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.
Election/Restrictions
Applicant’s election without traverse of Group II (clams 41-50) in the reply filed on 16 September 2025 is acknowledged.
Status of Claims
Claims 31-50 are pending; claims 1-30 previously were cancelled; claims 31-40 have been withdrawn, and claims 41-50 currently are under consideration for patentability.
Information Disclosure Statement
The Information Disclosure Statements submitted on 01 April 2024 and 16 September 2025 have been acknowledged and considered by the Examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 41-50 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Jiang et al. (US 2016/0045746 A1).
Regarding claim 41, Jiang describes a method for stimulating tissue of a patient ([0021]) comprising
delivering a stimulation signal to the tissue via a lead having a proximal end and a distal end, wherein the distal end comprises a segmented electrode ([0075]: “neurostimulation lead 20 that includes a group of neurostimulation electrodes 40 at a distal end of the lead”)
measuring a compound muscle action potential resulting from the stimulation signal ([0011]) via an external sensing electrode ([0010]: “at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient”)
determining a location of the lead within the tissue of the patient using the measured CMAP ([0101]: “the system provides improved lead placement by determining lead position of a multi-electrode lead relative the target nerve with EMG”; [0102]: “the stimulation of the principal electrode is adjusted until an adequate motor response with a maximum amplitude CMAP is obtained at which point the stimulation level or amplitude is recorded”; [0110]: “EMG waveform displays 61 used to monitor a desired neuromuscular response, an Amplitude display 66 and an Electrode Status Indicator 64, which during lead placement includes a representation of the electrode portion of the lead 20…the EMG signal is used to evaluate placement quality based on stimulation amplitude to evoke a response”; please refer to the full process of determining the location of the lead as described in paragraphs [0101] - [0109])
Regarding claim 42, Jiang describes wherein, prior to determining the location of the lead, comparing the measured CMAP to a CMAP threshold ([0019], [0111] - [0112]), and adjusting an amplitude of the stimulation signal delivered when the measured CMAP is less than the CMAP threshold ([0019]; sweeping process as described in [0111] - [0112]).
Regarding claim 43, Jiang describes wherein the segmented electrode is a first segmented electrode of a plurality of segmented electrodes of the distal end ([0075], [0113]), and wherein the stimulation signal is delivered independently to each of the plurality of segmented electrodes ([0014], [0102]).
Regarding claim 44, Jiang describes wherein the CMAP threshold is unique for each of the plurality of segmented electrodes ([0014], the threshold value is associated with the electrode).
Regarding claim 45, Jiang describes wherein adjusting the amplitude comprises increasing the amplitude of the stimulation signal ([0014], [0019]).
Regarding claim 46, Jiang describes wherein the segmented electrode comprises two or more segments, each having a longitudinal span and a lateral span configured to cover concurrent stimulation sites (figures 10 and 12, electrodes 40 are configured as such; the Examiner respectfully compares the configuration of the electrodes labeled 0, 1, 2, and 3 with each branch of the paddle lead embodied in Applicant’s figure 5 and described in Applicant’s [0047] as providing concurrent stimulation).
Regarding claim 47, Jiang describes wherein the location of the lead is determined to assist in placement of the implantable device within the patient ([0018], [0052]).
Regarding claim 48, Jiang describes wherein the external sensing electrode is positioned on skin of the patient ([0010]).
Regarding claim 49, Jiang describes wherein the proximal end of the lead is coupled to an implantable neuromodulation stimulation ([0075]; figure 4, implantable pulse generator 10).
Regarding claim 50, Jiang describes wherein measuring the CMAP comprises visualizing the CMAP via an electromyograph ([0010]).
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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