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 .
Claim Objections
Claim 1 is objected to because of the following informalities: The term “move” in line 7 should be “moving”. 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 2 and 12 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.
The term “about” in claims 2, 4, 12, and 14 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination, the examiner is interpreting claims 2, 4, 12, and 14 as if the term “about” is not present in the claims.
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.
Claim(s) 1-2, 7-12, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doan et al. (Pub. No.: US 2021/0299448 A1); hereinafter referred to as “Doan”.
Regarding claims 1 and 11, Doan discloses a method for programming (e.g. see [0084]-[0085]) a spinal cord stimulator for providing spinal cord stimulation (SCS) for a patient (e.g. see abstract), the spinal cord stimulator having a plurality of electrodes comprising an array (e.g. see figures 6 and 7, elements E1-E16), the method comprising: (a) using a first external device (e.g. see figure 10 element 50) to provide a supra-perception stimulation field to the spinal cord stimulator (e.g. see figure 9 step 360), wherein the supra-perception stimulation field comprises a pole configuration formed in the electrode array (e.g. see [0070], element 301); (b) using the first external device to provide stimulation to the patient while move the pole configuration in the electrode array to a location that best treats a symptom of the patient (e.g. see figure 9 step 364); (c) determining, using the first external device (e.g. see figure 10 element 50), a perception threshold (pth) of the pole configuration at the location (e.g. see figure 9 step 366) by varying an amplitude of the supra-perception stimulation field (e.g. see [0079]); (d) using the pth to determine at least a first sub-perception stimulation program having an amplitude that is a first fraction of the pth and a second sub-perception stimulation program having an amplitude that is a second fraction of pth, wherein the second fraction of pth is greater than the first fraction of the pth (e.g. see figure 9 step 368, [0080], [0083]-[0085]. Note: The cited paragraphs disclose using 30%, 40%, 50%, and 60% of the pth. Any two of those percentages will read on “first fraction” and “second fraction”) and (e) using the first external device (e.g. see figure 10 element 50) to program a second external device (e.g. see figure 10 element 45) usable by the patient with the determined first and second sub-perception stimulation programs (e.g. see figure 9 steps 370-378).
Regarding claims 2 and 12, Doan discloses the first fraction is about 10% to about 50% of the pth and the second fraction is about 50% to about 80% of the pth (e.g. see [0080], [0083]-[0085]. Note: The cited paragraphs disclose using 30%, 40%, 50%, and 60% of the pth. 30% and 40% will read on the “first fraction” and 50% and 60% will read on the second fraction).
Regarding claims 7 and 19, Doan discloses the pole configuration comprises a bipole comprising an anode pole and a cathode pole (e.g. see [0056]-[0058], “anode” and “cathode”, figure 7B element 291).
Regarding claims 8 and 20, Doan discloses the bipole is at the location, the anode pole is formed at two or more electrodes, and wherein the cathode pole is formed at two or more different of the electrodes (e.g. see [0058], “The virtual bipole 301c is formed along a lead essentially spanning the length of four electrodes from E1 to E5” figure 7C, element 291).
Regarding claim 9, Doan discloses the bipole comprises an anode pole and a cathode pole, wherein more than one electrode is active to form the anode pole, and wherein more than one electrode is active to form the cathode pole (e.g. see [0058], “The virtual bipole 301c is formed along a lead essentially spanning the length of four electrodes from E1 to E5”, figure 7C, element 291).
Regarding claim 10, Doan discloses the first external device is used to move the pole configuration linearly along a length of the electrode array (e.g. see [0058], “This bipole 301d configuration need only be moved along a single linear path 296 along the electrode array that is parallel to the leads”).
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(s) 3, 5-6, 13, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doan, in view of Huertas Fernandez et al. (Pub. No.: US 2020/0147388 A1); hereinafter referred to as “Huertas”.
Regarding claims 3 and 13, Doan discloses the invention but is silent as to using the first external device to compose a schedule comprising a first duration during which the first sub-perception stimulation program is active to provide stimulation to the patient and a second duration during which the second sub-perception stimulation program is active to provide stimulation to the patient; and using the first external device to program the second external device with the schedule. Huertas teaches it is known to use a such a modification as set forth in [0092] (“Each program may be maintained for a specified time period before cycling to the next program. If the programs in the ALS provide sub-perception therapy, each program may be run for a number of days (e.g., 1-5 days) before cycling to the next program. If the programs provide supra-perception therapy, then each program may be run for a few minutes (e.g., 1-5 minutes) before cycling to the next program”) to provide sub-perception therapy programs to fine tune the stimulation prior to administering supra-threshold therapy (e.g. see [0092]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use such a modification as taught by Huertas in the system/method of Doan, since said modification would provide the predictable results of fine tuning the stimulation prior to administering supra-threshold therapy.
Regarding claims 5 and 15, Doan discloses the invention but is silent as to determining the first and second sub-perception stimulation programs and composing the schedule comprises executing a script, wherein the script: receives an indication of the pth; uses the pth to automatically determine the first and second fractions; and automatically composes the schedule. Huertas teaches it is known to use a such a modification as set forth in [0092] (“Referring again to FIG. 12, after each program in the ALS is run, the patient may be asked in the paresthesia overlaps with their pain 1216. If one of the stimulation programs is identified that produces overlapping paresthesia, then the neural dosage may be adjusted 1208 and the stimulation used for continuing therapy”) to provide sub-perception therapy programs to fine tune the stimulation prior to administering supra-threshold therapy (e.g. see [0092]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use such a modification as taught by Huertas in the system/method of Doan, since said modification would provide the predictable results of fine tuning the stimulation prior to administering supra-threshold therapy.
Regarding claims 6 and 16, Doan discloses the invention but is silent as to the script is a patient indication-specific script and wherein the method further comprises: receiving an input indicative of a patient indication; selecting the patient indication-specific script corresponding to the received input, and executing the selected patient indication-specific script to provide determine first and second fractions and compose a schedule that is specific for the patient indication. Huertas teaches it is known to use a such a modification as set forth in [0092] (“Referring again to FIG. 12, after each program in the ALS is run, the patient may be asked in the paresthesia overlaps with their pain 1216. If one of the stimulation programs is identified that produces overlapping paresthesia, then the neural dosage may be adjusted 1208 and the stimulation used for continuing therapy”) to provide sub-perception therapy programs to fine tune the stimulation prior to administering supra-threshold therapy (e.g. see [0092]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use such a modification as taught by Huertas in the system/method of Doan, since said modification would provide the predictable results of fine tuning the stimulation prior to administering supra-threshold therapy.
Regarding claim 17, Doan discloses the user interface enables a user to select the patient indication (e.g. see figure 9 step 378, figure 10 element 45).
Regarding claim 18, Doan discloses the patient indication is nociceptive pain (e.g. see [0005], [0040], Note: Chronic pain will read on nociceptive pain).
Claim(s) 4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Doan and Huertas, in view of Moffit et al. (Pub. No.: US 2020/0046980 A1); hereinafter referred to as “Moffit”.
Regarding claims 4 and 14, Doan and Huertas disclose the claimed invention except for the first duration is about 2 to about 6 hours and the second duration is about 1 to about 20 minutes. Moffit teaches it is known to use such a modification as set forth in [0221] (“A bolus comprises stimulation that is provided for a set unit of time, such as ten minutes, thirty minutes, one hour, two hours, or any other duration that is effective, with gaps of time with no stimulation between the administration of boluses”) to prevent over-stimulation and habituation of the tissue (e.g. see [0221]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use such a modification as taught by Moffit in the system/method of Doan and Huertas, since said modification would provide the predictable results of preventing over-stimulation and habituation of the tissue.
Conclusion
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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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