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 .
Response to Arguments
Applicant's arguments filed 5/20/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In the instant case, Applicant argues against Meadows indicating Fig. 3B discloses two separate groups of electrodes and not the use of the same electrodes for the first and second waveforms (see page 8 under the Remarks). However, the Examiner did not rely on Meadows for the groupings of electrodes and instead relied on Parramon. Meadows was instead relied on to provide a visual representation of the differing pulse amplitudes, widths and polarities for the applied waveforms of Parramon. Specifically, Parramon disclose sin par. [0041], “ Any of the N electrodes may be assigned to up to k possible groups or "channels." In one embodiment, k may equal four. The channel identifies which electrodes are selected to synchronously source or sink current to create an electric field in the tissue to be stimulated. Amplitudes and polarities of electrodes on a channel may vary, e.g., as controlled by the RC 16.” Par. [0043] further states “Further, the amplitude of the current pulse being sourced or sunk to or from a given electrode may be programmed to one of several discrete current levels, e.g., between 0 to 10 mA in steps of 0.1 mA. Also, the pulse width of the current pulses is preferably adjustable in convenient increments, e.g., from 0 to 1 milliseconds (ms) in increments of 10 microseconds (.mu.s). Similarly, the pulse rate is preferably adjustable within acceptable limits, e.g., from 0 to 1000 pulses per second (pps).” Lastly, par. [0044] incorporates Meadows by reference indicating how the parameters can be changed for each channel. Thus, when viewing Parramon and Meadows as a whole, the Examiner maintains there is sufficient teaching illustrating how modifying the pulse widths, amplitudes and parameters from a first waveform at a first point in time on a channel to the next application of a waveform on the channel after a sensing period would have been obvious to one having ordinary skill in the art. The rejection is maintained.
Claim Rejections - 35 USC § 103
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 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.
Claims 1-8, 10-13, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Parramon et al. (PGPUB 2010/0331916) in view of Meadows et al. (U.S. Patent 6,516,227).
Regarding Claims 1 and 10, Parramon discloses an electrical stimulation system having at least one stimulation lead 12 having a plurality of electrodes 26 (Fig. 1; par. [0027-0028]) and a processor 62 (Fig. 6). Parramon discloses directing delivery of a first waveform using electrodes E6, E7 and E8 (See Fig. 9 and annotated figure below) and then directing sensing of a first electrical signal on electrode 13 on the sensing channel 150 after delivery of the stimulation on electrodes E6, E7 and E8 (see Fig. 9 and annotated figure below). Parramon additionally discloses directing delivery of a second waveform on electrodes E6, E7 and E8 after delivery of the first waveform on electrodes E6, E7 and E8 and after sensing on electrode E13. With respect to the second waveform differing from that of the first waveform by having different polarities, amplitudes, pulse widths, etc., Parramon discloses that these parameters are adjustable over time and able to be changed as desired (par. [0041, 0043]). While Parramon does not have a specific, illustrated example of the second waveform having different values of amplitude, polarity, etc. from the first waveform, Parramon does incorporate by reference U.S. Patent 6,516,227 (Meadows et al.) and indicates the programming and delivery of stimulation pulses can occur according to the principles therein (see par. [0044]). Specifically, Meadows provides an example of the timing channels in which a first, multi-polar waveform is delivered on electrodes E1-E5 and E7 having first pulse widths, amplitudes, etc. and then a second waveform in a separate timing channel is delivered on the same electrodes having different pulse amplitudes, widths, etc. (see Fig. 3B). This would provide the benefit of addressing variable stimulation parameters requirements at multiple sites of delivery (col. 1, line 65-col. 2, line 6) This process can be repeated over time, iteratively according to a programmed schedule thus resulting in another sensing period after the delivery of the second waveform (see par. [0076]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Parramon reference to include variable parameters in each stimulation channel, as taught and suggested by Meadows, for the purpose of addressing variable stimulation parameters requirements at multiple sites of delivery.
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In regards to Claim 2, Parramon discloses the first and second waveforms form these stimulation channels are therapeutic waveforms (par. [0008, 0035]; Claim 1).
With regard to Claim 3, Parramon discloses the sensed signal can be an electrical field potential (par. [0006, 0008]).
Regarding Claim 4, Parramon differs from the currently amended claim in that the example of Parramon discloses a different electrode E13 for sensing rather than using electrode E6, E7 or E8. Applicant’s specification indicates any electrodes can be chosen for stimulation and sensing and there is no assertion of unexpected results associated with any particular electrode combination (see par. [0051, 0052] that indicates any electrodes can be chosen and does not require the same electrode to be used for application of first and second waveforms as well as sensing. See also Fig. 7 and its corresponding disclosure in par. [0071-0078], which is the embodiment currently claimed, indicates any electrodes can be used for the first waveform, second waveform and sensing. No requirement is made that they must all use the same electrode.
Likewise, Parramon discloses one example of many in Fig. 9 and states in par. [0069], “The particular electrodes that are used with each of the four timing channels illustrated in FIG. 8 are only exemplary of many different combinations of electrode paring and electrode sharing that could be used. That is, any of the timing channels may be programmed to connect to any grouping of the electrodes, including the IPG case.”.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use one electrode or electrode set, such as E6, E7 or E8 of Parramon, for stimulation and sensing because Applicant has not disclosed that using a single electrode or set of electrodes provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the invention of Parramon, and applicant’s invention, to perform equally well with either the multi-electrode combination taught by Parramon or the claimed use of a single electrode or combination of electrodes because both configurations would perform the same function of stimulation and sensing equally well given that each phase is in a non-overlapping time slot.
Therefore, it would have been prima facie obvious to modify Parramon to obtain the invention as specified in claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Parramon.
Additionally, it would have been obvious to try and use a single electrode or set of electrodes for first and second stimulation waveforms as well as sensing since there are a finite number of identified, predictable solutions as set forth by Parramon, each with a reasonable expectation of success.
Regarding Claims 5 and 11, Parramon discloses extracting features (signal magnitudes) from the sensed signals (par. [0046-0047]).
With regard to Claims 6 and 12, Parramon indicates the signals can be evoked action potential data (neural responses), see par. [0047]).
In regard to Claims 7 and 13, Parramon discloses the process can be repeated and thus producing third and fourth waveforms with sensing performed between those waveforms (par. [0076]), much like with the first and second waveforms discussed with respect to claim 1.
Regarding Claim 8, Parramon discloses the stimulation channels produce biphasic stimulation pulses (see Example of Fg.8; par. [0064]).
In regards to Claims 21 and 22, Parramon discloses the positive and negative phases are asymmetric with respect to each other (see waveforms on E8, Fig. 9).
Claims 9, 14 and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Parramon et al. (PGPUB 2010/0331916) in view of Meadows et al. (U.S. Patent 6,516,227), further in view of Franke et al. (2014/0336728).
Regarding Claims 9, 14, 23, 24 and 26, Parramon and Meadows disclose all of the claimed invention, such as repeating the delivery of multiple biphasic stimulation pulses followed by a sensing period but fails to disclose reversing the order of the biphasic pulse. However, in the same field of endeavor of neural stimulation, Franke discloses using biphasic pulses that are reversed in order to provide charge balancing of the overall waveform for two or more periods (par. [0041]; Fig. 8). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Parramon and Meadows combination to include reversing the biphasic pulses, as taught and suggested by Franke, for the purpose of providing charge balancing of the waveform for two or more periods.
In regard to Claim 25, Parramon discloses the positive and negative phases are asymmetric with respect to each other (see waveform on E6, E7 and E8, Fig. 9).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLEN PORTER whose telephone number is (571)270-5419. The examiner can normally be reached Mon - Fri 9:00-6:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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