DETAILED ACTION
Response to Arguments
Applicant’s arguments, see page 6, filed on 6/03/2026, with respect to the 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The previous 112(b) rejections of claims 1, 7, and 19 have been withdrawn.
Applicant's arguments, see pages 6-9, filed on 6/03/2026, with respect to the 35 U.S.C. 103 rejections have been fully considered but they are not persuasive. The Applicant discusses how Lee teaches intrapulse shape modulation, wherein each sub-pulse within the pulse either increases or decreases in amplitude from an immediately preceding sub-pulse. It is of the Examiner’s opinion that the sub-pulses disclosed in Lee are in fact pulses. Furthermore, a quick internet search demonstrates that sub-pulses are smaller secondary pulses contained within a single larger pulse window or waveform. Therefore, it is of the Examiner’s opinion that Figures 13A-13C in Lee disclose a waveform that comprises a train of monophasic pulses, wherein each successive pulse either increases or decreases in amplitude from an immediately preceding pulse. The 103 rejection of claim 1 under Lee in view of Abouelsoud is not withdrawn, and thus claims 3-4 and 6-20 are also still rejected under the previous 103 rejections.
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.
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.
Claims 1, 3-4, 6-10, and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (U.S. Patent No. 10,589,099) in view of Abouelsoud (U.S. PGPub No. 2021/0370063) (both cited previously).
Regarding claim 1, Lee teaches a method of neurostimulation (Col. 3, line 13 and
Col. 6, lines 46-51) comprising: generating a waveform (Fig. 13A-13C, Col. 10, lines 60-63) comprising a train (Fig. 13A-13C, Col. 11, line 4) of monophasic (Fig. 13A-13C, Col. 8, lines 60-61) or biphasic pulses wherein each successive pulse either increases in amplitude from an immediately preceding pulse (Fig. 13B-13C, Col. 10, lines 65-67) or decreases in amplitude from an immediately preceding pulse (Fig. 13A, Col. 10, lines 63-65); and delivering the waveform to a brain of a subject (Col. 6, lines 1-2 and Col. 18, lines 5-7).
Lee does not teach that the method includes non-invasively delivering the
waveform to the brain of a subject, as the system taught in Lee uses implantable stimulation leads (Fig. 1, Col. 6, lines 6-7) with a plurality of electrodes (Fig. 1, Col. 6, lines 12-13) and an implantable pulse generator (IPG) (Fig. 1, Col. 6, lines 7-8).
Abouelsoud, however, teaches a neural stimulation device and method that utilizes
a wearable electrical stimulation device (Fig. 1A, Paragraph 0037, lines 1-2) that uses a plurality of electrodes (Fig. 1A, Paragraph 0037, line 7) to non-invasively deliver electrical stimulation (Paragraph 0031, lines 6-7) waveforms comprising a train of pulses (Paragraph 0032, lines 17-20) to the brain of a subject (Paragraph 0031, lines 5-8).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Lee to incorporate the teachings of
Abouelsoud to include that the waveform is delivered to the brain of a subject in a non-invasive manner. Doing so would mitigate the risks of invasive forms of brain neurostimulation, such as deep brain stimulation (DBS), and would ensure that more
patients could afford said treatment (Paragraph 0006, lines 9-16), as recognized by
Abouelsoud.
Lee also does not teach that the waveform has a constant or varying frequency. Abouelsoud, however, teaches that the pulses can have a waveform frequency that is constant or varying (Paragraph 0018, lines 12-14). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee to incorporate the teachings of Abouelsoud to include that the waveform has a constant or varying frequency. Doing so would ensure that pulse parameters such as frequency, amplitude, and polarity can be altered (Paragraph 0019, lines 22-27) to optimize patient therapeutic outcomes, as recognized by Abouelsoud.
Regarding claim 3, Lee in view of Abouelsoud discloses the claimed invention of
claim 1. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 wherein the waveform (Fig. 13A-13C, Col. 10, lines 60-63) is monophasic and anodic (Fig. 13A-13C, Col. 8, lines 60-61).
Regarding claim 4, Lee in view of Abouelsoud discloses the claimed invention of claim 1. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 wherein the waveform (Fig. 13A-13C, Col. 10, lines 60-63) is monophasic and cathodic (Fig. 13A-13C, Col. 8, lines 60-61). Lee teaches that the monophasic waveforms are shown as having a single polarity. Therefore, it would be well understood by a person of ordinary skill in the art that the polarity could be negative and cathodic, rather than positive and anodic.
Regarding claim 6, Lee teaches the method (Col. 3, line 13 and Col. 6, lines 46-
51) of claim 1 that comprises generating a waveform (Fig. 13A-13C, Col. 10, lines 60- 63). Lee does not teach that the waveform is biphasic and asymmetric.
Abouelsoud, however, teaches a neural stimulation device and method that utilizes a wearable electrical stimulation device (Fig. 1A, Paragraph 0037, lines 1-2) that delivers
waveforms comprising a train of pulses (Paragraph 0032, lines 17-20) to the brain of a
subject (Paragraph 0031, lines 5-8). Abouelsoud also teaches that the waveform can be
biphasic (Paragraph 0018, lines 16-18) and asymmetric (Paragraph 0034, lines 12-15).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Lee to incorporate the teachings of
Abouelsoud to include that the waveform can be biphasic. Doing so would allow for
certain regions of the brain to be depolarized for therapeutic effect (Paragraph 0034, lines
14-15), as recognized by Abouelsoud.
Regarding claim 7, Lee in view of Abouelsoud discloses the claimed invention of claim 1. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 wherein each pulse has a duration in a range of 10 µs to 10 ms (Fig. 13A-13B, Col. 11, line 1 and Col. 12, lines 27-30).
Regarding claim 8, Lee in view of Abouelsoud discloses the claimed invention of claim 8. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 7 wherein all pulses in the train have identical widths (Fig. 13A-13B, Col. 11, lines 1-3).
Regarding claim 9, Lee in view of Abouelsoud discloses the claimed invention of claim 7. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 7 wherein some of the pulses in the train have different widths than other pulses in the train (Fig. 13C, Col. 11, lines 3-5).
Regarding claim 10, Lee teaches the method (Col. 3, line 13 and Col. 6, lines 46-
51) of claim 1 that comprises generating a waveform (Fig. 13A-13C, Col. 10, lines 60-
63). Lee does not teach that the waveform has a frequency that is in the range of 1 Hz to 1 kHz.
Abouelsoud, however, teaches a neural stimulation device and method that utilizes a wearable electrical stimulation device (Fig. 1A, Paragraph 0037, lines 1-2) that delivers waveforms comprising a train of pulses (Paragraph 0032, lines 17-20) to the brain of a subject (Paragraph 0031, lines 5-8). Abouelsoud also teaches that the pulses can have a
waveform frequency of 0 Hz to 100 kHz (Paragraph 0059, lines 1-4).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Lee to incorporate the teachings of Abouelsoud to include that the waveform has a frequency in the range of 1 Hz to 1 kHz. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior
art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ
90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
(The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim
was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.) MPEP § 2144.05-I.
Regarding claim 12, Lee in view of Abouelsoud discloses the claimed invention of claim 1. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 wherein the pulses comprising the waveform (Fig. 13A-13C, Col. 10, lines 60-63) are rectangular in shape (Fig. 13A-13C).
Regarding claim 13, Lee in view of Abouelsoud discloses the claimed invention of claim 1. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 wherein the waveform has an envelope (see dashed lines in Fig. 13A-13C) and further where the envelope is linear or exponential in shape (Fig. 13A-13C, Col. 10, lines 63-67).
Regarding claim 14, Lee in view of Abouelsoud discloses the claimed invention of claim 1. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 wherein each successive pulse increases or decreases in amplitude (Fig. 13B-13C, Col. 10, lines 63-67) in the range of 10% to 500% over the previous pulse.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of the range for the change in amplitude over
the previous pulse (See Paragraph 0024 of the Applicant's Specification), this particular arrangement is deemed to have been known by those skilled in the art since the instant
specification and evidence of record fail to attribute any significance (novel or
unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ
7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 15, Lee in view of Abouelsoud discloses the claimed invention of claim 1. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 wherein the waveform is delivered in bursts of between 2 and 10 pulses (Fig. 13A-13B, Col. 11, lines 1-3).
Regarding claim 16, Lee in view of Abouelsoud discloses the claimed invention of claim 15. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 15 wherein the bursts of between 2 and 10 pulses (Fig. 13A-13B, Col. 11, lines 1-3) are delivered over a time period between 5 ms and 100 ms.
Furthermore, since applicants have not disclosed that these modifications solve
any stated problem or are for any particular purpose and it appears that the device would perform equally well with either design, these modifications are a matter of design choice. Absent a teaching as to criticality of the time period in which the bursts are
delivered (See Paragraph 0025 of the Applicant's Specification), this particular arrangement is deemed to have been known by those skilled in the art since the instant
specification and evidence of record fail to attribute any significance (novel or
unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555, 188 USPQ 7, 9 (CCPA 1975). MPEP 2144.05.
Regarding claim 17, Lee in view of Abouelsoud discloses the claimed invention of claim 1. Lee further discloses the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 wherein the waveform (Fig. 13A-13C, Col. 10, lines 60-63) is focused to a specific area of the brain (Col. 6, lines 1-2 and Col. 18, lines 5-7).
Regarding claim 18, Lee teaches the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 that comprises generating a waveform (Fig. 13A-13C, Col. 10, lines 60-63). Lee does not teach that the waveform is delivered via a transcranial electrical stimulation technique.
Abouelsoud, however, teaches a neural stimulation device and method that utilizes
a wearable electrical stimulation device (Fig. 1A, Paragraph 0037, lines 1-2) that delivers
waveforms comprising a train of pulses (Paragraph 0032, lines 17-20) via a transcranial
electrical stimulation technique (Paragraph 0031, lines 6-7).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Lee to incorporate the teachings of Abouelsoud to include that the waveform is delivered via a transcranial electrical stimulation technique. Doing so would mitigate the risks of invasive forms of brain
neurostimulation, such as deep brain stimulation (DBS), and would ensure that more patients could afford said treatment (Paragraph 0006, lines 9-16), as recognized by
Abouelsoud.
Regarding claim 19, Lee teaches the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1 that comprises generating a waveform (Fig. 13A-13C, Col. 10, lines 60-63). Lee does not teach that the waveform is delivered via a plurality of electrodes placed on a skull of the subject.
Abouelsoud, however, teaches a neural stimulation device and method that utilizes
a wearable electrical stimulation device (Fig. 1A, Paragraph 0037, lines 1-2) that uses a
plurality of electrodes (Fig. 1A, Paragraph 0037, line 7) placed on the skull of the subject
(Paragraph 0072, lines 1-3) to deliver waveforms comprising a train of pulses (Paragraph
0032, lines 17-20) to the brain of the subject (Paragraph 0031, lines 5-8).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Lee to incorporate the teachings of
Abouelsoud to include that waveform is delivered via a plurality of electrodes placed on
the skull of the subject. Doing so would mitigate the risks of invasive forms of brain
neurostimulation, such as deep brain stimulation (DBS), and would ensure that more
patients could afford said treatment (Paragraph 0006, lines 9-16), as recognized by
Abouelsoud.
Regarding claim 20, Lee teaches a system (Fig. 1, Col. 6, line 5) comprising: a processor (Col. 14, line 29); a pulse generator (Fig. 1, Col. 6, lines 7-8); and software (Col. 14, line 31) that, when executed by the processor (Col. 14, lines 29-31), controls the pulse generator (Col. 14, lines 32-40) to implement the method (Col. 3, line 13 and Col. 6, lines 46-51) of claim 1.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (U.S. Patent No. 10,589,099) in view of Abouelsoud (U.S. PGPub No. 2021/0370063) as applied to claim 1 above, and further in view of Cholette et al. (U.S. PGPub No. 2024/0165402) (cited previously).
Regarding claim 11, Lee teaches the method (Col. 3, line 13 and Col. 6, lines 46-
51) of claim 1 that comprises generating a waveform (Fig. 13A-13C, Col. 10, lines 60-
63). Lee does not teach that the pulses comprising the waveform are unevenly spaced in time.
Cholette, however, teaches a method for providing electrical stimulation (Paragraph 0007, line 1) that involves using stimulation waveforms (Paragraph 0007, line 4) with a series of stimulation pulses (Paragraph 0007, lines 6-7). Cholette teaches that
the method can be applicable for deep brain stimulation (Paragraph 0151, line 10).
Cholette also teaches that the stimulation waveforms can be monotonic (Fig. 13D-13E,
Paragraph 0112, lines 1-4) and unevenly spaced in time (Fig. 13G-13H, Paragraph 0113,
lines 3-6).
It would have been obvious to one of ordinary skill in the art before the effective
filing date of the claimed invention to modify Lee to incorporate the teachings of
Cholette to include that the pulses comprising the waveform are unevenly spaced in time. Doing so would allow for many different waveform combinations of varying frequency, amplitude, and pulse width (Paragraph 0113, lines 7-9), as recognized by Cholette.
Conclusion
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 Heidi Hilsmier whose telephone number is (571)272-2984. The examiner can normally be reached Monday - Fridays from 7:30 AM - 3:30 PM.
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, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights