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 .
Election/Restrictions
Applicant's election with traverse of Species 1A and 2B in the reply filed on January 21, 2026 is acknowledged. The traversal is on the grounds that the features of claim 1 are special technical features since the Loddenkemper reference allegedly fails to teach using feature values from both EEG and PPG data to detect and classify events, and allegedly teaches away from using EEG. This is not found persuasive because Loddenkemper explicitly teaches in e.g. Para. 61, claims 18, 30 and 41 that a second sensor, which can be EEG, can be included for multi-modal analysis. Loddenkemper thus cannot possibly “teach away” from using it. Noting disadvantages of a given modality is not the same as “teaching away” from it, and certainly not when the reference explicitly teaches including it.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-4, 12 and 14-15 are withdrawn as being directed to the non-elected species.
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 1-2, 5-11, 13, 16-19 and 37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more.
Step 1: All of claims 1-19 and 37 are directed either to a method/process or to a system/machine.
Step 2A, Prong One: The claims recite a mental process, e.g. in claim 1 the steps carried out under the “analysis routine” are steps which could be performed by the human mind and/or by a human with a physical aid such as pen and paper.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process using generic processing technology and add insignificant extra-solution activity. Specifically: the step of sensing (“gathering”) data, such as EEG and PPG data, is considered insignificant pre-solution activity of mere data gathering, since it merely collects the data necessary to carry out the mental process; the step of “recommending” a change in pharmacological agent administration in claim 13 is considered insignificant post-solution activity since it merely outputs the result of the mental process and does not actually require the treatment to be performed; similarly, also in claim 13, the limitation of “administer, via a treatment device coupled to the microprocessor, a change in a dose, concentration, timing, or frequency of a pharmacological agent” is considered insignificant post-solution activity since, at a minimum, it is not specific/particular and thus does not qualify as a particular treatment or prophylaxis. Furthermore, merely carrying out mental steps using generic computing technology such as a processor device, microprocessor, static model, etc. is well established to not amount to an integration into a practical application under the § 101 analysis. See, e.g., MPEP §§ 2106.04(a)(2)(III)(C) and 2106.04(d)(I) and 2106.05(f).
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements recited in the claims are generic processing/computing components and generic data collection and output components. The Examiner takes official notice that these are basic, generic components which are well-understood, routine and conventional in the medical diagnostic arts, and the claims here merely use them for their well-understood, routine and conventional functions. As such, those additional elements cannot be considered “significantly more” than the judicial exception in Step 2B of the § 101 analysis.
Dependent claim 2 merely adds further generic computing technology, and thus follows the same analysis above.
Dependent claims 5-11 and 16 merely add further mental steps and thus follow the same analysis above.
Dependent claim 13 was already discussed above; this claim merely adds further insignificant post-solution activity.
Dependent claims 17-18 merely add further insignificant pre-solution activity (additional data gathering) and further mental steps, and thus follow the same analysis above.
Independent claims 19 and 37 follow the same analysis as claim 1 above as they are substantially identical in scope for the purposes of § 101 evaluation.
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.
Claims 1-2, 11, 16, 18-19 and 37 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2019/0298248 A1 to Loddenkemper et al. (hereinafter “Loddenkemper”).
Regarding Claims 1, 19 and 37, Loddenkemper teaches a system for analyzing a physiological condition associated with an epilepsy patient, the system comprising:
a processor device comprising a microprocessor, a memory, and communication circuitry (see e.g. Paras. 23, 26-28);
an array of electroencephalogram (EEG) electrodes configured to be disposed on the patient, the array (i) communicatively coupled to the processor device via the communication circuitry, (ii) generating electroencephalogram (EEG) data from signals detected by the array while the array is disposed on the patient, and (iii) providing the EEG data to the processor device (see e.g. Paras. 61, 79-85, claims 18, 30 and 41);
a photoplethysmography sensor configured to be disposed on the patient, the sensor (i) communicatively coupled to the processor device via the communication circuitry, (ii) generating photoplethysmogram (PPG) data from signals detected by the sensor while the sensor is disposed on the patient, and (iii) providing the PPG data to the processor device (see e.g. Paras. 27, claim 2, 22); and
an analysis routine, stored in the memory and configured to be executed by the microprocessor, the analysis routine operable to (1) receive the EEG data and the PPG data;(2) determine a plurality of feature values, the plurality of feature values including each of: (i) one or more feature values of the EEG data (see e.g. Paras. 61, 79-85, claims 18, 30 and 41) , and (ii) one or more feature values of the PPG data (see e.g. Paras. 44-55); and(3) based on the plurality of feature values, detect and classify events associated with the physiological condition (see e.g. Paras. 59-63, claims 18, 30 and 41).
Regarding Claim 2, Loddenkemper teaches wherein the analysis routine comprises a static model (see e.g. Paras. 43, 55-60).
Regarding Claim 11, Loddenkemper teaches wherein the events associated with the physiological condition are classified by the analysis routine as epileptic events or non-epileptic events (see e.g. Paras. 59-61).
Regarding Claim 16, Loddenkemper teaches wherein the analysis routine is further operable to predict, based on the plurality of feature values one or more future events associated with the physiological condition (see e.g. Para. 59-61).
Regarding Claim 18, Loddenkemper teaches further comprising an accelerometer communicatively coupled to the processor device via the communication circuitry, wherein: the analysis routine is further operable to receive data from the accelerometer, the plurality of feature values includes one or more feature values of the accelerometer data, and based on the plurality of feature values including the accelerometer data, detect and classify events associated with the physiological condition (see “accelerometer” in Loddenkemper, e.g. in claims 18, 30 and 41 of Loddenkemper which teach that PPG can be combined with multiple other modalities including EEG and accelerometry).
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-10, 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Loddenkemper in view of US 8,684,921 B2 to Osorio (hereinafter “Osorio”).
Regarding Claim 5, Loddenkemper teaches the system of claim 1 as discussed above, but fails to teach a routine that monitors event data and classified events and determines, from the monitored event data, an efficacy of an administered therapeutic treatment. Another reference, Osorio, teaches an analogous invention including this limitation (see e.g. claim 1; Col. 19 lines 11-41; Col. 29 lines 26-65). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Loddenkemper to use the collected and analyzed data to monitor efficacy of an administered therapeutic treatment, as taught by Osorio, because this would predictably and advantageously allow for the treatment to be changed to be more effective when necessary.
Regarding Claim 6, Osorio further teaches wherein the efficacy is determined according to a number of occurrences of clinical events of the monitored event data (see e.g. Col. 20 lines 11-25; Col. 29 lines 51-65). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Loddenkemper to include this feature from Osorio since it would predictably enhance the accuracy of the determination of the treatment efficacy.
Regarding Claim 7, Osorio further teaches wherein the efficacy is determined according to a weighted score determined from the monitored event data (see e.g. Col. 17 lines 16-30). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Loddenkemper to include this feature from Osorio since it would predictably enhance the accuracy of the determination of the treatment efficacy.
Regarding Claim 8, Osorio further teaches wherein the event data includes side-effect events (see e.g. Col. 29 lines 26-65). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Loddenkemper to include this feature from Osorio since it would predictably enhance the accuracy of the determination of the treatment efficacy.
Regarding Claim 9, Osorio further teaches wherein the efficacy is classified as (i) sub-therapeutic or (ii) therapeutic (see e.g. Col. 29 lines 26-65). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Loddenkemper to include this feature from Osorio since it would predictably enhance the accuracy of the determination of the treatment efficacy.
Regarding Claim 10, Osorio further teaches wherein the efficacy is classified as (i) side-effect free or (ii) causing one or more side-effects (see e.g. Col. 29 lines 26-65). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to further modify Loddenkemper to include this feature from Osorio since it would predictably enhance the accuracy of the determination of the treatment efficacy.
Regarding Claim 13, Osorio further teaches the system further comprising a treatment strategy routine, stored in the memory and configured to be executed by the microprocessor, the treatment strategy routine operable to (i) recommend a change in a dose, concentration, timing, or frequency of a pharmacological agent to treat the physiological condition according to the detected and classified events; and/or (ii) administer, via a treatment device coupled to the microprocessor, a change in a dose, concentration, timing, or frequency of a pharmacological agent to treat the physiological condition according to the detected and classified events (see Col. 20 lines 42-55 and Col. 27 lines 50-67). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Loddenkemper to include these limitations because it would advantageously help treat the patient.
Regarding Claim 17, Osorio further teaches, further comprising a microphone communicatively coupled to the processor device via the communication circuitry, wherein: the analysis routine is further operable to receive data from the microphone, the plurality of feature values includes one or more feature values of the microphone data, and based on the plurality of feature values including the microphone data, detect and classify events associated with the physiological condition (see e.g. Col. 32 lines 35-63). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Loddenkemper to further include microphone data since it would advantageously and predictably enhance the seizure detection and/or prediction by factoring in additional relevant data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792