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 11 is objected to because of the following informalities: line 5 recites, “the electrodes of the electrical stimulation lead” and should recite, “the plurality of electrodes of the electrical stimulation lead” to maintain consistence with what is recited in line 3. Appropriate correction is required.
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 4 and 11-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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 4 recites the limitation "at least three time intervals" in line 4. There is insufficient antecedent basis for this limitation in the claim because it is unclear if these “at least three time intervals” are referencing the “non-overlapping time intervals” introduced in claim 1 or are directed to separate and distinct time intervals.
Claim 11 recites the limitation “one of the at least two sets of stimulation parameter values” in line 7. There is insufficient antecedent basis for this limitation in the claim because it references something that has not yet been introduced in the claim.
Claim 14 recites the limitation "at least three time intervals" in line 4. There is insufficient antecedent basis for this limitation in the claim because it is unclear if these “at least three time intervals” are referencing the “non-overlapping time intervals” introduced in claim 11 or are directed to separate and distinct time intervals.
Claims 12-20 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 11.
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.
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.
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 clinical effect that is a therapeutic effect, a therapeutic response, a side effect, or a testing result and the at least one specified clinical effect 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 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 clinical effect 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 clinical effect 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 clinical effect 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 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 clinical effect that is a therapeutic effect, a therapeutic response, a side effect, or a testing result and the at least one specified clinical effect 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]).
De Ridder does not expressly disclose the 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 clinical effect 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 clinical effect 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 clinical effect 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 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
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