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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 27, 2025 has been entered.
Response to Amendment
The amendment filed September 29, 2025 has been entered. Claims 42, 53 and 64 have been amended. Currently, claims 42-71 are pending for examination.
Response to Arguments
35 U.S.C. 101
Applicant's arguments filed September 29, 2025 have been fully considered but they are not persuasive. Applicant argues (p. 8) the amended features recited by independent 42 cannot be fairly interpreted as an abstract idea because “a person cannot possibly, with pen and paper or in their head, deliver a neurostimulation therapy or cause such a therapy to be delivered to a patient using pen and paper or by a mental act”. Applicant argues (p. 8) the amended features recited by independent claim 53 “specifically recites the hardware that enables machine-to-machine interaction and that enables a device to control delivery of a neurostimulation therapy”. Applicant argues (p. 8) the amended features recited by independent claim 64 “specifically recites the hardware for delivering a neurostimulation therapy to a patient as well as the hardware for controlling the delivery of neurostimulation therapy”.
In response, these emphasized features of delivering neurostimulation therapy, hardware to enable machine-to-machine interaction, delivering and controlling the delivery of neurostimulation therapy continue to be regarded as insignificant extra-solution activity. As stated in the July 28, 2025 Office action, Applicant has not presented the neurostimulation therapy as a step to integrate the results of the judicial exception into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application”. As recited, the neurostimulation therapy only has a nominal relationship to the judicial except and are therefore regarded as insignificant extra-solution activity or field of use. See MPEP 2106.04(d)(2). The recited hardware components (processor, one or more electrodes) to enable machine-to-machine interaction and to deliver or control delivery of therapy are recited at a high level of generality and do not amount to significantly more than the judicial exception because it is simply appending well-understood, routine and conventional activities previously known in the industry, requiring no more than a generic computer (processor) to perform generic computer functions that are well understood, routine and conventional activities previously known in the industry (Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)). Using electrodes is well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality). Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011). Machine-to-machine interaction is extra-solution activity or field of use because it only has a nominal relationship to the judicial exception under Prong Two. See MPEP 2016.05(g). It is regarded as language specifying that the abstract idea is to be implemented using a “communication medium” because this limitation merely limits the use of the exception to a particular technological environment, Intellectual Ventures I v. Capital One Bank, 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1640 (Fed. Cir. 2015).
35 U.S.C. 112
Applicant emphasizes (p. 7) the exchanging of information with a programming device having a display and causing the programming device to render the graphical display and update the graphical display in the manner required for claim 53. The history of the application indicates claim 53 was introduced March 6, 2024 and not an original claim. Original claim 42, filed December 18, 2023 which is the closest support to claim 53 recites,
Claim 42:
A method, comprising:
generating a graphical display comprising an x-axis associated with time and a y-axis associated with a measure of a neurostimulation therapy;
updating the graphical display as the neurostimulation therapy is applied to a patient;
indicating on the graphical display a posture state of the patient, wherein a posture state indication is provided on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing the neurostimulation therapy being delivered to the patient; and
recording the posture state indication in a posture state history file.
The recited limitations of original claim 42, specifically of “indicating on the graphical display a posture state of the patient, wherein a posture state indication is provided on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing the neurostimulation therapy being delivered to the patient” is not disclosed in the originally filed specification or claims, and is only found in claim 42. However, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Original claim 42 however, does not support the limitation of exchanging of information with a programming device having a display and causing the programming device to render the graphical display and update the graphical display in the manner required for claim 53.
Figure 7A-C is the closest corresponding figure for claim 42, where a graphical display comprising an x-axis associated with time and a y-axis associated with a measure of neurostimulation therapy is provided. Corresponding paragraphs [0126-0144] of the published application discuss Figures 7A-C but do not provide adequate written description for the exchanging of information with a programming device having a display and causing the programming device to render the graphical display and update the graphical display in the manner as required by claim 53. Therefore a 35 U.S.C. 112 rejection applies for claim 53 and its dependent claims.
35 U.S.C. 103
Graupe et al. (US 5,081,989) has been identified as pertinent prior art and is presented below in a 35 U.S.C. 103 rejection.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: original claims 42-50 filed December 18, 2023 recite subject matter not disclosed in the remainder of the specification. The applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Claim Objections
Claim 64 is objected to because of the following informalities: lines 12-13 recite, “continue to deliver the neurostimulation therapy to the patient based with the one or more electrodes” and should instead state, “continue to deliver the neurostimulation therapy to the patient . 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 53-63 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.
Claim 53 recites,
memory coupled with the processor, wherein the memory includes instructions that, when executed by the processor, enable the processor to:…
exchange information with a programming device having a display, wherein the information exchanged with the programming device causes the programming device to:
render a graphical display comprising a first axis associated with time and a second axis associated with a measure of the neurostimulation therapy;
re-render the graphical display as the neurostimulation therapy continues to be delivered to the patient; and
render an indication on the graphical display of the posture state of the patient, wherein a posture state indication is rendered on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing the neurostimulation therapy being delivered to the patient…
The history of the application indicates claim 53 was introduced March 6, 2024 and not an original claim. There is no support in the originally filed specification and originally filed claims for a processor to exchange information with a programming device having a display, wherein the information exchanged with the programming device causes the programming device to perform the recited steps (see above Response to Arguments).
Claims 54-63 are rejected to for being dependent on claim 53.
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 42-71 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-14 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
The analysis of independent claim 42 is as follows:
Step 1: Claim 42 is drawn to a process.
Step 2A – Prong 1: Claim 42 is drawn to an abstract idea in the form of a process that, under its broadest reasonable interpretation, covers performance of the limitations with pen and paper. In particular, claim 42 recites limitations:
programming a device to deliver a neurostimulation therapy to a patient
delivering the neurostimulation therapy to the patient with the device based, at least in part, on a posture state of the patient;
generating a graphical display comprising a first axis associated with time and a second axis associated with a measure of a neurostimulation therapy as programmed and delivered to the patient
continuing to deliver the neurostimulation therapy to the patient with the device based, at least in part, on the posture state of the patient
updating, the graphical display as the neurostimulation therapy continues to be delivered to a patient
rendering an indication on the graphical display of the posture of the patient, wherein a posture state indication is rendered on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing neurostimulation therapy being delivered to the patient
recording the posture state indication in a posture state history file
The bolded limitations are drawn to a judicial exception because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being performed with pen and paper. For example, a skilled artisan is capable of using the mental process of observation to monitor the application of neurostimulation therapy and posture state of a patient, and using the monitoring to generate and update a graph by rendering indications or annotations created on paper with a pen.
Step 2A – Prong Two: The underlined limitations are beyond the judicial exception because they do not integrate the exception into a practical application of the exception. Programming the device to deliver neurostimulation therapy, delivering neurostimulation therapy and continuing to deliver neurostimulation therapy only have a nominal relationship to the judicial exception and are regarded as merely extra-solution activity or field of use. See MPEP 2106.04(d)(2). Unlike Classen Immunotherapies Inc. v. Biogen IDEC (659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011)), the amended independent claims do not recite meaningful limitations that integrate the results of the analysis into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application”. They are further regarded as an extra-solution activity as a necessary precursor for monitoring and updating the graphical display. Applicant has not presented the neurostimulation therapy as a step to integrate the results of the judicial exception into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application”. Recording the posture state indication in a posture state history file is a matter of storing information and regarded as a generic computer function, regarded as insignificant extra-solution activity and does not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 42 does not recite additional elements that amount to significantly more than the judicial exception itself. Nothing in the claim amounts to significantly more than the judicial exception because the recited limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48. Recording posture state indication in a posture state history file are steps that the courts have recognized as well-understood, routine, conventional activity, claimed in a merely generic manner or as an insignificant extra-solution activity. Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. It is considered mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 and regarded as electronic record keeping Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755. Programming a device to deliver a neurostimulation therapy to a patient and delivering neurostimulation is well-understood, routine and conventional activity as is shown by Andrews (US 2002/0055779) “a microprocessor programmed with any of several conventional control techniques for stimulation of nerves” ([0045]) and when they are claimed in a merely generic manner (e.g., at a high level of generality). Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011).
In view of the above, the additional elements do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the element taken individually. There is no indication that the element improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome.
Claims 43-52 depend on claim 42 and recite the same abstract idea as the independent claim. These claims only contain recitations that either further limit the abstract idea, or recite additional elements beyond the judicial exception (i.e., electrodes, sensors, implantable medical device, accelerometer) that are recited at a high level of generality to perform an abstract idea (MPEP 2106.04(d) and 2106.05(f)) and do not integrate the abstract idea into a practical application because it does not impose any meaningful limitations on practicing the abstract idea. These additional elements are well-understood, routine and conventional activities previously known in the industry (Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)). An implantable medical device is regarded as a well-understood, routine and conventional element, as evidenced by and not limited to Burnes et al. (US 2014/0031787), Rogers et al. (US 2012/0157804), Mann et al. (US 5,833,623). Sensors and accelerometers are regarded as mere data gathering that is well known in the art to establish the inputs of analysis and does not add a meaningful limitation (TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48). Using electrodes to deliver neurostimulation therapy is well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality). Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011).
The analysis of independent claim 53 is as follows:
Step 1: Claim 53 is drawn to an apparatus.
Step 2A – Prong 1: Claim 53 is drawn to an abstract idea in the form of an apparatus that, under its broadest reasonable interpretation, covers performance of the limitations with pen and paper. In particular, claim 53 recites limitations:
a processor
memory coupled with the processor, wherein the memory includes instructions that, when executed by the processor, enable the processor to:
control delivery of a neurostimulation therapy to a patient based, at least in part, on a posture state of the patient;
exchange information with a programming device having a display, wherein the information exchanged with the programming device causes the programming device to:
render a graphical display comprising a first axis associated with time and a second axis associated with a measure of neurostimulation therapy
re-render, the graphical display as the neurostimulation therapy continues to be delivered to the patient;
render an indication on the graphical display of the posture state of the patient, wherein a posture state indication is rendered on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing the neurostimulation therapy being delivered to the patient; and
record the posture state indication in a posture state history file.
The bolded limitations are drawn to a judicial exception because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being performed with pen and paper. For example, a skilled artisan is capable of using the mental process of observation to monitor the application of neurostimulation therapy and posture state of a patient, and using the monitoring to render/generate and update a graph by rendering indications or annotations created on paper with a pen.
Step 2A – Prong Two: The underlined limitations are beyond the judicial exception because they do not integrate the exception into a practical application of the exception. The processor and memory are recited at a high level of generality to perform an abstract idea (MPEP 2106.04(d) and 2106.05(f)). Delivering neurostimulation therapy and continuing to deliver neurostimulation therapy only have a nominal relationship to the judicial exception and are regarded as merely extra-solution activity or field of use. See MPEP 2106.04(d)(2). Unlike Classen Immunotherapies Inc. v. Biogen IDEC (659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011)), the amended independent claims do not recite meaningful limitations that integrate the results of the analysis into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application”. They are further regarded as an extra-solution activity as a necessary precursor for monitoring and updating the graphical display. Applicant has not presented the neurostimulation therapy as a step to integrate the results of the judicial exception into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application”. Exchanging information with a programming device is extra-solution activity or field of use because it only has a nominal relationship to the judicial exception under Prong Two. See MPEP 2016.05(g). It is regarded as language specifying that the abstract idea is to be implemented using a “communication medium” because this limitation merely limits the use of the exception to a particular technological environment, Intellectual Ventures I v. Capital One Bank, 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1640 (Fed. Cir. 2015). Recording the posture state indication in a posture state history file is a matter of storing information and regarded as a generic computer function, regarded as insignificant extra-solution activity and does not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 53 does not recite additional elements that amount to significantly more than the judicial exception itself. Nothing in the claim amounts to significantly more than the judicial exception because the recited limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48. Recording posture state indication in a posture state history file are steps that the courts have recognized as well-understood, routine, conventional activity, claimed in a merely generic manner or as an insignificant extra-solution activity. Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. It is considered mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 and regarded as electronic record keeping Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755. Delivering neurostimulation is well-understood, routine and conventional activity as is shown by Andrews (US 2002/0055779) “a microprocessor programmed with any of several conventional control techniques for stimulation of nerves” ([0045]) and when they are claimed in a merely generic manner (e.g., at a high level of generality). Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011). The processor and memory do not amount to significantly more than the judicial exception because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)). Exchanging information with a programming device does not add significantly more. It is regarded as language specifying that the abstract idea is to be implemented using a “communication medium” because this limitation merely limits the use of the exception to a particular technological environment, Intellectual Ventures I v. Capital One Bank, 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1640 (Fed. Cir. 2015). It is further regarded as well-understood, routine, conventional activity in the life science arts (col. 2, lines 62-65) as shown in Silvian (US 5,769,876).
In view of the above, the additional elements do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the element taken individually. There is no indication that the element improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 54-63 depend on claim 53 and recite the same abstract idea as the independent claim. These claims only contain recitations that either further limit the abstract idea, or recite additional elements beyond the judicial exception (i.e., electrodes, sensors, implantable medical device, accelerometer, lead, electrodes) that are recited at a high level of generality to perform an abstract idea (MPEP 2106.04(d) and 2106.05(f)) and do not integrate the abstract idea into a practical application because it does not impose any meaningful limitations on practicing the abstract idea. These additional elements are well-understood, routine and conventional activities previously known in the industry (Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)). An implantable medical device is regarded as a well-understood, routine and conventional element, as evidenced by and not limited to Burnes et al. (US 2014/0031787), Rogers et al. (US 2012/0157804), Mann et al. (US 5,833,623). Sensors on a lead and accelerometers are regarded as mere data gathering that is well known in the art to establish the inputs of analysis and does not add a meaningful limitation (TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48). Using electrodes to deliver neurostimulation therapy is well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality). Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011).
The analysis of claim 64 is as follows:
Step 1: Claim 64 is drawn to an apparatus.
Step 2A – Prong 1: Claim 64 is drawn to an abstract idea in the form of an apparatus that, under its broadest reasonable interpretation, covers performance of the limitations with pen and paper. In particular, claim 64 recites limitations:
one or more electrodes
a processor coupled with the one or more electrodes
memory coupled with the processor, wherein the memory includes instructions that, when executed by the processor, enable the processor to:
control delivery of a neurostimulation therapy by the one or more electrodes based, at least in part, on a posture state of a patient
generate a graphical display comprising a first axis associated with time and a second axis associated with a measure of the neurostimulation therapy
update the graphical display as the neurostimulation therapy is delivered to a patient via the one or more electrodes as programmed and delivered to the patient
continue to deliver the neurostimulation therapy to the patient based with the one or more electrodes based, at least in part, on the posture state of the patient
render an indication on the graphical display of the posture state of the patient, wherein a posture state indication is rendered on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing the neurostimulation therapy being delivered to the patient; and
record the posture state indication in a posture state history file
The bolded limitations are drawn to a judicial exception because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being performed with pen and paper. For example, a skilled artisan is capable of using the mental process of observation to monitor the application of neurostimulation therapy and posture state of a patient, and using the monitoring to generate and update a graph by rendering indications or annotations created on paper with a pen.
Step 2A – Prong Two: The underlined limitations are beyond the judicial exception because they do not integrate the exception into a practical application of the exception. The one or more electrodes, processor and memory are recited at a high level of generality to perform an abstract idea (MPEP 2106.04(d) and 2106.05(f)). Delivering neurostimulation therapy and continuing to deliver neurostimulation therapy only have a nominal relationship to the judicial exception and are regarded as merely extra-solution activity or field of use. See MPEP 2106.04(d)(2). Unlike Classen Immunotherapies Inc. v. Biogen IDEC (659 F.3d 1057, 100 USPQ2d 1492 (Fed. Cir. 2011)), the amended independent claims do not recite meaningful limitations that integrate the results of the analysis into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application”. They are further regarded as an extra-solution activity as a necessary precursor for monitoring and updating the graphical display. Applicant has not presented the neurostimulation therapy as a step to integrate the results of the judicial exception into a specific and tangible method that resulted in the method “moving from abstract scientific principle to specific application”. Recording the posture state indication in a posture state history file is a matter of storing information and regarded as a generic computer function, regarded as insignificant extra-solution activity and does not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 64 does not recite additional elements that amount to significantly more than the judicial exception itself. Nothing in the claim amounts to significantly more than the judicial exception because the recited limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48. Recording posture state indication in a posture state history file are steps that the courts have recognized as well-understood, routine, conventional activity, claimed in a merely generic manner or as an insignificant extra-solution activity. Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93. It is considered mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 and regarded as electronic record keeping Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014); Ultramercial, 772 F.3d at 716, 112 USPQ2d at 1755. Delivering neurostimulation is well-understood, routine and conventional activity as is shown by Andrews (US 2002/0055779) “a microprocessor programmed with any of several conventional control techniques for stimulation of nerves” ([0045]) and when they are claimed in a merely generic manner (e.g., at a high level of generality). Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011). The processor and memory do not amount to significantly more than the judicial exception because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)). Using one or more electrodes to deliver neurostimulation therapy is well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality). Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011).
In view of the above, the additional elements do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the element taken individually. There is no indication that the element improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 65-71 depend on claim 64 and recite the same abstract idea as the independent claim. These claims only contain recitations that either further limit the abstract idea, or recite additional elements beyond the judicial exception (i.e., sensors, implantable medical device, accelerometer, lead, electrodes) that are recited at a high level of generality to perform an abstract idea (MPEP 2106.04(d) and 2106.05(f)) and do not integrate the abstract idea into a practical application because it does not impose any meaningful limitations on practicing the abstract idea. These additional elements are well-understood, routine and conventional activities previously known in the industry (Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)). An implantable medical device is regarded as a well-understood, routine and conventional element, as evidenced by and not limited to Burnes et al. (US 2014/0031787), Rogers et al. (US 2012/0157804), Mann et al. (US 5,833,623). Sensors on a lead and accelerometers are regarded as mere data gathering that is well known in the art to establish the inputs of analysis and does not add a meaningful limitation (TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48). Using electrodes to deliver neurostimulation therapy is well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality). Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 42-43, 45, 47, 50-52, 64-65, 67, 69 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Graupe et al. (US 5,081,989) in view of Suzuki et al. (US 2003/0204132).
Regarding claims 42, 51-52, 64, Graupe et al. discloses a method and system comprising: one or more electrodes 102 to deliver neurostimulation therapy to a patient (fig. 1); a processor 104 coupled with the one or more electrodes; and a memory (claim 1) coupled with the processor comprising instructions for executing by the processor; programming a device to deliver a neurostimulation therapy to a patient (col. 8, lines 25-48); control delivery of a neurostimulation therapy to the patient based, at least in part, on a posture state of the patient (“sit-down command from the standing position” col. 8, lines 65-66); generate a graphical display comprising a first axis (x-axis) associated with a time and second axis (y-axis) associated with a measure (“stimulus level”) of the neurostimulation therapy (fig. 7a-b); update the graphical display as the neurostimulation therapy is delivered to the patient via the one or more electrodes as programmed and delivered to the patient (fig. 7a-b; col. 8, line 60 to col. 9, line 4; updating by displaying the stimulus levels at more than one instantaneous moment); continue to deliver the neurostimulation therapy to the patient based with the one or more electrodes based, at least in part, on the posture state of the patient (fig. 7a-b); render an indication on the graphical display of the posture state of the patient (“Note that at the time indicated, T.sub.SD indicating the time of the sit-down command from the standing position as received and recognized by the computer, that the stimulus levels to both the right and left quadriceps muscles are increased, by between ten to twenty percent preferably, for a short time duration (on the order of seconds) prior to decreasing the stimulus level by ramping the level of the stimulus signals to the right and left quadriceps to the zero level of full sitting” col. 8, line 60 to col. 9, line 4), wherein the posture state indication is rendered on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing the neurostimulation therapy being delivered to the patient (fig. 7a-b).
Graupe et al. does not expressly disclose recording the posture state indication in a posture state history file. Suzuki et al. teaches determining posture state via an acceleration sensor 1036 ([0070]) and recording the posture state in a history file 1011 along with measurement times ([0098]), this posture state also provided on a graphical display, along with other provided data, to indicate a point in time where the posture state of the patient has changed ([0148], fig. 8a, 9a). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Graupe et al. to record and store the posture state indication in a posture state history file as taught by Suzuki et al. in order to allow for the recall of saved information when desired.
Regarding claim 43, 65, Graupe et al. discloses the neurostimulation therapy comprises an electrical stimulation and wherein the measure comprises an amplitude of the neurostimulation therapy (col. 6, lines 61-65).
Regarding claims 45, 47, 50, 67, 69, Graupe et al. does not expressly disclose the posture state indication is obtained by one or more sensors and determined according to a defined posture vector. However Graupe et al. does state control inputs for stimulation can be automatically generated from feedback signals (i.e. closed loop) derived from the patient such as from sensing electrodes (col. 2, lines 37-40). Suzuki et al. teaches it is known in the art to determine posture state via an acceleration sensor 1036 ([0070]) using posture vectors (“three-dimensional acceleration sensor” [0073]). It would have been obvious to one of ordinary skill in the art at the time the inventio was made to modify Graupe et al. to use an acceleration sensor as taught by Suzuki et al. to sense posture vectors to provide automatic control inputs for stimulation as suggested by Graupe et al., as Suzuki et al. teaches these are known devices for the purposes of determining posture states, such a modification being reasonably predictable and would not alter the overall operation of the device.
Claims 48 and 70 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Graupe et al. (US 5,081,989) in view of Suzuki et al. (US 2003/0204132) and further in view of Singhal et al. (US 2005/0060001).
Regarding claims 48 and 70, Graupe et al. does not expressly disclose wherein the information comprises a patient’s response to the neurostimulation therapy in the posture state based on received data. Singhal et al. teaches determining information of a patient’s posture state over time (“activity level of patient 14” [0069]; fig. 8) based on received data 42 ([0043]), this information comprising a patient’s response to neurostimulation therapy ([0068-0069]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Graupe et al. to include information comprising a patient’s response to the neurostimulation therapy in the posture state based on received data such as continual posture state data (fig. 8) as taught by Singhal et al. in order to better monitor and track the patient’s posture as neurostimulation therapy is being delivered, and to ensure the detected posture is appropriate for the therapy being currently delivered.
Claims 53-54, 56, 58-59, 61-63 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Graupe et al. (US 5,081,989) in view of Suzuki et al. (US 2003/0204132) and further in view of Singhal et al. (US 2005/0060001).
Regarding claims 53, 62-63, Graupe et al. discloses a method and system comprising: a processor 104; a memory (claim 1) coupled with the processor comprising instructions for executing by the processor; programming a device to deliver a neurostimulation therapy to a patient (col. 8, lines 25-48); control delivery of a neurostimulation therapy to the patient based, at least in part, on a posture state of the patient (“sit-down command from the standing position” col. 8, lines 65-66); render a graphical display comprising a first axis (x-axis) associated with a time and second axis (y-axis) associated with a measure (“stimulus level”) of the neurostimulation therapy (fig. 7a-b); re-render the graphical display as the neurostimulation therapy is delivered to the patient (fig. 7a-b; col. 8, line 60 to col. 9, line 4; re-rendering by displaying the stimulus levels at more than one instantaneous moment); render an indication on the graphical display of the posture state of the patient (“Note that at the time indicated, T.sub.SD indicating the time of the sit-down command from the standing position as received and recognized by the computer, that the stimulus levels to both the right and left quadriceps muscles are increased, by between ten to twenty percent preferably, for a short time duration (on the order of seconds) prior to decreasing the stimulus level by ramping the level of the stimulus signals to the right and left quadriceps to the zero level of full sitting” col. 8, line 60 to col. 9, line 4), wherein the posture state indication is provided on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing the neurostimulation therapy being delivered to the patient (fig. 7a-b).
Graupe et al. does not expressly disclose recording the posture state indication in a posture state history file. Suzuki et al. teaches determining posture state via an acceleration sensor 1036 ([0070]) and recording the posture state in a history file 1011 along with measurement times ([0098]), this posture state also provided on a graphical display, along with other provided data, to indicate a point in time where the posture state of the patient has changed ([0148], fig. 8a, 9a). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Graupe et al. to record and store the posture state indication in a posture state history file as taught by Suzuki et al. in order to allow for the recall of saved information when desired.
Graupe et al. does not expressly disclose exchange information with a programming device having a display, wherein the information exchanged with the programming device causes the programming device to perform the above described rendering steps. Singhal et al. teaches it is known in the art to transmit data from one device to a clinician programmer and presented to the clinician via display ([0068]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Graupe et al. to incorporate a programming device such as a clinician programmer for exchanging information with the device as taught by Singhal et al., wherein the information exchanged causes the programming device to perform the claimed rendering on a display, in order to better communicate the information to the clinician through the clinician interface.
Regarding claim 54, Graupe et al. discloses the neurostimulation therapy comprises an electrical stimulation and wherein the measure comprises an amplitude of the neurostimulation therapy (col. 6, lines 61-65).
Regarding claims 56, 58, 61, Graupe et al. does not expressly disclose the posture state indication is obtained by one or more sensors and determined according to a defined posture vector. However Graupe et al. does state control inputs for stimulation can be automatically generated from feedback signals (i.e. closed loop) derived from the patient such as from sensing electrodes (col. 2, lines 37-40). Suzuki et al. teaches it is known in the art to determine posture state via an acceleration sensor 1036 ([0070]) using posture vectors (“three-dimensional acceleration sensor” [0073]). It would have been obvious to one of ordinary skill in the art at the time the inventio was made to modify Graupe et al. to use an acceleration sensor as taught by Suzuki et al. to sense posture vectors to provide automatic control inputs for stimulation as suggested by Graupe et al., as Suzuki et al. teaches these are known devices for the purposes of determining posture states, such a modification being reasonably predictable and would not alter the overall operation of the device.
Regarding claim 59, Graupe et al. does not expressly disclose wherein the information comprises a patient’s response to the neurostimulation therapy in the posture state based on received data. Singhal et al. teaches determining information of a patient’s posture state over time (“activity level of patient 14” [0069]; fig. 8) based on received data 42 ([0043]), this information comprising a patient’s response to neurostimulation therapy ([0068-0069]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Graupe et al. to include information comprising a patient’s response to the neurostimulation therapy in the posture state based on received data such as continual posture state data (fig. 8) as taught by Singhal et al. in order to better monitor and track the patient’s posture as neurostimulation therapy is being delivered, and to ensure the detected posture is appropriate for the therapy being currently delivered.
Claim 42-47, 49-52, 64-69, 71 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bourget et al. (US 2007/0150026) in view of Graupe et al. (US 5,081,989) and Suzuki et al. (US 2003/0204132).
Regarding claim 42, 44, 49, 51-52, 64, 66, Bourget et al. discloses a method and system comprising: one or more electrodes 30a-e (fig. 2) positioned to deliver neurostimulation therapy (“spinal cord stimulation” [0028]) proximal to a spine of a patient (fig. 1); a processor 34; a memory 36 coupled with the processor comprising instructions for executing by the processor; programming a device to deliver a neurostimulation therapy to a patient ([0026]); causing the device to deliver the neurostimulation therapy to the patient based, at least in part, on a posture state of the patient 154, 156 (fig. 10) and continuing to deliver the neurostimulation therapy to the patient with the device based, at least in part, on the posture state of the patient (fig. 10).
Bourget et al. does not expressly disclose generating a graphical display comprising a first axis associated with time and a second axis associated with a measure of the neurostimulation therapy as programmed and delivered to the patient; updating the graphical display as the neurostimulation therapy continues to be delivered to the patient; rendering an indication on the graphical display of the posture state of the patient, wherein a posture state indication is rendered on the graphical display to indicate a point in time when the posture state of the patient has changed with information describing the neurostimulation therapy being delivered to the patient. Graupe et al. teaches generate a graphical display comprising a first axis (x-axis) associated with a time and second axis (y-axis) associated with a measure (“stimulus level”) of the neurostimulation therapy (fig. 7a-b); update the graphical display as the neurostimulation therapy is delivered to the patient via the one or more electrodes as programmed and delivered to the patient (fig. 7a-b; col. 8, line 60 to col. 9, line 4; updating by displaying the stimulus levels at more than one instantaneous moment); render an indication on the graphical display of the posture state of the patient (“Note that at the time indicated, T.sub.SD indicating the time of the sit-down command from the standing position as received and recognized by the computer, that the stimulus levels to both the right and left quadriceps muscles are increased, by between ten to twenty percent preferably, for a short time duration (on the order of seconds) prior to decreasing the stimulus level by ramping the level of the stimulus signals to the right and left quadriceps to the zero level of full sitting” col. 8, line 60 to col. 9, line 4), wherein the posture state indication is rendered on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing the neurostimulation therapy being delivered to the patient (fig. 7a-b). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Bourget et al. to include the graphical display comprising all the information about the neurostimulation and the posture state of the patient as taught by Graupe et al. in order to provide a visual presentation of the delivered stimulation therapy based at least in part on the posture state of the patient to better assist the user in reviewing the therapy.
Bourget et al. does not expressly disclose recording the posture state indication in a posture state history file. Suzuki et al. teaches determining posture state via an acceleration sensor 1036 ([0070]) and recording the posture state in a history file 1011 along with measurement times ([0098]), this posture state also provided on a graphical display, along with other provided data, to indicate a point in time where the posture state of the patient has changed ([0148], fig. 8a, 9a). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Bourget et al. to record and store the posture state indication in a posture state history file as taught by Suzuki et al. in order to allow for the recall of saved information when desired.
Regarding claim 43 and 65, Bourget et al. in view of Graupe et al. discloses the neurostimulation therapy comprises an electrical stimulation and wherein the measure comprises an amplitude of the neurostimulation therapy (col. 6, lines 61-65).
Regarding claim 45-47, 67-69, Bourget et al. discloses the posture state indication is obtained by one or more sensors (“accelerometer”) and determined according to a defined posture vector ([0078]), wherein the one or more sensors is associated with a lead connected to an implantable medical device ([0057]).
Regarding claims 50 and 71, Bourget et al. discloses wherein the neurostimulation therapy is spinal cord stimulation therapy ([0028]) and wherein the posture state indication is used to provide subsequent closed loop neurostimulation therapy (“As a patient changes posture, the stimulation may need to be adjusted in order to maintain efficacy.” [0026]).
Claims 48, 70 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bourget et al. (US 2007/0150026) in view of Graupe et al. (US 5,081,989) and Suzuki et al. (US 2003/0204132) and further in view of Singhal et al. (US 2005/0060001).
Regarding claims 48 and 70, Bourget et al. does not expressly disclose wherein the information comprises a patient’s response to the neurostimulation therapy in the posture state based on received data. Singhal et al. teaches determining information of a patient’s posture state over time (“activity level of patient 14” [0069]; fig. 8) based on received data 42 ([0043]), this information comprising a patient’s response to neurostimulation therapy ([0068-0069]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Bourget et al. to include information comprising a patient’s response to the neurostimulation therapy in the posture state based on received data such as continual posture state data (fig. 8) as taught by Singhal et al. in order to better monitor and track the patient’s posture as neurostimulation therapy is being delivered, and to ensure the detected posture is appropriate for the therapy being currently delivered.
Claims 53-63, is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bourget et al. (US 2007/0150026) in view of Graupe et al. (US 5,081,989), Suzuki et al. (US 2003/0204132) and Singhal et al. (US 2005/0060001).
Regarding claim 53, 55, 60, 62-63, Bourget et al. discloses a device comprising: a processor 34; a memory 36 coupled with the processor, wherein the memory includes instructions that, when executed by the processor, enable the processor to: control delivery of a neurostimulation therapy to the patient based, at least in part, on a posture state of the patient 154, 156 (fig. 10) and continuing to deliver the neurostimulation therapy to the patient with the device based, at least in part, on the posture state of the patient (fig. 10).
Bourget et al. does not expressly disclose render a graphical display comprising a first axis associated with time and a second axis associated with a measure of the neurostimulation therapy; re-render the graphical display as the neurostimulation therapy continues to be delivered to the patient; render an indication on the graphical display of the posture state of the patient, wherein a posture state indication is rendered on the graphical display to indicate a point in time when the posture state of the patient has changed with information describing the neurostimulation therapy being delivered to the patient. Graupe et al. teaches render a graphical display comprising a first axis (x-axis) associated with a time and second axis (y-axis) associated with a measure (“stimulus level”) of the neurostimulation therapy (fig. 7a-b); re-render the graphical display as the neurostimulation therapy is delivered to the patient (fig. 7a-b; col. 8, line 60 to col. 9, line 4; re-rendering by displaying the stimulus levels at more than one instantaneous moment); render an indication on the graphical display of the posture state of the patient (“Note that at the time indicated, T.sub.SD indicating the time of the sit-down command from the standing position as received and recognized by the computer, that the stimulus levels to both the right and left quadriceps muscles are increased, by between ten to twenty percent preferably, for a short time duration (on the order of seconds) prior to decreasing the stimulus level by ramping the level of the stimulus signals to the right and left quadriceps to the zero level of full sitting” col. 8, line 60 to col. 9, line 4), wherein the posture state indication is provided on the graphical display to indicate a point in time where the posture state of the patient has changed along with information describing the neurostimulation therapy being delivered to the patient (fig. 7a-b). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Bourget et al. to include the graphical display comprising all the information about the neurostimulation and the posture state of the patient as taught by Graupe et al. in order to provide a visual presentation of the delivered stimulation therapy based at least in part on the posture state of the patient to better assist the user in reviewing the therapy.
Bourget et al. does not expressly disclose recording the posture state indication in a posture state history file. Suzuki et al. teaches determining posture state via an acceleration sensor 1036 ([0070]) and recording the posture state in a history file 1011 along with measurement times ([0098]), this posture state also provided on a graphical display, along with other provided data, to indicate a point in time where the posture state of the patient has changed ([0148], fig. 8a, 9a). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Bourget et al. to record and store the posture state indication in a posture state history file as taught by Suzuki et al. in order to allow for the recall of saved information when desired.
Bourget et al. does not expressly disclose exchange information with a programming device having a display, wherein the information exchanged with the programming device causes the programming device to perform the above described rendering steps. Singhal et al. teaches it is known in the art to transmit data from one device to a clinician programmer and presented to the clinician via display ([0068]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Bourget et al. to incorporate a programming device such as a clinician programmer for exchanging information with the device as taught by Singhal et al., wherein the information exchanged causes the programming device to perform the claimed rendering on a display, in order to better communicate the information to the clinician through the clinician interface.
Regarding claim 54, Bourget et al. in view of Graupe et al. discloses the neurostimulation therapy comprises an electrical stimulation and wherein the measure comprises an amplitude of the neurostimulation therapy (col. 6, lines 61-65).
Regarding claim 56-58, Bourget et al. discloses the posture state indication is obtained by one or more sensors (“accelerometer”) and determined according to a defined posture vector ([0078]), wherein the one or more sensors is associated with a lead connected to an implantable medical device ([0057]).
Regarding claims 59, Bourget et al. does not expressly disclose wherein the information comprises a patient’s response to the neurostimulation therapy in the posture state based on received data. Singhal et al. teaches determining information of a patient’s posture state over time (“activity level of patient 14” [0069]; fig. 8) based on received data 42 ([0043]), this information comprising a patient’s response to neurostimulation therapy ([0068-0069]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Bourget et al. to include information comprising a patient’s response to the neurostimulation therapy in the posture state based on received data such as continual posture state data (fig. 8) as taught by Singhal et al. in order to better monitor and track the patient’s posture as neurostimulation therapy is being delivered, and to ensure the detected posture is appropriate for the therapy being currently delivered.
Regarding claim 61, Bourget et al. discloses wherein the posture state indication is used to provide subsequent closed loop neurostimulation therapy (“As a patient changes posture, the stimulation may need to be adjusted in order to maintain efficacy.” [0026]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796