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 .
Response to Arguments
Applicant’s arguments filed 8/3/2026 with respect to the rejection of claims 1-10 under 35 USC 101 have been fully considered and are persuasive. Independent Claim 1 has been amended to recite “a stimulation device configured to deliver the neurostimulation according to a stimulation configuration … a programming device … configured to … determine the stimulation configuration … wherein the programming device is configured to program the stimulation device to control the delivery of the neurostimulation according to the determined stimulation configuration.” These limitations are being interpreted to collectively require that stimulation is delivered in accordance with the determination which constitutes an abstract idea. Such affirmative delivery of stimulation is sufficient to integrate the recited abstract idea into a practical application. The Examiner thus agrees that Claim 1 recites patent eligible subject matter. Therefore, the rejection has been withdrawn.
Applicant’s arguments regarding the rejection of Claim 1, and Claims 2-10 by dependency, under 35 U.S.C. 112(a) as failing to comply with the written description requirement have been fully considered.
Applicant argues that the amendments to Claim 1 removing the term “information for programming the stimulation device” have resolved the rejection thereto based on the Present Specification not describing what “information for programming the stimulation device” entails. The Examiner agrees. This rejection has been withdrawn.
Applicant argues that the amendments to Claim 1 such that it recites “data selection circuitry configured to determine selection criteria based on at least the received patient-specific information and to select relevant data from the received aggregate data according to the determined selection criteria, the relevant data including portions of the received aggregate data that are useful for determining the stimulation configuration for the patient, the selection criteria allowing for selecting the useful portions of the received aggregate data based on the received patient-specific information” address the Examiner’s contention that “The Present Specification defines neither ‘relevant data’ nor ‘selection criteria,’ instead listing only broad examples of how the selection criteria may be determined….” The Examiner respectfully disagrees. It is not clear in what sense these amendments clarify what type of data is being selected. The rejection is maintained.
Applicant’s arguments regarding the rejection of Claims 3-4 and 6-9 are rejected under 35 U.S.C. 112(b) have been fully considered and are persuasive. The Examiner agrees that Applicant’s amendments are sufficient to resolve the cited indefiniteness issues. The rejection is withdrawn.
Applicant’s arguments regarding the rejection of Claims 1-10 under 35 U.S.C. 102(a)(1) as being anticipated by WO 2016/019129 A1 to Carcieri et al. (“Carcieri”) have been fully considered and are persuasive. The Examiner agrees that the amendments to Claim 1 have altered its scope such that Carcieri no longer discloses its entirety. Applicant’s arguments regarding Claims 2-10 are based on Applicant’s arguments regarding Claim 1, and are persuasive for the same reasons. The rejection has been withdrawn. However, upon further consideration, new grounds of rejection is made in view of US 2012/0296396 A1 to Moffit et al. (“Moffit”).
With respect to Applicant’s arguments that Carcieri does not disclose “wherein the data selection circuitry is further configured to determine the selection criteria,” Applicant’s arguments are not persuasive.
As best understood by the Examiner, such “selection criteria” is a set of traits that are used to determine whether a particular comparison is appropriate to make. Carcieri uses “biomarkers characterizing a current brain state of the patient” for this purpose. Accordingly, Carcieri’s “biomarkers” are such “selection criteria” as claimed. As best understood by the Examiner, to “determine selection criteria” includes use of pre-determined selection criteria. Carcieri uses “biomarkers characterizing a current brain state of the patient” for new patients, and thus “determine[s] selection criteria” via a pre-determination programmed directly into Carcieri’s device. Carcieri’s “VOAs” correspond to Moffit’s “fields” (see Carcieri at Para. [13], describing VOAs as regions which are activated via stimulation), and are unique to their associated stimulation parameters. That is, by administering a particularly configured stimulation, a particular volume is activated, which volume is unique the administered stimulation configuration. Carcieri “search[es] 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” based on Carcieri’s biomarkers. That is, Carcieri looks at a biomarker of a particular brain state (i.e., Carcieri’s “selection criteria”), looks at which VOAs “produce the response which provide[s] the desired change” from that brain state, and determines stimulation parameters accordingly. Which VOAs “produce the response which provide[s] the desired change” are Carcieri’s “relevant data.”
Claim Objections
Claim 25 is objected to because of the following informalities: Claim 25 recites “wherein the stimulation configuration circuitry is configured to receive a user command using the user input device…” at Ln. 1-2, but should recite -- wherein the stimulation configuration circuitry is configured to receive a user command using the user input device…--. Appropriate correction is required.
Claims 27-30 are objected to because of the following informalities: Claims 27-30 recites “the aggregate data comprise” at Ln. 1, but should recite --the aggregate data comprises--. Appropriate correction is required.
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.
Claims 1, 2, 4, 8-10, 22-23 and 27-28, and Claims 3, 5-7, 21, 24-26 and 29-30 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 “data selection circuitry configured to determine selection criteria based on at least the received patient-specific information and to select relevant data from the received aggregate data according to the determined selection criteria, the relevant data including portions of the received aggregate data that are useful for determining the stimulation configuration for the patient, the selection criteria allowing for selecting the useful portions of the received aggregate data based on the received patient-specific information.” 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]). The Present Specification does not describe how the recited “selection criteria” are determined. One of ordinary skill in the art would not understand from the Present Specification what type of data is being selected, how/why it is being selection, or what it is being used to select. One of ordinary skill in the art would be unable to identify what inputs are used for the computer-implemented determination of “selection criteria,” what outputs are produced, how those outputs are used to “select relevant data,” or what outputs are produced by the selection of “relevant data.” No specific examples are provided. As such, the Present Specification 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.
Claim 1 recites a manner of programming a stimulation device which looks at settings successful in other patients and adjusts parameters based on those similarities. The invention appears to identify what characteristics make a patient similar to other patients in the database. This “identifying” appears to be reflected by the Claim 1 language of Ln. 12-17, describing “determin[ing] selection criteria” based on which “relevant data” is selected.” Claim 1 fails to comply with the written description requirement because this process is not described in a manner that is reproducible. One of ordinary skill in the art would be unable to discern what may constitute appropriate “selection criteria” for carrying out the invention. One of ordinary skill in the art would not understand what makes a particular piece of data “relevant.” One of ordinary skill in the art would be unable even to deduce what types of data should be used. As such, neither the inputs or outputs of the subject algorithm are described sufficiently 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 is significant to claim interpretation.
Regarding Claim 2, Claim 2 recites “wherein the data selection circuitry is further configured to determine the selection criteria automatically using the received patient-specific data and additional information including diagnostic information relevant to the patient's indications for the neurostimulation and therapeutical goals of the neurostimulation for the patient.”
The Present Specification does not describe what “diagnostic information relevant to the patient's indications for the neurostimulation” entails in a manner sufficient to convey to a person of ordinary skill in the art what input is required. Further, the Present Specification does not describe what makes a particular piece of diagnostic information “relevant to the patient’s indications” in a manner sufficient to convey to a person of ordinary skill in the art what input is required.
The Present Specification does not describe in what sense “diagnostic information relevant to the patient's indications for the neurostimulation” is used to “determine the selection criteria” in a manner sufficient to convey to a person of ordinary skill in the art what is being done.
Regarding Claim 4, Claim 4 recites “wherein the target recommendation includes an output recommendation or an input recommendation including data required by an intermediate step in generating the output recommendation from the selected relevant data and the patient- specific data….” The Present Specification does not describe what “an intermediate step in generating the output recommendation” entails, does not describe what type of data “data required by an intermediate step in generating the output recommendation” envisions, and does not apprise a person of ordinary skill in the art of what is being done.
Regarding Claim 8, Claim 8 recites “determine the data presentation for guiding lead placement during implantation of the stimulation device using portions of the selected relevant data.” The Present Specification does not describe what “portions of the selected relevant data” entails, does not describe how “portions of the selected relevant data” are used, and does not apprise a person of ordinary skill in the art of what is being done.
Regarding Claim 9, Claim 9 recites “wherein the presentation control circuit is configured to determine the data presentation for guiding an identification of a stimulation target using portions of the selected relevant data.” The Present Specification does not describe what “portions of the selected relevant data” entails, does not describe how “portions of the selected relevant data” are used, and does not apprise a person of ordinary skill in the art of what is being done.
Regarding Claim 10, Claim 10 recites “wherein the presentation control circuit is configured to determine the data presentation using portions of the selected relevant data.” The Present Specification does not describe what “portions of the selected relevant data” entails, does not describe how “portions of the selected relevant data” are used, and does not apprise a person of ordinary skill in the art of what is being done.
Regarding Claim 22, Claim 22 recites “wherein the data selection circuitry is further configured to determine the selection criteria for selecting the relevant data based on the profiles and specified parameter ranges.” The Present Specification discusses this limitation at Para. [0095], but does not describe how “the profiles and specified parameter ranges” are used for determining “the selection criteria” in a manner sufficient to apprise one of ordinary skill in the art of what is being done. No particular input is listed, no specific aspect is described as being compared, and no discernable output is discussed. As such, the Present Specification 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.
Regarding Claim 23, Claim 23 recites “wherein the data selection circuitry is further configured to determine the selection criteria for selecting the relevant data further based on a number of qualified patients of the patient population.” Of the “qualified patients,” the Present Specification states only “[t]he qualified patients can include patients whose data are selected based on the profiles or the profiles and the specified parameter ranges” (Present Specification at Para. [0095]). The Present Specification does not describe how a patient is determined to be a “qualified patient” in such a way as to apprise one of ordinary skill in the art of the term’s meaning. The Present Specification does not describe the manner in which “selection criteria” is determined “based on a number of qualified patients” in a manner sufficient to convey how “selection criteria” is being determined. As such, the Present Specification 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.
Regarding Claim 27, Claim 27 recites “wherein the aggregate data comprise data representing signals sensed from a patient of the patient population.” The Present Specification does not describe what “signals sensed from a patient” entail, and provides no examples of such signals. One of ordinary skill in the art would be unable to discern what information is contemplated for use. As such, the Present Specification 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.
Regarding Claim 28, Claim 28 recites “wherein the aggregate data comprise data representing information tracking operation of each device used to treat a patient of the patient population.” The Present Specification does not describe what “information tracking operation of each device” entail, and provides no examples of such information. One of ordinary skill in the art would be unable to discern what information is contemplated for use. As such, the Present Specification 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 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 1 and 22, and Claims 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 Independent Claim 1:
Claim 1 recites “data selection circuitry configured to determine selection criteria based on at least the received patient-specific information and to select relevant data from the received aggregate data according to the determined selection criteria, the relevant data including portions of the received aggregate data that are useful for determining the stimulation configuration for the patient, the selection criteria allowing for selecting the useful portions of the received aggregate data based on the received patient-specific information.” 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]). The Present Specification does not describe how the recited “selection criteria” are determined. One of ordinary skill in the art would not understand from the Present Specification what type of data is being selected, how/why it is being selection, or what it is being used to select. One of ordinary skill in the art would be unable to identify what inputs are used for the computer-implemented determination of “selection criteria,” what outputs are produced, how those outputs are used to “select relevant data,” or what outputs are produced by the selection of “relevant data.”
Claim 1 recites a manner of programming a stimulation device which looks at settings successful in other patients and adjusts parameters based on those similarities. The invention appears to identify what characteristics make a patient similar to other patients in the database. This “identifying” appears to be reflected by the Claim 1 language of Ln. 12-17, describing “determin[ing] selection criteria” based on which “relevant data” is selected.” Claim 1 fails to comply with the written description requirement because this process is not described in a manner that is reproducible. One of ordinary skill in the art would be unable to discern what may constitute appropriate “selection criteria” for carrying out the invention. One of ordinary skill in the art would not understand what makes a particular piece of data “relevant.” One of ordinary skill in the art would be unable even to deduce what types of data should be used.
In view of the above, Claim 1 is so broad that it does not set forth that which the inventor or a joint inventor regards as the invention. The scope of Claim 1 cannot be discerned in view of this breadth. Where a claim “is too broad because it does not set forth that which the inventor or a joint inventor regards as the invention as evidenced by statements outside of the application as filed, a rejection under 35 U.S.C. 112(b) … would be appropriate.” MPEP 2173.04. Claim 1 is thus rejected under 35 U.S.C. 112(b).
The Examiner’s interpretation of Claim 1 in view of the above is set forth below at the rejection of Claim 1 under 35 USC 103.
Claim 1 recites “a programming device including a user interface including a presentation device, a user input device, and a stimulation programming circuit.” It is grammatically unclear whether (a) the “programming device” includes all three of “a user interface,” “a user input device” and “a stimulation programming circuit,” or (b) the “programming device” includes “a user interface” and the system additionally includes “a user input device” and “a stimulation programming circuit.”
For purposes of this Office Action, Claim 1 is being interpreted to mean that the “programming device” includes all three of “a user interface,” “a user input device” and “a stimulation programming circuit.”
Regarding Claim 22, Claim 22 recites “wherein the data selection circuitry is further configured to determine the selection criteria for selecting the relevant data based on the profiles and specified parameter ranges.” It is unclear what “the profiles” is intended to reference. Claim 22 depends from Claims 3 and 21, between which several different profiles are recited. It is unclear which of these profiles is referenced by Claim 22.
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.
Claims 1-10 and 21-27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0296396 A1 to Moffit et al. (“Moffit”) in view of previously cited WO 2016/019129 A1 to Carcieri et al. (“Carcieri”)
Regarding Independent Claim 1, Moffit teaches:
A system for delivering neurostimulation to a patient, the system comprising: (Fig. 1, “ DBS neurostimulation system 10”);
a stimulation device (Fig. 1, “IPG 14”);
configured to deliver the neurostimulation according to a stimulation configuration including stimulation parameters defining one or more stimulation waveforms and one or more stimulation fields; (Para. [0036], “…the IPG 14 includes pulse generation circuitry that delivers electrical stimulation energy in the form of a pulsed electrical waveform (i.e., a temporal series of electrical pulses) to the electrode array 26 in accordance with a set of stimulation parameters;” Para. [0018], “The system may optionally comprise a processor configured for generating a stimulation field model based on the selected stimulation parameter set…”);
and a programming device (Fig. 1, “CP 18;” Para. [0055], “…the CP 18 may actively control the characteristics of the electrical stimulation generated by the IPG 14 to allow the optimum stimulation parameters … and for subsequently programming the IPG 14 with the optimum stimulation parameters.”);
including a user interface including a presentation device, (Fig. 6, “display monitor 76;” Para. [0056], “… the CP 18 includes … a display monitor 76…”);
a user input device, (Para. [0056], “…the CP 18 includes a standard user input device 72…”);
and a stimulation programming circuit coupled to the presentation device and the user input device (Fig. 1, “The CP 18 generally includes a controller/processor 80 (e.g., a central processor unit (CPU)) …, which can be executed by the controller/processor 80 to allow the user to program the IPG 14, and RC 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).” Moffit’s “controller/processor 80” is such a circuit.
and configured … to receive patient-specific data collected from the patient, and to determine the stimulation configuration, (Para. [0057], “These display screens allow the clinician … to select or enter patient profile information … enter procedure information … generate a therapeutic map … of the patient, define the configuration and orientation of the leads, initiate and control the electrical stimulation energy output by the leads 12, and select and program the IPG 14 with stimulation parameters in both a surgical setting and a clinical setting…”);
Moffit’s “CP 18” receives “patient profile information,” and is used to “select and program the IPG 14 with stimulation parameters.” Moffit’s “patient profile information” is such “patient-specific data collected from the patient” as claimed. Moffit’s “select[ing] and program[ming] the IPG 14 with stimulation parameters” is “determin[ing] the stimulation configuration.”
wherein the programming device is configured to program the stimulation device to control the delivery of the neurostimulation according to [a] determined stimulation configuration. (Para. [0036], “…the IPG 14 includes pulse generation circuitry that delivers electrical stimulation energy in the form of a pulsed electrical waveform (i.e., a temporal series of electrical pulses) to the electrode array 26 in accordance with a set of stimulation parameters;” Para. [0057]).
Moffit’s “CP 18” programs Moffit’s “IPG 14” with stimulation parameters which Moffit’s “CP 18” determines (Moffit at Para. [0057]). Moffit’s “IPG 14” delivers neurostimulation according with those determined parameters (Moffit at Para. [0036]).
The Examiner notes that Moffit does not determine its stimulation configuration using aggregate data in the manner claimed, and as such does not control delivery according to “the” determined stimulation configuration whose specifics are recited by Claim 1. This deficiency is addressed below.
Moffit differs from the invention of Claim 1 in that Moffit uses only patient-specific data in optimizing its parameters, and does not consider “aggregate data collected from a patient population.” Moffit thus does not disclose:
and configured to receive aggregate data collected from a patient population,
the stimulation programming circuit including:
data selection circuitry configured to determine selection criteria based on at least the received patient-specific information and to select relevant data from the received aggregate data according to the determined selection criteria,
the relevant data including portions of the received aggregate data that are useful for determining the stimulation configuration for the patient, the selection criteria allowing for selecting the useful portions of the received aggregate data based on the received patient-specific information;
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
Carcieri describes “Systems and methods for stimulation-related volume analysis, creation, and sharing with integrated surgical planning and stimulation programming” (Title). Carcieri is analogous art.
Carcieri teaches:
and configured to receive aggregate data collected from a patient population, (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: data selection circuitry configured to determine selection criteria based on at least the received patient-specific information and to select relevant data from the received aggregate data according to the determined 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. … 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;” Para. [0016], describing processor-based implementation of this function);
As addressed above in the rejection of Claim 1 under 35 USC 112(a), the Present Specification provides no guidance as to what “selection criteria” entails, and provides no details regarding how it is determined or what is used in the determination. This deficiency is significant to claim construction, as it is impactful upon the scope of the claims.
As best understood by the Examiner, such “selection criteria” is a set of traits that are used to determine whether a particular comparison is appropriate to make.
Carcieri uses “biomarkers characterizing a current brain state of the patient” for this purpose. Accordingly, Carcieri’s “biomarkers” are such “selection criteria” as claimed.
As best understood by the Examiner, to “determine selection criteria” includes use of pre-determined selection criteria.
Carcieri uses “biomarkers characterizing a current brain state of the patient” for new patients, and thus “determine[s] selection criteria” via a pre-determination programmed directly into Carcieri’s device.
Carcieri’s “VOAs” correspond to Moffit’s “fields” (see Carcieri at Para. [13], describing VOAs as regions which are activated via stimulation), and are unique to their associated stimulation parameters. That is, by administering a particularly configured stimulation, a particular volume is activated, which volume is unique the administered stimulation configuration.
Carcieri “search[es] 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” based on Carcieri’s biomarkers. That is, Carcieri looks at a biomarker of a particular brain state (i.e., Carcieri’s “selection criteria”), looks at which VOAs “produce the response which provide[s] the desired change” from that brain state, and determines stimulation parameters accordingly.
Which VOAs “produce the response which provide[s] the desired change” are Carcieri’s “relevant data.”
the relevant data including portions of the received aggregate data that are useful for determining the stimulation configuration for the patient, (Para. [176], “…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.”);
As explained above, which VOAs “produce the response which provide[s] the desired change” are Carcieri’s “relevant data.” The VOAs “includ[e] portions of the received aggregate data that are useful for determining the stimulation configuration for the patient,” by virtue of their inclusion in Carcieri’s “library.”
the selection criteria allowing for selecting the useful portions of the received aggregate data based on the received patient-specific information; (Para. [176]);
As noted above, Carcieri’s “biomarkers characterizing a current brain state of the patient” is such “selection criteria” as claimed.
Carcieri’s “selection criteria” “allow[s] for selecting the useful portions of the received aggregate data based on the received patient-specific information” in that patient brain state is the comparator via which VOAs that “produce the response which provide[s] the desired change” (which VOAs are Carcieri’s “relevant data, as noted above) are determined.
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]).
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 Moffit with the teachings of Carcieri (i.e., to modify the device of Moffit such that it considers aggregate data collected from a patient population when optimizing its stimulation in the manner taught by Carcieri) in order to maximize the use of and facilitate efficient use of large amounts of data pertinent to which therapy regimen is best suited for a particular patient (Carcieri at Paras. [11] and [12]).
Regarding Claim 2, the combination of Moffit and Carcieri renders obvious 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 additional information including diagnostic information relevant to the patient’s indications for the neurostimulation and therapeutical goals of the neurostimulation for the patient (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;” Paras. [178] through [180]; Para. [180], “…other potential parameters for filtered analyses include, for example, demographics, health state, body position, and/or disease type or subtype.”).
Carcieri’s “filtering” described at Paras. [178] through [180] is such “additional information” as claimed. Carcieri’s “demographics, health state, body position, and/or disease type or subtype” are all such “diagnostic information relevant to the patient’s indications for the neurostimulation and therapeutical goals of the neurostimulation for the patient” as claimed.
Regarding Claim 3, the combination of Moffit and Carcieri renders obvious the entirety of Claim 2 as explained above.
Carcieri 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 of the patient population and a personal profile of the patient, the collective patient profiles each extracted from the aggregate data as a profile of 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], “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, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the target recommendation includes an output recommendation or an input recommendation including data required by an intermediate step in generating the output recommendation from the selected relevant data and the patient-specific data, the recommendation circuitry is configured to generate the input recommendation, and the stimulation configuration circuitry is configured to execute an algorithm configured to determine the 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, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri 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, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the presentation circuitry is configured to present visual representation showing overlapping between the target recommendation and corresponding current settings of the stimulation device. (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, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri 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 settings of the stimulation device (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, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the presentation control circuit is configured to determine the data presentation for guiding lead placement during implantation of the stimulation device using portions of the selected relevant data, (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, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the presentation control circuit is configured to determine the data presentation for guiding an identification of a stimulation target using portions of the selected relevant data, the 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, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri 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….” Carcieri’s initial dial settings are such “default settings … based on symptoms, and are used in the manner claimed.
Regarding Claim 21, the combination of Moffit and Carcieri renders obvious the entirety of Claim 3 as explained above.
Carcieri additionally discloses:
wherein the data selection circuitry is configured to determine the selection criteria for selecting the relevant data from patients having similar profiles. (Para. [24], “… provide characteristics of the population group and an atlas based on anatomical images of the population group, wherein the population groups have been identified by analyzing clinical effects data stored in association with volumes of activation (VOA) of a patient population for commonalities or disparities in clinical effect; obtaining characteristics of a new patient; identifying which of the population groups are associated with characteristics that are most similar to those of the patient;..”);
Regarding Claim 22, the combination of Moffit and Carcieri renders obvious the entirety of Claim 21 as explained above.
Carcieri additionally discloses:
wherein the data selection circuitry is further configured to determine the selection criteria for selecting the relevant data based on the profiles and specified parameter ranges. (Para. [24]; Para. [29], “… determining stimulation parameter settings that are estimated to provide stimulation in at least a portion of the target volume;…”);
Regarding Claim 23, the combination of Moffit and Carcieri renders obvious the entirety of Claim 22 as explained above.
Carcieri additionally discloses:
wherein the data selection circuitry is further configured to determine the selection criteria for selecting the relevant data further based on a number of qualified patients of the patient population. (Para. [26], describing traits upon which patients for comparison are selected);
Regarding Claim 24, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the recommendation circuitry is configured to automatically generate target recommendation based on the selected relevant data and the patient- specific data. (Para. [26], “…the method further includes outputting a target region for stimulation based, at least in part, on the VOAs of the population group identified as most similar to the patient.”).
Regarding Claim 25, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the stimulation configuration circuitry is configured to receive a user command using the user input device and to generate the stimulation configuration based on the target recommendation and the user command. (Claim 14, “…wherein determining a new target volume comprises obtaining user input of at least one clinical effect;...”).
Regarding Claim 26, the combination of Moffit and Carcieri renders obvious the entirety of Claim 7 as explained above.
Carcieri additionally discloses:
wherein the presentation circuitry is configured to present a visual measure of likelihood of the intended outcome of the delivery of the neurostimulation. (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,…”).
Regarding Claim 27, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the aggregate data comprise data representing signals sensed from a patient of the patient population (Para. [176], “…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 29, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the aggregate data comprise data representing information tracking operation of each device used to treat a patient of the patient population. (Para. [216], “…the system is configured for storing associated groups of data, e.g., groups of VOAs and/or associated stimulation parameter sets,…”).
Carcieri’s “library” includes parameter settings associated with VOAs, which parameter settings are such “data representing information tracking operation.”
Regarding Claim 30, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
Carcieri additionally discloses:
wherein the aggregate data comprise data representing information extracted from a medical record of a patient of the patient population. (Para. [203], “…he system compares characteristics, e.g., medical record characteristics, which can include, for example, demographics, of new patient E to the respective characteristic sets associated with each of Clusters 1 and 2.”).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over US 2012/0296396 A1 to Moffit et al. (“Moffit”) in view of previously cited WO 2016/019129 A1 to Carcieri et al. (“Carcieri”) as applied to Claim 1 above, and further in view of US 20040181262 A1 to Bauhahn (“Bauhahn”).
Regarding Claim 28, the combination of Moffit and Carcieri renders obvious the entirety of Claim 1 as explained above.
The combination of Moffit and Carcieri does not disclose:
wherein the aggregate data comprise data representing answers to questions presented to a patient of the patient population
Bauhahn describes “…neurostimulation devices and, more particularly, collection of information relating to neurostimulation therapy” (Para. [0001]). Bauhahn is analogous art.
Bauhahn teaches:
wherein the aggregate data comprise data representing answers to questions presented to a patient of the patient population (Para. [0066], “The data may offer greater precision and be used to build a base of clinical information for use by the clinician in establishing improved neurostimulation therapy efficacy;” Para. [0041], “… memory 64 may store question set 66, selection criteria 68, contextual data 69 and stimulation settings 71. Question set 66 may contain a set of questions formulated by a clinician for presentation to patient 12 via patient programmer 22. Selection criteria 68 maps questions in question set 66 to specific neurostimulation therapy contexts.”).
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 combined Moffit and Carcieri with the teachings of Bauhahn (i.e., to use such questions and their answers as taught by Bauhahn as part of Carcieri’s library of VOAs) in order to “offer greater precision” in parameter selection, thereby “establishing improved neurostimulation therapy efficacy” (Bauhahn at Para. [0066]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
