Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed on 7/1/2026. Currently claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see pgs. 10-12, filed 7/1/2026, with respect to the previous rejection(s) of
claim(s) 1, 7, 10, 13 and 16 rejected under 35 USC 102(a)(2) as being anticipated by Ajala
claim(s) 2-3, 11, 17 rejected under 35 USC 103 as being unpatentable over Ajala in view of Grill
claim(s) 4, 12 and 18 rejected under 35 USC 103 as being unpatentable over Ajala in view of Arlotti
claim(s) 5-6, 14 and 19 rejected under 35 USC 103 as being unpatentable over Ajala in view of Esteller in view of Grill
claim(s) 8-9, 15 and 20 rejected under 35 USC 103 as being unpatentable over Ajala in view of McLaughlin
have been fully considered and are persuasive based on the amendments to the claims. These prior art rejections of claims 1-20 have been withdrawn.
Applicant's arguments, see pgs. 7-10 filed 7/1/2026 have been fully considered but they are not persuasive.
The crux of applicant’s arguments is focused on the independent claims and the specific amendments to these claims. Applicant argues that the invention as amended is integrated into a practical application. Applicant supports this assertion by arguing that the claims require physical interaction with a DBS (deep brain stimulation) device during a programming session and that the sampling iterations are not extra-solution activity. Applicant further argues that the conventional state of determining DBS parameters is a process of trial and error of testing different parameters, while the claimed invention recites a specific order combination that is an improvement over the conventional manual trial and error as it is faster and more precise. [see pgs. 7-9 of applicant’s arguments].
In response, these arguments are not persuasive. The claims have been amended to use a specific acquisition function (i.e. a meta-active-learning acquisition function) to repeat test different parameters for deep brain stimulation, observing a result in the form of a biomarker and then test additional parameters. It also includes looking back at the history, but doesn’t specify in any way how the history is used. The issue is everything the claim with respect to what the acquisition function does is recited at a high level of generality. For example the no specific parameters are recited (i.e. frequency, intensity, etc), no specific biomarkers are being used (i.e. an evoked potential, a specific local max evoked potential, a local min motor evoked potential, etc.), and even how the history is recited at very generic high level. Essentially, under broadest reasonable interpretation, the claims could be interpreted as performing trial and error by applying a machine learning model comprising a meta-active-learning acquisition function by generic processor to find the stimulation parameters. MPEP 2106.05... “i. Adding the words "apply it" (or an equivalent) with the judicial exception, or 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 (see MPEP § 2106.05(f));” Thus, this high level of generality seems to indicate that the judicial exception is not integrated into a practical application as argued by application. This is further supported by the high-level generality of a deep brain stimulation device / or processor of a deep brain stimulation device as this a level of generality for the structures is well-known and conventional as pointed out in the previous and current rejections are well known and conventional. While applicant articulates a strong point about improvement the sequential sampling architecture recited in this claim is understood improve the speed and efficiency at selecting the appropriate deep brain stimulation (DBS) parameters for an individual which is understood to be an improvement to the technical field of deep brain stimulation (a fact which is supported in para 120 of applicant’s specification received on 8/29/2024) without much detail on how the history is being used, this seems to under broadest reasonable interpretation essentially be automating random testing using algorithm instead of by an individual which as discussed by applicant appears to be the current state of deep brain stimulation. Given the high level generality with respect to how the sampling is being done, this advantage seems to be just automation via a computer rather than a specific architecture. Thus, while the grounds of rejection have been updated to account for the changes in the claim language, the 101 rejection has been maintained. Some suggestions to overcome the 101 include clarifying some of the specifics to reduce the generality (i.e. what type of biomarkers are being used, how the history being used, etc) to help integrate the abstract idea into a practical application.
Claim Rejections - 35 USC § 112
Claims 16-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the DBS device" in the limitation of “instructing the DBS device to deliver stimulation”. There is insufficient antecedent basis for this limitation in the claim. For this examination “the DBS device” is interpreted as “a DBS device”. Applicant should clarify what is being claimed here. Claims 17-20 are rejected based on dependency to claim 16.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea (mental process) without significantly more.
Independent claims:
The claim(s) 1 recite(s):
“selecting, using a machine learning model comprising a meta-active-learning
acquisition function, a next candidate set of, DBS parameters to sample based on a sample history comprising previously sampled DBS parameter sets and
corresponding biomarker responses measured for a patient”
“instructing the DBS device to deliver simulation according to the next candidate set of DBS parameters”
“recording, in response to the delivered stimulation, a biomarker response for
the patient”
“updating the sample history based on the recorded biomarker response”
“selecting a subsequent candidate set of DBS parameters based on the updated
sample history”
This is a mental process because the human mind with a pen and paper is fully capable of selecting, instructing, recording, updating and selecting as claimed.
This judicial exception is not integrated into a practical application because the additional limitation of “wherein the system is configured to generate, data based on the plurality of sequential sampling iterations, a patient-specific set of stimulation parameters for deep brain stimulation” in the broadest form is just inputting data into a calculation to produce an output in the form stimulation parameters which as ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) insignificant extra-solutional activity. Thus, at most the limitations amount to mere instructions to apply an exception and automated analysis. And, as ruled by Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) in MPEP 2106.05(f) such mere instructions to apply the judicial exception does not integrate the judicial exception into a practical application and. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim only recites a processor, a memory and a stimulation device. These elements are well known and conventional as evidenced by disclosure in Ajala et al (US 20240138698) hereafter known as Ajala [see Fig. 1 and para 37 elements 3 (processor), element 4 (memory) and Fig. 2 element 20 (i.e. stimulation device)] and Miocinovic et al hereafter known as Miocinovic (US 20210346699) [see Fig. 1 element 122 (i.e. stimulation device) and para 29 and para 8… “the system may include one or more processors; and one or more hardware storage devices having stored thereon computer-executable instructions.” Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 1 is rejected under 101.
The claim(s) 10 recite(s):
“selecting, using a machine learning model comprising a meta-active-learning acquisition function, a next candidate set of DBS parameters to sample based on a sample history comprising previously sampled DBS parameter sets and corresponding biomarker responses measured for a patient”
“instructing the DBS device to deliver stimulation according to the next candidate set of DBS parameters”
“recording, in response to the delivered stimulation, a biomarker response for the patient” and
“updating the sample history based on the recorded biomarker response”
“selecting a subsequent candidate set of DBS parameters based on the updated sample history”
This is a mental process because the human mind with a pen and paper is fully capable of selecting, instructing, recording, updating, and selecting as claimed.
This judicial exception is not integrated into a practical application because the additional limitation of “generating, based on the plurality of sequential sampling iterations, a patient-specific set of stimulation parameters for deep brain stimulation” in the broadest form is just inputting data into a calculation to produce an output in the form stimulation parameters which as ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) insignificant extra-solutional activity. Thus, at most the limitations amount to mere instructions to apply an exception and automated analysis. And, as ruled by Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) in MPEP 2106.05(f) such mere instructions to apply the judicial exception does not integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim only recites a stimulation device. These elements are well known and conventional as evidenced by disclosure in Ajala [see Fig. 2 element 20 (i.e. stimulation device)] and Miocinovic [see Fig. 1 element 122 (i.e. stimulation device)] Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 10 is rejected under 101.
The claim(s) 16 recite(s):
“selecting, using a machine learning model comprising meta-active-learning acquisition function, a next candidate set of DBS parameters to sample based on a sample history comprising previously sampled DBS parameter sets and corresponding biomarker responses measured for a patient”
“instructing the DBS device to deliver stimulation according to the next
candidate set of DBS parameters”
“recording, in response to the delivered stimulation, a biomarker response for
the patient”
“updating the sample history based on the recorded biomarker response”
“selecting a subsequent candidate set of DBS parameters based on the updated
sample history”
This is a mental process because the human mind with a pen and paper is fully capable of selecting, instructing, recording, updating, and selecting as claimed. This judicial exception is not integrated into a practical application because the additional limitation of “generate, based on the plurality of sequential sampling iterations, a patient-specific set of stimulation parameters for deep brain stimulation” in the broadest form is just inputting data into a calculation to produce an output in the form stimulation parameters which as ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) insignificant extra-solutional activity. Thus, at most the limitations amount to mere instructions to apply an exception and automated analysis. And, as ruled by Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) in MPEP 2106.05(f) such mere instructions to apply the judicial exception does not integrate the judicial exception into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim only recites a processor, memory, and a stimulation device. These elements are well known and conventional as evidenced by disclosure in Ajala [see Fig. 1 and para 37 elements 3 (processor), element 4 (memory) and Fig. 2 element 20 (i.e. stimulation device)] and Miocinovic [see Fig. 1 element 122 (i.e. stimulation device) and para 29 and para 8… “the system may include one or more processors; and one or more hardware storage devices having stored thereon computer-executable instructions.” (i.e. processor and memory] Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 16 is rejected under 101.
Dependent claims:
Regarding claims 2-9, 11-15 and 17-20, these claims only further describe the mental process and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claims 2-9, 11-15 and 17-20 are rejected under 35 USC 101 for similar reasons as claims 1, 10 and 16 above.
Examiner’s Note
No prior art was found to anticipate and/or obviate the combination of limitations recited in claims 1-20. Therefore, claims 1-20 are only rejected under 35 USC 101 for the reasons outlined above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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