DETAILED ACTION
This application is being examined under pre-AIA first-to-invent provisions.
Status of claims
Canceled:
6 and 13
Pending:
1-5, 7-12 and 14-19
Withdrawn:
none
Examined:
1-5, 7-12 and 14-19
Independent:
1, 10 and 15
Allowable:
none
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
x
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 12/8/2020 filing receipt, this application claims priority to as early as 11/3/2011. At this point in examination, all claims have been interpreted as being accorded this priority date.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The claim objections are withdrawn.
The 112/2nd rejections are withdrawn, except as noted below, and a new rejection is applied.
The previous 112/1st rejections are withdrawn.
Referring to 101 analysis as organized in MPEP 2106, the 101 rejections are withdrawn at least in view of the analysis Step 2A, 2nd prong, 2nd consideration relating to treatment integrating possible judicial exceptions into a practical application (MPEP 2106.04(d) and (d)(2)), the treatment in this instance comprising at least the recited initiating an electrical signal therapy. In this regard, Applicant's 5/28/2026 remarks at pp. 12 support withdrawal of the rejection.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
Claim rejections - 112/2nd
The following is a quotation of 112/2nd:
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.
Response to arguments regarding Claim Rejections - 112/2nd
Applicant states (original emphasis removed, bold emphasis added, applicant remarks: p. 12):
...The claims have been amended to remove the 112 issues discussed by the Office to further prosecution on the merits.
It is not clear that the 112/b rejections relating to 112/f have been addressed, and below they are maintained. The 3/3/2026 Response to Applicant's 10/13/2025 remarks also still pertain, further noting here that it is insufficient to recite or disclose only inputs and outputs. For software-implemented means, what is needed regarding structure of the claimed means is support for software pertaining to how to proceed from inputs to outputs.
Rejections
Claims 4, 10-14 and 17-19 are rejected under 112/2nd, as indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate. Regarding any suggested amendment below, for claim interpretation during the present examination it is assumed that each amendment suggested here is made. However, equivalent amendments also would be acceptable.
The following issues cause the respective claims to be rejected under 112/2nd as indefinite:
Claim
Recitation
Comment
4
...comprises the following indices:
...
In the subsequent list of indices, the last lacks a grammatical conjunction specifying the logical relationship among the list elements, rendering the claim indefinite. For compact examination, it is assumed that, as before the last amendment, "or" will be amended into the list.
10
a seizure detection unit
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "seizure detection") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. 4:23), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. If the function is thought to be well-known, reducing the disclosure burden, then this may be argued. MPEP 2181 pertains, and MPEP 2187 and FP 7.34.23 list options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains. This rejection is maintained.
10
a classification unit
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "classification") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. 34:10-35:5), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. If the function is thought to be well-known, reducing the disclosure burden, then this may be argued. MPEP 2181 pertains, and MPEP 2187 and FP 7.34.23 list options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains. This rejection is maintained.
11
a signal module
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "signal") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. 20:23-21:16), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. If the function is thought to be well-known, reducing the disclosure burden, then this may be argued. MPEP 2181 pertains, and MPEP 2187 and FP 7.34.23 list options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains. This rejection is maintained.
14
therapy unit
Indefinite under 112/b after invoking 112/f. Recites means (or an equivalent, nonce term, here "unit") and function and/or result (here "therapy") without specifying steps or structure to prevent invoking, and it is not clear that the specification discloses sufficient structure, material, or acts rather than just function and results (e.g. 25:8-18), noting that any disclosure must be clearly linked to the invoking recitation and that the above citation to the specification does not clearly disclose structure sufficient to satisfy 112/b. While inputs and/or outputs are disclosed, there is not clear disclosure of analysis required to proceed from inputs to outputs. If the function is thought to be well-known, reducing the disclosure burden, then this may be argued. MPEP 2181 pertains, and MPEP 2187 and FP 7.34.23 list options for overcoming the rejection. MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains. This rejection is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-5, 7-12 and 14-18 are rejected under pre-AIA 35 U.S.C. 103(a) as unpatentable over Quigg (US 2011/0230730 as cited on the 7/14/2025 Form 892) in view of Nathan (US 2009/0062696 as cited on the 7/14/2025 Form 892), Rauchenzauner (as cited on the 3/3/2026 Form 892) and Tinuper (as cited on the 7/14/2025 Form 892).
Regarding claim 1, the recited detecting reads on Quigg as a method and a system for distinguishing epileptic from non-epileptic pseudoseizures (Quigg: ¶12-13). In Quigg a seizure is detected solely based on a first body neurological signal, an EEG. There are no other means for detecting seizures in Quigg and thus, the detection is made solely on the EEG.
The recited analyzing, determining, classifying, generating and the final "wherein" clause read on Quigg's Fig. 1B which teaches a sensor module 22 measures physical movement of a subject 10 by providing electronic data representing the movement (Quigg: ¶24). The sensor includes an accelerometer (¶ 26). Referring to figure 1A the system and method provide for measuring and accumulating an electronic data stream 20 representing and motor activity of subject 10 and processing and analyzing 60 said motor activity electronic data to distinguish epileptic from non-epileptic pseudoseizures 80. The distinguished data is compared to CV-EEG 70 and/or implemented with subsystems of the CV-EEG 70 (Quigg: ¶23). Motor activity is quantified to distinguish the two seizure types based on limb movements of the subject (or other areas of the subject as required) (¶41). The system includes a processor for processing data representative of motor activity to distinguish epileptic (ES) from non-epileptic pseudoseizures (PS) (¶ 13).
The recited initiating therapy reads on Quigg's output of the diagnostic convulsion system is used by a doctor for appropriate actions for treatment or diagnosis of the subject or patient 160 (Quigg: [0041]) in combination with Tinuper's "...insertion of a cardiac pacemaker..." (Tinuper: p. 2369, last sentence; and entire document).
Quigg does not teach that the detection is based on an extra-cerebral body signal of the patient.
Nathan teaches a seizure monitor that provides intelligent epilepsy seizure detection, monitoring, and alerting for epilepsy patients and/or other people that experience seizures (Nathan: ¶ 20).
Referring to Nathan figure 1, motion detector 110 is a small device (accelerometer, a gyro sensor, and/or a hybrid of both ) that can fit into an enclosure the size of a wristwatch and is mounted on a patient 108 so that motions of the patient may be measured (¶ 29 and 32).
Neither Quigg nor Nathan teaches the recited second extra-cerebral body signal as an endocrine signal or a tissue stress marker signal. However, Rauchenzauner teaches this limitation as "Postictal measurement of plasma NT-proBNP seems to be useful in discriminating different types of epilepsy... in child hood" (Rauchenzauner: p. 101, §"Summary;" and entire document), "NT-proBNP" being Brain-type natriuretic peptide (BNP).
Regarding the recited metabolic index of a normal serum potassium concentration, Rauchenzauner teaches analysis of potassium (Rauchenzauner: p. 102, last sentence; and entire document).
Regarding claim 2, the recited threshold reads on Quigg's threshold value for the minimum ApEn during an event of 1.4 distinguishes epilectic from non-epilectic ([Quigg: 81]).
Regarding claim 3, the two extra-cerebral body signals read on Quigg's two orthogonal axes. For example, in the case of wrist emplacement, this would add sensitivity to movement along the radio-ulnar axis. This inherently teaches use of two "channels" of sensor, signal conditioning, digitization, and recording functions (Quigg: [39]).
Regarding claims 4 and 17, Quigg teaches determining an onset of a generalized motor activity (¶ 84).
Regarding the recited index options, Rauchenzauner teaches analysis of body temperature (Rauchenzauner: p. 103, 1st para.; and entire document).
Regarding claim 5, Quigg teaches EEG input to distinguishing seizure types (Fig. 1A).
Regarding claim 7, Quigg teaches that the output of the diagnostic convulsion system including the analysis is delivered wirelessly to a portable device (PDA) and/or to a diagnostic and monitoring center ([0042]).
The output of the diagnostic convulsion system is used by a doctor for appropriate actions for treatment or diagnosis of the subject or patient 160 ([0041]).
As just described the analysis (output of the diagnostic convulsion system) includes whether a seizure is epileptic or a non-epileptics seizure.
Quigg teaches information output [43] and distinguishing non-epileptic seizures ([Fig. 1A).
Quigg teaches treatment ([41]).
Regarding claim 8, the recited second classification from the listed indices reads on Quigg's combination of an approximate entropy and a peak-to-peak amplitude of repeated patterns techniques (Quigg: [13]).
Regarding claim 9, Quigg teaches classifying the seizure as a non-epileptic seizure only if the at least a first classification index is within non-epileptic seizure reference values, wherein, as just described, a determination of a non-epileptic seizure is based on a comparison with a threshold value.
Regarding claims 10 and 18, Nathan teaches the instantly recited medical device system, wherein referring to Nathan Fig. 1, motion detector 110 is a small device (accelerometer, a gyro sensor, and/or a hybrid of both) that can fit into an enclosure the size of a wristwatch and is mounted on a patient 108 so that motions of the patient may be measured (Nathan: ¶ 29 and 32).
Nathan's seizure detection system is able to detect seizures using any of four strategies: (1) learning based and/or (2) rules, conditions and/or logic based, (3) probabilistic/statistical models and detection methods and (4) analysis of local, regional, global features which include both data and temporal information (¶ 47). Nathan teaches at least one sensor (monitor with motion sensor) configured to receive a non-cerebral neurologic signal indicative of neurologic activity of the patient (motion sensor acquires data pertaining to the movement of the patient or user, limb/body movement is neurologic a non-cerebral body signal) and a seizure detection unit (monitor includes a processor with algorithms for detection of seizures) configured to detect a seizure solely on a non-cerebral neurologic body signal. As in Nathan Fig. 7, seizure detection is based only on measurement of motions via a wearable monitor which includes an accelerometer.
Nathan does not teach a classification unit configured to classify said seizure as one of an epileptic seizure and a non-epileptic seizure.
Quigg teaches a method and a system for providing clinically-useful sensitivity and specificity for diagnosis of epileptic (ES) vs non-epileptic pseudoseizures (PS) outside of the inpatient monitoring unit embodied in devices and systems that are fully portable, non-encumbering to the patient, and relatively inexpensive (¶ 11).
Referring to Fig. 1A, the diagnostic convulsion system and related method provides for measuring and accumulating an electronic data stream 20 representing and motor activity of subject 10; and processing and analyzing 60 said motor activity electronic data to distinguish epileptic seizure from non-epileptic pseudoseizures 80 (¶ 32).
Nathan and Quigg are related to the same field of endeavor: monitoring patient suffering from seizures.
The art is further applied to claims 10 and 18 as described above for claim 1.
Regarding claim 11, Nathan teaches a neurological signal module capable of collecting signals indicative of a motor activity of the patient wherein, the system includes a sensor for collection of motion activity signals.
As described for claim 10, Nathan teaches that the classification unit is configured to classify said epileptic seizures based on at least one non-cerebral kinetic index indicating one of an onset or a lack of generalized motion activity based on said signals indicative of the motor activity wherein, the device calculates statistical parameters reflecting regularity and rhythmicity of movement which include ApEn and a threshold value for ApEn. Seizures are classified as one of a non-epileptic or epileptic based on the extra-cerebral classification index.
Nathan does not teach that the classification is performed based also on a cardiac index indicating that cardiac indices are below a reference value following the onset of generalized motor activity.
Tinuper teaches that ictal epileptic discharges cause changes in cardiac rhythm (Tinuper: p. 2361, col. 1). Autonomic nervous system changes associated with seizures were investigated by non-invasively monitoring ECG, plethysmogram, breathing and blood pressure concurrently with EEG. (p. 2362, col. 1).
Referring to figure 3, Tinuper teaches that after the onset of a seizure bradycardia is detected.
Tinuper teaches a cardiac index (heart rate) remaining below a reference value (bradycardia) after the onset of a seizure.
Combining Quigg, Nathan, Rauchenzauner and Tinuper
It would have been obvious to one with ordinary skill in the art at the time the invention was made to modify the apparatus by Nathan with the classification unit as taught by Quigg to enable discernment between ES and PS based on motion data via a wearable device by analyzing the motion data to obtain statistical parameters reflecting regularity and rhythmicity include ApEn and a threshold value for ApEn and distinguishing ES and PNES by comparing ApEn to a threshold. This modification is advantageous since it would minimize the number of false alerts provided to a third party in Nathan systems arising from a seizure which does not originate from abnormal brain activity.
It would have been prima facie obvious for PHOSITA to modify the seizure teaching of Quigg and Nathan using the related teaching of Rauchenzauner. As motivation to combine, an advantage taught by Rauchenzauner of modifying methods such as those of Quigg and Nathan would have been the teaching of Rauchenzauner that "Postictal measurement of plasma NT-proBNP seems to be useful in discriminating different types of epilepsy... in child hood" (Rauchenzauner: p. 101, §"Summary;" and entire document). Thus, PHOSITA would have been motivated to modify Quigg and Nathan using the above techniques of Rauchenzauner in order to achieve the above advantage. One would have had a reasonable expectation of success in doing so because Quigg, Nathan and Rauchenzauner are generally drawn to related teaching, and PHOSITA would have understood how to and would have been motivated to apply the teaching of Rauchenzauner to the related teaching of Quigg and Nathan.
It would have been obvious to one with ordinary skill in the art at the time the invention was made to modify the method by Quigg with the teachings by Tinuper to not only provide a therapeutic action based on seizure classification but to particularly provide the electrical signal treatment taught by Tinuper. This combination would have been an example of combining prior art elements according to known methods to yield predictable results (MPEP 2143.I pertains).
Citations to art
In the above citations to documents in the art, rejections refer to the portions of each document cited as example portions as well as to the entirety of each document, unless otherwise noted in the situation of lengthy, multi-subject documents. Other passages not specifically cited within a document may apply as well.
Conclusion
No claim is allowed.
A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this communication.
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/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
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