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 .
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 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.
Status of Claims
Claims 1-5 and 7-21 are pending and currently under consideration for patentability; claim 6 previously was cancelled.
Information Disclosure Statement
The Information Disclosure Statement submitted on 12 February 2025 has been acknowledged and considered by the Examiner.
Response to Arguments
Applicant’s arguments with respect to the rejections of claims 1-5 and 7-21 under 35 U.S.C. 103 over Perryman in view of Cook have been fully considered and are persuasive. Therefore, the previous rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Jacobson et al. (US 2015/0196709 A1) and Koltzow (US 2016/0206502 A1).
Regarding claim 12, Applicant argues against the Office’s contention that configuring the pulse generator device such that it had a rounded back side and a plurality of protrusions would be matter of obvious design choice. In support of this, Applicant argues that the references “fail to recognize the importance of the shape of a pulse generator in comfort and ease of use” (Arguments, p. 11), concluding that “the Office Action has failed to support the design choice rationale and has improperly relied on hindsight” (Arguments, p. 12). Although the Examiner respectfully disagrees with Applicant’s assessment, the Examiner has introduced herein the Koltzow reference, which addresses the obviousness of having a device with a rounded back and plurality of protrusions.
Due to the new grounds of rejection, this Office Action is NON-FINAL.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Perryman et al. (US 2018/0169423 A1) in view of Jacobson et al. (US 2015/0196709 A1) and Cook et al. (US 2014/0135886 A1).
Regarding claim 1, Perryman describes a method for trigeminal nerve stimulation ([0037]), the method comprising
producing, by at least one processor of a pulse generator, pulses delivered to an electrode assembly for at least one therapy session for a patient ([0038]), wherein the pulses have defined characteristics ([0038], [0049])
logging, by the at least one processor of the pulse generator, data from the at least one therapy session for the patient ([0038], [0043], feedback monitoring; [0095], the application may retain a database that logs all system diagnostic results and values)
wherein the data comprises impedance of the electrode assembly connected to the pulse generator during the at least one therapy session and current amplitude of the pulses produced during the at least one therapy session ([0007], [0083])
determining, by the at least one processor of the pulse generator, an average current amplitude by using the data comprising the current amplitude for at least one of the at least one therapy session ([0117] - [0118])
determining, by the at least one processor of the pulse generator, an average therapy impedance by using the data comprising the impedance for at least one of the at least one therapy session ([0117] - [0118])
determining, by the at least one processor of the pulse generator, a charge capacity of a battery of the pulse generator prior to beginning a subsequent therapy session for the patient ([0095], displaying battery capacity; [0099], interrogating the power supply battery to determine if the remaining power is below a threshold)
displaying, by a display of the pulse generator, a screen showing average therapy data for at least one of the at least one therapy session for the patient ([0047], [0095])
Regarding claim 1, although Perryman describes determining a low battery state ([0099]), which inherently corresponds to a battery of insufficient capacity to perform a given task, Perryman does not explicitly disclose determining, by the at least one processor of the pulse generator, whether the charge capacity of the battery of the pulse generator is sufficient to complete the subsequent therapy session for the patient for a designated duration of time by using the average current amplitude and the average therapy impedance. However, Jacobson also describes a method of determining battery capacity, including determining, by at least one processor, whether the charge capacity of a battery is sufficient to complete a subsequent therapy session for a patient for a designated duration of time by using the average current amplitude and the average therapy impedance ([0117]: “if an infusion therapy is started purely on battery power, an algorithm may be used to estimate the amount of time the infusion pump will remain active, and whether there is sufficient charge available to completely execute the programmed infusion”…“the algorithm utilized to estimate whether there is sufficient charge, divides the current capacity in ampere-hours by the current amperage drain of the apparatus, for example pump motor and current display drain to determine the amount of time remaining”). As Jacobson is also directed towards determining battery capacity in a medical apparatus and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a battery capacity algorithm similar to that described by Jacobson when using the method described by Perryman, as doing so advantageously allows the resulting method to account for the power demands of the device when determining if there is sufficient battery to complete the ensuing task.
Regarding claim 1, although Perryman describes the use of an external programmer or pulse generator ([0042], [0081]), Perryman describes the above steps in relation to an implantable neural stimulator. Therefore, Perryman does not explicitly disclose attaching a cutaneous electrode assembly to a patient, wherein the cutaneous electrode assembly comprises a first pair of contacts and a second pair of contacts configured to contact a portion of the face of the patient overlying the cutaneous distribution of at least one branch of the trigeminal nerve. However, Cook also describes a method for trigeminal nerve stimulation, including the step of attaching a cutaneous electrode assembly to a patient, wherein the cutaneous electrode assembly comprises a first pair of contacts and a second pair of contacts configured to contact a portion of the face of the patient overlying the cutaneous distribution of at least one branch of the trigeminal nerve ([0014]). As Cook is also directed towards trigeminal nerve stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a method similar to that described by Perryman with a cutaneous electrode assembly similar to that described by Cook, as doing so advantageously allows the cutaneous electrode assembly to better monitor the applied therapy and ensure that a given therapy session can be successfully completed.
Regarding claim 2, Perryman describes generating, by the at least one processor of the pulse generator, an alert to the patient indicating that the charge capacity of the battery of the pulse generator is insufficient to complete the subsequent therapy session for the designated duration of time, when the at least one processor of the pulse generator determines that the charge capacity of the battery is insufficient to complete the subsequent therapy session for the patient for the designated duration of time ([0099]).
Regarding claim 3, Perryman describes wherein the alert is a visual alert ([0099]).
Regarding claim 4, Perryman describes wherein the visual alert comprises at least one of text or an icon ([0099]).
Regarding claim 5, Perryman describes wherein the screen comprises a graphical user interface ([0047]).
Regarding claim 7, Perryman describes wherein the screen further shows a history of the at least one therapy session for the patient ([0095], [0100]).
Regarding claim 8, Perryman describes wherein the screen further shows a history of the current amplitude of the pulses produced during at least one of the at least one therapy session for the patient ([0083], current values; [0095], [0100], displaying global runtime history).
Regarding claim 9, Perryman describes wherein the screen further shows a history of the impedance of the electrode assembly connected to the pulse generator during at least one of the at least one therapy session for the patient ([0083], impedance values; [0095], [0100], displaying global runtime history).
Claims 12-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Perryman in view of Jacobson, Cook, and Kutzlow (US 2016/0206502 A1).
Regarding claim 12, Perryman describes a pulse generator device for trigeminal nerve stimulation ([0037]), the pulse generator device comprising
at least one processor ([0038]) configured to
produce pulses delivered to an electrode assembly for at least one therapy session for a patient ([0038]), wherein the pulses have defined characteristics ([0038], [0049])
log data from the at least one therapy session for the patient ([0038], [0043], feedback monitoring; [0095], the application may retain a database that logs all system diagnostic results and values), wherein the data comprises impedance of the electrode assembly connected to the pulse generator during the at least one therapy session and current amplitude of the pulses produced during the at least one therapy session ([0007], [0083])
determine an average current amplitude by using the data comprising the current amplitude for at least one of the at least one therapy session ([0117] - [0118])
determine an average therapy impedance by using the data comprising the impedance for at least one of the at least one therapy session ([0117] - [0118])
determine a charge capacity of a battery of the pulse generator device prior to beginning a subsequent therapy session for the patient ([0095], displaying battery capacity; [0099], interrogating the power supply battery to determine if the remaining power is below a threshold)
a display configured to display a screen comprising a graphical user interface ([0047]), wherein the screen comprising the GUI displays average therapy data for at least one of the at least one therapy session for the patient ([0095])
Regarding claim 12, Perryman does not explicitly disclose
wherein the processor determines whether the charge capacity of the battery of the pulse generator device is sufficient to complete the subsequent therapy session for the patient for a designated duration of time by using the average current amplitude and the average therapy impedance
a channel comprising grooves that are configured to accept an end of one or more lead wires of a cutaneous electrode assembly, wherein the cutaneous electrode assembly comprises a first pair of contacts and a second pair of contacts configured to contact a portion of the face of the patient overlying the cutaneous distribution of at least one branch of the trigeminal nerve
a rounded back side
a plurality of protrusions on the rounded back side
Regarding determining the charge capacity, although Perryman describes determining a low battery state ([0099]), which inherently corresponds to a battery of insufficient capacity to perform a given task, Perryman does not explicitly disclose wherein the processor determines whether the charge capacity of the battery of the pulse generator device is sufficient to complete the subsequent therapy session for the patient for a designated duration of time by using the average current amplitude and the average therapy impedance. However, Jacobson also describes a method of determining battery capacity, including determining, by at least one processor, whether the charge capacity of a battery is sufficient to complete a subsequent therapy session for a patient for a designated duration of time by using the average current amplitude and the average therapy impedance ([0117]: “if an infusion therapy is started purely on battery power, an algorithm may be used to estimate the amount of time the infusion pump will remain active, and whether there is sufficient charge available to completely execute the programmed infusion”…“the algorithm utilized to estimate whether there is sufficient charge, divides the current capacity in ampere-hours by the current amperage drain of the apparatus, for example pump motor and current display drain to determine the amount of time remaining”). As Jacobson is also directed towards determining battery capacity in a medical apparatus and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a battery capacity algorithm similar to that described by Jacobson when using the method described by Perryman, as doing so advantageously allows the resulting method to account for the power demands of the device when determining if there is sufficient battery to complete the ensuing task.
Regarding the channels and overall design of the pulse generator device, Cook also describes a pulse generator device for trigeminal nerve stimulation, including an electrode assembly comprising a first pair of contacts and a second pair of contacts configured to contact a portion of the face of the patient overlying the cutaneous distribution of at least one branch of the trigeminal nerve ([0014]). As Cook is also directed towards trigeminal nerve stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use a method similar to that described by Perryman with a cutaneous electrode assembly similar to that described by Cook, as doing so advantageously allows the cutaneous electrode assembly to better monitor the applied therapy and ensure that a given therapy session can be successfully completed. Specifically regarding the limitation of “a channel comprising grooves that are configured to accept an end of one or more lead wires” of the cutaneous electrode assembly, Cook describes wherein the electrode assembly is connectable to an external stimulator via an electric cable or wire ([0112]), thereby implicitly disclosing some structure on the pulse generator that is configured to accept an end of one or more lead wires of the electrode assembly. The Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure this structure as “a channel comprising grooves,” as doing so would be a matter of obvious design choice and would have the advantage of better guiding and securing the lead wires in the pulse generator.
Regarding the device having a rounded back side and a plurality of protrusions on the rounded back side, Koltzow also describes a device for providing nerve stimulation ([0005]), including using a device having a rounded back side and a plurality of protrusions on the rounded back side ([0030] - [0031], [0058]). As Koltzow is also directed towards a device for providing nerve stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to design Perryman’s device such that it had a rounded back and a plurality of protrusions, as doing so advantageously allows the resulting device to a have a better form factor and to more easily contour to a user’s skin.
Regarding claim 13, Perryman describes wherein the at least one processor is further configured to generate an alert to the patient indicating that the charge capacity of the battery of the pulse generator device is insufficient to complete the subsequent therapy session for the designated duration of time, when the at least one processor determines that the charge capacity of the battery is insufficient to complete the subsequent therapy session for the patient for the designated duration of time ([0099]).
Regarding claim 14, Perryman describes wherein the alert is a visual alert ([0099]).
Regarding claim 15, Perryman in view of Jacobson and Cook suggests the system of claim 14, but Perryman, Jacobson, and Cook do not explicitly disclose wherein the display is one of a liquid crystal display or an organic light-emitting diode display. Perryman does, however, describe the use of a conventional computer device or a smart device including a graphical user interface in the form of a touchscreen ([0039], [0047]). Perryman also refers to a user interacting with an application screen ([0096]). As an LCD and an OLED are known forms of a display as may be included with a conventional computer system or smart device, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to use an LCD or OLED display when using the system described by Perryman, Jacobson, and Cook, as doing so advantageously allows the user to visualize and interact with the resulting system.
Regarding claim 16, Perryman describes at least one button configured for programming the designated duration of time ([0039], use of a computer device such as a smart phone).
Regarding claim 17, Perryman describes wherein the pulse generator device comprises dimensions such that the pulse generator fits within a hand of a user ([0039], smart phone).
Regarding claim 18, Perryman in view of Jacobson and Cook suggests the system of claim 12, but Perryman, Jacobson, and Cook do not explicitly disclose wherein the current amplitude of the pulses produced has an upper limit of 8.0 mA. Perryman does, however, describe that the pulse parameters may be adjusted as desired ([0039]), including the use of a current limiter in order to ensure that current of the pulses does not exceed a threshold value ([0066]). Perryman further provides examples of pulses of 1 mA and 3 mA ([0072]) and includes a table with pulse amplitudes adjustable between 0 mA and 20 mA (Table 1). Based on the above, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to adjust the upper limit of the amplitude, for example to 8.0 mA, as doing so would be a matter of optimizing the result-effective variable of pulse amplitude via routine experimentation (please see MPEP 2144.05).
Regarding claim 21, Perryman describes wherein the screen comprising the GUI further displays
a history of the at least one therapy session for the patient ([0095], [0100])
a history of the current amplitude of the pulses produced during at least one of the at least one therapy session for the patient ([0083], current values; [0095], [0100], displaying global runtime history)
a history of the impedance of the electrode assembly connected to the pulse generator device during at least one of the at least one therapy session for the patient ([0083], impedance values; [0095], [0100], displaying global runtime history)
a combination thereof ([0095], [0100])
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Perryman in view of Jacobson and Cook, further in view of Ballakur et al. (US 2017/0020597 A1).
Regarding claims 10 and 11, Perryman in view of Jacobson and Cook suggests the method of claim 1, including measuring, by the at least one processor of the pulse generator, the impedance of the electrode assembly connected to the pulse generator to generate a measured impedance (Perryman: [0083] - [0084]). However, Perryman, Jacobson, and Cook do not explicitly disclose the steps of
determining, by the at least one processor of the pulse generator, whether the measured impedance is less than a base threshold impedance value (claim 10) or greater than a maximum threshold impedance value (claim 11)
generating, by the at least one processor of the pulse generator, an alert to the patient indicating that the measured impedance is below the base threshold impedance value (claim 10) or above the maximum threshold impedance value (claim 11), when the at least one processor of the pulse generator determines that the measured impedance is less than the base threshold impedance value (claim 10) or above the maximum threshold impedance value (claim 11)
Ballakur also describes a method for nerve stimulation ([0026]), including
determining, by a processor of a pulse generator, whether a measured impedance is less than a base threshold impedance value or greater than a maximum threshold impedance value ([0057] - [0058], [0063])
generating, by the processor of the pulse generator, an alert to a patient indicating that the measured impedance is below the base threshold impedance value or above the maximum threshold impedance value, when the processor of the pulse generator determines that the measured impedance is less than the base threshold impedance value or above the maximum threshold impedance value ([0057] - [0058], [0063])
As Ballakur is also directed towards nerve stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a threshold test similar to that described by Ballakur when using the method described by Perryman, Jacobson, and Cook, as doing so advantageously allows the resulting method to operate within an optimal impedance range.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Perryman in view of Jacobson, Cook, and Koltzow, further in view of Yoo et al. (US 2019/0126039 A1).
Regarding claim 19, Perryman in view of Jacobson, Cook, and Koltzow suggests the system of claim 12, but Perryman, Jacobson, Cook, and Koltzow do not explicitly disclose wherein the at least one processor is further configured to restrict use of the pulse generator by requiring a password for the patient. However, Yoo also describes a pulse generator device for nerve stimulation ([0049]), including restricting use of the pulse generator by requiring a password for the patient ([0123], [0141]). As Yoo is also directed towards nerve stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate password protection, similar to that described by Yoo, when using the system described by Perryman, Jacobson, Cook, and Koltzow, as doing so advantageously allows the resulting system to be more secure and minimizes the chances that an unintentional change is made to the pulse parameters.
Regarding claim 20, Yoo describes wherein the password for the patient is programmable ([0151]).
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM 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, Carl Layno, can be reached by telephone 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796