DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group III, claims 11-13, in the reply filed on September 19, 2026 is acknowledged.
Claims 1-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 19, 2026.
Drawings
The Applicant is reminded to carefully review the drawing figures and the accompanying specification to ensure that all reference numerals present in the drawing figures are defined within the specification.
Specification
The disclosure is objected to because of the following informalities: prior to allowance, Applicant is advised to update the first paragraph of the specification to indicate the present status of all applications referred to therein.
Appropriate correction is required.
Claim Objections
Claim 11 objected to because of the following informalities: in line 3, the claim recites “a current heat rate” and it is believed the claim should recite “a current heart rate”. Appropriate correction is required.
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.
Claims 11-13 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 11 recites the limitation "the patient’s heart rate value" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the occurrence of an epileptic seizure" in line 16. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the delta non-ictal value" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the delta detection value" in lines 17-18. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the determining" in line 17. It is unclear which determining is being referenced by “the determining”, as the claim recites determining at lines 4, 6, and 13.
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 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 11-13 are directed to a method.
Step 2A, Prong One
Regarding claim 1, the recited steps are directed to a mental process of performing concepts in a human mind or by a human using a pen and paper. See MPEP § 2106.04(a)(2)(Ill). The limitation(s) of “obtaining the time series of heart beats”, “determining a current heat [sic] rate from the time series of heart beats”, “providing a first reference heart rate value, providing a second reference heart rate value”, “determining at least one of a non-ictal component of the patient's heart rate value, wherein the non-ictal component equals the current heart rate value minus the second reference heart rate value; a delta detection component of the patient's heart rate value, wherein the delta detection component equals the first reference heart rate value minus the current heart rate value; Anda delta ictal value, wherein the delta ictal value equals the first reference heart rate value minus the second reference heart rate value”, and “and determining at least one of a risk of a false positive indicator, a risk of a false negative indicator, and an indicator of the occurrence of an epileptic seizure, wherein the determining is based on at least one of the delta non-ictal value, the delta detection value, and the delta ictal value” is/are a process that, as drafted, covers performance of the limitation by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard interpretation. For example, obtaining the time series of beats and providing first and second reference heart rate values require nothing more than a user obtaining a written record of the data. Similarly, the determining steps require nothing more than calculations that can be performed by a human using pen and paper, or within their mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the human mind or by a human using a pen and paper, then it falls with the “Mental Processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. In particular, the claims do not recite any structure or element for performing any aspect of the claims. There is nothing recited beyond the abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, there are no additional elements beyond the abstract idea of receiving data and analyzing data in the human mind or using pen and paper.
Regarding dependent claims 12 and 13, the limitations of claims 12 and 13 further define the limitations already indicated as being directed to the abstract idea.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 11-13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Gommesen et al. (U.S. 2012/0283526), herein Gommesen. Regarding claim 11, Gommesen discloses a method for detecting an epileptic seizure based upon a time series of beats of a patient's heart (“The invention relates to a system and a method for the prediction of epileptic seizures by continuous measurement of at least one signal on the body of a user. A sensor unit measures the heart rate continuously”, Abstract), comprising: obtaining the time series of heart beats (“the sensor unit 1 performs a continuous measurement of the heart rate and heartbeats”, paragraph [0041]); determining a current heat rate from the time series of heart beats (“If the measurement performed over a given time period contains a verifiable heartbeat or heart rate, the measurement is stored in the memory”, paragraph [0045]); providing a first reference heart rate value, providing a second reference heart rate value (“The reference parameters describe the heart rate and the heartbeats in a plurality of different non-seizure related states, which, in combination, give a detailed characteristic of the heart under normal conditions.”, paragraph [0047]), determining at least one of: a non-ictal component of the patient's heart rate value, wherein the non-ictal component equals the current heart rate value minus the second reference heart rate value (“The calculations may take place by simple summation and subtraction”, paragraph [0055] and “The summed value may then be compared with one or more threshold values, where each level indicates whether the value of the epilepsy signal is to be increased or reduced by a predetermined value or remain unchanged”, paragraph [0057]);a delta detection component of the patient's heart rate value, wherein the delta detection component equals the first reference heart rate value minus the current heart rate value (“The calculations may take place by simple summation and subtraction”, paragraph [0055] and “The summed value may then be compared with one or more threshold values, where each level indicates whether the value of the epilepsy signal is to be increased or reduced by a predetermined value or remain unchanged”, paragraph [0057]); Anda delta ictal value, wherein the delta ictal value equals the first reference heart rate value minus the second reference heart rate value (“The calculations may take place by simple summation and subtraction”, paragraph [0055] and “The summed value may then be compared with one or more threshold values, where each level indicates whether the value of the epilepsy signal is to be increased or reduced by a predetermined value or remain unchanged”, paragraph [0057]); and determining at least one of a risk of a false positive indicator, a risk of a false negative indicator, and an indicator of the occurrence of an epileptic seizure (see Figure 2),wherein the determining is based on at least one of the delta non-ictal value, the delta detection value, and the delta ictal value (see Figure 2).
Regarding claim 12, Gommesen discloses that the first reference heart rate value is an ictal threshold of heart rate as a function of patient activity level (“the reference parameters are determined by performing a plurality of measurements over a plurality of given time periods, so that the heart rate and the heartbeats are measured under the various activities which may occur during one or more normal days of the user.”, paragraph [0049]).
Regarding claim 13, Gommesen discloses that the second reference heart rate value is a resting heart rate of the patient (“the reference parameters are determined by performing a plurality of measurements over a plurality of given time periods, so that the heart rate and the heartbeats are measured under the various activities which may occur during one or more normal days of the user. The activities may be…sleep”, paragraph [0049]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liao et al. (WO 2012/148504) discloses a method of characterizing seizure activity in a patient based on heart rate (see Abstract) that includes detecting a seizure based on a difference between a current heart rate and a threshold (see paragraph [H101]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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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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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
