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
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 7, 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.
The term “suggested/suggestion” in claim 7, 8 are relative terms which render the claims indefinite. The term “suggested/suggestion” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. These limitations recite a suggested lead movement and a suggestion for initializing and/or changing the stimulation or sensing settings. These claims are rendered indefinite because these terms do not clearly define the nature of the suggestions. Therefore, it is the inability to clearly determine the distinction between suggestive and non-suggestive information which make it impossible to determine the metes and bounds. Examiner interprets these limitations to include any indications of divergence from optimal conditions, or the display of any information defining any condition of the lead.
Claim 15 recites the limitation "the acquisition criteria" in --line 1--. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the acquisition criteria” as “acceptance criteria” for continued examination of 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step (1): Independent claims 1, 16, and 17 are directed to a system or a method, and thus, the claims all fall under one of the four patent eligible categories.
To Step 2(a) prong 1:
Independent claim 1 recites “determining, using the controller and a sensing circuit configured to sense evoked responses (ERs), sensed ERs to the electrostimulation delivered in accordance with a sensing setting and the stimulation setting”, “determining acceptance criteria using user input received via a user interface”, and “comparing, using the controller, the sensed ERs to the acceptance criteria to provide a comparison result.”
Under the broadest reasonable interpretation, these limitations require the identification and comparison of sensed ERs and acceptance criteria given predetermined sensing and stimulation settings or input from a user interface respectively. Since the controller and sensing circuit are configured to sense ERs, these limitations are a process that may be practically performed in the mind through a series of observations, calculations, and judgements.
For example, a person may adjust sensing and/or stimulation settings to identify the
minimum required settings to produce measurable sensed ERs. Through observations made from a user interface, that person may use mathematical calculations to determine adjustment parameters based on mental judgements of efficacy; thereby determining a floor threshold for sensed ERs while also determining the minimum acceptance criteria to measure sensed ERs. This person may use the minimum acceptance criteria as a reference to compare sensed ERs and mentally compare outcomes. Accordingly, claim 1 is directed to a judicial exception including one or more abstract ideas under mental processes and mathematical calculations.
Independent claim 16 recites “A non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method comprising:” followed by the method of claim 1. Accordingly, claim 16 is directed to a judicial exception including one or more abstract ideas under mental processes and mathematical calculations.
Independent claim 17 recites “a controller operably connected to the electrostimulator, the sensing circuit and the user interface, and configured to:” followed by the method of claims 1 and 16. Accordingly, claim 17 is directed to a judicial exception including one or more abstract ideas under mental processes and mathematical calculations.
The dependent claim 3 recite additional limitations for receiving acceptance criteria through user-provided bounds. This limitation is also directed to a judicial exception including one or more abstract ideas under mental processes.
The dependent claims 7 and 8 recite additional limitations for determining and suggesting lead movements, stimulation settings, and sensing settings. These limitations are also directed to a judicial exception including one or more abstract ideas under mental processes and mathematical calculations.
The dependent claims 9 and 10 recite additional limitations for implementing algorithms that execute instructions to modify, compare, and/or perform mathematical calculations with data. These limitations are also directed to a judicial exception including one or more abstract ideas under mental processes and mathematical calculations.
The dependent claims 11-13 recite additional limitations that index acceptance criteria by categories. These limitations are also directed to a judicial exception including one or more abstract ideas under mental processes and mathematical calculations.
The dependent claims 14 and 15 recite additional limitations that use statistical techniques to determine ER distributions and features. These limitations are also directed to a judicial exception for mathematical calculations.
Under Step 2(a) prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claims 1, 16, 17 recites additional elements of “electrostimulator”, “sensing circuit”, “user interface”, and “controller” but they merely define the general field of use of the current claim. These elements do not improve upon any technology, technical field, or effect a particular treatment. Furthermore, when the claims, under its broadest reasonable interpretation, covers performance of the abstract mental process using generic computer elements, then it is still in the mental processes grouping unless the claim limitation cannot practically be performed in the mind. Likewise, performance of a claim limitation using generic computer components does not preclude the claim limitation from being in the mathematical concepts grouping or the certain methods of organizing human activity grouping.
Claims 1, 16, 17 recites “delivering, using a controller, electrostimulation from an electrostimulator in accordance with a stimulation setting” and “displaying an indicator of the comparison result on the user interface.” These limitations do not practically integrate the recited judicial exception because they are directed to insignificant extra-solution activity, specifically pre-solution and post-solution respectively.
Under Step 2b: The claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of “electrostimulator”, “sensing circuit”, “user interface” and “controller” in the field of neurostimulation are well-understood, routine, and conventional activities previously known in the industry as indicated in the following references provided in the Applicant' s own IDS and from additional sources:
US 10905882 B2: See [33] implanted pulse generator for electrostimulator, [34] a sensor system for sensing circuit, [29] the system for user interface, [40] the system control for controller. Also, see Figure 1 and 4.
US 11273310 B2: See [33] pulse generator for electrostimulator, [34] a sensor system for sensing circuit, [29] the system for user interface, [40] the system control for controller.
WO 2009051965 A1: See [0046] stimulator for electrostimulator and sensor for sensing circuit, [00144] interface for user interface, [0065] microcontroller for controller.
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.
Claim(s) 1-7, 9, 10, 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Esteller et al (US Pre Grant Publication 2022/0296892).
Regarding claim 1, Esteller teaches a method comprising:
delivering, using a controller (60 or 70), electrostimulation from an electrostimulator (10) in accordance with a stimulation setting (Fig. 7, [0051], [0088])
determining, using the controller (60 or 70) and a sensing circuit (implicit) (Fig. 6, [0063]) configured to sense evoked responses (ERs), sensed ERs to the electrostimulation delivered in accordance with a sensing setting and the stimulation setting ([0113]; “the system is capable of causing stimulation of a defined waveform to be applied using selected one or more electrode on the lead, and of sensing/recording responses evoked by the stimulation”)
determining acceptance criteria using user input received ([0117], Fig. 12, [0118], Fig. 13A; baseline signal configuration through user selection) via a user interface (1100);
comparing, using the controller (70), the sensed ERs to the acceptance criteria to provide a comparison result ([0127-0129], Fig. 18, Fig. 9B; comparison result indicates therapy [0127] or can associate probabilities);
displaying an indicator of the comparison result on the user interface ([0076], [0130]; implantable pulse generator may communicate with GUI 100 on clinician programmer 70);
Regarding claim 2, Esteller teaches the method of claim 1, and further teaches that the electrostimulator (10) is configured to provide electrostimulation to a therapy target in a brain of the patient or other preferred location [0051] via a deep brain stimulator (DBS) lead (15 or 33), and the evoked responses include Evoked Resonant Neural Activity (ERNA) ([0084], [0086], Fig. 10, [0113])
Regarding claim 3, Esteller teaches the method of claim 1, and teaches the method further comprising receiving, using the user interface (1700), user-provided acceptance bounds for the sensed ERs, wherein the acceptance criteria include the user-provided acceptance bounds ([0116], [0118]; user selection determines signal bounds).
Regarding claim 4, Esteller teaches the method of claim 1, and the method further comprising receiving a user selection of a target ER template from stored ER templates, wherein the acceptance criteria include the target ER template ([0118]; target ER template may be a saved ER signal or a combination of ER signals to produce a desired result or target), and the comparing includes comparing the sensed ERs to the target ER template to provide the comparison result [0119]
Regarding claim 5, Esteller teaches the method of claim 4, and further teaches that the stored ER templates are stored within storage of an operating room (OR) system (1000) configured to be used during a lead placement procedure ([0112], [121], [0136]), the OR system including at least the electrostimulator (10), the sensing circuit (Fig. 6, [0063]), the user interface (1100); or
the stored ER templates are stored in a cloud-based storage in a cloud-computing system. Examiner would note that the above limitation directed to the cloud-computing system is an optional limitation. Therefore, even though Esteller does not teach the limitation, Esteller still anticipates the claim as it teaches the alternative that the stored ERs are within an operating room system.
Regarding claim 6, Esteller teaches the method of claim 1, and further teaches that displaying the indicator of the comparison result includes displaying on the user interface (1700) representations of the acceptance criteria and the sensed ERs and/or derivatives thereof ([0119], [0125]).
Regarding claim 7, Esteller teaches the method of claim 1, and the method further including:
displaying on the user interface (100) a representation of the lead (102 or 107) (Fig. 7, [0079], [0080]); and
determining and displaying a suggested lead movement to cause the sensed ERs to compare more favorably to the acceptance criteria ([0009], [0133]).
Regarding claim 8, Esteller teaches the method of claim 1, and a method further including determining and displaying on the user interface a suggestion for initializing and/or changing the stimulation setting or the sensing setting to cause the sensed ERs to compare more favorably to the acceptance criteria ([0125], Fig. 17; indicator bar changes to indicate value from optimal values, which is interpreted to comprise suggesting changes to settings).
Regarding claim 9, Esteller teaches the method of claim 1, and the method further including providing ER templates available for user selection by modifying ER templates or creating new ER templates based on sensed ERs and patient outcome for one or more patients, wherein the acceptance criteria include a user-selected ER template, and wherein the providing ER templates includes implementing one or more machine learning algorithms to ([0121]; intelligence programmed into GUI and pre-programmed information modify recorded signals, [0127], Fig. 18):
modify or create the ER templates by determining relationships among data where the data include the sensed ERs, the patient outcomes, and at least one lead implant procedure input [0127]; and
determine the sensed ERs that corresponds to a desirable patient outcome when electrostimulation is delivered to the neural target ([0127], Fig.18).
Regarding claim 10, Esteller teaches the method of claim 9, and further teaches that the machine learning algorithm is implemented using at least one of a cloud-based application or a deployed system (system 1000 (at least one of external controller 60 or programmer 70 and electrostimulator (10)), [0127]). Examiner would note that the above limitation directed to the cloud-computing system is an optional limitation. Therefore, even though Esteller does not teach the cloud computing, Esteller still anticipates the claim as it teaches the claimed alternative.
Regarding claim 15, Esteller teaches the method of claim 1, and further teaches that the acquisition criteria include at least one target representative ER feature, the determining sensed ERs includes determining at least one measured ER feature from the sensed ERs, and the comparing includes comparing the at least one target representative ER feature to the at least one measured ER feature [0125].
Regarding claim 16, Esteller teaches a non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method comprising [0019]:
delivering, using a controller (60 or 70), electrostimulation from an electrostimulator (10) in accordance with a stimulation setting (Fig. 7, [0051], [0088])
determining, using the controller (60 or 70) and a sensing circuit (Fig. 6, [0063]) configured to sense evoked responses (ERs), sensed ERs to the electrostimulation delivered in accordance with a sensing setting and the stimulation setting [0113]
determining acceptance criteria using user input received ([0117], Fig. 12, [0118], Fig. 13A) via a user interface (1100)
comparing, using the controller (70), the sensed ERs to the acceptance criteria to provide a comparison result ([0127-0129], Fig. 18, Fig. 9B)
displaying an indicator of the comparison result on the user interface ([0076], [0130]).
Regarding claim 17, Esteller teaches a system, comprising:
an electrostimulator configured to provide electrostimulation to a neural target patient via electrodes on a lead [0113];
a sensing circuit configured to sense, at a plurality of sensing locations, evoked responses (ERs) to the electrostimulation [0012];
a user interface; and
a controller operably connected to the electrostimulator, the sensing circuit and the user interface, and configured to:
deliver the electrostimulation in accordance with a stimulation setting;
determine the sensed ERs to the electrostimulation delivered in
accordance with a sensing setting and the stimulation setting
(Fig. 7, [0051], [0088]);
determine acceptance criteria using user input received via the user
interface ([0117], Fig. 12, [0118], Fig. 13A);
compare the sensed ERs to the acceptance criteria to provide a
comparison result ([0127-0129], Fig. 18, Fig. 9B); and
display on the user interface an indicator of the comparison result
([0076], [0130]).
Regarding claim 18, Esteller teaches the system of claim 17, and further teaches that the electrostimulator is configured to provide electrostimulation to a therapy target or other preferred lead placement location in a brain of the patient via a deep brain stimulator (DBS) lead, and the evoked responses include Evoked Resonant Neural Activity (ERNA) ([0084], [0086], Fig. 10, [0113]).
Regarding claim 19, Esteller teaches the system of claim 17, and further teaches that the controller is configured to receive, using the user interface, user-provided acceptance bounds for the sensed ERs, and the acceptance criteria include the user-provided acceptance bounds ([0116], [0118]).
Regarding claim 20, Esteller teaches the system of claim 17, and a system further comprising a storage system configured to store a plurality of ER templates, the ER templates each representing one or more of a single, patient-specific response or a population-based response to electrostimulation of the neural target, wherein the user input received via the user interface includes a user selection of a target ER template from the stored ER templates, the acceptance criteria include the target ER template, and the controller is configured to compare the sensed ERs to the target ER template to provide the comparison result ([0119], [0121]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 11, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esteller et al (US Pre Grant Publication 2022/0296892), in view of Bradley (US Pre Grant Publication 2015/0012068), and further in view of McClintock et al (US Patent No. 9,607,507).
Regarding claim 11, Esteller teaches the method of claim 1 but fails to teach indexing the acceptance criteria by region, clinical institution, group, or participants information, wherein the acceptance criteria are based at least in part on an identification of an institution where the patient is implanted or treated with the electrostimulation, a group, or the participants information.
Bradley teaches a device and method for electrostimulation including storage and retrieval of evoked potentials based on available clinical information and conditions such as time and date [0125]. The retrieval of the stored evoked potentials or acceptance criteria implies the use of an indexing system. Bradley is silent regarding the identification of an institution where the patient is implanted or treated with the electrostimulation.
However, McClintock teaches a system and method of determining the activity level of a user, including location, movement, and usage. McClintock is analogous to the claimed invention as it is reasonably pertinent to the problem of tracking user information. McClintock further teaches sorting by group such as occupation or by participant’s information such as demographics [47].
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Esteller with the indexing of stored evoked potentials by clinical information and conditions as taught by Bradley and further by including the indexing of acceptance criteria by sorting it into groups or by participant’s information as taught by McClintock. One of ordinary skill in the art would have been motivated to make this modification to generate standardized or baseline profile data for future applications [47].
Regarding claim 12, Esteller teaches the method of claim 1 but fails to teach indexing the acceptance criteria by implanter information, wherein the acceptance criteria are based at least in part on an identification of an implanter that implants the lead.
Bradley teaches a device and method for electrostimulation, including storage and retrieval of evoked potentials based on clinical information and conditions such as time and date [0125]. The retrieval of the stored evoked potentials or acceptance criteria implies the use of an indexing system. Bradley is silent regarding the identification of an implanter that implants the lead.
However, McClintock teaches a system and method of determining the activity level of a user, including location, movement, and usage. McClintock is analogous to the claimed invention as it is reasonably pertinent to the problem of tracking user information. McClintock further teaches sorting by group such as occupation or by participant’s information such as demographics [47].
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Esteller with the indexing of stored evoked potentials by clinical information and conditions as taught by Bradley and further by including the indexing of acceptance criteria by sorting it into groups or by participant’s information as taught by McClintock. The participant is construed to include the implanter along with any available clinical information or conditions associated with the implanter. One of ordinary skill in the art would have been motivated to make this modification to generate standardized or baseline profile data for future use [47].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esteller et al (US Pre Grant Publication 2022/0296892) in view of Bradley (US Pre Grant Publication 2015/0012068).
Regarding claim 13, Esteller teaches the method of claim 1 and further teaches optimal therapy targets to meet symptom relief goals for brain diseases that affect motor functions such as Parkinson’s [0010]. Esteller is silent regarding indexing the acceptance criteria by sensed indication of symptom relief by the patient.
However, Bradley teaches a device and method of electrostimulation including indexing the acceptance criteria by sensed indication of symptom relief by the patient ([0333], [0325], [0326], Fig. 32C).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the optimization method of therapy targets for symptom relief of Parkinson’s patients as taught by Esteller with the sensed indications of symptom relief provided by patients as taught by Bradley. These indications are associated with optimized therapy targets or acceptance criteria by symptom relief goals. One of ordinary skill in the art would have been motivated to apply this modification in order to optimize the stimulation parameters for each patient thereby delivering targeted treatment (Bradley [0334]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Esteller et al (US Pre Grant Publication 2022/0296892) in view of Stolen et al (US Pre Grant Publication 2017/0079598).
Regarding claim 14, Esteller teaches the method of claim 1. Esteller is silent regarding the acceptance criteria which includes a target distribution of evoked response (ER) data, determining a distribution of sensed ERs, comparing distribution of sensed ERs to distribution of ER data, and displaying the distribution of sensed ERs and target distribution ER data.
However, Stolen teaches a system and method for recording electrostimulation evoked responses (ER) including statistical techniques. These techniques quantify ER data against reference values which include mean reference values or distributions of reference values [0130]. In addition, these techniques determine and compare the statistical distributions of the quantified measured responses [0130]. These same statistical techniques are used to convert the measured responses into a standardized form such as Z-scores and T-scores [0131]. Z-scores are used to generate a heatmap [Fig. 26A] which illustrates a distribution of measured responses over a given sample size [0144].
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Esteller using the statistical techniques that determine, compare, and display the calculated distributions or visualizations as taught by Stolen. One of ordinary skill in the art would have been motivated to apply these modifications to monitor inconsistent evoked responses to neural stimulation (Stolen, [0006]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792