DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see pages 11-13, filed on 02/09/2026, with respect to the prior art rejections of claims 1, 18, and 20 have been fully considered and are persuasive. The prior art rejections of claims 1, 18, and 20 have been withdrawn.
Applicant's arguments filed on 02/09/2026 have been fully considered but they are not persuasive.
Rejections Under 35 USC 101
Regarding the pending 101 rejection of claims 1-20, Applicant argues that the claims recite predictive algorithms that involve mathematical modeling of medication-therapy interactions, data transformation to enable cross-medication-state comparison, and multi-dimensional parameter space optimization that cannot practically be performed in the human mind. Examiner respectfully disagrees and notes that as currently written, claims 1 and 18 recite, “…executing a predictive algorithm that translates the CED to compensate for the medication effects on the condition”. Claim 20 currently recites, “…applying a computational model that translates CED values between medication states…”. Examiner notes that the human mind is capable of translating the CED to compensate for the medication effects on the condition to enable a comparison of CEDs. Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675 (MPEP 2106.04(a)(2)(III)).
Applicant argues that the claims are integrated with a medical device configured to treat a condition by delivering a therapy within a therapy space defined by different parameter sets and addresses the concrete problem that medication-induced symptom fluctuations confound the programming of such medical devices. Applicant further argues that the claims constitute a practical application of treating a medical condition using a particular machine. Examiner respectfully disagrees and notes that as currently written, the claims only alternatively recite implementing the adjusted parameter set. Therefore, the claims do not require a practical application of treating a medical condition using a particular machine. Further, the medical device is generally recited and the limitation of “acquire clinical effect data (CED) for the condition by testing a subset of the different parameter sets within the therapy space” appears to be directed towards data gathering (MPEP 2106.05(g)), which fails to amount to significantly more. Moreover, the use of a medical device including a plurality of electrodes is considered to be well-known, routine, and conventional in the art. For examples, see Litvak et al (US 2022/0266023) [0062] and Annoni et al (US 2018/0192943) [0047].
Applicant argues that transforming clinical values or optimizing therapy parameters through search space exploration provides significantly more than any abstract idea. Applicant respectfully disagrees as transforming clinical values and optimizing therapy parameters are part of the abstract idea itself and can be performed by the human mind.
Applicant argues that dependent claims 4-5 recite the use of accelerometers and recite integration with specific sensor systems and particular neurostimulation devices which shows that the method operates on actual physiological measurements from medical devices, not abstract concepts. Examiner respectfully disagrees and maintains that the accelerometers are used for data gathering which fails to amount to significantly more. Moreover, the use of accelerometers to gather movement data is considered to be well-known, routine, and conventional in the art. For examples see Annoni et al (US 2018/0192943) [0056] and Moffitt et al (US 11344732) Col. 18, lines 60-61.
Regarding claim 6, Applicant argues that the claim specifies electrical stimulation for cardiovascular therapy using blood pressure or cardiac activity to detect CED, demonstrating application to cardiac rhythm management devices. Examiner respectfully disagrees and notes that claim 6 does not recite delivering electrical stimulation using the adjusted parameter set. Examiner also notes that using blood pressure or cardiac activity to detect CED is further directed towards mere data gathering.
Regarding claim 7, Applicant argues that the claim recites concrete electrical stimulation parameters showing control of specific physical parameters of electrical therapy delivery rather than abstract idea manipulation. Examiner respectfully disagrees as the claim does not recite delivering electrical stimulation using the adjusted parameter set and fails to integrate the abstract idea into a practical application.
Regarding claims 10-14, Applicant argues that the claims recite iterative learning which improves prediction accuracy over time through verification and map updating, which is a specific technological improvement in medical device programming and is significantly more than abstract data processing. Examiner respectfully disagrees as claims 10-14 are further directed towards the abstract idea and do not recite delivery of the adjusted parameter set.
The additional limitation of “…or automatically implementing the adjusted parameter set” fails to integrate the abstract idea into a practical application. In order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration.
Claim Objections
Claim 15 is objected to because of the following informalities: Claim 15 recites, “…maintains the
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of identifying an adjusted parameter set) without significantly more.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a method/system for identifying an adjusted parameter set.
Step 2A, Prong One
Regarding claims 1-20, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.05(a)(2) subsection (III)).
Regarding claims 1 and 20, the limitations of “computationally adjust the CED…”, “identify an adjusted parameter set…”, and “communicate the adjusted parameter set” are a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) under the broadest reasonable interpretation.
Regarding claim 18, the limitations of “computationally estimate third CED”, “identify an adjusted parameter set…”, “communicate the adjusted parameter set” are a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) under the broadest reasonable interpretation.
For example, these limitations recited in claims 1, 18, and 20 are nothing more than a medical professional analyzing gathered data and suggesting an adjusted parameter set.
Step 2A, Prong Two
For claims 1-20, the judicial exception is not integrated into a practical application. For claims 1-20, the additional limitation of “a processing system” is recited at a high level of generality and amounts to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application.
Further, the limitations of “acquire CED data…”, and “acquire a medication state…” amount to nothing more than the pre-solution activity of mere data gathering, while the limitation “communicate the adjusted parameter set…” amounts to nothing more than the post activity solution of providing results (MPEP 2106.05(g)).
Step 2B
The claims do not include additional elements that are sufficient enough to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations of “acquire CED data…”, “acquire a medication state…”, and “communicate the adjusted parameter set…” are directed towards insignificant extra-solution activities (MPEP 2106.05(g)). In addition, “a medical device” is recited at a high level of generality and considered to be well known, routine, and conventional in the art. For examples, see Litvak et al (US 2022/0266023) [0062] and Annoni et al (US 2018/0192943) [0047].
Dependent claims 2, 7-17, and 19 are further directed towards to abstract idea and do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Dependent claims 3-6 are further directed towards insignificant extra-solution activities and do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses. Further, the use of “at least one sensor to determine the medication state by detecting a concentration of medicine in the patient” is considered to be well-known, routine, and conventional in the art. For examples, see Tcheng et al (US 2003/0149457) [0072] and Bulkes et al (US 2008/0039904) [0225]. Additionally, the use of an accelerometer to gather movement data is considered to be well-known, routine, and conventional in the art. For examples, see Annoni et al (US 2018/0192943) [0056] and Moffitt et al (US 11,344,732) Col. 18, lines 60-61.
Examiner’s Note Regarding Prior Art
The following is a statement of reasons for the indication of allowable subject matter: Claims 1-20 are rejected under 35 USC 101, however, Examiner has not found any prior art references that teach or suggest in combination the limitations recited in claims 1, 18, and 20. Specifically, Examiner has not found any art that teaches:
“acquire clinical effect data (CED) for the condition by testing a subset of the different parameter sets within the therapy space;
acquire a medication state of medication administered to treat the condition;
computationally adjust the CED acquired from the tested subset of parameter sets based on the medication state to provide medication-adjusted CED by executing a predictive algorithm that translates the CED to compensate for the medication effects on the condition,
wherein the medication-adjusted CED includes transformed CED values that account for medication effects to enable comparison of CED across different medication states and estimation of CED for untested parameter sets within the therapy space;
identify an adjusted parameter set from the therapy space for the medical device to deliver the therapy based on the medication-adjusted CED by using the processing system to search the therapy space through evaluation of the medication-adjusted CED to select the adjusted parameter set”.
Litvak discloses using a processing system to: acquire clinical effect data (CED) for the condition ([0097] patient state information may include one or more of a tremor, a gait, bradykinesia);
acquire a medication state of medication administered to treat the condition ([0101] current drug state for patient 112);
adjust the CED based on the medication state to provide medication- adjusted CED ([0104] associate the patient state information with the cluster of the neural data to generate patient assessment information);
identify an adjusted parameter set for the medical device to deliver the therapy based on the medication-adjusted CED ([0106] determine to change a program for electrical stimulation provided by IMD 106).
Litvak fails to disclose using a processing system to: acquire clinical effect data (CED) for the condition by testing a subset of the different parameter sets within the therapy space;
computationally adjust the CED acquired from the tested subset of parameter sets based on the medication state to provide medication-adjusted CED by executing a predictive algorithm that translates the CED to compensate for the medication effects on the condition,
wherein the medication-adjusted CED includes transformed CED values that account for medication effects to enable comparison of CED across different medication states and estimation of CED for untested parameter sets within the therapy space; and
identify an adjusted parameter set from the therapy space for the medical device to deliver the therapy based on the medication-adjusted CED by using the processing system to search the therapy space through evaluation of the medication-adjusted CED to select the adjusted parameter set.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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