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 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.
Claims 1-6 and 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doan et al. (U.S. PGPub No. 2021/0275811).
Regarding claim 1, Doan teaches a method for programming (Paragraph 0025, lines 1-2) a spinal cord stimulator (Fig. 1, Paragraph 0004, lines 1-2, 10) using an external system (Fig. 4, Paragraph 0013, line 4, 50) in communication with the spinal cord stimulator (Paragraph 0018, lines 1-3), the spinal cord stimulator comprising an electrode array (Fig. 1, Paragraph 0004, line 6, 17) comprising a plurality of electrodes (Fig. 1, Paragraph 0004, lines 5-6, 16) implanted in a spinal column of a patient (Paragraph 0005, lines 6-9), the method comprising: (a) accessing (Paragraph 0246, lines 34-36) a graphical user interface (Fig. 4-5, Paragraph 0020, line 3, 64) of the external system to cause the spinal cord stimulator to provide stimulation pulses (Paragraph 0240, lines 3-4) of a first amplitude (Paragraph 0246, lines 21-24) and a first pulse width (Fig. 14, Paragraph 0246, lines 2-8 and Paragraph 0248, lines 4-6) from at least one electrode in the electrode array (Fig. 14, Paragraph 0246, line 17 and Paragraph 0247, lines 5-7), wherein the stimulation pulses are sub-perception for the patient (Paragraph 0246, lines 36-37); (b) accessing the graphical user interface to cause the spinal cord stimulator to increase the first pulse width to a second pulse width where the stimulation pulses are supra-perception for the patient (Paragraph 0250, lines 7-9); (c) accessing the graphical user interface to cause the spinal cord stimulator to decrease the first amplitude to a second amplitude where the stimulation pulses are sub-perception for the patient (Paragraph 0251, lines 5-7); and (d) providing therapeutic sub-perception stimulation to the patient via the stimulation pulses at the second amplitude and at the second pulse width (Paragraph 0250, lines 7-9 and Paragraph 0251, 1-10).
Regarding claim 2, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, wherein the stimulation pulses have a first frequency of 10 Hz or less (Table 1, Row 8, Paragraph 0235, lines 1-4).
Regarding claim 3, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, wherein the stimulation pulses form a bipole in the electrode array (Paragraph 0008, lines 1-12 and Paragraph 0058, lines 1-5).
Regarding claim 4, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 3, further comprising, before step (a), accessing the graphical user interface of the external system to cause the spinal cord stimulator to provide stimulation pulses which are supra-perception for the patient (Fig. 14, Paragraph 0249, lines 1-11).
Regarding claim 5, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 4, further comprising moving the bipole in the electrode array (Fig. 7B-7D, Paragraph 0193, lines 1-4 and Paragraph 0195, lines 24-26, 296).
Regarding claim 6, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 5, wherein the bipole is moved longitudinally in the electrode array (See Annotated Fig. 7D, Paragraph 0196, lines 16-17, 296) to address a symptom of the patient (Paragraph 0196, lines 17-19).
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Annotated Fig. 7D (Doan)
Regarding claim 9, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, wherein the stimulation pulses comprise biphasic pulses comprising a first phase of a first polarity and a second phase of a second polarity (Paragraph 0028, lines 1-3).
Regarding claim 10, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 9, wherein the first and second phases are symmetric (Paragraph 0028, lines 5-7).
Regarding claim 11, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 9, wherein the first and second phases are actively driven by stimulation circuitry in the spinal cord stimulator (Paragraph 0028, lines 1-5).
Regarding claim 12, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, wherein the steps are performed in order (Paragraph 0246, lines 1-37, Paragraph 0250, lines 7-9, and Paragraph 0251, 1-10).
Regarding claim 13, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, wherein in step (b), if the second pulse width is maximized before the stimulation pulses are supra-perception for the patient (Paragraph 0250, lines 2-9), adjusting the first amplitude to a higher value where the stimulation pulses are supra-perception for the patient (Paragraph 0248, lines 7-10 and Paragraph 0260, lines 11-16).
Regarding claim 14, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, wherein in step (b), if the second pulse width is maximized before the stimulation pulses are supra-perception for the patient (Paragraph 0250, lines 2-9), adjusting the first amplitude to a higher value (Paragraph 0248, lines 7-10 and Paragraph 0260, lines 11-16), setting the pulse width to the first pulse width (Paragraph 0248, lines 7-10), and repeating step (b) (Paragraph 0249, lines 1-8).
Regarding claim 15, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, wherein performance of the method is enabled via selection of an option of the graphical user interface (Paragraph 0021, lines 1-8 and Paragraph 0245, lines 4-6).
Regarding claim 16, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, wherein in step (c) the first amplitude is decreased to the second amplitude by a pre-determined amount (Paragraph 0055, lines 6-8 and Paragraph 0124, lines 7-8).
Regarding claim 17, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, wherein step (d) comprises providing therapeutic sub-perception stimulation to the patient via the stimulation pulses at the second amplitude (Paragraph 0251, lines 1-10), the second pulse width (Paragraph 0250, lines 7-9), and the first frequency (Table 1, Row 8, Paragraph 0235, lines 1-4).
Regarding claim 18, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 1, further comprising programming (Paragraph 0016, lines 1-7) a patient external controller (Fig. 4, Paragraph 0013, line 3, 45) with the therapeutic sub-perception stimulation (Paragraph 0185, lines 14-18 and Paragraph 0244, lines 1-6).
Regarding claim 19, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 18, wherein the patient external controller (Fig. 4, Paragraph 0013, line 3, 45) is configured to allow the patient to adjust the second amplitude of the therapeutic sub-perception stimulation (Paragraph 0014, lines 12-13), wherein adjustment of the second amplitude is limited to a maximum comprising the first amplitude (Paragraph 0215, lines 8-15).
Regarding claim 20, Doan teaches an external system (Fig. 4, Paragraph 0013, line 4, 50) configured for communication with (Paragraph 0018, lines 1-3) a spinal cord stimulator (Fig. 1, Paragraph 0004, lines 1-2, 10), the spinal cord stimulator comprising an electrode array (Fig. 1, Paragraph 0004, line 6, 17) comprising a plurality of electrodes (Fig. 1, Paragraph 0004, lines 5-6, 16) implanted in a spinal column of a patient (Paragraph 0005, lines 6-9), the external system comprising a graphical user interface (Fig. 4-5, Paragraph 0020, line 3, 64) and control circuitry (Fig. 4, Paragraph 0020, line 11, 70) configured to: (a) receive via the graphical user interface a first input (Paragraph 0246, lines 34-36) to cause the spinal cord stimulator to provide stimulation pulses (Paragraph 0240, lines 3-4) of a first amplitude (Paragraph 0246, lines 21-24) and a first pulse width (Fig. 14, Paragraph 0246, lines 2-8 and Paragraph 0248, lines 4-6) from at least one electrode in the electrode array (Fig. 14, Paragraph 0246, line 17 and Paragraph 0247, lines 5-7), wherein the stimulation pulses are sub-perception for the patient (Paragraph 0246, lines 36-37); (b) receive via the graphical user interface a second input to cause the spinal cord stimulator to increase the first pulse width to a second pulse width where the stimulation pulses are supra-perception for the patient (Paragraph 0250, lines 7-9); and (c) receive via the graphical user interface a third input to cause the spinal cord stimulator to decrease the first amplitude to a second amplitude where the stimulation pulses are sub-perception for the patient (Paragraph 0251, lines 5-7), whereby the spinal cord stimulator provides therapeutic sub-perception stimulation for the patient via the stimulation pulses at the second amplitude and at the second pulse width (Paragraph 0250, lines 7-9 and Paragraph 0251, 1-10).
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.
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Doan et al. (U.S. PGPub No. 2021/0275811) in view of Huertas Fernandez et al. (U.S. PGPub No. 2022/0233867).
Regarding claim 7, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 5, wherein the bipole is moved laterally in the electrode array (See Annotated Fig. 7C, Paragraph 0196, lines 1-12). Doan does not teach that the bipole is moved laterally to a point where the patient perceives symmetric stimulation on a left and right side of his body.
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Annotated Fig. 7C (Doan)
Huertas Fernandez, however teaches a method for determining sub-perception stimulation for a patient having a spinal cord stimulator (Fig. 1, Paragraph 0003, lines 1-2, 10) and an external system (Fig. 4, Paragraph 0012, line 4, 50) in communication with the spinal cord stimulator (Paragraph 0012, lines 1-4). Huertas Fernandez teaches that the spinal cord stimulator provides stimulation pulses (Paragraph 0006, lines 1-2) that form a bipole (Fig. 6, Paragraph 0073, lines 1-5, 297) that is moved laterally (Fig. 6) in an electrode array (Fig. 1, Paragraph 0003, line 6, 17).
Huertas Fernandez also teaches that a graphical user interface (Fig. 34B, Paragraph 0230, line 4, 710) receives patient mapping information during a fitting procedure (Fig. 39B, Paragraph 0252, lines 1-4, 780). Huertas Fernandez teaches that the GUI can display whether stimulation is felt in a body region (Xx), the perceived intensity of stimulation in that region, and the extent to which the patient feels that the stimulation is “covering” their pain (Fig. 39B, Paragraph 0252, lines 10-14). While not shown in Figure 39B, Huertas Fernandez teaches that the body portions (X1-X4) may be displayed on both the left and right sides of the patient’s body (Paragraph 0250, lines 13-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doan to incorporate the teachings of Huertas Fernandez to include that the bipole is moved laterally to a point where the patient perceives symmetric stimulation on a left and right side of his body. Doing so would ensure that the bipole is moved to a location where the patient perceives symmetric stimulation on both the left and right side of his body (Fig. 39B, Paragraph 0252, lines 10-14), and the effectiveness of stimulation is maximized (Paragraph 0252, lines 1-4), as recognized by Huertas Fernandez.
Regarding claim 8, Doan teaches the method (Paragraph 0025, lines 1-2) of claim 3. Doan does not teach that the stimulation pulses form a spread bipole configured to approximate a linear electric field in tissue of the patient.
Huertas Fernandez, however, teaches a method for determining sub-perception stimulation for a patient having a spinal cord stimulator (Fig. 1, Paragraph 0003, lines 1-2, 10) that provides stimulation pulses (Paragraph 0006, lines 1-2) that form a bipole (Fig. 6, Paragraph 0073, lines 1-5, 297). Huertas Fernandez also teaches that the stimulation pulses form a spread bipole (Fig. 7D, Paragraph 0255, line 13) configured to approximate a linear electric field in tissue of the patient (Paragraph 0255, lines 13-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Doan to incorporate the teachings of Huertas Fernandez to include that the stimulation pulses form a spread bipole configured to approximate a linear electric field in tissue of the patient. Doing so would ensure that physiological coordinates (Paragraph 0256, lines 1-4) of neural pain sites can be indicated (Paragraph 0260, lines 1-7) in order to identify optimal stimulation parameters for a patient (Paragraph 0260, lines 7-10), as recognized by Huertas Fernandez.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zhang et al. (U.S. PGPub No. 2020/0230410) discloses a fitting algorithm for recruiting of neural targets in a spinal cord stimulator system that uses an external system with a graphical user interface to configure different bipoles in an electrode array (Abstract).
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/H.A.H./Patent Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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