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 with traverse of Claims 1-10 in the reply filed on 2/2/2026 is acknowledged. The traversal is on the ground that Claims 11 and 20 have been amended to recite “presenting the determined data presentation using a user interface,” and as such “the process could not be practiced without a user interface.” This is not found persuasive. As acknowledged by Applicant, the Examiner reasons at Para. 3 of the Requirement for Restriction dated 12/19/2025 that the inventions of Claims 1-10 and 11-20 are distinct because “the process of Invention II can be practiced by another and materially different apparatus than that of Invention I. For example, the process of Invention II could be practiced using an apparatus that selects relevant data and generates a target recommendation via a processor that does not include a user interface” (emphasis added).
The relevant question is not whether both inventions require a user interface, but whether both inventions require that relevant data be selected and a target recommendation be generated by a user interface. The invention of Claims 1-10 painstaking recites definitively structured circuitry configured in a particular manner. With respect to the “user interface,” Claim 1 recites:
…a user interface including a presentation device, a user input device, and a stimulation programming circuit coupled to the presentation device and the user input device and configured to receive aggregate data collected from a patient population, to receive patient-specific data collected from the patient, and to determine the stimulation configuration, the stimulation programming circuit including: data selection circuitry configured to select relevant data from the received aggregate data according to selection criteria; recommendation circuitry configured to generate a target recommendation based on the selected relevant data and the patient-specific data; presentation control circuitry configured to determine a data presentation using the presentation device based on the selected relevant data and the patient-specific data; and stimulation configuration circuitry configured to determine the stimulation configuration using the target recommendation (emphasis added).
In contrast to the affirmative structural requirements of the elements configured to perform the above-noted functions, the invention of Claims 11-20 is far more lax with respect to what structures perform similar functions. Claim 11 recites:
… selecting relevant data from the received aggregate data according to selection criteria using a processor; generating a target recommendation based on the selected relevant data and the patient- specific data using the processor; determining a data presentation based on the selected relevant data and the patient-specific data using the processor; presenting the determined data presentation using a user interface; determining a stimulation configuration using the target recommendation using the processor… (emphasis added).
Despite Applicant’s amendments to Claims 11 and 20, the process of Invention II (i.e., Claims 11-20) can still be practiced by another and materially different apparatus than that of Invention I (i.e., Claims 1-10) for the same reasons as set forth in the Requirement for Restriction dated 12/19/2025. Significantly, this distinction is impactful on how the two inventions are interpreted for purposes of evaluation under 35 U.S.C. 101 as well as 35 U.S.C. 112. The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, and Claims 2-10 by dependency, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Independent Claim 1:
Claim 1 recites “a programming control circuit configured to generate information for programming the stimulation device to control the delivery of the neurostimulation according to a stimulation configuration including stimulation parameters defining one or more stimulation waveforms and one or more stimulation fields.” The Present Specification does not describe what “information for programming the stimulation device” entails. Accordingly, one of ordinary skill in the art would not understand from the Present Disclosure what “information” the “programming control circuit” is “configured to generate,” and as such fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Claim 1 recites “data selection circuitry configured to select relevant data from the received aggregate data according to selection criteria.” The Present Specification defines neither “relevant data” nor “selection criteria,” instead listing only broad examples of how the selection criteria may be determined (see, e.g., Present Specification at Para. [0095]). One of ordinary skill in the art would not understand from the Present Specification what type of data is being selected, and as such fails to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
The Examiner notes that this issue compounds throughout Claim 1. Claim 1 subsequently recites “recommendation circuitry configured to generate a target recommendation based on the selected relevant data and the patient-specific data; presentation control circuitry configured to determine a data presentation using the presentation device based on the selected relevant data and the patient-specific data; and stimulation configuration circuitry configured to determine the stimulation configuration using the target recommendation.” As one of ordinary skill in the art would not understand from the Present Disclosure what type of data is being selected as “relevant data,” one of ordinary skill would similarly be unable to deduce (i) what “a target recommendation based on the selected relevant data” is made based on; (ii) what “a data presentation using the presentation device based on the selected relevant data” is determined based on; and (iii) how a “stimulation configuration [determined] using the target recommendation” is determined.
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 6-9 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.
Regarding Claim 3, Claim 3 recites “… the collective patient profiles each extracted from the aggregate data for a patient of the patient population….” There is insufficient antecedent basis for the term “the aggregate data for a patient of the patient population,” and it is consequently unclear from what “the collective patient profiles” are “extracted.”
For purposes of this Office action, the above limitation is being interpreted to mean that the subject data is extracted from the “aggregate data” of Claim 1.
Regarding Claim 4, Claim 4 recites “wherein the recommendation circuitry is configured to generate an input recommendation of the target recommendation….” It is grammatically unclear in what sense this limits the claim. Claim 1 recites “a target recommendation” being “generate[d] … based on the selected relevant data and the patient-specific data,” from which it appears grammatically that “the selected relevant data and the patient-specific data” would be the “input.” However, a separate component (i.e., the “data selection circuitry”) is recited as selecting such input, wheras Claim 4 recites “the recommendation circuitry” as generating the “input recommendation. The scope of Claim 4 is thus unclear.
For purposes of this Office Action, the above limitation is being interpreted to mean that some additional input is used in determining the target recommendation.
Regarding Claim 6, Claim 6 recites “wherein the presentation circuitry is configured to present visual representation showing overlapping between the target recommendation and corresponding current state of the system.” The Present Specification includes similar language, but makes clear that the “system” of the Present Specification is different from that of the preamble of Claim 1, which is the only place from which antecedent basis for the term can be drawn (see, e.g., Present Specification at Para. [0101], “The ‘current state of the system’ can include current settings of the stimulation device…”). It is thus unclear what the term “corresponding current state of the system” is in reference to in the context of Claim 6.
For purposes of this Office Action, the above limitation is being interpreted to mean that a visual representation is shown between current settings and optimal settings in the manner recited.
Regarding Claim 7, Claim 7 similarly recites “corresponding current state of the system,” which is indefinite for the same reasons as explained above with respect to Claim 6 and is being interpreted similarly.
Regarding Claim 8, Claim 8 recites “wherein the presentation control circuit is configured to determine the data presentation using portions of the selected relevant data for guiding lead placement during implantation of the stimulation device.” It is grammatically unclear whether the term “for guiding lead placement during implantation of the stimulation device” is intended to modify the term “portions of the selected relevant data” (e.g., the selected relevant data is relevant “for guiding…”), the term “determine” (e.g., the purpose of the determination is “for guiding…”), or something else.
For purposes of this Office Action, the above limitation is being interpreted in accordance with the latter.
Regarding Claim 9, Claim 9 recites “wherein the presentation control circuit is configured to determine the data presentation using portions of the selected relevant data for guiding an identification of a stimulation target being an are a or a volume of tissue to which the neurostimulation is to be delivered.” It is grammatically unclear in what sense the phrase “for guiding an identification of a stimulation target being an area or a volume of tissue to which the neurostimulation is to be delivered” limits the claim.
For purposes of this Office Action, the above limitation is being interpreted to mean that the stimulation target is graphically displayed.
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 1-10 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Eligibility Step 1 – The Four Categories of Statutory Subject Matter
Claims 1-10 each fall within one of the four categories of statutory subject matter. Claims 1-10 are drawn to a “system” (i.e., a machine), and thus fall within one of the four statutory categories.
Eligibility Step 2A, Prong One
Claims 1-10 recite abstract ideas:
Regarding Independent Claim 1, Claim 1 as a whole amounts to “‘collecting information, analyzing it, and displaying certain results of the collection and analysis,’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,” MPEP 2106.04(a)(2)(III)(A), citing Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). As such, Claim 1 recites a mental process. More particularly:
“a programming control circuit configured to generate information for programming the stimulation device to control the delivery of the neurostimulation according to a stimulation configuration including stimulation parameters defining one or more stimulation waveforms and one or more stimulation fields” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). Such “generating” is practically performable in the human mind. For example, a human could exercise judgment to perform such processing as the claimed “generating” requires (see below) to “generate” information “for programming the stimulation device….”
The term “generate information for programming the stimulation device…” is quite broad, spanning anything from data for subsequent analysis to rudimentary computer code for determining whether stimulation should be initiated. Notably, the “information” is “generated.” This implies more than mere data gathering: some processing is required for information to be “generated.” This “generation” (and the processing required of it) is operative: the remainder of the recitation simply details what the “generated” information contains/is used for.
“and a user interface including a presentation device, a user input device, and a stimulation programming circuit coupled to the presentation device and the user input device and configured to receive aggregate data collected from a patient population, to receive patient-specific data collected from the patient, and to determine the stimulation configuration” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). Such “determining” is practically performable in the human mind, as it is a judgment.
As alluded to above, the Examiner notes the significance of the recited “a user interface.” The recited “user interface” is used uniquely in Claim 1 as a self-lexicographically defined structure which “includes” several sub-structure (i.e., a presentation device, a user input device, and a stimulation programming circuit) linked structurally to one another in a particular manner. As such, those several sub-structures and their associated functions are addressed individually herein.
“the stimulation programming circuit including: data selection circuitry configured to select relevant data from the received aggregate data according to selection criteria” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). Such “selecting” is practically performable in the human mind, as it is a judgment.
“recommendation circuitry configured to generate a target recommendation based on the selected relevant data and the patient-specific data” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). Such “generat[ing] a target recommendation” is practically performable in the human mind, as it is a judgment.
“presentation control circuitry configured to determine a data presentation using the presentation device based on the selected relevant data and the patient-specific data” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). Such “determining” is practically performable in the human mind, as it is a judgment.
“and stimulation configuration circuitry configured to determine the stimulation configuration using the target recommendation” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). Such “determining” is practically performable in the human mind, as it is a judgment.
Regarding Claims 2-3, Claims 2-3 depend from and further limit the abstract ideas of Claim 1, and recite abstract ideas for the same reasons as explained above with respect to Claim 1.
Regarding Claim 4:
“generate an input recommendation of the target recommendation” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(III). Such “generating” is practically performable in the human mind, as it is a judgment.
“execute an algorithm configured to determine an output recommendation automatically based on the input recommendation” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation in light of the Specification. See MPEP 2106.04(a)(2)(I)(C).
“determine the stimulation configuration…” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 1.
Regarding Claims 6-10, Claims 6-10 depend from and further limit the abstract ideas of Claim 1, and recite abstract ideas for the same reasons as explained above with respect to Claim 1
Eligibility Step 2A, Prong Two
Claims 1-10 do not recite additional elements that integrate the judicial exception into a practical application.
Regarding Independent Claim 1:
“and a user interface including a presentation device, a user input device, and a stimulation programming circuit coupled to the presentation device and the user input device and configured to receive aggregate data collected from a patient population, to receive patient-specific data collected from the patient, and to determine the stimulation configuration” (i.e., the that information for subsequent analysis is received by the system) amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“a programming control circuit,” “a user interface including a presentation device, a user input device, and a stimulation programming circuit” “recommendation circuitry,” “presentation control circuitry,” and “stimulation configuration circuitry” (i.e., the physical circuitry used to implement the recited functions) are generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
The Examiner notes that this interpretation is consistent with the Present Specification. See Present Specification at Para. [0063].
Regarding Claims 2-4, Claims 2-4 further limit certain additional elements recited in Claim 1 but do not themselves recite any additional elements.
Regarding Claim 5:
“present visual representation of at least one of portions of the selected relevant data or data derived from the selected relevant data using the presentation device” amounts to necessary data outputting in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
Regarding Claim 6:
“present visual representation showing overlapping between the target recommendation and corresponding current state of the system” amounts to necessary data outputting in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
Regarding Claims 7-10, Claims 7-10 further limit certain additional elements recited in Claim 1 but do not themselves recite any additional elements.
Eligibility Step 2B
Claims 1-10 do not amount to significantly more than the abstract ideas recited therein:
Regarding Independent Claim 1:
“and a user interface including a presentation device, a user input device, and a stimulation programming circuit coupled to the presentation device and the user input device and configured to receive aggregate data collected from a patient population, to receive patient-specific data collected from the patient, and to determine the stimulation configuration” (i.e., the that information for subsequent analysis is received by the system) does not contribute an inventive concept. Such data acquisition is well-understood, routine and conventional in the art. See, e.g., US 20090187424 A1 at Para. [0021], US 20140358018 A1 at Para. [0023], US 20100257214 A1 at Para. [0025].
“a programming control circuit,” “a user interface including a presentation device, a user input device, and a stimulation programming circuit” “recommendation circuitry,” “presentation control circuitry,” and “stimulation configuration circuitry” (i.e., the physical circuitry used to implement the recited functions) do not contribute an inventive concept. The claimed units are generic computer components for performing a generic computer function, and are recited at a high level of generality. Contextually, the inclusion of such units amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
Regarding Claims 2-4, Claims 2-4 further limit certain additional elements recited in Claim 1 but do not themselves recite any additional elements.
Regarding Claim 5:
“present visual representation of at least one of portions of the selected relevant data or data derived from the selected relevant data using the presentation device” does not contribute an inventive concept. Such data acquisition is well-understood, routine and conventional in the art. See, e.g. US 20040077995 A1 at Para. [0042].
Regarding Claim 6:
“present visual representation showing overlapping between the target recommendation and corresponding current state of the system” does not contribute an inventive concept. Such data acquisition is well-understood, routine and conventional in the art. See, e.g. US 20040077995 A1 at Para. [0042].
Regarding Claims 7-10, Claims 7-10 further limit certain additional elements recited in Claim 1 but do not themselves recite any additional elements.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2016/019129 A11 to Carcieri et al. (“Carcieri”)
Regarding Independent Claim 1, Carcieri discloses:
A system for delivering neurostimulation to a patient using a stimulation device configured to deliver the neurostimulation, the system comprising: (Figure 15 depicts such a system, see “Implantable stimulator 1502” in relation to the remainder of the depicted system; see also Para. [84]; see Annotated Fig. 15, below);
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a programming control circuit configured to generate information for programming the stimulation device to control the delivery of the neurostimulation according to a stimulation configuration including stimulation parameters defining one or more stimulation waveforms and one or more stimulation fields; (Fig. 15, “remote control (RC) 1504, 1504a;” “clinician programmer (CP) 1506 cloud or other central storage 1508 with a database 1510;” and “a smartphone 1512 or other computing devices that can access applications 1514 (Apps)” are all such “programming control circuits” as claimed; see Para. [84]; see Annotated Fig. 15, above);
It is noted that the limitation “configured to generate information for programming the stimulation device to control the delivery of the neurostimulation according to a stimulation configuration including stimulation parameters defining one or more stimulation waveforms and one or more stimulation fields” is not being interpreted to require that “the delivery of neurostimulation” actually be controlled, but is instead being interpreted to mean that the information generated (regardless of its content) is used “for programming the stimulation device to control…” in the manner subsequently recited.
and a user interface (Figures 1-3, “remote control 100”);
including a presentation device, (Figure 1, “screen 102” of “remote control 100;” Para. [93]);
a user input device, (Figure 1, “one or more buttons 112” of “remote control 100”);
and a stimulation programming circuit coupled to the presentation device and the user input device (Para. [177], “The system then provides that VOA (and associated stimulation settings) as a target volume for treating the entered indication;” Para. [16]);
The term “stimulation programming circuit” is being interpreted in accordance with Para. [0063] of the Present Specification, which states “the circuit of user interface 110, stimulation control circuit 214, programming control circuit 316, and stimulation programming circuit 320, including their various embodiments discussed in this document, can be implemented using an application-specific circuit constructed to perform one or more particular functions and/or a general-purpose circuit programmed to perform such function(s). Such a general-purpose circuit includes, but is not limited to, a microprocessor or a portion thereof, a microcontroller or portions thereof, and a programmable logic circuit or a portion thereof.”
Carcieri’s Para. [16] makes clear that the Carcieri’s above-equated components are similarly structured.
It is noted that similar structural elements of Claim 1 (i.e., elements of the form “an [xyz] circuit”) are being interpreted similar, but that this is not expressly so-stated for brevity.
and configured to receive aggregate data collected from a patient population, to receive patient-specific data collected from the patient, and to determine the stimulation configuration, (Para. [176], “In an example embodiment, location-specific data on brain response to respective VOAs, for example as indicated by changes to location-specific biomarkers in the brain, is aggregated over a large number of patients. For treatment of a new patient, the system is configured to obtain biomarkers characterizing a current brain state of the patient. The system is configured to obtain biomarkers representing a desired brain state for the patient. The system is then configured to automatically determine and output a target volume of activation estimated as most likely to achieve the change in brain state from the current brain state to the desired brain state.”);
the stimulation programming circuit including: (Para. [16]);
data selection circuitry configured to select relevant data from the received aggregate data according to selection criteria; (Para. [176], “For treatment of a new patient, the system is configured to obtain biomarkers characterizing a current brain state of the patient.”);
recommendation circuitry configured to generate a target recommendation based on the selected relevant data and the patient-specific data; (Para. [176], “The system is then configured to automatically determine and output a target volume of activation estimated as most likely to achieve the change in brain state from the current brain state to the desired brain state.”);
presentation control circuitry configured to determine a data presentation using the presentation device based on the selected relevant data and the patient-specific data; (Figure 11; Para. [165], “Figure 11 shows an example current VOA 1100, an Optimal VOA 1102 for improvement with respect to tremor, and a tremor improvement path 1104 outlining a trajectory from the current VOA 1100 to the Optimal VOA 1102;” Figure 12; Para. [185], “In an example embodiment of the present invention, a user can input stimulation program settings in response to which the system outputs a display in the graphical user interface (GUI) a map of neighborhood effects showing the respective next change in effects associated with a change in the VOA position, in each of a plurality of directions, from the current VOA position. For example, For example, Figure 12 shows an example of a neighborhood effects map 1200 with labels 1202, 1204, 1206, 1208 indicating the change in an effect with a change in the VOA 1210 position.”);
and stimulation configuration circuitry configured to determine the stimulation configuration using the target recommendation. (Para. [176] to [177]).
Regarding Claim 2, Carcieri discloses the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the data selection circuitry is further configured to determine the selection criteria automatically using the received patient-specific data and information required for generating the target recommendation (Para. [0176], “In an example embodiment, location-specific data on brain response to respective VOAs, for example as indicated by changes to location-specific biomarkers in the brain, is aggregated over a large number of patients. For treatment of a new patient, the system is configured to obtain biomarkers characterizing a current brain state of the patient. The system is configured to obtain biomarkers representing a desired brain state for the patient.”)
Regarding Claim 3, Carciera discloses the entirety of Claim 2 as explained above.
Carciera additionally discloses:
wherein the data selection circuitry is configured to determine the selection criteria for selecting the relevant data based on profiles including collective patient profiles and a personal profile of the patient, the collective patient profiles each extracted from the aggregate data for a patient of the patient population, the personal profile extracted from the patient-specific data, each profile of the collective patient profiles and the personal profile including at least one of diagnostic information or therapeutic information. (Para. [0176], “[176] In an example embodiment, location-specific data on brain response to respective VOAs, for example as indicated by changes to location-specific biomarkers in the brain, is aggregated over a large number of patients. For treatment of a new patient, the system is configured to obtain biomarkers characterizing a current brain state of the patient. The system is configured to obtain biomarkers representing a desired brain state for the patient. The system is then configured to automatically determine and output a target volume of activation estimated as most likely to achieve the change in brain state from the current brain state to the desired brain state. For this determination, the system is configured to search the library of VOAs and the corresponding aggregated location- specific brain response data to determine which VOA has been shown to produce the response which provide the desired change.”).
Regarding Claim 4, Carciera discloses the entirety of Claim 1 as explained above.
Carciera additionally discloses:
wherein the recommendation circuitry is configured to generate an input recommendation of the target recommendation, and the stimulation configuration circuitry is configured to execute an algorithm configured to determine an output recommendation automatically based on the input recommendation, to receive a user command, and to determine the stimulation configuration using the output recommendation and the user command. (Para. [176], “The system is then configured to automatically determine and output a target volume of activation estimated as most likely to achieve the change in brain state from the current brain state to the desired brain state;” Para. [29], “ In at least some embodiments, determining a new target volume includes obtaining user input of at least one clinical effect; obtaining a plurality of estimated volumes of activation (VOA) associated with stimulations of the patient population, which VOAs are associated with the at least one clinical effect; and based on the VOAs, determining the new target volume.”);
Regarding Claim 5, Carciera discloses the entirety of Claim 1 as explained above.
Carciera additionally discloses:
wherein the presentation circuitry is configured to present visual representation of at least one of portions of the selected relevant data or data derived from the selected relevant data using the presentation device (Figure 11; Para. [165]; Figure 12; Para. [185])
Carcieri’s “VOAs” are such “data derived from the selected relevant data” as claimed.
Regarding Claim 6, Carciera discloses the entirety of Claim 1 as explained above.
Carciera additionally discloses:
wherein the presentation circuitry is configured to present visual representation showing overlapping between the target recommendation and corresponding current state of the system (Figure 11; Para. [43], “Figure 11 illustrates an example of a trajectory between a current VOA and an optimal VOA, according to an example embodiment of the present invention;” Para. [165] to [166]).
Regarding Claim 7, Carciera discloses the entirety of Claim 1 as explained above.
Carciera additionally discloses:
wherein the presentation circuitry is configured to present a measure of likelihood of an intended outcome of the delivery of the neurostimulation determined based on a comparison of the target recommendation to corresponding current state of the system (Para. [157], “ According to an example embodiment, the system is configured to generate a probability voxel map that maps the probability that stimulation of each respective voxel will contribute to the specified effect, the system then selects all voxels whose probabilities meet a predetermined or user-input threshold probability, and the system then draws a three-dimensional surface outline around all the voxels meeting the threshold which are at the extremities to form the target or side effect volume.”).
Regarding Claim 8, Carciera discloses the entirety of Claim 1 as explained above.
Carciera additionally discloses:
wherein the presentation control circuit is configured to determine the data presentation using portions of the selected relevant data for guiding lead placement during implantation of the stimulation device, (Para. [81], “Pre -op lead location information and a pre-op CT can be provided to the stimulation programming module for use to determine the lead location, on which basis to select stimulation settings for stimulating a target volume. MER data of the surgical planning module can also be accessed by the programming module.”);
the data presentation including stimulation field models associated with lead positions collected from patients of the patient population having implanted stimulation devices, the stimulation field models (SFMs) each representing a volume of tissue activated by the delivery of the neurostimulation (Para. [13], “The data may pertain to, for example, stimulation of a patient for deep brain stimulation (DBS) therapy and/or spinal cord stimulation (SCS) therapy. It may include graphical information, such as estimated volumes of activation (VOA), also referred to herein as a stimulation field model (SFM). It may include information used for rendering the SFMs, such as image registration and/or leadwire location data. … It may further include information concerning stimulation programs applied to the patient for the patient therapy. It may include target volumes selected for a patient, and/or volumes of estimated activation (VOA) for various stimulation parameters input for the patient.”).
Regarding Claim 9, Carciera discloses the entirety of Claim 1 as explained above.
Carciera additionally discloses:
wherein the presentation control circuit is configured to determine the data presentation using portions of the selected relevant data for guiding an identification of a stimulation target being an area or a volume of tissue to which the neurostimulation is to be delivered, (Para. [13], “The data may pertain to, for example, stimulation of a patient for deep brain stimulation (DBS) therapy and/or spinal cord stimulation (SCS) therapy. It may include graphical information, such as estimated volumes of activation (VOA), also referred to herein as a stimulation field model (SFM). It may include information used for rendering the SFMs, such as image registration and/or leadwire location data;” Para. [176]);
the data presentation including prior stimulation targets associated with lead positions collected from patients of the patient population, and the patient population is a population of patients having implanted stimulation devices (Fig. 7, Paras. [223] through [227]; Para. [176]).
Regarding Claim 10, Carciera discloses the entirety of Claim 1 as explained above.
Carciera additionally discloses:
wherein the presentation control circuit is configured to determine the data presentation using portions of the selected relevant data, the data presentation including setup features determined using the portions of the selected relevant data and used as input used for generating the target recommendation automatically. (Para. [164], “Thus, for example, a presently set stimulation program is defined (partially) by amplitude, pulse width, rate, and location of stimulation pulses. A control, such as a dial, is provided for a corresponding effect or symptom. For example, a dial can be provided for tremor control. As the user turns the dial, the system auto-adjusts the parameters, e.g., auto- adjusts the amplitude setting, to gradually evolve the VOA corresponding to the current settings to the VOA associated with optimal tremor control, with each incremental turn of the dial moving the VOA another step along a tremor improvement path that extends from the current VOA location to that corresponding to the optimal tremor control.”).
The term “setup features” is being interpreted in accordance with Para. [0054] of the Present Specification as “e.g., default settings for the implantable stimulator based on symptoms, lead position, and search type….” Carciera’s initial dial settings are such “default settings … based on symptoms, and are used in the manner claimed.
Conclusion
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
1 WO 2016/019129 A1 was disclosed by Applicant in the IDS dated 2/2/2026
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