DETAILED ACTION
This application is being examined under pre-AIA first-to-invent provisions.
Status of claims
Canceled:
none
Pending:
1-16
Withdrawn:
none
Examined:
1-16
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
x
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
x
102, 103
JE
Judicial Exception
x
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The previous objections are withdrawn, however new objections are applied.
The previous 112/2nd rejections are withdrawn, except as noted below.
Rejections and/or objections not maintained from previous office actions are withdrawn.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 objections
Claims 1 and 10 is objected to because of the following informalities. Appropriate correction is required. In each objection the claims are definite with respect to the issues cited here because interpretation would have been sufficiently clear to PHOSITA, but nonetheless the claims are objected to for consistency among the claims or as otherwise indicated. Regarding any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate.
The following issues are objected to:
Claim
Recitation
Comment
1
analyzing... a endocrine
"an endocrine..."
10
initiating
Should read "initiate"
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 112f rejections of Claim 10 should be withdrawn because there is clearly enough structure in the claim (e.g., processor, memory, etc.). Further, the Office's position that administering is not detailed in the specification should be withdrawn because a person of ordinary skill in the art would understand that the specification is enabled with regard to the administering function.
The issue is not only or even primarily the recitation of some minimal physical structure. The recited "process, memory, etc." are generic to the recited functions, providing only minimal and insufficient support. The issue is how the recited functions are to be performed, e.g. "seizure detection," "classification," etc. As noted in the rejection, MPEP 2161.01.I also pertains regarding "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation." The claims are indefinite as improperly invoking 112f for lack of support in the specification as to how the recited functions particularly are to be performed.
Rejections
Claims 1-16 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
1, 9
classifying the epileptic seizure
In claim 1, the recitations are inconsistent. The "seizure" is instantiated as "epileptic," rendering a classification as "epileptic" redundant and a classification as "non-epileptic" inconsistent. A similar issue occurs in claim 9. Possibly the "seizure" should be instantiated in claim 1 simply as "a seizure" and then later classified as "epileptic" vs. "non-epileptic."
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 - 112/1st
The following is a quotation of 112/1st:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Regarding issues of written description support stemming even from the original claims and original disclosure, MPEP 2161.01.I (e.g. 6th para.), 2163.I and 2163.I.A pertain: "[O]riginal claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed" (MPEP 2161.01.I,6th para.).
Response to arguments regarding Claim Rejections - 112/1st
Applicant states (original emphasis removed, bold emphasis added, applicant remarks: p. 12):
...the Office's position that administering is not detailed in the specification should be withdrawn because a person of ordinary skill in the art would understand that the specification is enabled with regard to the administering function.
Regarding claim 14 depending from claim 10 a medical device system, i.e. a form of 101 machine or manufacture, PHOSITA would be a person able to make such a system, e.g. an engineer and programmer. The issue is whether there is support for how such a PHOSITA would make the "system" so as to automate the recited "administering a therapy," and it is not clear that there is such support. It is not clear that ordinary skill in the art includes automated and/or robotic administration of therapy, and it is not clear that there is support disclosed for this function.
In contrast, it can be agreed that for a claim to a "method," i.e. a form of 101 process, e.g. claims 1 and 7, there PHOSITA would include a clinician who would have known how to administer a therapy.
Additionally, the specification at 41:12-16 discloses particular therapies such as "cognitive therapy, behavioral therapy, or biofeedback" and "patient may receive a message that the seizure is non-epileptic, which may be followed by instructions to relax, breathe deeply..." And, the specification at 35:18-36:3 discloses particular therapies such as "parameters... that define therapeutic electrical signals delivered by the medical device..." Thus, there is support for certain types of "system"-delivered therapies. However, there is not support for the recited "initiating one or more therapeutic actions" (claim 10) and "administering a therapy appropriate for a non-epileptic seizure" (claim 14), each of which read on all possible types of seizure therapy, including all of those known to be administered by a clinician.
Written description
This rejection is maintained and revised.
Claims 10-14 are rejected under 112/1st as failing to comply with the written description requirement. The claims read on subject matter which is not described in the specification in such a way as to reasonably convey to PHOSITA that the inventors, at the time the application was filed, had possession of the claimed invention. Claims depending from rejected claims are rejected similarly, unless otherwise noted. Regarding any suggested amendment(s) below to overcome a rejection, equivalent amendments also would be acceptable.
Claim 10 recites "initiating one or more therapeutic actions," and claim 14 recites "...administering a therapy appropriate for a non-epileptic seizure..."
The specification at 41:12-16 discloses particular therapies such as "cognitive therapy, behavioral therapy, or biofeedback" and "patient may receive a message that the seizure is non-epileptic, which may be followed by instructions to relax, breathe deeply..." And, the specification at 35:18-36:3 discloses particular therapies such as "parameters... that define therapeutic electrical signals delivered by the medical device..." Thus, there is support for certain types of "system"-delivered therapies. However, there is not support for the recited "initiating one or more therapeutic actions" (claim 10) and "administering a therapy appropriate for a non-epileptic seizure" (claim 14), each of which read on all possible types of seizure therapy, including all of those known to be administered by a clinician.
Regarding claim 14 depending from claim 10 a medical device system, i.e. a form of 101 machine or manufacture, PHOSITA would be a person able to make such a system, e.g. an engineer and programmer. The issue is whether there is support for how such a PHOSITA would make the "system" so as to automate the recited "administering a therapy," and it is not clear that there is support for a BRI of the recited "therapy." It is not clear that ordinary skill in the art includes automated and/or robotic administration of therapy, for a BRI of the recited "therapy."
In contrast, it can be agreed that for a claim to a "method," i.e. a form of 101 process, e.g. claims 1 and 7, there PHOSITA would include a clinician who would have known how to administer a therapy, for the entire BRI of the recited "therapy."
MPEP 2161.01.I "Determining Whether There Is Adequate Written Description For A Computer-Implemented Functional Claim Limitation" also pertains.
As appropriate, these rejections may be overcome, for example, (i) by narrowing to clearly supported embodiments (e.g. the particular disclosed forms of system-deliverable therapy) and/or (ii) by clarifying on the record where support can be found and how that support relates to the recitations, for the entire BRI of the recited "therapy."
In general, it is requested that any claim amendment in this regard be accompanied by citations to support in the original disclosure.
MPEP 2163 generally pertains.
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.
Response to arguments regarding Claim Rejections - 103
The rejection is revised in view of the amendment, adding the reference Rauchenzauner.
Claims 1-3, 5 and 7-10 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) and Rauchenzauner (as cited on the attached 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]).
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 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 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 claim 10, 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 claim 10 as described above for claim 1.
Combining 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 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.
Combining Quigg, Nathan and Rauchenzauner
In the absence of a secondary consideration to the contrary, 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.
Claims 4, 11-12 and 14-16 are rejected under pre-AIA 35 U.S.C. 103(a) as unpatentable over Quigg in view of Nathan and Rauchenzauner as applied to claims 1-3, 5 and 7-10 and further in view of Tinuper (as cited on the 7/14/2025 Form 892).
Regarding claim 4, Quigg teaches determining an onset of a generalized motor activity (¶ 84).
Malarvili teaches a method for automatic seizure detection based on heartrate variability (Abstract).
The method includes extracting HRV features which differentiate between seizure and non-seizure states (pg. 2595, col. 2).
Thus, Malarvili teaches detecting a seizure based on a non-cerebral autonomic body signal.
Heart rate is a non-cerebral signal.
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 Malarvili to include an HRV based seizure detection
Quigg does not teach that the first classification index comprises a cardiac index remaining below a reference value following the onset of generalized motor activity (as in claim 4).
Tinuper teaches that ictal epileptic discharges cause changes in cardiac rhythm (pg. 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. (pg. 2362, col. 1).
Referring to figure 3, Tinuper teaches that after the onset of a seizure bradycardia is detected:
Thus, Tinuper teaches a cardiac index (heart rate) remaining below a reference value (bradycardia) after the onset of a seizure.
Quigg is already configured to measure heart rate.
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 provide a cardiac index remaining below a reference value following the onset of a seizure by monitoring and determining the occurrence of bradycardia after the onset of a seizure.
As just indicated, in Quigg the onset of a seizure is determined based on motor activity.
A person of ordinary skill in the art would be motivated for such modification because, as just indicated, ictal epileptic discharges cause changes in cardiac rhythm.
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
Previously cited references are combined as described above.
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 Nathan with the teachings by Tinuper to provide a cardiac index remaining below a reference value following the onset of a seizure by monitoring and determining the occurrence of bradycardia after the onset of a seizure. A person of ordinary skill in the art would be motivated for such modification because, as just indicated, ictal epileptic discharges cause changes in cardiac rhythm.
Regarding claim 12, Quigg teaches use of an accelerometer to measure frequency associated with movement ([76]).
Regarding claim 14, Quigg teaches distinguishing non-epileptic seizures ([12-13, 84]; claims 1 and 3).
Regarding claim 15, the art is applied as described for claims 1, 11 and 7.
Regarding claim 16, Quigg teaches pattern analysis ([13, 55, 80-81]).
Claim rejections - 101
35 USC 101 reads:
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.
Response to arguments regarding Claim Rejections - 101
Applicant states (original emphasis removed, bold emphasis added, applicant remarks: p. 12):
Independent Claims 1 and 10 include the limitations of initiating one or more therapeutic actions based on the seizure classification signal. Therefore, the claims are 101 eligible.
Referring to the Office's organization of 101 analysis at MPEP 2106, Applicant's remarks are understood as arguing at Step 2A, 2nd prong that the 2nd consideration regarding treatment applies (MPEP 2106.04(d) and (d)(2)). That is arguing that treatment integrates the identified judicial exceptions (JEs) into a practical application. This argument is not yet persuasive because such a treatment should be physical, particular and informed by the identified JEs. Regarding claim 1 for example, the recited "initiating one or more therapeutic actions based on the seizure classification signal" is not clearly physical and is not clearly sufficiently particular as to the treatment type. Also, the relationship between the treatment type and the JE is not clear.
Judicial exceptions (JE) to 101 patentability
Claims 1-16 are rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more JEs (i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature), as identified below. Any elements or combination of elements beyond the JE(s) (i.e. "additional elements") are conventional and do not constitute significantly more than the JE(s). Thus, no claim includes additional elements amounting to significantly more than the JE(s), as explained below.
In Alice, citing Mayo and Bilski, two Mayo/Alice questions determine eligibility under 101: First, is a claim directed to a JE? And second, if so, does the claim recite significantly more than the JE?
MPEP 2106 organizes JE analysis into Steps 1, 2A (1st & 2nd prongs) and 2B as follows below.
MPEP 2106 and the following USPTO website provide further explanation and case law citations: www.uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter? -- MPEP 2106.I and 2106.03
[Step 1: claims 1-16: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- abstract idea -- MPEP 2106.I and 2106.04
Preliminarily, in a 1st prong of Step 2A, elements of independent claim 1 are interpreted as directed to the abstract idea of distinguishing a non-epileptic seizure from an epileptic seizure including the JE elements of "detecting...," "analyzing...," "determining...," "classifying...," "generating..." and "initiating...," each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below.
Claim 10 is analyzed similarly.
Preliminarily, in a 1st prong of Step 2A, elements of independent claim 15 are interpreted as directed to the abstract idea of distinguishing an epileptic seizure from a non-epileptic seizure including the JE elements of "identifying...," "determining..." (two instances), "classifying..." and "taking...," each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below.
BRIs of the claims are analogous to an abstract idea in the form of at least a mental process, at least equivalent to a computer-implemented process, including obtaining and comparing intangible data (e.g. Cybersource, Synopsys and Electric Power Group). In a BRI, it is not clear that the claim embodiments are limited so as to require complexity precluding analogy to a mental process.
BRIs of the claims are analogous to an abstract idea in the form of at least a method of organizing human activity, such as the practice of a technologist, scientist, medical professional or a computer performing analogous functions (e.g. BASCOM, BSG, Meyer as cited in MPEP 2106), as a particularly relevant example "a mental process that a neurologist should follow when testing a patient for nervous system malfunctions" (MPEP 2106.04(a)(2).II.C.iii).
BRIs of the claims also are analogous to an abstract idea in the form of a mathematical concept, including mathematical relationships and calculations, as found in the following case law, as cited and discussed above: collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group) and/or obtaining and comparing intangible data (e.g. Cybersource, Ambry and Myriad CAFC) and/or execution of an algorithm to implement mathematical relationships and/or formulas, including image processing (e.g. TLI, Digitech, Benson, Flook, Diehr, FuzzySharp, In re Grams and In re Abele all as cited in MPEP 2106).
The preceding case law examples are cited for the basic form of their identified abstract ideas, and analogy to these example abstract ideas need not be within the same technology field, 101 analysis generally being assumed to be neutral with respect to technology field.
[Step 2A, 1st prong, abstract idea: claims 1, 10 and 15: YES]
Step 2A, 2nd prong: If the claims recite a judicial exception under the 1st prong, then is the judicial exception integrated into a practical application? -- MPEP 2106.I and 2106.04(d)
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
In Step 2A, 1st prong above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B.
Here in Step 2A, 2nd prong, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
At this point in examination it is not yet the case that any of the Step 2A, 2nd prong considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement.
Also, regarding the second consideration at MPEP 2106.04(d)(2), the recited "therapeutic actions" (e.g. claim 1) are insufficiently specific to satisfy patent eligibility (MPEP 2106.04(d) and (d)(2) pertains). Such a therapy should be physical, particular and informed by the identified JEs. Regarding claim 1 for example, the recited "initiating one or more therapeutic actions based on the seizure classification signal" is not clearly physical and is not clearly sufficiently particular as to the treatment type. Also, the relationship between the treatment type and the JE is not clear.
[Step 2A, 2nd prong: claims 1, 10 and 15: NO]
Step 2B: Do the claims recite a non-conventional arrangement of additional elements in addition to the identified JEs? -- MPEP 2106.I and 2106.05
All elements of claims 1, 10 and 15 are part of a JE as identified above such that no element is recited which is additional to the identified JE(s). Therefore, no claim recites significantly more than the identified JE(s), and it is not clear that any claim is otherwise sufficiently analogous to controlling case law identifying an example of an eligible claim.
[Step 2B: claims 1, 10 and 15: NO]
Summary and conclusion regarding claims 1, 10 and 15
Summing up the above analysis of claims 1, 10 and 15, each viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the identified JE(s), into patent eligible subject matter, and it is not clear that any claim is sufficiently analogous to controlling case law identifying an example of an eligible claim.
Remaining claims
Claims 2-9, 11-14 and 16 add elements which also are part of the identified JEs for the same reasons described above regarding the independent claims and therefore do not provide the something significantly more necessary to satisfy 101.
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.
Applicant's amendments necessitated the new grounds for rejection in this 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 extension fee 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 date of this final action.
Inquiries
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The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686