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 .
References to the instant application’s as-filed specification has been made using USPGPub. version of the specification in this Office action.
Status of Claims
Claims 1-23 are currently pending and under review.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 186b, as shown in Fig. 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “50” has been used to designate both “stimulating pulse” in [0035] for example and “activating pulse” in [0036] for example. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Claim Objections
Claims 8, 19, and 22 objected to because of the following informalities:
In claims 8 and 19, the limitation “have duration of” should be corrected to -have a duration of-.
In claim 22, the phrase “a first and second electrode portion” should be corrected to --a first and second electrode portions--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 4, 15, 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.
Claims 4 and 15 recite the limitation "the stimulating pulses" in line 2 of both claims. The antecedent basis for this limitation seems indefinite since it is unclear if there is any difference between “activating pulse” recited in claims 1 and 12 and “stimulating pulses” recited in claims 4 and 15. In addition, claims 4 and 16 are further indefinite since it is unclear if the term “stimulating pulses” is in a plural form is referring to the term “activating pulse” in a singular in claims 1 and 12. For the purpose of examination, claims 4 and 15 have been interpreted as --wherein the nullifying pulse has a lower average frequency content than the activating pulse--.
Claim 23 recites the limitation " the first and second electrode portions" in line 1. There is insufficient antecedent basis for this limitation in the claim. Applicant is recommended to change the dependency of claim 23 to be dependent on claim 22.
Claim Rejections - 35 USC § 102
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 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 1-7, 12-18, and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tai (US 20210106831 A1, published 04/15/2021).
Regarding claim 1, Tai discloses a system for stimulating tissue having voltage-gated ion channels (“applying an electrical stimulation to a nerve or neuron” [0142], ¶0026 of the specification discloses “nerve fibers 12 within a nerve 14 although the present device may be used with a variety of tissue having voltage-gated ion channels including cardiac, skeletal, muscle, and epithelial tissues ) comprising:
a first electrode positionable to interact with first tissue having voltage-gated ion channels (“one or more skin surface electrodes or magnetic coils are configured to apply an electrical stimulation to a nerve or neuron…activation/inactivation of the ion channels near the block electrode” [0088], [0162]);
a second electrode positionable to interact with second tissue having voltage-gated ion channels ([0088], [0162]); and
an electrical circuit (“processor can thereafter instruct the power source/pulse generator to apply a first increased intensity electrical stimulation” [0152], it is well known in the art that a pulse generator is an electrical circuit) applying:
(a) an activating pulse (“electrical stimulation can include electrical pulses that can have any suitable characteristic” [0132]) having a first waveform shape (“waveform may be of any useful shape, including without limitation: sine, square, rectangular, triangular…” [0137]) to the first electrode adapted to activate the voltage-gated ion channels in the first tissue (“activation of the ion channels near the block electrode” [0162]); and
(b) a nullifying pulse (“inactivation of the ion channels near the block electrode” [0162]) having a second waveform shape different from the first waveform shape to the second electrode (“waveform may be of any useful shape, including without limitation: sine, square, rectangular, triangular…” [0137]), the nullifying pulse at a predetermined synchronization with the activating pulse (“the axon membrane is alternately depolarized and hyperpolarized with large sodium and potassium currents…the behavior of the membrane potentials and ionic currents can be further explained by the activation/inactivation of the sodium and potassium channels as shown in FIG. 11, panels d-f” [0162], Fig. 11) and adapted to nullify activation of the voltage-gated ion channels in the second tissue by a combination of the activating pulse and nullifying pulse (“the combination of activation (m) and inactivation (h) of sodium channels (FIG. 11, panels d and e) determines that the amplitude of the sodium current gradually attenuates at nodes close to the block electrode and eventually becomes a pulsed inward current at the node (0.0 mm) under the block electrode (FIG. 11, panel b)” [0162]).
Regarding claims 2 and 13, Tai discloses the system and method as described in claims 1 and 12, wherein the electrical circuit independently controls a current of the activating pulse and nullifying pulse (“controller includes a program, code, a set of instructions, or some combination thereof, executable by the processor for independently…instructing the device to interact and operate as programmed” [0150]).
Regarding claims 3 and 14, Tai discloses the system and method as described in claims 1 and 12, wherein an average spectral frequency of the activating pulse is greater than the average spectral frequency of the nullifying pulse (“for blocking nerves, useful frequencies range above 1 Hz (Hertz)…stimulation is applied at 1.5 kHz, or 1.2 kHz” [0133]).
Regarding claims 4 and 15, Tai discloses the system and method as described in claims 1 and 12, wherein the nullifying pulses have a lower average frequency content than the stimulating pulses (“for blocking nerves, useful frequencies range above 1 Hz (Hertz)…stimulation is applied at 1.5 kHz, or 1.2 kHz” [0133]).
Regarding claims 5 and 16, Tai discloses the system and method as described in claims 1 and 12, wherein the first and second tissue are nerves and the first and second electrodes are cuff electrodes fitting around nerves and supporting multiple circumferentially displaced electrodes (“applying an electrical stimulation to a nerve or neuron…device includes a first conductive lead and a first nerve cuff, and a second conductive lead with a second nerve cuff” [0142], [0145]).
Regarding claims 6 and 17, Tai discloses the system and method as described in claims 1 and 12, wherein the first and second electrodes are on a common substrate (“conductive leads and can be combined into a single lead to connect the nerve cuffs…designs with different leads, probes, electrodes, or electrical contacts, or combinations thereof will be apparent to those of ordinary skill” i.e., the conductive leads can be replaced by electrodes, [0145]).
Regarding claims 7 and 18, Tai discloses the system and method as described in claims 1 and 12, wherein the activating pulse is a biphasic, charge balanced pulse (“biphasic stimuli may be used…’biphasic current,’ ‘biphasic pulses,’ or ‘biphasic waveforms’ refer to two or more pulses that are of opposite polarity that may be of equal or substantially equal net charge (hence, biphasic and charge balanced)” [0136]).
Regarding claim 12, Tai discloses a method of stimulating tissue having voltage-gated ion channels employing a stimulation device (“applying an electrical stimulation to a nerve or neuron” [0142], ¶0026 of the specification discloses “nerve fibers 12 within a nerve 14 although the present device may be used with a variety of tissue having voltage-gated ion channels including cardiac, skeletal, muscle, and epithelial tissues") having:
a first electrode positionable to interact with first tissue having voltage-gated ion channels (“one or more skin surface electrodes or magnetic coils are configured to apply an electrical stimulation to a nerve or neuron…activation/inactivation of the ion channels near the block electrode” [0088], [0162]);
a second electrode positionable to interact with second tissue having voltage-gated ion channels ([0088], [0162]); and
an electrical circuit (“processor can thereafter instruct the power source/pulse generator to apply a first increased intensity electrical stimulation” [0152], it is well known in the art that a pulse generator is an electrical circuit) applying: an activating pulse (“electrical stimulation can include electrical pulses that can have any suitable characteristic” [0132]) having a first waveform shape (“waveform may be of any useful shape, including without limitation: sine, square, rectangular, triangular…” [0137]) to the first electrode adapted to activate the voltage-gated ion channels in the first tissue (“activation of the ion channels near the block electrode” [0162]); and a nullifying pulse (“inactivation of the ion channels near the block electrode” [0162]) having a second waveform shape different from the first waveform shape to the second electrode (“waveform may be of any useful shape, including without limitation: sine, square, rectangular, triangular…” [0137]), the nullifying pulse at a predetermined synchronization with the activating pulse (“the axon membrane is alternately depolarized and hyperpolarized with large sodium and potassium currents…the behavior of the membrane potentials and ionic currents can be further explained by the activation/inactivation of the sodium and potassium channels as shown in FIG. 11, panels d-f” [0162], Fig. 11) and adapted to nullify activation of the voltage-gated ion channels in the second tissue by a combination of the activating pulse and nullifying pulse (“the combination of activation (m) and inactivation (h) of sodium channels (FIG. 11, panels d and e) determines that the amplitude of the sodium current gradually attenuates at nodes close to the block electrode and eventually becomes a pulsed inward current at the node (0.0 mm) under the block electrode (FIG. 11, panel b)” [0162]); the method comprising
(a) applying an activating pulse to the first tissue to activate voltage-gated ion channels in the first tissue (“an “electrical contact” is inclusive of any structure useful for directly applying an electrical current to a nerve or tissue in a patient, such as to the skin of a patient…activation of the ion channels near the block electrode” [0145], [0162]); and
(b) applying a nullifying pulse to the second tissue (“inactivation of the ion channels near the block electrode” [0162]) synchronized to the activating pulse to nullify activation of the voltage-gated ion channels in the second tissue by a combination of the activating pulse and nullifying pulse (“the combination of activation (m) and inactivation (h) of sodium channels (FIG. 11, panels d and e) determines that the amplitude of the sodium current gradually attenuates at nodes close to the block electrode and eventually becomes a pulsed inward current at the node (0.0 mm) under the block electrode (FIG. 11, panel b)” [0162]).
Regarding claim 23, Tai discloses the system and method as described in claim 12, wherein the first and second electrode portions are positioned on a patient’s skin (“one or more skin surface electrodes” [0009]).
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.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tai in view of Dinsmoor et. al, (WO 2022155032, published 07/21/2022, hereinafter known as Dinsmoor). For the purpose of prior art citation, US 20240066304 A1 has been used as an equivalent document for Dinsmoor reference.
Regarding claims 8 and 19, while Tai further discloses that as will be recognized by a person of skill in the art, characteristics of the electrical pulses, including, without limitation, amplitude (pulse strength, referring to the magnitude or size of a signal voltage or current), voltage, amperage, duration, frequency, polarity, phase, relative timing, and symmetry of positive and negative pulses in biphasic stimulation, and/or wave shape (e.g., square, sine, triangle, sawtooth, or variations or combinations thereof) may be varied in order to provide the desired sub-threshold stimulation and resultant post-stimulation blocking in a patient or class of patients ([0132]), Tai does not disclose wherein the activating pulse and nullifying pulse have duration of less than 100 ms.
However, Dinsmoor teaches systems, devices, and techniques for adjusting electrical stimulation based on a posture state of a patient (Abstract). The period of time for a single sample that includes delivering the control pulse and detecting the resulting ECAP signal may be 20 ms or less [0145].
Therefore, it would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the duration of electrical stimulation of Dinsmoor with the system and method for stimulating tissue of Tai because pulse duration determines how strong, and ultimately effective, the electrical stimulation will be. Further, one of ordinary skill in the art would recognize that characteristics of the electrical pulses, including specific duration, can be varied in provide the desired sub-threshold stimulation and resultant post-stimulation blocking in a patient or class of patients.
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tai in view of Guenther et. al, (US 20240350199 A1, published 10/24/2024, hereinafter known as Guenther).
Regarding claims 9 and 20, Tai discloses the electrical circuit operates to control the nullifying pulse to reduce the monitoring signal from the third electrode (“this reintroduced stimulation can be of a reduced intensity and/or an increased frequency compared to the stimulation required to provide the initial block” [0134]).
Tai does not disclose the electrical circuit receives a monitoring signal from a third electrode positioned in communication with the second tissue.
However, Guenther teaches systems and procedures for tissue ablation and the induction of immunological responses, including a technique for creating temporary openings in cell membranes through electrical pulses (Abstract). Finite element models are employed for these predictions, and tissue impedance monitoring may adjust these parameters in real time [0059].
Therefore, it would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the monitoring signal of Guenther with the system and method for stimulating tissue of Tai because it allows for updating parameters in real time to enhance model accuracy (Guenther, [0057]).
Claims 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Tai in view of Schepis et. al, (US 20200179697 A1, published 06/11/2020, hereinafter known as Schepis).
Regarding claims 10 and 21, Tai does not disclose the electrical circuit includes a multiplexer for selectively connecting a set of different electrodes communicating with the first and second tissue to change the electrodes of the set operating as the first electrode and second electrode; and whereby electrodes of the set of different electrodes may be selected to optimize stimulation of the first tissue and nullification of the second tissue.
However, Schepis teaches a system and method for selectively and reversibly modulating targeted neural and non-neural tissue of a nervous system for the treatment of pain (Abstract). Stimulation parameters can be optimized [0171]. Interface may include one or more components configured to transmit and receive data via a communication network…interface may include one or more… multiplexers [0292].
Therefore, it would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of a multiplexer for optimization purposes of Schepis with the system and method for stimulating tissue of Tai because optimization of the stimulation parameters allows for selectively inhibiting perception of pain while preserving nerve activity (Schepis, [0171]).
Claims 11 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Tai in view of Rauscher (US 20120109241 A1, published 05/03/2012).
Regarding claim 11, Tai discloses an average frequency greater than the frequency of the nullifying pulse (“for blocking nerves, useful frequencies range above 1 Hz (Hertz)…stimulation is applied at 1.5 kHz, or 1.2 kHz”, through the lens of the broadest reasonable interpretation, technically anything above 1Hz could be equal to 1.5kHz or 1.2kHz, and the average frequency of the activating pulse could still be greater than that of the nullifying pulse [0133]). Tai further discloses that as will be recognized by a person of skill in the art, characteristics of the electrical pulses, including, without limitation, amplitude (pulse strength, referring to the magnitude or size of a signal voltage or current), voltage, amperage, duration, frequency, polarity, phase, relative timing, and symmetry of positive and negative pulses in biphasic stimulation, and/or wave shape (e.g., square, sine, triangle, sawtooth, or variations or combinations thereof) may be varied in order to provide the desired sub-threshold stimulation and resultant post-stimulation blocking in a patient or class of patients ([0132]).
Tai does not disclose the nullifying pulse is a beat frequency produced by an interference between at least two signals having a relative frequency difference equal to a frequency of the nullifying pulse.
However, Rauscher teaches treating a living being with multiple, concurrent, superimposed non-phase-locked signals, at physiologically acceptable intensities and duty cycles such that the signals entrain the tissue (Abstract). The beat frequency intermix is critical to the proper operation of the device of this invention [0085].
Therefore, it would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the beat frequency and frequency difference of Rauscher with the system and method for stimulating tissue of Tai because beat frequencies aid in a more effective electrical stimulation treatment.
Regarding claim 22, Tai discloses the second electrode includes a first and second electrode portion (“isolated sciatic nerve is stimulated by a bipolar hook electrode”, it is well known in the art that bipolar hook electrodes have two electrode portions, [0154]) and an average frequency greater than the frequency of the nullifying pulse (“for blocking nerves, useful frequencies range above 1 Hz (Hertz)…stimulation is applied at 1.5 kHz, or 1.2 kHz”, through the lens of the broadest reasonable interpretation, technically anything above 1Hz could be equal to 1.5kHz or 1.2kHz, and the average frequency of the activating pulse could still be greater than that of the nullifying pulse [0133]).
Tai does not disclose wherein the nullifying pulse is expressed as a beat frequency produced in an interference by at least two signals having a relative frequency difference.
However, Rauscher teaches treating a living being with multiple, concurrent, superimposed non-phase-locked signals, at physiologically acceptable intensities and duty cycles such that the signals entrain the tissue (Abstract). The beat frequency intermix is critical to the proper operation of the device of this invention [0085].
Therefore, it would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the beat frequency and frequency difference of Rauscher with the system and method for stimulating tissue of Tai because beat frequencies aid in a more effective electrical stimulation treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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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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/F.M.K./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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