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 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 101 see the analysis below.
Step 1
The invention claimed in claims 1-20 are directed to statutory subject matter as the claims recite an apparatus.
Step 2A, Prong 1
Regarding Claims 1 and 13, the recited steps of “assigning” symptom values, “determining” severity score based on the symptom values, “generating” a prediction of a neurological even based on the symptom severity scores, and “triggering” an alert based on the prediction are directed to a mental process of performing concepts in the human mind (including by a human using the aid of pen and paper) and/or a mathematical concept. For example, this limitation simply amounts to the mental process of a clinician reviewing data (such as images, audio, motion etc.) and performing a mental analysis assigning values, using values to mentally determine scores and making a prediction if the patient is suffering a stroke and if it is determined they are suffering a stroke then determining an alert is necessary such as calling upon assistance etc. Additionally, “assigning”, “generating” using a machine learning model are mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas; while the use of mathematical relationships, mathematical formulas or equations, mathematical calculations are Mathematical concepts. Accordingly, the claim recites an abstract idea. Examiner notes that in another interpretation the “assigning” step could be interpreted as part of the extra-solution activity of data gathering instead of part of the mental concept.
Step 2A, Prong 2
Regarding Claims 1 and 13, the judicial exception is not integrated into a practical application. The claims include the additional elements of “receiving” data and “generating” a display for the alert. The step of “receiving . . .” the data amounts to insignificant, extra-solution activity in that the it is data gathering (or in an alternative interpretation this also includes the steps of “assigning”). The step of “generating . . .” the display for the alert is extra solution as merely outputting a result. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, “user device”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
Regarding Claims 1 and 13, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As with step 2A, Prong 2 above, the additional elements of “receiving” data and “generating” a display for the alert. The step of “receiving . . .” the data amounts to insignificant, extra-solution activity in that the it is data gathering (or in an alternative interpretation this also includes the steps of “assigning”). The step of “generating . . .” the display for the alert is extra solution as merely outputting a result. The processor (i.e., “processor”, “computer processor”, “cloud-computing device”, “mobile device”, “user device”) in computing steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of determining outputs from inputs) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Additionally, per the Berkheimer requirement, the sensor, display, processing device and data storage: (1) Eichler see citations below; (2) US 20180140203 – Cited in IDS dated 8/2/23 – see [0042]-[0044], [0053]-[0054], Figs. 1-3; (3) Strasser cited below: abstract, [0118]-[0120], Fig. 1; (4) US20180177451 - Cited in IDS dated 8/2/23 – see [0040]-[0041], [0049], [0054]-[0055], Figs. 1A-B. As such the elements are shown to be WRC.
The claim limitations when viewed individually and in combination therefore do not amount to significantly more than the abstract idea itself. The claims are therefore ineligible.
Claims 2-12, 14-20 only further define the data gathering (insignificant, extra-solution activity) or further define elements of the model (i.e., only further define the mental process). Therefore, the claims do not include any additional elements that show integration into a practical application and do not include any additional elements that amount to significantly more than the abstract idea. The claims 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9, 11-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20220044821 to Eichler et al.
Regarding Claim 1, an interpretation of Eichler discloses a computer-implemented method, comprising:
receiving, using at least one processor, data corresponding to one or more symptoms, detected by one or more sensors, associated with a subject, the one or more sensors including at least one of the following sensors: one or more sensors positioned directly on the subject, one or more sensors being positioned away from the subject, and any combination thereof ([0005], [0032] including “The processor is configured to receive clinical measurement data pertaining to the subject. The clinical measurement data is acquired from at least one sensor that is configured to sense at least one of image data, sound data, movement data, and tactile data pertaining to the subject. The processor is configured to extract from the clinical measurement data, potential stroke features”, [0040], Figs. 1-4; Examiner notes that “at least one of the following sensors: one or more sensors positioned directly on the subject, one or more sensors being positioned away from the subject, or any combination” covers any sensor that senses the user), the at least one processor being communicatively coupled to the one or more sensors ([0005], [0032], [0035], Figs. 1-4, 8);
assigning, using the at least one processor, one or more symptom values to the one or more detected symptoms ([0037], [0047] including “configured and operative to extract potential stroke features (e.g., attributes and their corresponding value) from the clinical measurement data”, [0048]-[0050], Figs. 3-4, 7-8);
determining, using the at least one processor, a severity score for each of the one or more symptoms ([0066], [0071] including “individual scores for various subtests”, Tables 1-12, Figs. 7, 14, 16), the severity scores being determined using one or more machine learning models receiving the one or more assigned symptom values as input ([0066], [0071] including “individual scores for various subtests”, Tables 1-12, Figs. 14, 16 see also [0043], [0057]; tables include recitations that they use “MLC” (aka machine learning classifier) to determine score for subtest/category based on features);
generating, using the at least one processor, a prediction that the subject is experiencing at least one neurological event and at least a type of the at least one neurological event using a combination of the determined severity scores corresponding to the one or more symptoms ([0032] including “The systems of the disclosed technique are configured and operative to provide an indication of a stroke as soon (i.e., immediate, in real-time) as it is detected (i.e., estimated at a high likelihood, i.e., over a threshold probability).”, [0072], [0074], [0076], [0078] including “After quantifying each category of the NIHSS, the total score can define the stroke severity” Figs. 17A-B, 19 see also [0002], [0042], [0077]; stroke severity score includes “no stroke” option thus a determination of whether or not the user is suffering from a stroke);
triggering, using the at least one processor, a generation of one or more alerts based on the prediction ([0042] including “systems 101 1, and 101 2 are configured and operative to alert the user, the user's relatives, and medical professionals, as will be detailed hereinbelow.”, [0075]-[0076], Figs. 17A-B, 19); and
generating, using the at least one processor, one or more user interfaces for displaying the one or more alerts ([0037], [0042] including “systems 101 1, and 101 2 are configured and operative to alert the user, the user's relatives, and medical professionals, as will be detailed hereinbelow.”, [0075]-[0076], Figs. 7, 17A-B, 19).
Regarding Claim 2, an interpretation of Eichler further discloses wherein the at least one neurological event includes a stroke (abstract, [0042]).
Regarding Claim 3, an interpretation of Eichler further discloses wherein the one or more sensors include at least one of the following: an audio sensor ([0005], [0032] including “The processor is configured to receive clinical measurement data pertaining to the subject. The clinical measurement data is acquired from at least one sensor that is configured to sense at least one of image data, sound data, movement data, and tactile data pertaining to the subject. The processor is configured to extract from the clinical measurement data, potential stroke features”, Figs. 1-4).
Regarding Claim 4, an interpretation of Eichler further discloses wherein the one or more symptoms include at least one of the following: one or more symptoms determined based on one or more physiological responses from the subject ([0054], [0060], Figs. 1-4, Tables 1-12 see also [0055]-[0057]).
Regarding Claim 5, an interpretation of Eichler further discloses wherein the one or more physiological responses include at least one of the following: one or more facial landmarks ([0054], [0069]-[0070] including “a graph of an amalgamated position of right facial landmarks as well as a graph of an amalgamated position of left facial landmarks that are related to smiling of a subject of FIG. 11, and their interrelationship”, Figs. 1-4, Tables 1-12 see also [0055]-[0057]).
Regarding Claim 6, an interpretation of Eichler further discloses wherein the one or more symptoms include at least one of the following: facial paralysis ([0054], [0069]-[0070] including “a graph of an amalgamated position of right facial landmarks as well as a graph of an amalgamated position of left facial landmarks that are related to smiling of a subject of FIG. 11, and their interrelationship”, Figs. 1-4, Tables 5 see also [0004], [0055]-[0057]).
Regarding Claim 7, an interpretation of Eichler further discloses wherein the one or more biological parameters include at least one of the following: a blood pressure ([0040] including “a blood pressure measurement device (not shown) may be used as to acquire clinical measurement blood pressure data (not shown).”).
Regarding Claim 8, an interpretation of Eichler further discloses wherein the type of the at least one neurological event includes at least one of the following: an ischemic stroke ([0060] including “determined stroke type and its probability PT”, [0074]-[0075] including “information pertaining to the stroke type (ischemic. . .”).
Regarding Claim 9, an interpretation of Eichler further discloses wherein the receiving includes at least one of the following: receiving the data resulting from actively requiring the subject to perform an action ([0051]-[0052], [0066]-[0067] including “acquired from subject during a user interaction prompt of system”, [0072], Tables 1-12, Figs. 10-11).
Regarding Claim 11, an interpretation of Eichler further discloses wherein at least one of the receiving, the assigning, the determining, the generating the prediction, the triggering, and the generating the one or more user interfaces is performed in substantially real time ([0032] including “The systems of the disclosed technique are configured and operative to provide an indication of a stroke as soon (i.e., immediate, in real-time) as it is detected (i.e., estimated at a high likelihood, i.e., over a threshold probability).”, [0072]).
Regarding Claim 12, an interpretation of Eichler further discloses wherein the generating the one or more user interfaces includes arranging one or more graphical objects corresponding to the one or more symptoms, the prediction, the one or more alerts, in the one or more user interfaces in a predetermined order ([0061], [0074], [0076], Figs. 17A-B, 19).
Regarding Claim 13, an interpretation of Eichler discloses a system comprising:
at least one programmable processor ([0032], [0035]-[0036], [0038], Figs. 1-3, 8); and
a non-transitory machine-readable medium storing instructions that, when executed by the at least one programmable processor ([0032], [0035]-[0036], [0038]-[0039], [0054] Figs. 1-3, 8), cause the at least one programmable processor to perform operations comprising:
receiving data corresponding to one or more symptoms, detected by one or more sensors, associated with a subject, the one or more sensors including at least one of the following sensors: one or more sensors positioned directly on the subject, one or more sensors being positioned away from the subject, and any combination thereof ([0005], [0032] including “The processor is configured to receive clinical measurement data pertaining to the subject. The clinical measurement data is acquired from at least one sensor that is configured to sense at least one of image data, sound data, movement data, and tactile data pertaining to the subject. The processor is configured to extract from the clinical measurement data, potential stroke features”, [0040], Figs. 1-4; Examiner notes that “at least one of the following sensors: one or more sensors positioned directly on the subject, one or more sensors being positioned away from the subject, or any combination” covers any sensor that senses the user), the at least one programmable processor being communicatively coupled to the one or more sensors ([0005], [0032], [0035], Figs. 1-4, 8);
assigning one or more symptom values to the one or more detected symptoms ([0037], [0047] including “configured and operative to extract potential stroke features (e.g., attributes and their corresponding value) from the clinical measurement data”, [0048]-[0050], Figs. 3-4, 7-8);
determining a severity score for each of the one or more symptoms ([0066], [0071] including “individual scores for various subtests”, Tables 1-12, Figs. 7, 14, 16), the severity scores being determined using one or more machine learning models receiving the one or more assigned symptom values as input ([0066], [0071] including “individual scores for various subtests”, Tables 1-12, Figs. 14, 16 see also [0043], [0057]; tables include recitations that they use “MLC” (aka machine learning classifier) to determine score for subtest/category based on features);
generating a prediction that the subject is experiencing at least one neurological event and at least a type of the at least one neurological event using a combination of the determined severity scores corresponding to the one or more symptoms ([0032] including “The systems of the disclosed technique are configured and operative to provide an indication of a stroke as soon (i.e., immediate, in real-time) as it is detected (i.e., estimated at a high likelihood, i.e., over a threshold probability).”, [0072], [0074], [0076], [0078] including “After quantifying each category of the NIHSS, the total score can define the stroke severity” Figs. 17A-B, 19 see also [0002], [0042], [0077]; stroke severity score includes “no stroke” option thus a determination of whether or not the user is suffering from a stroke);
triggering a generation of one or more alerts based on the prediction ([0042] including “systems 101 1, and 101 2 are configured and operative to alert the user, the user's relatives, and medical professionals, as will be detailed hereinbelow.”, [0075]-[0076], Figs. 17A-B, 19); and
generating one or more user interfaces for displaying the one or more alerts ([0037], [0042] including “systems 101 1, and 101 2 are configured and operative to alert the user, the user's relatives, and medical professionals, as will be detailed hereinbelow.”, [0075]-[0076], Figs. 7, 17A-B, 19).
Regarding Claim 14, an interpretation of Eichler wherein the at least one neurological event includes a stroke (abstract, [0042]).
Regarding Claim 15, an interpretation of Eichler further discloses wherein the one or more sensors include at least one of the following: an audio sensor ([0005], [0032] including “The processor is configured to receive clinical measurement data pertaining to the subject. The clinical measurement data is acquired from at least one sensor that is configured to sense at least one of image data, sound data, movement data, and tactile data pertaining to the subject. The processor is configured to extract from the clinical measurement data, potential stroke features”, Figs. 1-4).
Regarding Claim 16, an interpretation of Eichler further discloses wherein the one or more symptoms include at least one of the following: one or more symptoms determined based on one or more physiological responses from the subject ([0054], [0060], Figs. 1-4, Tables 1-12 see also [0055]-[0057]).
Regarding Claim 17, an interpretation of Eichler further discloses wherein the one or more physiological responses include at least one of the following: one or more facial landmarks ([0054], [0069]-[0070] including “a graph of an amalgamated position of right facial landmarks as well as a graph of an amalgamated position of left facial landmarks that are related to smiling of a subject of FIG. 11, and their interrelationship”, Figs. 1-4, Tables 1-12 see also [0055]-[0057]).
Regarding Claim 18, an interpretation of Eichler further discloses wherein the one or more symptoms include at least one of the following: facial paralysis ([0054], [0069]-[0070] including “a graph of an amalgamated position of right facial landmarks as well as a graph of an amalgamated position of left facial landmarks that are related to smiling of a subject of FIG. 11, and their interrelationship”, Figs. 1-4, Tables 5 see also [0004], [0055]-[0057]).
Regarding Claim 19, an interpretation of Eichler further discloses wherein the one or more biological parameters include at least one of the following: a blood pressure ([0040] including “a blood pressure measurement device (not shown) may be used as to acquire clinical measurement blood pressure data (not shown).”).
Regarding Claim 20, an interpretation of Eichler further discloses wherein the type of the at least one neurological event includes at least one of the following: an ischemic stroke ([0060] including “determined stroke type and its probability PT”, [0074]-[0075] including “information pertaining to the stroke type (ischemic. . .”).
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.
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eichler in view of US 20210106238 to Strasser et al. (hereinafter Strasser).
Regarding Claim 10, an interpretation of Eichler further discloses continuously monitoring the subject using the one or more sensors ([0040], [0042], [0047], [0072] including “continuously tracks a detected and ongoing stroke condition in real-time (i.e., real-time diagnosis)”);
determining, one or more new symptom values ([0074], Fig. 17B; receives additional sensor data adds new symptom values based on new sensing modality);
updating, using the at least one processor, the determined severity score for each of the one or more symptoms, and the generated prediction ([0042] including “systems 100 1 and 100 2 to monitor, detect, and alert to changing trends in the clinical measurement data (e.g., speech irregularities get progressively worse, etc.), so as to facilitate early estimation and detection of a stroke condition before it occurs (upcoming stroke event).”, [0066], [0071], [0074] Figs. 14, 16, 19 see also [0040], [0053], [0072]-[0073], tables 1-12; when clinical data is gathered it generates the respective scores);
triggering, using the at least one processor, a generation of one or more updated alerts based on the updated prediction ([0042] including “systems 101 1, and 101 2 are configured and operative to alert the user, the user's relatives, and medical professionals, as will be detailed hereinbelow.”, [0075]-[0076], Figs. 17A-B, 19; the alert is based on current prediction); and
generating, using the at least one processor, one or more updated user interfaces for displaying the one or more updated alerts ([0037], [0042] including “systems 101 1, and 101 2 are configured and operative to alert the user, the user's relatives, and medical professionals, as will be detailed hereinbelow.”, [0075]-[0076], Figs. 7, 17A-B, 19; the alert interface is based on current prediction).
an interpretation of Eichler may not explicitly disclose determining, based on the continuous monitoring, one or more new symptom values
However, in the same field of endeavor (medical diagnostic system), Strasser teaches stroke determination based on a sensed values continuously ([0123]-[0124], [0135] including “Continuous monitoring for a stroke event may improve the response time.” see also [0115],-[0116], [0159], [0195], Figs. 40), determining based on the continuous monitoring one or more new symptom values ([0123]-[0124], [0181] see also [0135], [0159], [0195])
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the data gathering and determination of a stroke as recited by Eichler to include determining a new symptom based on continuously monitored data as recited by Strasser because the continuous sensing/determination of a stroke event provides quicker response/treatment which can dramatically decrease reduce the risk of death and disability ([0004], [0011], [0135])
Conclusion
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/James Moss/Examiner, Art Unit 3792