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 .
Information Disclosure Statement
The Information Disclosure Statement filed 12/19/2024 has been considered by the Examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 320. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
*Reference character 320 is shown in Fig. 3, but is not included in the specification.
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 3-4 and 8 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 3 recites the limitation “stimulation therapy” in line 3, whereas stimulation therapy was already introduced in a claim that claim 3 depends from (claim 1). It is unclear whether the Applicant intended to claim the same or a different stimulation therapy. Consider changing to “the stimulation therapy”.
Claim 4 recites the limitation “an electrode stimulation” in line 2, whereas electrode stimulation was already introduced in a claim that claim 4 depends from (claim 2). It is unclear whether the Applicant intended to claim the same or a different electrode stimulation. Consider changing to “the electrode stimulation”.
Claim 8 recites the limitation "the trigger" in lines 2 and 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the patient’s behavior" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the patient’s pain score" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed machine readable storage medium does not fall within at least one of the four categories of patent eligible subject matter because it can be interpreted as a transitory form of signal transmission (i.e., “signals per se”), which has been found to be non-statutory subject matter (MPEP 2106.03).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Xi, et al. (US 2014/0005739 – cited on IDS).
Regarding claim 1, Xi teaches (Fig. 3, # 302 – NS device, i.e. signal generator) a signal generator (100) for a neurological stimulation system (Par. [0002] – Neurostimulation systems (NS) are devices that generate electrical pulses and deliver the pulses to nerve tissue to treat a variety of disorders; Par. [0053] – The NS device 302 will activate different combinations of the electrodes 305), comprising:
(Fig. 1, # 152 – pulse generating circuitry, i.e. signal generation module; Fig. 3, # 302, 312, 314, 316, 318) a signal generation module (110) connectable to a plurality of implantable electrodes (11-18; 21-28) and configured to provide electrical signals to the plurality of implantable electrodes (11-18; 21-28) for neurological stimulation (Par. [0031]; Par. [0034]; Par. [0053] – The NS device 302 will activate different combinations of the electrodes 305, such as to electronically shift a placement where and configuration at which an NS therapy is delivered on a particular vertebra. For example, during NS configurations #1, #2 and #3, different electrode column combinations 314, 316 and 318, respectively, may be active.); and
(Fig. 1, # 150, 151 – controller, 152; Fig. 3, # 302; Fig. 5) a controller (120) configured to operate the signal generation module (110), wherein the controller (120) is configured to automatically change a stimulation parameter, used in stimulation therapy at time intervals (Par. [0031] – Chronic cardiac rhythm feedback can also be used to automatically adjust the current NS parameters such as the pacing amplitude, duration and pacing dosage per day etc.; Par. [0032] – In such case (as would likely be computed by logistic regression run on a networked server such as Merlin.net), dedicated NS configurations deemed "best" at the particular time of day or particular patient status may be programmed in cycle mode or dynamically in order to provide ongoing optimization of NS anti-arrhythmic therapy.; Par. [0034]; Par. [0085] – The process of 502-514 repeats for an extended period of time (e.g., several days, weeks or months) to record a CV for each arrhythmia and each NS configuration; Par. [0087] – …one NS configuration… over a 1 week period. … a second NS configuration… over the next 1 week period).
Therefore, claim 1 is unpatentable over Xi, et al.
Regarding claim 2, Xi teaches the signal generator (100) of claim 1, wherein (Fig. 3, # 302, 313-318; Fig. 5, # 516) the stimulation parameter is at least one of an electrode selection of the plurality of implantable electrodes (11-18; 21-28) (Par. [0031]; Par. [0053]; Par. [0085]), stimulation frequency, stimulation pulse width, stimulation amplitude, or duty cycle.
Therefore, claim 2 is unpatentable over Xi, et al.
Regarding claim 3, Xi teaches the signal generator (100) of claim 2, wherein (Fig. 3, # 302, 313-318; Fig. 5, # 516) the controller (120) is configured to change the electrode selection by selecting a different subset of electrodes of the plurality of implantable electrodes (11-18; 21-28) for stimulation therapy (Par. [0031]; Par. [0053]; Par. [0085]).
Therefore, claim 3 is unpatentable over Xi, et al.
Regarding claim 4, Xi teaches the signal generator (100) of claim 2, wherein (Fig. 3, # 302, 313-318) the controller (120) is configured to change the electrode selection by shifting an electrode selection upward or downward (Par. [0031]; Par. [0053] – Similarly, the active electrode row combinations 313, 315 and 317 could be switched to shift a position of the NS therapy in a vertical direction up or down relative to a vertical reference point on a vertebra.; Par. [0090]).
Therefore, claim 4 is unpatentable over Xi, et al.
Regarding claim 5, Xi teaches the signal generator (100) of claim 1, wherein the controller (120) is configured to change the stimulation parameter by changing an electrode selection without changing one or more signal characteristics of the electrical signals, wherein the one or more signal characteristics are selected from the group consisting of an amplitude, a pulse width, a frequency, and a duty cycle (Pars. [0013-0014] - The changing operation may include switching between at least one of i) first and second electrode combinations, ii) first and second stimulus patterns, and iii) first and second active electrode placements, utilized to deliver an NS therapy from the NS lead.; Par. [0045]; Examiner notes that Xi requires switching between at least one (i.e., could be “only one”) of i-iii switching changing operations listed in Par. [0013]. For instance, the changing operation may include only switching between first and second electrode combinations. Par. [0014] details different stimulus pattern characteristics that can be altered if “ii) first and second stimulus patterns” is the selected changing operation).
Therefore, claim 5 is unpatentable over Xi, et al.
Regarding claim 6, Xi teaches the signal generator (100) of claim 1, wherein (Fig. 3, # 302, 313-318; Fig. 5, # 516) the controller (120) is configured to operate the signal generation module (110) in a plurality of program modes, wherein each program mode is associated with one or more stimulation parameters used in the stimulation therapy performed in accordance with the program mode (Par. [0031]; Par. [0032] – In such case (as would likely be computed by logistic regression run on a networked server such as Merlin.net), dedicated NS configurations deemed "best" at the particular time of day or particular patient status may be programmed in cycle mode or dynamically in order to provide ongoing optimization of NS anti-arrhythmic therapy; Par. [0053] – For example, during NS configurations #1, #2 and #3, different electrode column combinations 314, 316 and 318, respectively, may be active. By moving between NS configurations, and thus active electrode column combinations 314, 316 and 318, the NS therapy can be delivered at different lateral or longitudinal positions along the vertebra relative to a lateral reference point; Par. [0085]).
Therefore, claim 6 is unpatentable over Xi, et al.
Regarding claim 7, Xi teaches the signal generator (100) of claim 1, wherein (Fig. 5, # 504-514) the time interval is a periodic interval or an aperiodic interval, in particular within the range of one or more days or one or more weeks (Par. [0031] – An automatic searching algorithm can be applied such as switching to each of the different NS configurations for W weeks and record the corresponding AT/AF burden; Par. [0032] – Alternately, each given NS configuration may be programmed for H hours (instead of W weeks) and recorded AT/AF burden trends are associated with the respective NS configuration at the time.; Par. [0053]; Par. [0084] – For example, when a predetermined long-term period of time ends (e.g., 1 week, 1 month), at 512 the method would determine to change the NS configuration.; Par. [0085] – The process of 502-514 repeats for an extended period of time (e.g., several days, weeks or months) to record a CV for each arrhythmia and each NS configuration.).
Therefore, claim 7 is unpatentable over Xi, et al.
Regarding claim 8, Xi teaches the signal generator (100) of claim 1, wherein (Fig. 5) at least one of the stimulation parameter, the time interval, or the trigger is determined by the controller (120) or by an external device or an external server (Par. [0077] – FIG. 5 illustrates a computer implemented method performed by one or more of the devices and systems described herein, to control a configuration of an NS system in connection with chronic cardiac rhythm feedback; Par. [0078] – The method begins at 502 wherein an NS operating configuration is selected. For example, an initial NS operating configuration may be selected from a memory database of potential NS configurations.),
wherein the time interval or trigger is determined based on input data on at least one of an initial programming of the signal generator, implantation parameters, a patient's condition, etiology, changes in physiological function, changes in the patient's behavior, or changes in the patient's pain score (Par. [0031] – An automatic searching algorithm can be applied such as switching to each of the different NS configurations for W weeks and record the corresponding AT/AF burden… Chronic cardiac rhythm feedback can also be used to automatically adjust the current NS parameters such as the pacing amplitude, duration and pacing dosage per day etc.; Par. [0032]; Par. [0078] – Optionally, the NS operating configuration may be selected based on the time of day, neurologic therapy, past physiologic behavior of the patient, type of arrhythmia and the like.; Par. [0090]).
Therefore, claim 8 is unpatentable over Xi, et al.
Regarding claim 9, Xi teaches the signal generator (100) of claim 1, wherein (Fig. 5) the controller (120) is configured to determine one or both of the stimulation parameter or the time interval using a rule-based process and/or artificial intelligence (Par. [0031] – An automatic searching algorithm can be applied such as switching to each of the different NS configurations for W weeks and record the corresponding AT/AF burden.; Par. [0077] – FIG. 5 illustrates a computer implemented method performed by one or more of the devices and systems described herein, to control a configuration of an NS system in connection with chronic cardiac rhythm feedback).
Therefore, claim 9 is unpatentable over Xi, et al.
Regarding claim 10, Xi teaches (Fig. 3) a neurological stimulation system (Par. [0052]), comprising:
(Fig. 3, # 306) a plurality of implantable electrodes (11-18; 21-28) configured to deliver electrical signals to neurological tissue (e.g., Par. [0052] – The NS lead 304 includes electrodes 306 that are arranged in a two dimensional array of rows 308 and columns 310. The electrodes 306 delivery NS therapies based on the current operating NS configuration.); and
the signal generator (100) of claim 1 (please see the 35 U.S.C. 102 rejection of claim 1 over Xi, et al. hereinabove).
Therefore, claim 10 is unpatentable over Xi, et al.
Regarding claim 11, Xi teaches the neurological stimulation system of claim 10, wherein (Fig. 1; Fig. 3) the neurological stimulation system is configured for spinal cord stimulation (Par. [0002]; Par. [0033] – For example, system 100 may be adapted to stimulate spinal cord tissue, peripheral nerve tissue, deep brain tissue, cortical tissue, or any other nervous tissue within a patient's body.; Par. [0053]).
Therefore, claim 11 is unpatentable over Xi, et al.
Regarding claim 12, Xi teaches (Fig. 5) a method for neurological stimulation (Par. [0077] – FIG. 5 illustrates a computer implemented method performed by one or more of the devices and systems described herein, to control a configuration of an NS system in connection with chronic cardiac rhythm feedback), comprising:
(Fig. 1, # 150, 151 – controller, 152; Fig. 3, # 302, 313-318; Fig. 5) determining, by a controller (120), a first subset of electrodes of a plurality of implantable electrodes (11-18; 21-28) and performing neurological stimulation by applying electrical signals to the first subset of electrodes; and
determining, by the controller (120), a second subset of electrodes of the plurality of implantable electrodes (11-18; 21-28) and performing neurological stimulation by applying electrical signals to the second subset of electrodes (Par. [0031]; Par. [0053]).
Therefore, claim 12 is unpatentable over Xi, et al.
Regarding claim 13, Xi teaches the method of claim 12, wherein (Fig. 3, # 302, 313-318) determining the second subset of electrodes includes shifting an electrode selection corresponding to the first subset of electrodes upwards or downwards to obtain the second subset of electrodes (Par. [0053]; Par. [0090]).
Therefore, claim 13 is unpatentable over Xi, et al.
Regarding claim 14, Xi teaches the method of claim 12, wherein (Fig. 3) the electrical signals applied to the first subset of electrodes and the second subset of electrodes have the same signal characteristics, including one or more of the same amplitude, the same pulse width, the same frequency, or the same duty cycle (Par. [0013] – The changing operation may include switching between at least one of i) first and second electrode combinations, ii) first and second stimulus patterns, and iii) first and second active electrode placements, utilized to deliver an NS therapy from the NS lead.; Par. [0045]; Par. [0053]; Xi’s disclosure accounts for only changing the electrode combination and keeping stimulus patterns (see Par. [0013-0014]) the same).
Therefore, claim 14 is unpatentable over Xi, et al.
Regarding claim 15, Xi teaches (Fig. 1) a machine-readable storage medium, comprising instructions executable by one or more processors to implement the method for neurological stimulation of claim 12 (Par. [0034] – Software code is typically stored in memory of the NS device 150 for execution by the microcontroller or processor to control the various components of the device; Also, please see 35 U.S.C. 102 rejection over Xi, et al. of claim 12 hereinabove).
Therefore, claim 15 is unpatentable over Xi, et al.
Regarding claim 16, Xi teaches the signal generator (100) of claim 1, wherein (Fig. 1; Fig. 3) the controller (120) is configured to change the stimulation parameter by changing one or more signal characteristics of the electrical signals, wherein the one or more signal characteristics are selected from the group consisting of an amplitude, a pulse width, a frequency, and a duty cycle, without changing an electrode selection (Pars. [0013-0014] - The changing operation may include switching between at least one of i) first and second electrode combinations, ii) first and second stimulus patterns, and iii) first and second active electrode placements, utilized to deliver an NS therapy from the NS lead… The changing operation may include changing a configuration value of at least one configuration parameter from the set of configuration parameters that includes stimulus phase, frequency, pulse width, pulse amplitude, number of active electrodes, active electrode pattern, active electrode position within an electrode array, active electrode placement with respect to a reference anatomy. ).
Therefore, claim 16 is unpatentable over Xi, et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Goetz, et al. (US 2006/0229687)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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