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(s) (IDS) submitted on 8/7/24 has/have been acknowledged and is/are being considered by the Examiner.
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(s) 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1- Claim 1
Claim 1 and dependent claims 2-19 are drawn to a system and thus meet the requirements for step 1.
Step 2a (prong 1) - Claim 1
Claims 1 recites the step of “determine as optimal stimulation for the patient” Under the broadest reasonable interpretation, this step covers a concept capable of being performed in the human mind, and thus falls within the mental processes grouping of abstract ideas. Other than reciting the system is “computer-implemented” in the preamble, nothing in the claim precludes the step from practically being performed in the mind.
Accordingly, claim 1 recites an abstract idea.
Step 2a (prong 2) – Claim 1
The judicial exception is not integrated into a practical application. Claim 1 recites the additional elements of:
Iteratively testing sets of stimulation parameters is insignificant extra-solution activity (i.e., data gathering),
Record an entry comprising the stimulation and at least one score indicative of the efficacy of the stimlation is insignificant extra-solution activity (i.e., data gathering), and
Present a set of stimulation parameters to a user is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data) is insignificant extra-solution activity (i.e., data output).
These steps do not integrate the abstract idea into a practical application because they are insignificant extra solution activity.
Step 2b- Claim 1
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, determining as optimal stimulation for the patient the stimulation associated with the entry having a best score is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data). Further, iteratively test sets of stimulation parameters is considered data gathering. It is noted that presenting parameters and receiving indication that the user accepts the parameters is recited at a high level of generality.
The additional elements that were considered insignificant extra solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine and conventional when considered individually and in combination with evidence provided. Specifically:
Allowing the user to define or accept one or more rules for the stimulation is well understood, routine, and conventional (i.e., receiving data MPEP 2106.05(d)(II)).
Record an entry comprising the stimulation and at least score indicative of the efficacy of the stimulation is well-understood routine and conventional (i.e., gathering data/statistics MPEP 2106.05(d)(II)).
Present a set of stimulation parameters to a user is considered to be well-understood, routine, and conventional (i.e., presenting data MPEP 2106.05(d)(II)).
Claim 1 is thus consider to be directed to an abstract idea without significantly more.
Claims 2-19 depend from claim 1. The type of data analyzed as stated in claims 2-17 are considered extra solution activity. The devices utilized to collect the data as stated in claims 18-19 are stated at a high level of generality in applicant’s specification (“a smart watch; a touchpad device; a steering wheel; a smart handheld device; a waveform analysis kiosk; and a connected device”) and are merely used as a tool to carry out the data gathering. Thus, the dependent claims do not change the overall analysis that claims 2-19 are also directed to an abstract idea.
Claim 20
Independent claim 20 contains limitations similar to claim 1 and is similarly rejected as patent ineligible subject matter.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goetz et al. (U.S. Pub. 2016/0375257 hereinafter “Goetz”) in view of Blum et al. (U.S. Pub. 2018/0104500 hereinafter “Blum”).
Regarding claims 1, 5-10 and 20, Goetz discloses a system, comprising: a non-transitory computer-readable medium (e.g. 88) comprising an algorithm configured to be executed by control circuitry of an external system (e.g. 19) configured to program an implantable stimulator device (ISD) (e.g. 20) of a patient, wherein the ISD comprises a lead (e.g. 14) with a plurality of electrodes (e.g. 32A-D, 40A-H) for providing stimulation in accordance with a plurality of stimulation parameters, wherein the algorithm is configured to: allow a user to define or accept one or more rules for the stimulation parameters, wherein the one or more rules are consistent with a parameter space to be tested (e.g. see Figs. 6, 22; “276”); test sets of stimulation parameters (e.g. Fig. 23), wherein at each iteration the algorithm is configured to present a set of stimulation parameters to a user within the parameter space (e.g. 286), receive either (i) an indication that the user accepts the set of stimulation parameters, or (ii) user-defined stimulation parameters, assess compliance of the user-defined stimulation parameters, if received, with the one or more rules (e.g.288), program the ISD to provide stimulation using (i) the set of stimulation parameters if accepted, else (ii) the user-defined stimulation parameters (e.g. Fig. 22), and record an entry comprising the stimulation and at least one score indicative of the efficacy of the simulation (e.g. 290), flag the entry with a first flag if the stimulation was provided using the user-defined stimulation parameters and if the user-defined stimulation parameters are not compliant with the one or more rules (e.g. 476), and determine a next set of stimulation parameters to test within the parameter space using entries that are not flagged with the first flag (e.g. 478); and determine as optimal stimulation for the patient the stimulation associated with the entry having a best score (e.g. 482). Goetz does not disclose iterative testing. However, Blum discloses "and determining the optimized longitudinal position and the first optimized amplitude using at least the at least one first score at each of the first combinations" (Para. [0090], "The patient 506 provides feedback which is reported as clinical response values 508 to the pulse generator feedback control logic 501. In some embodiments, the patient 506 provides feedback automatically or semi-automatically via a sensor 507 which are sent to the pulse generator feedback control logic 501 as clinical response values 508. The control logic 501 then adjusts the values of stimulation parameters 503 based upon the received feedback 508 and based upon models implemented by one or more machine learning engines 502. The control logic 501 then sends these adjusted (new or revised) stimulation parameter values (504) to further configure the controller 505 to change the stimulation parameters of the leads implanted in patient 506 to the adjusted values. The feedback-control loop then continues until an outcome is reached that is considered optimal, desired, or acceptable, or until some other stop condition is reached such as number of iterations, time spent in programming session, or the like. An outcome may be considered optimal, desired, or acceptable if it meets certain threshold values or tests (e.g., better outcomes for the patient, faster programming of the device, increased battery life, and/or control multiple independent current sources and directional lead)."); "); Blum's use of "threshold values" in determining optimization using an iterative process ([Para. 167]) is such optimization based on score as claimed when the term is afforded its broadest reasonable interpretation.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Goetz with the teachings of Blum (i.e., to determine optimal positions based on a score attributed to tested combinations) in order to account for potential degradation in a patient's response to administered stimulation (Blum at Para. [0091]).
Regarding claim 2, meeting the limitations of claim 1, Goetz further discloses wherein the score is indicative of the efficacy of the stimulation in treating a symptom of the patient and/or a side effect caused by the stimulation (e.g. ¶5).
Regarding claim 3, meeting the limitations of claim 1, Blum further discloses wherein at least one of the one or more rules comprises a rule requiring the stimulation to have a pulse width or frequency that is constant (e.g. ¶124).
Regarding claim 4, meeting the limitations of claim 1, Blum further discloses wherein at least one of the one or more rules comprises a rule requiring the stimulation to have a consistent polarity (e.g. ¶117).
Regarding claim 11, meeting the limitations of claim 1, Goetz further discloses wherein the parameter space comprises a range of rotational positions around the lead (e.g. ¶¶71, 95).
Regarding claim 12, meeting the limitations of claim 1, Goetz further discloses wherein at least one of the one or more rules comprises a rule requiring the stimulation to have a rotational position within the range of rotational positions (e.g. ¶¶71, 95).
Regarding claim 13, meeting the limitations of claim 1, Goetz further discloses wherein the parameter space further comprises a range of amplitudes, wherein at least one of the one or more rules comprises a rule requiring the stimulation to have an amplitude with the range of amplitudes (e.g. ¶¶12, 94).
Regarding claim 14, meeting the limitations of claim 1, Blum further discloses wherein at least one of the one or more rules comprises a rule requiring the stimulation to be at a longitudinal position along the lead, or within a range of longitudinal position along the lead (e.g. ¶¶94, 106, 109).
Regarding claim 15, meeting the limitations of claim 1, Goetz further discloses wherein determining the next set of stimulation parameters to test comprises determining a rotational position around the lead and an amplitude (e.g. ¶¶12, 94).
Regarding claim 16, meeting the limitations of claim 1, Blum further discloses wherein, during iteratively testing the sets of stimulation parameters, the algorithm is further configured to selectively determine if one or more stopping criterium have been met, and thus stop iteratively testing the sets of stimulation parameters, before determining the optimal stimulation for the patient (e.g. ¶167).
Regarding claim 17, meeting the limitations of claim 1, Blum further discloses wherein if the stimulation was provided using the user-defined stimulation parameters, the algorithm is configured to not determine if the one or more stopping criterium have been met (e.g. ¶¶90, 167).
Regarding claim 18, meeting the limitations of claim 1, Goetz further comprising the ISD (e.g. “20”).
Regarding claim 19, meeting the limitations of claim 1, Goetz further comprising the external system (e.g. “19”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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