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 April 23, 2026 have been fully considered in light of the amendment to the pending claims have been fully considered. However, the claims remain rejected under new grounds of rejection necessitated by amendment as detailed below.
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 1-33, 62 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Doan et al. (US 20200197704 A1).
As to claims 1, 33, 62 and 72, Doan et al. discloses treating pain in a patient by delivering a first paresthesia-free electrical signal to the patient's spinal cord region via an implanted signal delivery device (Abstract, [0004, 0025, 0165]) for a first stimulation period and according to a first stimulation schedule in which the first paresthesia-free electrical signal is delivered for at least 12 hours per day, wherein the first paresthesia-free electrical signal reduces the patient's pain ([0167, 0246]); and after the first stimulation period, delivering a second paresthesia-free electrical signal to the patient's spinal cord region via the implanted signal delivery device for a second stimulation period and according to a second stimulation schedule in which the second paresthesia-free electrical signal is delivered for less than 6 hours per day ([0114]), wherein the second paresthesia- free electrical signal at least partially maintains the reduction in the patient's pain achieved during the first stimulation period ([0114-0115]).
Doan et al. discloses the invention substantially as claimed but does not explicitly disclose the individual pulses having a pulse width within a pulse width range from 5 milliseconds to 2 seconds. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stimulation session duration, frequency of occurrence and parameters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of modifying the treatment to meet specific patient therapeutic needs and requirements.
As to claim 2, Doan et al., and thus the modified Doan et al., disclose delivering the first paresthesia- free electrical signal according to the first stimulation schedule includes continuously delivering the first paresthesia-free electrical signal during the first stimulation period ([0167, 0246]; Figure 6).
As to claim 3, the modified Doan et al. discloses the claimed invention substantially as claimed except for the explicitly discloses delivering the first paresthesia-free electrical signal for 24 hours at a pulse dose rate of less than 100%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stimulation session duration, frequency of occurrence and parameters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of modifying the treatment to meet specific patient therapeutic needs and requirements.
As to claim 4, Doan et al., and thus the modified Doan et al., disclose delivering the second paresthesia-free electrical signal according to the second stimulation schedule includes delivering the second paresthesia-free electrical signal during only a single stimulation session per day ([0114-0115]).
As to claim 5, Doan et al., and thus the modified Doan et al., disclose the single stimulation session has a duration of between about 10 minutes and about 4 hours ([0114-0115]).
As to claim 6, Doan et al., and thus the modified Doan et al., disclose the single stimulation session has a duration of between about 10 minutes and about 2 hours ([0114-0115]).
As to claim 7, Doan et al., and thus the modified Doan et al., disclose the single stimulation session has a duration of between about 10 minutes and about 1 hours ([0114-0115]).
As to claims 8 and 10-12, the modified Doan et al. discloses the claimed invention substantially as claimed except for the explicitly disclose the single stimulation session has a duration of between about 15 minutes and about 45 minutes. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stimulation session duration, frequency of occurrence and parameters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of modifying the treatment to meet specific patient therapeutic needs and requirements.
As to claim 9, Doan et al., and thus the modified Doan et al., disclose the single stimulation session has a duration of about 1 hour ([0114-0115]).
As to claims 13-21, 23-27, 29 and 32, the modified Doan et al. discloses the claimed invention substantially as claimed except for the explicitly discloses the stimulation session durations, number of stimulation sessions and frequency. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the stimulation session duration, frequency of occurrence and parameters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (see MPEP 2144.05). Furthermore, such a modification would provide the predictable results of modifying the treatment to meet specific patient therapeutic needs and requirements.
As to claim 22, Doan et al., and thus the modified Doan et al., disclose the first stimulation period has a predetermined duration (see Claim 1 on page 19).
As to claim 28, Doan et al., and thus the modified Doan et al., disclose at least one of the first paresthesia-free electrical signal or the second paresthesia-free electrical signal has a frequency in a frequency range of from about 1 Hz to about 1000 Hz ([0185, 0251]).
As to claim 30, Doan et al., and thus the modified Doan et al., disclose delivering the first paresthesia- free electrical signal and delivering the second paresthesia-free electrical signal includes using an implanted signal generator with a primary cell battery to generate the first paresthesia-free electrical signal and the second paresthesia-free electrical signal ([0165, 0208, 0229]).
As to claim 31, Doan et al., and thus the modified Doan et al., disclose delivering the first paresthesia- free electrical signal and delivering the second paresthesia-free electrical signal includes using an external signal generator to generate and deliver the first paresthesia-free electrical signal and the second paresthesia-free electrical signal ([0054, 0144-0145, 0230, 0252]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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