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 .
Claim Interpretation
The MPEP states:
2111.04 "Adapted to," "Adapted for," "Wherein," "Whereby," and Contingent Clauses [R-10.2019]
II. CONTINGENT LIMITATIONS
The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met. For example, assume a method claim requires step A if a first condition happens and step B if a second condition happens. If the claimed invention may be practiced without either the first or second condition happening, then neither step A or B is required by the broadest reasonable interpretation of the claim. If the claimed invention requires the first condition to occur, then the broadest reasonable interpretation of the claim requires step A. If the claimed invention requires both the first and second conditions to occur, then the broadest reasonable interpretation of the claim requires both steps A and B.
The broadest reasonable interpretation of a system (or apparatus or product) claim having structure that performs a function, which only needs to occur if a condition precedent is met, requires structure for performing the function should the condition occur. The system claim interpretation differs from a method claim interpretation because the claimed structure must be present in the system regardless of whether the condition is met and the function is actually performed.
See Ex parte Schulhauser, Appeal 2013-007847 (PTAB April 28, 2016) for an analysis of contingent claim limitations in the context of both method claims and system claims. In Schulhauser, both method claims and system claims recited the same contingent step. When analyzing the claimed method as a whole, the PTAB determined that giving the claim its broadest reasonable interpretation, "[i]f the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed" (quotation omitted). Schulhauser at 10. When analyzing the claimed system as a whole, the PTAB determined that "[t]he broadest reasonable interpretation of a system claim having structure that performs a function, which only needs to occur if a condition precedent is met, still requires structure for performing the function should the condition occur." Schulhauser at 14. Therefore "[t]he Examiner did not need to present evidence of the obviousness of the [ ] method steps of claim 1 that are not required to be performed under a broadest reasonable interpretation of the claim (e.g., instances in which the electrocardiac signal data is not within the threshold electrocardiac criteria such that the condition precedent for the determining step and the remaining steps of claim 1 has not been met);" however to render the claimed system obvious, the prior art must teach the structure that performs the function of the contingent step along with the other recited claim limitations. Schulhauser at 9, 14.
Claims 1, 19, and 20, as now amended have the contingent limitation “in response to a determination that any one of the detected physiological signals indicates that the user is suffering a seizure, and only after that determination, then determining”.
The invention will necessarily perform the steps of detecting physiological signals and determining whether any one of the detected physiological signals indicates that the user is suffering a seizure. However, it will not necessarily perform the final step of “determining, by a trained neural network and based on a plurality of the detected physiological signals, a seizure condition of the user, wherein the seizure condition of the user comprises whether the user is or is not suffering a seizure”. In the case that the detected physiological signals do not indicate the user is suffering a seizure, the final step of the applicant’s method would not be performed and thus the prior art would meet the claimed limitations simply by sensing physiological signals and determining whether any one of the detected physiological signals indicates that the user is suffering a seizure. The applicant confirms stage 2 is contingent on stage 1 on pages 7 and 8 of the applicant’s arguments submitted 7/20/2026.
Response to Arguments
Applicant's arguments filed 7/20/2026 have been fully considered but they are not persuasive.
Regarding the prior art rejection, the applicant argues:
“While Mech discloses that AI/ML can be used to make multiple determinations, none of Mech's determinations involve a two-stage process as recited by the claims. For instance, while Mech discloses using AI/ML to detect that a person is experiencing a seizure, Mech does not disclose that this AI/ML detection is made "in response to a determination that any one of the detected physiological signals indicates that the user is suffering a seizure," as amended Claim 1 requires. Even further, Mech does not disclose that its AI/ML determinations are made "only after" the stage-1 determination that a detected physiological signal indicates that a user is suffering a seizure. In other words, Mech discloses using AI/ML to detect that a person is experiencing a seizure in the first instance, and does not disclose the two-stage process required by the independent claims.”
Regarding method claim 1, this argument is not found persuasive because it is based on a contingent limitation (see the claim interpretation section above). In the case that the detected physiological signals do not indicate the user is suffering a seizure, the final step of the applicant’s method would not be performed and thus the prior art would meet the claimed limitations simply by sensing physiological signals and determining whether any one of the detected physiological signals indicates that the user is suffering a seizure (which Mech discloses in figure 2 steps 202-205). The applicant confirms stage 2 is contingent on stage 1 on pages 7 and 8 of the applicant’s arguments submitted 7/20/2026.
Regarding claims 19 and 20, the examiner has now cited Shoaran et al. in a 35 USC § 103 rejection as follows:
“Regarding claims 19 and 20, Mech discloses the invention (see the rejection for claim 1 above) but is silent as to the “and only after that determination” contingent limitation. Shoaran teaches it is known to use such a modification as set forth in figure 7 [0091]-[0092], (Note: In [0092] of Shoaran, the “conditional computations”, “neural network pruning”, and “threshold quantization” all appear to be contingent steps aimed at energy efficiency, which is the problem the applicant is solving) to improve the energy efficiency (e.g. see [0092]) and provide superior results in terms of low power, small area, and small memory usage (e.g. see [0091]) in a seizure detection device ([0098]-[0099]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the energy efficient conditional computations in a neural network taught by Shoaran in the system/method of Mech, since said modification would provide the predictable results of to improve the energy efficiency and provide superior results in terms of low power, small area, and small memory usage in a seizure detection device”.
Regarding the 35 USC § 101 rejection, the applicant argues:
“The claims likewise recite the two-stage features that give rise to these improvements in specificity, sensitivity, reduced power consumption, and reduced compute usage. For instance, amended Claim 1 recites that if "any one of the detected physiological signals indicates that the user is suffering a seizure" in stage 1, then "only after that determination" is the higher-power and higher-compute process of stage 2 invoked to confirm that a wearer has in fact suffered a seizure. Thus, the claimed features save power consumption and compute resources, as well as provide both high sensitivity and high specificity, by gating stage 2 based on the outcome of the lower- power and lower-compute stage 1 process.
As the Specification explains, these features are an improvement to technology, and specifically improve the computational resources and power consumption of a wearable device that is used for seizure detection. In addition, these features also improve the ability of a wearable device to accurately detect seizures without committing false-positive errors, and therefore the claims recite an improvement to wearable-based seizure detection overall.”
This argument is not found persuasive because the improvement (as argued by the applicant) is part of the abstract idea and therefore cannot be the improvement. Per MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field”.
Additionally, the claims are not integrated into practical application as they are purely diagnostic (provide no active treatment step to the patient) and rely on generic structure (well-known sensing, processing, and memory components).
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 a judicial exception, specifically an abstract idea without significantly more.
Step 1
The claimed invention in claims 1-20 are directed to statutory subject matter as the claims recite a method, wearable device, and apparatus for determining a seizure condition of a patient.
Step 2A, Prong One
Regarding claims 1, 19, and 20, the recited steps are directed to a mental process and mathematical calculation of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (I) and (III)).
Regarding claims 1, 19, and 20, the limitations of “determining, by the wearable device, whether any one of the detected physiological signals indicates that the user is suffering a seizure; and in response to a determination that any one of the detected physiological signals indicates that the user is suffering a seizure, and only after that determination, then determining, by a trained neural network and based on a plurality of the detected physiological signals, a seizure condition of the user, wherein the seizure condition of the user comprises whether the user is or is not suffering a seizure” are nothing more than a mental process or mathematical calculation as drafted. For example, these steps are nothing more than a medical professional analyzing a patient’s physiological data to determine a seizure and then determining a seizure condition. The step of using a neural network is nothing more than mathematical calculation.
Step 2A, Prong Two
For claims 1, 19, and 20, the judicial exception is not integrated into a practical application. In particular, the claims recite “a plurality of sensors”, “one or more processors”, and “one or more non-transitory computer readable mediums” are recited a high-level of generality and amount to nothing more than generic sensors, processors, and computer readable mediums. The step of “detecting, by each of a plurality of sensors of a wearable device worn by a user, a physiological signal of the user” is recited at a high-level of generality and amounts to no more than pre-solution activity of data gathering. The “wearable device” is also is recited at a high-level of generality.
Accordingly, these additional limitations do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The one or more processors, one or more non-transitory computer readable mediums, a plurality of sensors, and wearable device disclosed by the applicant are well-understood, routine, and conventional. Simply appending well-understood, routine, conventional activities previously known to 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 to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 2-18 further limit the abstract idea already indicated in independent claims 1, 19, and 20 and they are ineligible for the same reasons provided for claims 1, 19, and 20 above.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 7-14, and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mech et al. (Pub. No.: US 2023/0248302 A1); hereinafter referred to as “Mech”.
Regarding claim 1, Mech discloses a method comprising: detecting, by each of a plurality of sensors of a wearable device (e.g. see [0068]) worn by a user, a physiological signal of the user (e.g. see figure 2 steps 202,203); determining, by the wearable device, whether any one of the detected physiological signals indicates that the user is suffering a seizure (e.g. see figure 2 step 205); and in response to a determination that any one of the detected physiological signals indicates that the user is suffering a seizure, and only after that determination, then determining, by a trained neural network (e.g. see [0005], [0094]-[0104]) and based on a plurality of the detected physiological signals, a seizure condition of the user (e.g. see figure 2 steps 205-207), wherein the seizure condition of the user comprises whether the user is or is not suffering a seizure (e.g. see figure 2 steps 205-207, Note: See the “claim interpretation” section above. In the case that the detected physiological signals do not indicate the user is suffering a seizure, the final step of the applicant’s method would not be performed and thus the prior art would meet the claimed limitations simply by sensing physiological signals and determining whether any one of the detected physiological signals indicates that the user is suffering a seizure (which Mech discloses in figure 2 steps 202-205). The applicant confirms stage 2 is contingent on stage 1 on pages 7 and 8 of the applicant’s arguments submitted 7/20/2026).
Regarding claim 2, Mech discloses the plurality of sensors comprises at least two of: an accelerometer, an EMG sensor, a skin-impedance sensor, an SpO2 sensor, and a PPG sensor (e.g. see figure 2 steps 202 and 203).
Regarding claim 7, Mech discloses determining a seizure condition of the user comprises determining, by the neural network (e.g. see [0005], [0094]-[0104]), whether the user suffered a seizure (e.g. see figure 2 step 205 and 207).
Regarding claim 8, Mech discloses determining a seizure condition of the user further comprises determining one or more of (1) an onset of the seizure and (2) a duration of the seizure (e.g. see [0005]).
Regarding claim 9, Mech discloses determining a seizure condition of the user comprises classifying, by the neural network (e.g. see [0005], [0094]-[0104]), a type of seizure suffered by the user (e.g. see figure 2 step 207, [0105]-[0106]).
Regarding claim 10, Mech discloses determining, for each of a plurality of types of seizures, a probability that the user suffered that particular type of seizure (e.g. see figure 2 step 207, [0105]-[0106]).
Regarding claim 11, Mech discloses the probability is determined based at least in part on the user’s seizure history (e.g. see figure 2 step 207, [0105]-[0106]).
Regarding claim 12, Mech discloses the trained neural network (e.g. see [0005], [0094]-[0104]) is deployed on the wearable device (e.g. see [0068]).
Regarding claim 13, Mech discloses determining, by a trained discriminator and based on the determined seizure condition, a priority of the seizure condition (e.g. see [0021], [0037]).
Regarding claim 14, Mech discloses the priority of the seizure condition is further determined based on the user’s seizure history (e.g. see [0021], [0037]).
Regarding claim 17, Mech discloses providing, to the user, a notification regarding the seizure condition (e.g. see figure 2 element 208).
Regarding claim 18, Mech discloses determining a severity of the seizure condition of the user; and making, based on the determined severity, a request for emergency aid for the user (e.g. see figure 2 element 208).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mech in view of Fuerst et al. (Pub. No.: US 2015/0272494 A1); hereinafter referred to as “Fuerst”.
Regarding claims 3 and 4, Mech discloses the invention but is silent as to determining whether any one of the detected physiological signals indicates that the user is suffering a seizure comprises determining that at least one of the detected physiological signals meets a predetermined threshold specific to that physiological signal and the predetermined threshold is defined at least in part by one or more user characteristics of the user. Fuerst teaches it is known to use such a modification as set forth in [0004]-[0005] to provide monitoring of symptoms of epileptic seizures, which may be idiosyncratic/unique/personalized to a person (e.g. see [0034]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use threshold determination as taught by Fuerst in the system/method of Mech, since said modification would provide the predictable results of monitoring of symptoms of epileptic seizures, which may be idiosyncratic/unique/personalized to a person.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mech in view of Osorio et al. (Pub. No.: US 2004/0133119 A1); hereinafter referred to as “Osorio”.
Regarding claim 5, Mech discloses the claimed invention but is silent as to determining, by the wearable device, whether each of the detected physiological signals meets a corresponding first signal-quality threshold; and in response to a determination that a detected physiological signal does not meet a corresponding first signal-quality threshold, then discarding that physiological signal prior to determining whether at least one of the detected physiological signals indicates that the user is suffering a seizure. Osorio teaches it is known to use such a modification as set forth in [0091]-[0092] to quantify the quality of the neurological signal received from each of the monitoring elements (e.g. see [0086]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the signal processing techniques taught by Osorio in the system/method of Mech, since said modification would provide the predictable results of quantifying the quality of the neurological signal received from each of the monitoring elements.
Regarding claim 6, Mech discloses the claimed invention but is silent as to determining, by the wearable device, whether each of the detected physiological signals meets a corresponding second signal-quality threshold; and in response to a determination that a detected physiological signal does not meet a corresponding second signal-quality threshold, then discarding that physiological signal prior to determining a seizure condition of the user. Osorio teaches it is known to use such a modification as set forth in [0091]-[0092] to quantify the quality of the neurological signal received from each of the monitoring elements (e.g. see [0086]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the signal processing techniques taught by Osorio in the system/method of Mech, since said modification would provide the predictable results of quantifying the quality of the neurological signal received from each of the monitoring elements.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mech in view of Misra et al. (Pub. No.: US 2023/0245769 A1); hereinafter referred to as “Misra”.
Regarding claims 15-16, Mech discloses finetuning the neural network (e.g. see [0005], [0094]-[0104]) but is silent as to the user’s seizure history comprises input from a health-care provider. Misra teaches it is known to use such a modification as set forth in [0043], [0041] (Note: “seizure tracking in [0043] will read on “seizure history, [0041] discloses the input may be from a physician) to provide visibility of episode-specific details and trends relative to the progression of epilepsy (e.g. see [0004]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use seizure history input from a health-care provider as taught by Misra in the system/method of Mech, since said modification would provide the predictable results of visibility of episode-specific details and trends relative to the progression of epilepsy.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mech in view of Shoaran et al. (Pub. No.: US 2025/0160725 A1) (Note: The provisional and the PCT filing dates both precede the applicant’s filing date); hereinafter referred to as “Shoaran”.
Regarding claims 19 and 20, Mech discloses the invention (see the rejection for claim 1 above) but is silent as to the “and only after that determination” contingent limitation. Shoaran teaches it is known to use such a modification as set forth in figure 7 [0091]-[0092], (Note: In [0092] of Shoaran, the “conditional computations”, “neural network pruning”, and “threshold quantization” all appear to be contingent steps aimed at energy efficiency, which is the problem the applicant is solving) to improve the energy efficiency (e.g. see [0092]) and provide superior results in terms of low power, small area, and small memory usage (e.g. see [0091]) in a seizure detection device ([0098]-[0099]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use the energy efficient conditional computations in a neural network taught by Shoaran in the system/method of Mech, since said modification would provide the predictable results of to improve the energy efficiency and provide superior results in terms of low power, small area, and small memory usage in a seizure detection device.
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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/P.C.E/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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