The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This office action is in response to Applicant’s submission filed on 23 February 2024. THIS ACTION IS NON-FINAL.
Status of Claims
Claims 1-20 are pending.
Claims 1-20 are rejected under 35 U.S.C. 112(b) as indefinite.
Claims 9 and 19 are rejected under 35 U.S.C. 112(d) for failing to further limit the subject matter of the claim upon which it depends.
Claim 1-20 are rejected under 35 U.S.C. 101 for being directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
There is no art rejection for claims 1-20.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
A claim is indefinite if, when read in light of the specification, it fails to inform, with reasonable certainty, those skilled in the art about the scope of the invention. Nautilus, Inc. v. Biosig Instruments, Inc., 110 USPQ.2d 1688, U.S. Supreme Court (2014).
Claims 1-20 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 pre-AIA the applicant regards as the invention.
Regarding claim 1 / 11,
(a)The claim recites “the neurostimulation treatment” lack of antecedent basis, the claim is therefor indefinite. For the purpose of applying prior art, this limitation is construed to be “the particular neurostimulation treatment” (as “a particular neurostimulation treatment” appeared before). The same term appeared in independent claims is treated the same way.
(b) The claim recites, "wherein the training operations on the programming selection model enable an updated set of parameters for the neurostimulation device." It is unclear what structure, act, or output is required to satisfy this limitation. The claim does not recite that the training operations generate, produce, output, or apply an updated set of parameters — only that they "enable" one. As written, this term is purely functional/aspirational and does not distinctly claim whether:
(i) the claimed device/method must affirmatively produce the updated parameter set as an output of the recited "training operations," or
(ii) the limitation is satisfied merely by the programming selection model possessing an inherent, unexercised capability to eventually produce such parameters, with no further claimed step required.
Under MPEP § 2173.05(g), a claim that recites a function without providing a clear metes-and-bounds indication of what structure or step is required to achieve that function is indefinite. Because the claim's scope turns entirely on whether "enable" requires an affirmative output or is satisfied by mere latent capability, one of ordinary skill cannot determine with reasonable certainty the scope of the claimed invention.
Suggested resolution: Amend "enable an updated set of parameters" to a step that is actually performed, e.g., "wherein the training operations on the programming selection model generate an updated set of parameters for the neurostimulation device" (consistent with the more definite language already used in claim 10: "the closed-loop programming causes a change to neurostimulation programming settings").
Regarding claims 2-10 / 12-20, which depend on above rejected claim 1 / 11, are rejected for the same reason.
Regarding claim 3 / 13, the claim recites, in relevant part, "one or more values that correspond to information missing from the training data required to perform the training operations." This phrase is grammatically ambiguous and admits of at least two reasonable readings:
(a) "information [that is] missing from [the training data that is required to perform the training operations]" (i.e., a gap-identification metric relative to a required data set), or
(b) "information [that is both] missing from the training data [and separately characterized as] required to perform the training operations" (i.e., two distinct properties predicated of the same information).
Because the claim does not make clear which parsing is intended, the metes and bounds of "one or more values" is indefinite. Claim 13 is rejected for the same reason as the mirroring method claim.
Suggested resolution: Amend to "one or more values that correspond to a difference between the training data required to perform the training operations and the training data available," or similar unambiguous phrasing consistent with ¶ [0107]–[0108] of the specification (input "gaps").
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9 and 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The claim recites a step of "determine usage of a particular neurostimulation treatment." Claim 9 recites "determine usage of multiple neurostimulation programs." Rather than adding a further restriction to the "determine usage of a particular neurostimulation treatment" limitation of claim 1 (e.g., by narrowing what "usage" means, or by adding an additional, separate step), claim 9 appears to substitute a different claimed act — determining usage of a plurality of "programs" — for the base claim's "a particular neurostimulation treatment" limitation. Because it is unclear (per Rejection 2, above) whether "neurostimulation programs" is a narrower species of, the same as, or an entirely different concept from "a particular neurostimulation treatment," it cannot presently be confirmed that claim 9 incorporates by reference and further limits every element of claim 1, as required by 35 U.S.C. § 112(d) and MPEP § 608.01(n).
Suggested resolution: Amend to clarify the dependency, e.g., "wherein the neurostimulation treatment comprises multiple neurostimulation programs, and wherein the instructions further cause the one or more processors to: determine usage of each of the multiple neurostimulation programs of the neurostimulation treatment..."
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.
Judicial Exception
Claims 1-20 of the claimed invention are directed to a judicial exception, an abstract idea, without significantly more.
Regarding claims 1-20,
(Independent Claims) With regards to claim 1 / 11,
Step 1: The claim recites a machine / process, which falls into one of the statutory categories.
Step 2A – Prong 1: the claim, in part, recites:
(a)“…determine usage of a particular neurostimulation treatment, wherein the neurostimulation treatment is associated with a set of parameters used by a neurostimulation device to deliver neurostimulation to a human patient…” (mental process and/or math concept), as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting generic computer elements, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the language about generic computer elements, “determine …”, in the limitation citied above encompasses analyzing parameters to determine usage of tools for patient treatment, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas;
(b) “…evaluate patient feedback data associated with the usage of the neurostimulation treatment, wherein the patient feedback data is obtained from the human patient…” (mental process and/or math concept), as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting generic computer elements, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the language about generic computer elements, “evaluate …”, in the limitation citied above encompasses evaluating patient feedback data, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas;
(c) “ calculate, based on the patient feedback data, an amount of training data required to perform training operations on a programming selection model, wherein the training data is provided at least in part from the patient feedback data, and wherein the training operations on the programming selection model enable an updated set of parameters for the neurostimulation device” (mental process and/or math concept), as drafted, is a process that, under its broadest reasonable interpretation, covers mathematical concepts but for the recitation of generic computer components. That is, the steps of “calculate”, based on their broadest reasonable interpretation, describe mathematical calculation. Mathematical calculation have been found by the courts to be abstract ideas, e.g., see MPEP 2106.04(a)(2) A. If a claim limitation, under its broadest reasonable interpretation, covers mathematical calculation, then it falls within the “Mathematical Concepts” grouping of abstract ideas.
Accordingly, the claim recites an abstract idea.
Step 2A – Prong 2: This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “A device to analyze data for neurostimulation programming, the device comprising: one or more processors; and one or more memory devices comprising instructions, which when executed by the one or more processors, cause the one or more processors to…”, “ …computer program”, which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly. the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
Step 2B Analysis: The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the claim recites the additional elements of “A device to analyze data for neurostimulation programming, the device comprising: one or more processors; and one or more memory devices comprising instructions, which when executed by the one or more processors, cause the one or more processors to…”, “ …computer program”, which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, the additional elements individually or in combination do not amount to significantly more than the judicial exception. The claim is not patent eligible.
(Dependent claims)
Claims 2-10 / 12-20 are dependent on claim 1 / 11 and include all the limitations of claim 1. Therefore, claims 2-10 / 12-20 recite the same abstract ideas.
Regarding claim 2 /12, The claim recites additional element of “generate a user interface display that includes a user-selectable option to cause the retraining of the programming selection model”, extra-solution activity of post-solution data output (see MPEP.2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “generate a user interface display that includes a user-selectable option to cause the retraining of the programming selection model”, which is extra-solution activity of post-solution data output (see MPEP.2106.05(g)). The courts have found limitations directed to obtaining/transmitting information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
Regarding claim 3 / 13, The claim recites additional element of “wherein the user interface display further includes one or more metrics that correspond to an amount of training data available to perform the training operations on the programming selection model, and one or more values that correspond to information missing from the training data required to perform the training operations”, extra-solution activity of post-solution data output (see MPEP.2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein the user interface display further includes one or more metrics that correspond to an amount of training data available to perform the training operations on the programming selection model, and one or more values that correspond to information missing from the training data required to perform the training operations”, which is extra-solution activity of post-solution data output (see MPEP.2106.05(g)). The courts have found limitations directed to obtaining/transmitting information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
Regarding claim 4 / 14, the claim recites further limitation of “… generate one or more recommendations to obtain additional portions of the training data required to perform the training operations” (mental process and/or math concept), which is further process of data analysis to support models for patient treatment, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
The claim recites additional element of “output the one or more recommendations in the user interface display”, extra-solution activity of post-solution data output (see MPEP.2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “output the one or more recommendations in the user interface display”, which is extra-solution activity of post-solution data output (see MPEP.2106.05(g)). The courts have found limitations directed to obtaining/transmitting information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
Regarding claim 5 / 15, The claim recites additional element of “wherein the one or more recommendations includes one or more of: one or more recommendations for selection of one or more neurostimulation programs; or one or more recommendations for an amount of usage of one or more neurostimulation programs”, extra-solution activity of post-solution data output (see MPEP.2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “wherein the one or more recommendations includes one or more of: one or more recommendations for selection of one or more neurostimulation programs; or one or more recommendations for an amount of usage of one or more neurostimulation programs”, which is extra-solution activity of post-solution data output (see MPEP.2106.05(g)). The courts have found limitations directed to obtaining/transmitting information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 6 / 16, the claim recites further limitation of “… evaluate device data associated with the usage of a particular neurostimulation program used to provide the neurostimulation treatment, wherein the device data is obtained from a wearable device or from the neurostimulation device, and wherein the training data is further provided from the device data; wherein operations to calculate the amount of training data required to perform the training operations are further based on the device data; and wherein operations to determine the usage of the neurostimulation treatment are further based on evaluating program usage as indicated by the device data” (mental process and/or math concept), which is further process of analyzing / evaluating data for patient treatment, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Except citing generic computer elements to implement the abstract idea, there is no additional element showing integration into a practical application or adding something significantly more to the abstract idea. The claim is not patent eligible.
With regards to claim 7 / 17, the claim recites further limitation of “… wherein the patient feedback data relates to one or more of: sleep, pain, movement, fatigue or restfulness, alertness, emotional state, medication state, mobility, or activity, in connection with use of the neurostimulation treatment, and wherein the patient feedback data is obtained from the human patient using one or more: questionnaires, surveys, text entries, or voice input” (mental process and/or math concept), which is further process of patient feedback data analysis, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Except citing generic computer elements to implement the abstract idea, there is no additional element showing integration into a practical application or adding something significantly more to the abstract idea. The claim is not patent eligible.
With regards to claim 8 / 18, the claim recites further limitation of “… identify, based on the calculated amount of training data required to perform training operations, availability for retraining of the programming selection model …”, which is data analysis for models, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
The claim recites additional element of “generate a user interface display that includes a user-selectable option to cause the retraining of the programming selection model”, extra-solution activity of post-solution data output (see MPEP.2106.05(g)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “generate a user interface display that includes a user-selectable option to cause the retraining of the programming selection model”, which is extra-solution activity of post-solution data output (see MPEP.2106.05(g)). The courts have found limitations directed to obtaining/transmitting information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”, "electronic record keeping," and "storing and retrieving information in memory"). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
With regards to claim 9 / 19, the claim recites further limitation of “… determine usage of multiple neurostimulation programs, wherein the multiple neurostimulation programs are associated with respective sets of parameters; wherein to evaluate the patient feedback data includes to evaluate the usage of each of the multiple neurostimulation programs and the patient feedback data associated with each of the multiple neurostimulation programs; and wherein to calculate the amount of training data required to perform training operations on the programming selection model is further based on the usage of each of the multiple neurostimulation programs and the patient feedback data associated with each of the multiple neurostimulation programs” (mental process and/or math concept), which is further process of data analysis / evaluation related to patient treatment, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Except citing generic computer elements to implement the abstract idea, there is no additional element showing integration into a practical application or adding something significantly more to the abstract idea. The claim is not patent eligible.
With regards to claim 10 / 20, the claim recites further limitation of “… wherein the programming selection model is used to provide closed-loop programming for the neurostimulation device; wherein the closed-loop programming causes a change to neurostimulation programming settings on the neurostimulation device; wherein the change to the neurostimulation programming settings controls one or more of: pulse patterns, pulse shapes, a spatial location of pulses, waveform shapes, or a spatial location of waveform shapes, of modulated energy provided with a plurality of leads of the neurostimulation device…”, which is data analysis for models, which is based on observation, evaluation, judgement, and/or opinion, that could be performed by human using paper / pen / calculator. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas.
The claim recites additional element of “wherein the programming selection model is trained at a remote data service based on the training data”, extra-solution activity of post-solution data output (see MPEP.2106.05(g)), which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2A, prong two, the additional elements individually or in combination do not integrate the judicial exception into a practical application. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above, the additional element of “generate a user interface display that includes a user-selectable option to cause the retraining of the programming selection model”, which is mere instructions to implement an abstract idea using generic computing device, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). Accordingly, at Step 2B the additional elements individually or in combination do not amount to significantly more than the judicial exception.
The claim is not patent eligible.
Allowable Subject Matter
Claims 1-20 include allowable subject matter since when reading the claims in light of the specification, as per, MPEP §2111.01 or Toro Co. v. White Consolidated Industries Inc., 199F.3d 1295, 1301, 53 USPQ2d 1065, 1069, 1069 (Fed.Cir. 1999), none of the references of record alone or in combination disclose or suggest the combination of limitations specified in claims 1-20.
In interpreting the claims, in light of the specification filed on 23 February 2024, the Examiner finds the claimed invention to be patentably distinct from the prior arts of record.
Regarding the claims, the primary reason for the allowance is the inclusion of the specific apparatus and process of evaluating patient feedback data associated with usage of an active neurostimulation treatment and calculating, from that feedback data, an amount of training data required to perform training operations on a programming selection model that produces an updated set of neurostimulation device parameters.
None of the cited prior art references, singly or in combination, fully teaches all limitations of independent claims 1 and 11.
Regarding the dependent claims, which include all the limitations of the independent claims, are also allowed.
The followings are references close to the invention claimed:
McDonald, US-PGPUB NO.20200282218A1 [hereafter McDonald] teaches obtaining patient efficacy feedback on an active neurostimulation program and generating updated model weights that produce updated neurostimulation device programming parameters. However, McDonald does not teach the specific claimed element of calculating an amount of training data required before retraining.
Wall et al., US-PGPUB NO. 20210133509A1 [hereafter Wall] teaches a digital therapeutic system capturing patient efficacy/compliance feedback and retraining a therapeutic machine-learning model to output an updated personal treatment plan. However, Wall does not teach the specific claimed element of calculating an amount of training data required for retraining.
Hoshino et al., US PATENT NO.11378522B2 [hereafter Hoshino] teaches acquiring a stored amount of training data, comparing it to a required reference amount, and enabling/displaying training once the amount is sufficient. However, Hoshino does not teach the specific claimed elements combination of neurostimulation treatment usage and patient-feedback-derived training data.
Hebb et al., "Creating the Feedback Loop: Closed-Loop Neurostimulation," Neurosurg Clin N Am 25(1):187-204, January 2014 [hereafter Hebb] teaches classification algorithms mapping neural/physiological signals to clinical states to adjust deep brain stimulation parameters in a closed loop. However, Hebb does not teach the specific claimed element of calculating a required training-data amount from patient feedback data.
Figueroa et al., "Predicting Sample Size Required for Classification Performance," BMC Medical Informatics & Decision Making 12:8, 2012 [hereafter Figueroa] teaches fitting a learning-curve model to predict the annotated training sample size required for a classifier to reach a target performance. However, Figueroa does not teach the specific claimed elements combination of neurostimulation treatment usage, patient feedback data, or updated device parameters.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TSU-CHANG LEE whose telephone number is 571-272-3567. The fax number is 571-273-3567.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Omar Fernandez Rivas, can be reached 571-272-2589.
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/TSU-CHANG LEE/
Primary Examiner, Art Unit 2128
