356 A1); hereinafter referred to as “Kara”.
Regarding claim 15, Maschino and Lesser disclose the claimed invention except for pulses have a frequency of about 1 kHz to about 20 kHz. Kara teaches that it is known to use such a modification as set forth in [0024]-[0025] and [0027], figures 3 and 4 to provide improved adjustment of the vagus nerve stimulation (VNS) device settings for an individual patient (e.g. see [0006]) to treat sleep disorders (e.g. see [0036], [0038], and [0039]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz as taught by Kara in the system of Maschino and Lesser, since said modification would provide the predictable results of improved adjustment of the vagus nerve stimulation (VNS) device settings for an individual patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: De Ridder (Pub. No.: US 2006/0095088 A1) as [0015]-[0016] cite pertinent/relevant stimulation ranges and [0124], [0137] cite sleep disorder treatment.
THIS ACTION IS MADE FINAL. 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 PHILIP C EDWARDS whose telephone number is (571)270-1804. The examiner can normally be reached Mon-Fri, 9:00-5:00 EST.
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
Prosecution Insights