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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,894,158. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following rationale:
Claim 1: US Appl. 18/583,405
Claim 1: US Pat. 10,894,158
A medical device…the device comprising one or more processors configured to:
An implantable medical device…the device comprising…a processor configured to:
apply a plurality of stimuli…to a spinal nerve, each stimulus having defined stimulus parameters;
process…a plurality of neural measurements of respective compound action potentials evoked by the respective stimuli;
apply from the at least one stimulus electrode to a nerve at least one stimulus having defined stimulus parameters;
process the plurality of neural measurements of at least one compound action potential evoked by the at least one stimulus;
process the plurality of neural measurements and the respective stimulus parameters in order to estimate a rheobase of a single fibre-size of the spinal nerve.
process the plurality of neural measurements in order to estimate an originating state of stimulation…at least one observable characteristic defined by a single fibre size.
As depicted above, the limitations of claim 1 of the present invention differ from claim 1 of US Pat ‘158 in that the device is directed towards the neural measurement of the spinal nerve, which represents an obvious species of the generic medical device of US Pat. ‘158, i.e. the generic medial device is directed to the neural measurement of a nerve. No additional structure or functional limitations between the two claim sets that would render the claims patentably distinct from one another.
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) 1, 3-5, 11-13, 15-21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bornzin et al. (US 2015/0360031) in view of Ward et al. (US 2014/0243714).
Bornzin et al. discloses;
Claim 1.
A medical device comprising a memory comprising computer-readable instructions…one or more processors
E.G. ([0035]-[0045]).
…apply a plurality of stimuli from at least one stimulus electrode to a spinal nerve/spinal cord
E.G. via the disclosed one or more electrodes including a stimulation electrodes 111/121 {[0036], [0041] & (Fig. 1)}.
…each stimulus having defined stimulus parameters comprising at least a first pulse width…
E.G. ([0013] & [0036])
…process from at least one sense electrode a plurality of neural measurements…evoked by the respective stimuli of the first pulse width.
E.G. via the disclosed sensing circuitry 158 configured to sense the ECAP response ([0035]-[0037]).
Obtaining compound action potentials evoked by the applied stimulation
E.G. ([0008], [0035], [0050]-[0057])
Modifying stimulation therapy based upon the neural measurements ([0017]-[0020]).
Bornzin et al. does not expressly teach:
Determining a first stimulus threshold at a first pulse width based upon the neural measurements and stimulus parameters;
Determining a second stimulus threshold at a second pulse width;
Processing the first and second threshold together with the respective pulse widths to estimate a rheobase of a single fibre-size of the spinal nerve.
Ward et al. teaches:
Measuring evoked compound action potential (CAP) responses resulting from applied neural stimulation to characterize nerve fiber activation (e.g., [0038]-[0039]).
Determining neural activation levels based upon measured CAP responses generated in response to applied stimulation (e.g., [0038]-[0040]).
Utilizing stimulus duration and stimulus amplitude in strength-duration (SD) relationships to characterize neural activation and estimate stimulation thresholds [0040].
Predicting stimulus amplitudes and stimulus durations that produce desired neural activation using strength-duration equations (e.g., [0040]).
Defining stimulus duration as the stimulation duration parameter within the strength-duration equation, wherein charge is determined as the product of stimulus current and stimulus duration (e.g., [0041]).
Utilizing the linear form of the Weiss strength-duration equation to generate a charge-duration relationship from which rheobase is determined, the rheobase corresponding to the slop of the charge-duration relationship (e.g., [0042]).
Under the broadest reasonable interpretation, a first stimulus duration and a second, different stimulus duration correspond to the claimed first pulse width and second pulse width, respectively, because Ward’s disclosed strength-duration analysis necessarily utilizes threshold measurements obtained at different stimulus durations to estimate rheobase (e.g., [0040]-[0042] and ‘Panel B’).
It would have been obvious to one of ordinary skill in the art at the of the invention to incorporate Ward’s known strength-duration/rheobase estimation techniques into Bornzin’s spinal cord stimulation system because both references utilize electrically evoked compound action potentials to characterize neural activation and optimize stimulation therapy. Incorporating Ward’s techniques would have predictably improved Borzin’s ability to characterize neural excitability, personalize stimulation parameters, and provide more accurate closed-loop neuromodulation using known neurophysiological relationships. Such a modification merely applies a known analytical technique to improve a known spinal cord stimulation system, yielding the predictable result of improved stimulation parameter determination. KSR Int’l Co. v. Teleflex Inc., 550 US.S 398 (2007).
Claim 3.
Bornzin et al. teaches applying multiple stimulation pulses.
Ward specifically teaches determining activation thresholds using multiple stimulation pulses at different pulse widths, including multiple stimulus pairs sufficient to estimate rheobase (e.g., Panel b).
Therefore, applying four stimuli to determine the threshold would have been an obvious implementation of Ward’s disclosed threshold estimation process.
Claim 4.
Bornzin et al. teaches controlling stimulation parameters to deliver therapeutic stimulation after neural measurements are obtained (e.g., [0017]-[0020)
Therefore, controlling at least two of the determined stimulation parameters to achieve therapeutic stimulation, i.e. therapeutic level of charge, would have been obvious.
Claim 5.
Ward et al. expressly teaches:
Generating a charge-duration (strength-duration) relationship,
Plotting charge versus pulse width,
Determining rheobase from the slope/intercept of the charge-duration relationship (e.g., [0040] and ‘Panel B’).
Therefore, estimating rheobase from a charge-duration curve plotting pulse widths against delivered charge at respective thresholds is taught by Ward et al.
Claims 11-12.
Bornzin et al. expressly teaches:
Implantable spinal cord stimulation systems (e.g., element 100),
Intraoperative implantation,
Postoperative programming and fitting of the implanted stimulator (e.g., [0033]-[0048]).
Claim 13.
Claim 13 recites limitations substantially corresponding to those of independent claim 1, but in method form. Accordingly, Bornzin et al. in view of Ward et al. teaches or suggests the limitations of claim 13 for the reasons discussed above with respect to claim 1. Therefore, claim 13 is unpatentable under 35 U.S.C § 103 for the same reasons set forth with respect to claim 1.
Claim 15.
Claim 15 recites limitations substantially corresponding to those of independent claim 3, but in method form. Accordingly, Bornzin et al. in view of Ward et al. teaches or suggests the limitations of claim 13 for the reasons discussed above with respect to claim 3. Therefore, claim 15 is unpatentable under 35 U.S.C § 103 for the same reasons set forth with respect to claim 3.
Claim 16.
Claim 16 recites limitations substantially corresponding to those of independent claim 4, but in method form. Accordingly, Bornzin et al. in view of Ward et al. teaches or suggests the limitations of claim 16 for the reasons discussed above with respect to claim 4. Therefore, claim 16 is unpatentable under 35 U.S.C § 103 for the same reasons set forth with respect to claim 4.
Claim 17.
Claim 17 recites limitations substantially corresponding to those of independent claim 5, but in method form. Accordingly, Bornzin et al. in view of Ward et al. teaches or suggests the limitations of claim 17 for the reasons discussed above with respect to claim 5. Therefore, claim 17 is unpatentable under 35 U.S.C § 103 for the same reasons set forth with respect to claim 5.
Claim 23.
Claim 23 recites a non-transitory computer readable medium storing instructions for performing operations substantially corresponding to those recited in independent method claim 13. Accordingly, Bornzin et al. in view of Ward et al. teaches or suggests the limitations of claim 23 for the reasons discussed above with respect to claims 1 and 13. Therefore, claim 23 is unpatentable under 35 U.S.C § 103 for the same reasons.
Claim Objections
Claims 6-9 & 18-21 are 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 applied prior art fails to teach or suggest a medical device or method that applies a single-fiber model to estimate a nerve-to-electrode distance from an estimated rheobase, wherein eh model comprises a fitted relationship between rheobase and nerve-to-electrode distance and further utilizes a fiber size associated with the estimated rheobase as an input to the single-fiber model. These limitations are not taught or suggested by the prior art of record. Therefore, the allowable claims are considered to define subject matter that would not have been obvious to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed May 12, 2026 have been fully considered but they are not persuasive. As explained above, Bornzin et al. teaches the spinal cord stimulation platform, while Ward et al. teaches utilizing neural activation thresholds obtained at different stimulus durations (pulse widths under the broadest reasonable interpretation) to estimate rheobase using strength-duration relationships. The combination would have predictably improved characterization of stimulation therapy. Therefore, the rejection of claims 1, 3-5, 11-13, 15-17 and 23 is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Errico et al. (US 2014/0330336) was reviewed as pertinent prior art because the reference discloses neurostimulation systems that utilize evoked compound action potential (CAP) measurements, strength-duration relationships, and rheobase estimations for characterizing neural activation and adjusting stimulation parameters.
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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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