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 Amendment
The amendment filed April 8, 2026 has been entered. Claims 1, 4, 11, 14 have been amended. Currently, claims 1-20 are pending for examination.
Response to Arguments
Applicant's arguments filed April 8, 2026 have been fully considered but they are not persuasive. Applicant argues (p. 7-8) that De Ridder (US 2017/0021161) does not expressly disclose selecting stimulation parameter values based on at least one specified therapeutic effect or therapeutic response because stimulation to “reduce neuroplasticity effects” ([0127]) is not considered a therapeutic effect or therapeutic response. The ordinary meaning of the term “therapeutic” defined by Merriam-Webster is: having a beneficial effect on the body or mind; producing a useful or favorable result or effect (https://www.merriam-webster.com/dictionary/therapeutic). The broadness of the phrase “therapeutic effect” and “therapeutic response” enables the interpretation of a reduction in neuroplasticity effects as a therapeutic effect or response. De Ridder explains a reduction, enhancement or otherwise treatment toward neuroplasticity effects may extend the efficacy period associated with a particular set of therapeutic stimulation parameters, or reverse existing neuroplasticity effects due to injury or disease, and undesirable conditions resulting from pre-existing neuroplasticity effects may be prevented from progressing further, reduced, or eliminated ([0015]). Therefore stimulation parameter values selected to reduce neuroplasticity effects is regarded as a therapeutic effect or therapeutic response as required by the claim.
The objection to claim 11 and the 35 U.S.C. 112 rejection to claims 4 and 11-20 are withdrawn.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over De Ridder (US 2017/0021161) in view of Goetz et al. (US 2006/0259099).
Regarding claim 1, De Ridder discloses a method for generating a stimulation program, the method comprising: selecting at least two sets of stimulation parameter values (“stimulation sets 150” [0123]), wherein at least two stimulation parameter values of each of the at least two sets of stimulation parameter values are selected based on at least one specified therapeutic effect or therapeutic response, wherein the at least one specified therapeutic effect or therapeutic response is different from at least two of the at least two sets of stimulation parameter values (“one or more stimulation pulses or sub-intervals may be designed to provide therapeutic electrical stimulation and one or more other stimulation pulses or sub-intervals may be designed to reduce neuroplasticity effects” [0127]); and generating a stimulation program (fig. 7-8) that comprises application of stimulation during a plurality of non-overlapping time intervals (fig. 8), wherein, for each of the non-overlapping time intervals, one of the at least two sets of stimulation parameter values 150 is selected for the application of the stimulation and the selection is different from the selection for an immediately preceding one of the non-overlapping time intervals (fig. 8).
De Ridder does not expressly disclose the therapeutic effect or therapeutic response is observed for each of a plurality of previous stimulation instances. Goetz et al. teaches it is a known practice in the art to test various stimulation parameter values for a specified therapeutic effect or therapeutic response observed for each of a plurality of previous stimulation instances in order to select the best stimulation parameter values ([0004-0006], [0012], [0054-0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify De Ridder to rely on selecting the at least two stimulation parameter values of each of the at least two sets of stimulation parameter values based on at least one specified therapeutic effect or therapeutic response observed for each of a plurality of previous test stimulation instances as taught by Goetz et al. as it is a known technique in the art for yielding the predictable result of determining the best stimulation values for treating specific desired clinical effects.
Regarding claim 2, De Ridder discloses wherein the at least two sets of stimulation parameter values is at least three sets of stimulation parameter values ([0130]) and the stimulation program comprises application of stimulation by each of the at least three sets of stimulation parameter values in a repeating sequential order (“the sequence may be executed one or more times” [0132]).
Regarding claim 3, De Ridder discloses modifying an order of the repeating sequential order (“may be arranged temporally in any suitable manner” [0127]; “A therapeutic stimulation set 150 may be separated from a successive therapeutic stimulation set 150 by any number of neuroplasticity reducing stimulation sets 150 and this number may be the same between each pair of therapeutic stimulation sets 150 or may vary between each pair of therapeutic stimulation sets 150 in a predetermined or randomized manner” [0128]).
Regarding claim 4, De Ridder discloses wherein the at least two sets of stimulation parameter values is at least three sets of stimulation parameter values ([0130]), and the stimulation program comprises application of stimulation by each of the at least three sets of stimulation parameter values in an order that does not repeat a same sequence of at least three time intervals by disclosing the sets are delivered in a repeating sequential order (“the sequence may be executed one or more times” [0132]), one particular example of Program 3 (fig. 7) and illustrated in Figure 8, where at least three sets of stimulation parameter values are provided and stimulation by each of the first three stimulation sets is applied in an order that does not repeat a same sequence of at least three of the non-overlapping time intervals (t3-t8).
Regarding claim 5, De Ridder discloses wherein the at least two sets of stimulation parameter values is at least three sets of stimulation parameter values ([0130]) and the stimulation program comprises application of stimulation by each of the at least three sets of stimulation parameter values in a random order ([0123]).
Regarding claim 6, De Ridder discloses wherein the sets of stimulation parameter values comprise stimulation parameter values for at least two of the following stimulation parameters: electrode selection, electrode fractionization, stimulation amplitude, pulse width, or pulse frequency ([0123]), wherein electrode selection comprises selection of at least one electrode for delivery of the stimulation (fig. 6) and electrode fractionization comprises a quantified distribution arrangement of the stimulation among two or more selected electrodes.
Regarding claim 7, De Ridder discloses wherein at least two of the at least two sets of stimulation parameter values differ in electrode selection (fig. 6).
Regarding claim 8, De Ridder discloses wherein at least two of the at least two sets of stimulation parameter values differ in stimulation amplitude ([0124], [0129]).
Regarding claims 9-10, De Ridder discloses wherein each of the non-overlapping time intervals has a same duration or differ in duration (“Although the time intervals 158 (t1-t0, t2-t1, etc.) during which the stimulation sets 150 are executed are shown as being equal, the present invention contemplates a particular stimulation set 150 being executed over a different time interval 158 than one or more other stimulation sets 150 according to particular needs.” [0130]).
Regarding claim 11, De Ridder discloses a method for electrical stimulation of tissue, the method comprising: providing a control module 12 and an electrical stimulation lead 10 coupled to the control module, the electrical stimulation lead comprising a plurality of electrodes 18 (fig. 1a); executing a stimulation program (fig. 7-8) on the control module ([0063]) to provide electrode stimulation through the electrodes of the electrical stimulation lead, wherein the stimulation program comprises application of stimulation during non-overlapping time intervals (fig. 8), wherein, for each of the non-overlapping time intervals, one of the at least two sets of stimulation parameter values (“stimulation sets 150” [0123]) is selected for the application of the stimulation and the selection is different from the selection for an immediately preceding one of the non-overlapping time intervals (fig. 8), wherein at least two of the stimulation parameter values for each of the sets of stimulation parameter values are selected based on at least one specified therapeutic effect or therapeutic response, wherein the at least one specified therapeutic effect or therapeutic response is different for at least two of the at least two sets of stimulation parameter values (“one or more stimulation pulses or sub-intervals may be designed to provide therapeutic electrical stimulation and one or more other stimulation pulses or sub-intervals may be designed to reduce neuroplasticity effects” [0127]).
De Ridder does not expressly disclose the at least one specified therapeutic effect or therapeutic response is observed for each of a plurality of previous stimulation instances. Goetz et al. teaches it is a known practice in the art to test various stimulation parameter values for a specified therapeutic effect or therapeutic response observed for each of a plurality of previous stimulation instances in order to select the best stimulation parameter values ([0004-0006], [0012], [0054-0055]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify De Ridder to rely on selecting the at least two stimulation parameter values of each of the at least two sets of stimulation parameter values based on at least one specified therapeutic effect or therapeutic response observed for each of a plurality of previous test stimulation instances as taught by Goetz et al. as it is a known technique in the art for yielding the predictable result of determining the best stimulation values for treating specific desired clinical effects.
Regarding claim 12, De Ridder discloses wherein the at least two sets of stimulation parameter values is at least three sets of stimulation parameter values ([0130]) and the stimulation program comprises application of stimulation by each of the at least three sets of stimulation parameter values in a repeating sequential order (“the sequence may be executed one or more times” [0132]).
Regarding claim 13, De Ridder discloses modifying an order of the repeating sequential order (“may be arranged temporally in any suitable manner” [0127]; “A therapeutic stimulation set 150 may be separated from a successive therapeutic stimulation set 150 by any number of neuroplasticity reducing stimulation sets 150 and this number may be the same between each pair of therapeutic stimulation sets 150 or may vary between each pair of therapeutic stimulation sets 150 in a predetermined or randomized manner” [0128]).
Regarding claim 14, De Ridder discloses wherein the at least two sets of stimulation parameter values is at least three sets of stimulation parameter values ([0130]), and the stimulation program comprises application of stimulation by each of the at least three sets of stimulation parameter values in an order that does not repeat a same sequence of at least three time intervals by disclosing the sets are delivered in a repeating sequential order (“the sequence may be executed one or more times” [0132]), one particular example of Program 3 (fig. 7) and illustrated in Figure 8, where at least three sets of stimulation parameter values are provided and stimulation by each of the first three stimulation sets is applied in an order that does not repeat a same sequence of at least three of the non-overlapping time intervals (t3-t8).
Regarding claim 15, De Ridder discloses wherein the at least two sets of stimulation parameter values is at least three sets of stimulation parameter values ([0130]) and the stimulation program comprises application of stimulation by each of the at least three sets of stimulation parameter values in a random order ([0123]).
Regarding claim 16, De Ridder discloses wherein the sets of stimulation parameter values comprise stimulation parameter values for at least two of the following stimulation parameters: electrode selection, electrode fractionization, stimulation amplitude, pulse width, or pulse frequency ([0123]), wherein electrode selection comprises selection of at least one electrode for delivery of the stimulation (fig. 6) and electrode fractionization comprises a quantified distribution arrangement of the stimulation among two or more selected electrodes.
Regarding claim 17, De Ridder discloses wherein at least two of the at least two sets of stimulation parameter values differ in electrode selection (fig. 6).
Regarding claim 18, De Ridder discloses wherein at least two of the at least two sets of stimulation parameter values differ in stimulation amplitude ([0124], [0129]).
Regarding claims 19-20, De Ridder discloses wherein each of the non-overlapping time intervals has a same duration or differ in duration (“Although the time intervals 158 (t1-t0, t2-t1, etc.) during which the stimulation sets 150 are executed are shown as being equal, the present invention contemplates a particular stimulation set 150 being executed over a different time interval 158 than one or more other stimulation sets 150 according to particular needs.” [0130]).
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 ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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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/ERICA S LEE/Primary Examiner, Art Unit 3796
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