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. Claim 1 line 4 states, “wherein of each of…” this appears to be a typographical error and should just read as “wherein
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 1-10 and 14-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Claim 1 recites the limitation "along the lead" in line 10. There is insufficient antecedent basis for this limitation in the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wacnik et al. (US 20130289667) in view of Doan et al (US 2019/0046800).
With regard to claim 1 and 16, Wacnik discloses a spinal cord stimulation system comprising using one or more leads comprising a plurality of electrodes implanted within the patient’s spinal column to provide a plurality of electrical pulses to the patient’s spinal cord (e.g. Fig. 1-2, paragraphs 34 and 37), wherein each of the pulses are below the patient’s perception threshold (e.g. paragraph 31, Wacnik discloses the therapy may begin with a minimal amplitude below the patient threshold), wherein each pulse comprises an amplitude and a pulse width (e.g. Examiner considers this claim limitation inherent to all stimulation pulses as all pulses will have some amplitude and pulse width; additionally Wacnik discloses amplitude and pulse width throughout for example paragraph 4), wherein the amplitudes of the pulses are ramped from a first amplitude value to a second amplitude value over a first duration (e.g. see paragraphs 4-8, see also Fig. 5a-b and 7a-b, see entire document as the entirety of the Wacnik disclosure is directed to ramping amplitudes in a spinal cord stimulation system). Wacnik additionally discloses in one embodiment a ramp rate of 0.01mA/minute or 0.5mA/minute.
Wacnik fails to teach wherein the one or more electrodes comprise a virtual anode pole and a virtual cathode pole situated at different rostral-caudal positions along the lead, and wherein the virtual anode pole comprises a first three or more adjacent electrodes sharing an anodic current fractionalized among each the first three or more adjacent electrodes and the cathode pole comprises a second three or more adjacent electrodes sharing a cathodic current fractionalized among the second three or more adjacent electrodes.
Doan teaches that it is known to create a virtual bipole with three or more electrodes forming a virtual anode and three or more electrodes forming a virtual cathode and the virtual anode electrodes sharing an anodic current that is fractionalized and the virtual cathode electrodes sharing a cathodic current that is fractionalized as set forth in paragraph 195 for providing the predictable results of improved shaping and steering of current to find the optimal target site. It would have been obvious one having ordinary skill in the art at the time the invention was made to modify the system as taught by Wacnik with the one or more electrodes comprise a virtual anode pole and a virtual cathode pole situated at different rostral-caudal positions along the lead, and wherein the virtual anode pole comprises a first three or more adjacent electrodes sharing an anodic current fractionalized among each the first three or more adjacent electrodes and the cathode pole comprises a second three or more adjacent electrodes sharing a cathodic current fractionalized among the second three or more adjacent electrodes since such a modification would provide the predictable results of improved shaping and steering of current to find the optimal target site.
With regard to claims 2, 4, 18-19 Wacnik discloses various ramping schedules where the first and second amplitudes may increase or decrease (e.g. Fig. 5a-b, and 7b-7c).
With regard to claim 3, Wacnik in view of Doan fail to teach the second amplitude value is 80% or less than an amplitude value that causes paresthesia in the patient. Wacnik explicitly discloses a goal of the invention is to avoid patient perception (paresthesia). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Wacnik with selecting parameters in a ramp schedule including a ramp of the amplitudes being a second amplitude value less than 80% of the paresthesia threshold since such a modification would provide an iterative stepwise ramp that would prevent exceeding the patient perception threshold which Wacnik explicitly discloses is a goal of their stimulation system. The value of 80% or less than an amplitude that causes paresthesia is a result effective variable tied to the principle of increasing/ramping amplitudes without exceeding a perception threshold. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Wacnik with the second amplitude value is 80% or less than an amplitude that causes paresthesia as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claim 5-6, Wacnik discloses providing no stimulation for a second duration and then repeating the steps of claim 1 (e.g. Fig. 7b-c show multiple pulses with no stimulation between the pulses, Examiner considers any two pairs of pulses defines the ramp and then the subsequent period of no stimulation will satisfy this claim limitation. In other words if you have two pulses and then no stimulation, then another two pulses you will have delivered a ramped stimulation, provided no stimulation, then provided another ramped stimulation). Additionally, Wacnik further discloses ramp schedules as seen in Fig. 9a-b which show a break in ramping periods lasting ~240 minutes.
With regard to claim 7-9 and 17, Wacnik discloses varying the pulse width with respect to the amplitude of the pulse as seen in Fig. 7b-c which shows as the pulse width shortens the amplitude increases and conversely as the pulse width increases the amplitude shortens.
With regard to claim 10, Wacnik discloses the invention as claimed but fails to teach the stimulation comprises biphasic pulses. Doan teaches that it is known to use biphasic pulses in spinal cord stimulation as set forth in paragraph 9 for providing the predictable results of active charge recovery and prevent latent charge build up on the region. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Wacnik with the stimulation comprising biphasic pulses since such a modification would provide the predictable results of active charge recovery and prevent latent charge build up on the region.
With regard to claim 14-15, as discussed above, Wacnik in view of Doan disclose the general conditions of the claims including the fractionalized current sharing amongst electrodes in a virtual bipole. The specific current sharing arrangement including sharing the current equally amongst three anode electrodes and 3 cathode electrodes, or the rostral and caudal anodes/cathodes sharing more current than the middle anodes/cathodes would be obvious to one having ordinary skill in the art at the time the invention was made to modify the combined teachings of Wacnik in view of Doan since such a modification would provide the predictable results of routine experimentation to arrive at the most appropriate configuration to shape the pulse to the appropriate target location.
Response to Arguments
Applicant's arguments filed 2/16/2026 have been fully considered but they are not persuasive. As a matter of clarity, it appears most of Applicant’s arguments are directed to the Moffit reference relied upon by the previous examiner. That reference is no longer being relied upon.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A STOKLOSA whose telephone number is (571)272-1213. The examiner can normally be reached M-F 930AM-530PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Teixeira-Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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