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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 13-20 in the reply filed on January 28, 2026 is acknowledged.
Priority
Claims 13-20 are deemed to have an effective filing date of April 28, 2023.
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 13-20 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 13 recites “stimulation device implanted in a person in response to an identified trend” in line 2, and “identifying … a trend of adjustment” in line 3. It is unclear to what “identified trend” “a schedule for the adjustment of the stimulation” is based in line 5 of the claim. Thus, the scope of claim 13 is indefinite.
With respect to claims 14-17, it is unclear to what “trend” is being referred in line 1 of those claims. Is it the “trend of adjustment” (claim 1, line 3) or “the identified trend” (claim 1, line 2)?
Claims 18-20 are rejected because they depend from an indefinite 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.
Claims 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 13-20 are directed to a method (process) for modifying stimulation by a stimulation system. Therefore, the claims fall within one of the statutory categories.
Step 2A, Prong 1:
Claims 13-20 recite identifying a trend of adjustment of the stimulation in response to a trigger event (observation of a clinician reviewing gathered data); defining a schedule for the adjustment (thinking about modifying a current schedule based on the reviewed historical data); and with affirmation by the clinician, directing the adjustment of the stimulation according to the schedule (outputting the result of the abstract idea – extra solution activity). The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitations in the mind of a clinician with insignificant extra-solution activity. With respect to recitation in dependent claims 14-20 the trend of the abstract step is further modified. However, those modification do not preclude the steps of the invention from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper, to be an abstract idea. In this case, aside from the recitation of a stimulation system comprising a stimulation device implanted in a patient (insignificant extra-solution activity of data gathering in the identifying step), claims 7-20 encompass a user observing the clinical data and making a judgement.
Step 2A, Prong 2:
Claim 1 recites “a stimulation system comprising a stimulation device implanted in a patient”. However, there is no active step of stimulating or implanted, as the stimulation system identifies a trend of adjustment”, which a clinician can do by observing the historical data of the stimulation system. The recited stimulation system is being used as a tool to gather data in the process under its broadest reasonable interpretation. The judicial exception is not integrated into a practical application because neither the stimulation system nor an implanted stimulation device integrates the judicial exception of mental process into a practical application as both additional elements are tangential to the extra-solution activity of data gathering and do nothing to integrate the mental processes of identifying a trend of adjustment, defining a schedule, and directing the adjustment of the abstract idea.
Step 2B:
As discussed above, the stimulation system of claim 13 is merely used as a tool to perform an existing process (see MPEP 2106.05(f)). A stimulation system comprising an implanted stimulation device is well-known in the art (see the applied prior art). Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims, taken as a whole, do not integrate the recited judicial exception into a practical application. Thus, the above-identified claims are directed to the judicial exception.
Claim Rejections - 35 USC § 102
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.
Claim 13 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 8,311,639 to Parker et al. (hereinafter referred to as “Parker”).
As best understood, Parker discloses a method for modifying stimulation by a stimulation system comprising a stimulation device implanted in a patient in response to an identified trend (e.g., title: system and methods for adjusting electrical therapy based on impedance changes), the method comprising: identifying, by the stimulation system and over a period of time, a trend of adjustment of the stimulation in response to a trigger event (e.g., column 3, lines 11-14: automatically identifying changes in the impedance of an electrical circuit that provides therapy to the patient as a function of time; and column 1, lines 40-50: changes to impedance are in response to the formation of scar tissue and/or a lead moving within the patient (trigger event)); defining a schedule based on the identified trend (e.g., column 3, lines 14-16: based on those identified changes, the method can predict a future value of the impedance (define/create a new schedule for the adjustment of the stimulation) and automatically, or with affirmation by the patient or clinician, directing the adjustment of the stimulation according to the schedule (e.g., column 3, lines 17-22: automatically perform a task/adjustment based on the predicted value/schedule) .
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.
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.
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 2021/01969064 to Schnell et al. (hereinafter referred to as “Schnell”) in view of US Patent Application No. 2014/0074180 to Heldman et al. (hereinafter referred to as “Heldman”).
Regarding claim 13, Schnell discloses a method for modifying stimulation by a stimulation system comprising a stimulation device implanted in a patient in response to an identified trend (e.g., paragraph [0047] and Fig. 1: system 100 includes an implantable medical device (IMD) 106 configured to deliver deep brain stimulation (DBS) to a patient where the IMD may adjust, increase, decrease the magnitude of one or more of the stimulation parameters of the DBS in response to changes in patient activity or movement, severity of a disease, or presence of side effects), the method comprising: identifying, by the stimulation system and over a period of time, a trend of adjustment of the stimulation in response to a trigger event (e.g., paragraphs [0008]: adjusting, by the processing circuitry, a medical device to deliver electrical stimulation so that at least one value of a stimulation parameter is changed to a second value at which a patient condition is identified; [0045]: the stimulation system adjusts the value of one of more stimulation parameters in order to maintain the brain signals above or below one or more respective thresholds; and [0047]: one or more sensed signals of the patient may be used as a control signal such that the IMD correlates the magnitude of the one or more parameters of the electrical stimulation to the magnitude of the one or more sensed signals); and automatically, or with affirmation by the patient or clinician, directing the adjustment of the stimulation according to the schedule (e.g., paragraph [0047]: system 100 via IMD 106 delivers electrical stimulation therapy having one or more parameters, such as current or voltage amplitude, adjusted in response to a signal deviating from a range defined by a homeostatic window). Schnell differs from the claimed invention in that it does not expressly disclose defining a schedule for the adjustment of the stimulation based on the identified trend, although Schnell does modify at least one stimulation parameters in the adaptive brain stimulation system (e.g., paragraph [0047]). However, Heldman, in a related art: movement disorder therapy systems, teaches that protocols for periodic measurement may follow particular schedules and that the schedule may change through the course of treatment and/or therapy (e.g., paragraph [0020] of Heldman) and that measurements and records are to be taken at scheduled intervals, or, based on stimulus measurements that a subject is performing a particular activity (e.g., paragraphs [0126] and [0185] of Heldman). Accordingly, one of ordinary skill in the art would have realized the benefits of defining/creating a schedule for adjustment of the stimulation based on the identified trend, which can be performing a particular activity in view of the teachings of Heldman. Consequently, one of ordinary skill in the art would have modified the method of Schnell to define a schedule for adjustment of the stimulation based on the identified trend in view of the teachings of Heldman that such was a well-known protocol for adjustment of stimulation, and because the combination would have yielded a predictable result.
With respect to claim 14, Schnell in view of Heldman teaches the method of claim 13, wherein the trend comprises the adjustment of the stimulation at a particular time of day (e.g., paragraph [0020] of Heldman: the schedule for adjustment of treatment and/or therapy can be hours, days, weeks, or months). Accordingly, one of ordinary skill in the art would have recognized the benefits of the schedule monitoring for adjustments of the stimulation being hourly or at a particular time of a day in view of the teachings of Heldman that such monitoring can occur hourly, daily weekly or monthly. Consequently, in the absence of criticality, the trend of Schnell in view of Heldman may comprise the adjustment of the stimulation at a particular time of day in view of the teachings of Heldman, and because the combination would have yielded a predictable result.
As to claim 15, Schnell in view of Heldman teaches the method of claim 13, wherein the trend comprises the adjustment of the stimulation in response to administration of medication (e.g., paragraphs [0049] and [0196] and Figs. 42-47 of Schnell: In this manner, user interface 400 can help a user understand real-world response of brain states to medications, stimulation, and other daily activities to inform future therapy management including stimulation parameter values and/or closed-loop control of stimulation).
With respect to claim 16, Schnell in view of Heldman teaches the method of claim 13, wherein the trend comprises the adjustment of the stimulation in response to a determination that the patient is engaging in a specified activity (e.g., paragraphs [0047] of Schnell: deep brain stimulation (DBS) may be adaptive in that the IMD may adjust, increase, or decrease the magnitude of one or more stimulation parameters of DBS in response to patient activity or movement; and [0090] of Schnell: system 100 creates a control loop for controlling the magnitude of delivered therapy so that the system can be less intrusive on the activity of the patient because the system adapts the stimulation to the current needs of the patient for whatever activity).
As to claim 17, Schnell in view of Heldman teaches the method of claim 13, wherein the trend comprises the adjustment of the stimulation in response to a change in a symptom of a disease or disorder or in a therapeutic effect or a side effect of stimulation by the stimulation system (e.g., paragraph [0047] and Fig. 1: system 100 includes an implantable medical device (IMD) 106 configured to deliver deep brain stimulation (DBS) to a patient where the IMD may adjust, increase, decrease the magnitude of one or more of the stimulation parameters of the DBS in response to changes in patient activity or movement, severity of a disease, or presence of side effects).
With respect to claim 18, Schnell in view of Heldman teaches the method of claim 17, further comprising detecting the change when the change comprises an increase or decrease for at least a predetermined period of time of at least one measured indicator (e.g., paragraph [0047] and Fig. 1: system 100 includes an implantable medical device (IMD) 106 configured to deliver deep brain stimulation (DBS) to a patient where the IMD may adjust, increase, decrease the magnitude of one or more of the stimulation parameters of the DBS in response to changes in patient activity or movement, severity of a disease, or presence of side effects - since the IMD makes an adjustment, the IMD necessarily must detect a change which indicates an adjustment is required).
As to claim 19, Schnell in view of Heldman teaches the method of claim 17, further comprising detecting the change when the change comprises an increase or decrease by a predetermined magnitude of at least one measured indicator (e.g., paragraph [0047] and Fig. 1: system 100 includes an implantable medical device (IMD) 106 configured to deliver deep brain stimulation (DBS) to a patient where the IMD may adjust, increase, decrease the magnitude of one or more of the stimulation parameters of the DBS in response to changes in patient activity or movement, severity of a disease, or presence of side effects - since the IMD makes an adjustment, the IMD necessarily must detect a change which indicates an adjustment is required).
With respect to claim 20, Schnell in view of Heldman teaches the method of claim 17, further comprising detecting the change using a sensor disposed on or within the patient (e.g., paragraph [0047] and Fig. 1: system 100 includes an implantable medical device (IMD) 106 configured to deliver deep brain stimulation (DBS) to a patient where the IMD may adjust, increase, decrease the magnitude of one or more of the stimulation parameters of the DBS in response to changes in patient activity or movement, severity of a disease, or presence of side effects – since the IMD makes an adjustment, the IMD necessarily must detect a change which indicates an adjustment is required).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2022/0176118 to John et al. is directed to a system for improving neurostimulation treatment compliance where the neurostimulator determines the therapeutic protocol for a given week or long periods using a pre-defined schedule that can be modified according to various factors (e.g., paragraph [0201]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792