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 .
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on August 07, 2026 is acknowledged.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Serrano Carmona (US 2018/0043172) in view of Block et al. (US 2020/0376272).
In re claim 1, Serrano Carmona discloses a method of treating a patient ([0020]: “neurostimulation treatment is provided to the human subject”), the patient having a lead implanted therein relative to the spinal cord (fig 4: 424; [0085]: “implantation near the spinal cord”), the lead carrying a plurality of electrodes (fig 2: 206; [0086]), the method comprising:
receiving a set of parameters including
a reference program for spinal cord stimulation (fig 11: 1102, “initial program”) defining a current fractionalization determining utilization of the plurality of electrodes [0078],
an indication of stimulation strength, location and perceived pain experienced by the patient when the reference program is in use ([0114]: first sentence; fig 8: 810, 820, 830);
determining a reference central point of stimulation (CPS) of the reference program (fig 10: 1006; CPS can be determined starting from an existing program);
automatically constructing a plurality of test programs ([0109]: “database to provide a plurality of programs”; [0111]: “program selection logic results in selection (and potentially, creation) of an entirely new program”), the plurality of test programs including:
at least one pain area-based test programs (fig 10: 1012; [0126]: “evaluation performed on a new program”) each having a test CPS at a distance from the reference CPS (1014, 1020, 1022); and
a set of anatomical-based test programs
([0103]: “programming control circuit to generate a plurality of stimulation parameters… with a selected or modified neuromodulation program”, “programming control circuit can… modify a virtual location of treatment”)
each using a different subgroup of the plurality of electrodes
([0103]: “programming control circuit can activate a different subset of electrodes”);
wherein each test program defines an active electrode set having at least one electrode to which a current fraction and therapy polarity is assigned ([0078]: each electrode can be an anode, cathode, or left off, have a positive, negative, or zero polarity, and can have a current distribution) and
testing at least one of the plurality of test programs by:
receiving an input from a patient for testing a selected one of the plurality of test programs ([0100]: “user interface device and allows the user… to select… a program”);
initiating therapy to the patient using the selected one of the plurality of test programs ([0100]: “user interface device can enable a user to implement… a program”); and
receiving feedback in response to the selected one of the plurality of test programs ([0087]).
Serrano Carmona lacks
data related to lead position in the spinal cord of the patient, and
an indication of paresthesia location experienced by the patient when the reference program is in use;
at least one paresthesia-based test programs each having a test CPS at a distance from the reference CPS; and
receiving a patient score in response to the selected one of the plurality of test programs.
Block teaches a method for delivering electrical stimulation to a spinal cord using a neuromodulation system [0144]. The system has an external device that shows the orientation and configuration of the leads ([0080]: last sentence). Different neuromodulation parameters can be set and stored into a neuromodulation program that can be used on the patient [0069]. An external trial stimulator can be used to induce paresthesia to determine where the patient initially feels paresthesia [0067]. The electro-stimulator can also stimulate at different set CPS locations to induce paresthesia [0119]. For each of the induced paresthesia sites, the user can provide a preference score for whether they were comfortable with the induced paresthesia [0121].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Serrano Carmona by receiving data located to the lead position, having the user indicate where they feel paresthesia during a program, and providing a score as taught by Block. One would be motivated to make this modification both because determining an indication of paresthesia and whether it was comfortable by receiving a score would allow the clinician to determine which areas can be stimulated without causing pain and/or discomfort and showing where the lead and electrodes are located relative to the spinal column would show which areas of the leads being stimulated were more uncomfortable based on the user’s anatomy.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Serrano Carmona (US 2018/0043172) in view of Block et al. (US 2020/0376272) in view of Zhang et al. (US 2020/0230410).
In re claim 2, the proposed combination lacks
further comprising:
defining a grid of spinal cord coordinates around the lead; and
assigning a grid metric to each location on the grid derived from the patient scores.
Zhang teaches a method for configuring an implantable stimulator device that has an electrode array implanted in a patient that an external device can communicate with [0028]. A user interface is used, which can show the position of the leads relative to a patient’s anatomical structure and the spacing of the lead and electrodes in the X and Y direction can be determined ([0055]; fig 7). A coupling parameter can be determined for some or all of the electrodes in the electrode array [0029] and can be determined using patient feedback or objective feedback [0029]. The coupling parameter is indicative of how well each electrode is coupled to the spinal cord [0029], the higher the coupling parameter the more poorly coupled the electrode is [0082].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination by determining coordinates and positioning of the leads and electrodes relative to anatomy and a metric for each electrode of an electrode array during stimulation as taught by Zhang, as this would allow the user to determine where the leads are positioned in respect to anatomy and within the leads, and which electrodes have better outcomes for stimulation.
Claim 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Serrano Carmona (US 2018/0043172) in view of Block et al. (US 2020/0376272) in view of Huertas Fernandez et al. (US 2020/0147388).
In re claim 6, the proposed combination lacks wherein the at least one at least one paresthesia-based test program uses a CPS that is approximately one to ten millimeters from the reference CPS in one of a lateral direction, a rostral direction, a caudal direction, or a combination of lateral, rostral and caudal directions.
Huertas Fernandez teaches a method of providing spinal cord stimulation using an implantable pulse generator, a plurality of electrodes, and an external controller [0007]. Different programs can be test that are based on paresthesia [0066], with each program moving the CPS from the original CPS [0078]. The CPS can move 10 mm in the rostral or caudal direction or 2 mm in the mediolateral direction from the original CPS [0078].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination by moving the CPS 1-10 mm in a lateral, rostral, or caudal direction as taught by Huertas Fernandez, as moving the CPS from its original location to evoke a paresthesia response that helps the patients pain is known and one could try moving the CPS different distances to determine which is most beneficial.
It would also have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide the recited values/ranges in the proposed system since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum features or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In re claim 8, Serrano Carmona lacks wherein the electrodes include two columns of electrodes, and the anatomical-based test programs allocate current to at least four electrodes in each of the two columns in a side-by-side fashion.
Block teaches two leads with a plurality of electrodes in a side-by-side column with each of the electrodes being allocated fractionalized current (fig 18).
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of Serrano Carmona by having current allocated to multiple electrodes on side-by-side leads as taught by Block, as multiple electrodes on each lead having current would cause stimulation to be distributed over a larger area.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Serrano Carmona (US 2018/0043172) in view of Block et al. (US 2020/0376272) in view of King et al. (US 2008/0004675).
In re claim 7, wherein the set of anatomical-based test programs includes one to about four anatomical-based test programs.
King teaches a technique for identifying combinations of electrodes from an array of electrodes implanted in a medical device [0008] that can be used in spinal cord stimulation [0011]. Five different groups of electrode combinations are identified [0213] and tested and saved if the patient reports a positive response and one or more groups can be eliminated after testing (fig 26). The electrodes in the combinations are defined as cathodes or anodes [0008].
It would be obvious to one of ordinary skill in the art at the time the instant invention was filed to modify the system of the proposed combination by testing only a few different electrode combinations in the anatomical tests as taught by King, as trying to determine an effective therapy for the patient is typically a lengthy trial and error process [0007] and using a limited number of tests with different subsets of electrodes pre-selected would cut down the amount of time is needed to find efficacious therapy programs that work for the individual patient.
It would also have been obvious to one of ordinary skill in the art at the time the instant invention was filed to provide the recited ranges in the proposed system since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum features or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Zhang et al. (US 2020/0230410).
In re claim 3, Serrano Carmona, Block, and Zhang yields (all mapping directed to Zhang),
wherein each metric includes a grade ([0061]: “coupling parameters are determined using subjective and objective measurements”; fig 7: 104), the grade determined using,
for at least one active electrode ([0062]: “determines a coupling parameter for at least some, and preferably all, electrodes”),
a therapy polarity of the at least one active electrode (130; [0057]), and
a current fraction of the at least one active electrode (130; [0057]).
Serrano Carmona, Block, and Zhang fails to disclose:
wherein each metric includes a grade for each one of the plurality of test programs which has been tested, the grade determined using,
for at least one active electrode in each one of the plurality of test programs which has been tested,
a distance to the at least one active electrode,
Prior art does not teach a reason why it would be obvious to modify the device of the proposed combination to determine wherein each metric assigned to a location on a grid includes a grade for each one of the plurality of test programs that has been tested. Additionally, it fails to disclose wherein for at least one active electrode which has been tested in each of the plurality of test programs, determining a grade by finding the distance to the active electrode, a therapy polarity, and a current fraction.
Claims 4-5 are indicated as allowable subject matter due to their dependence on Claim 3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Polefko et al. (US 2013/0060300) teaches a spinal cord stimulation system that stores position information of an implanted lead (abstract). The system also includes a display on an external device (fig 1:375) that shows multiple coordinates of the leads, to show where the electrodes are located [0088]. Additionally, the display overlays a set of regions, in a grid-like fashion ([0105]; fig 18A). Stimulation is performed at each region of the grid and a patient provides feedback about the effectiveness of stimulation in that region [0107].
Kaemmerer et al. (US 2016/0250476) teaches a processor of a system that evaluates a therapy program based on a score determine by a volume of tissue expected to be activated (abstract) that can be used for different types of electrical stimulation systems [0003]. Multiple therapy programs can be evaluated, each having its own stimulation parameters including electrode polarity and current [0027]. The therapy programs can be evaluated based on the expected volume of tissue activation region to determine a score (fig 6).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALEY N. PRUITT whose telephone number is (571)272-1955. The examiner can normally be reached M-T, 7:30 AM -5 PM. F, 7:30-4.
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, David Hamaoui can be reached at (571)270-5625. 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.
/HALEY N PRUITT/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
Prosecution Insights