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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/26/2026 has been entered.
Status of Claims
This action is in response to the RCE filed 7/26/2026.
Claims 1, 5, 7-9, 11, 13-15, 17-19 were amended 7/26/2026.
Claims 1-20 are currently pending and have been examined.
Claim Rejections - 35 USC § 112(b)
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 1 and 11 and therefore their dependent claims 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.
Claims 1 and 11 and therefore their dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. Claims 1 and 11 recite “determine, during the non-instantaneous physiological measurement process, that an accumulated amount of the sections for which the respective usability indicators indicate that the sections are usable for diagnosis satisfies a predetermined criterion”. The omitted steps are: how the predetermined criterion is determined and how the sections usable for diagnosis satisfy the predetermined criterion. Paragraph 368 recites that the determined many-valued quality score fulfills a predetermined criterion exceeded a predetermined amount, however the specification is silent as to how any of these determinations are made. Paragraphs 21, 50-51, 78-79, 100-101, 124-126, recite that the predetermined criterion exceeded a predetermined amount, but not how the predetermined criterion is determined nor how the criterion determines that the sections are usable for diagnosis to satisfy the predetermined criterion. Paragraph 361 recites that the predetermined criterion is a threshold, but not how the threshold is determined or calculated.
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 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-20 are drawn to a method and a device which are statutory categories of invention (Step 1: YES).
Independent claims 1 and 11 recite receiv[ing] during a non-instantaneous physiological measurement process of a patient, a plurality of sections of physiological data acquired, each of the sections representing a respective time period of the non-instantaneous physiological measurement process; analyz[ing] during the non-instantaneous physiological measurement process each received section of physiological data to determine a usability indicator indicating if the received section is usable for diagnosis of a medical condition of the patient or not, wherein the analysis comprises transforming the section of physiological data into a frequency domain representation, and wherein determining the usability indicator is based at least in part on the frequency domain representation, determine, during the non-instantaneous physiological measurement process, that an accumulated amount of the sections for which the respective usability indicators indicate that the sections are usable for diagnosis satisfies a predetermined criterion; in response to determining that the accumulated amount satisfies the predetermined criterion, provide a success indication configured to indicate that the non-instantaneous physiological measurement process can be stopped; identify[ing] a subset of the sections, wherein (a) the subset includes at least one of the seconds associated with the respective usability indicator indicating that the received section is usable for diagnosis of the medical condition of the patient, and (b) the subset does not include at least one of the sections associated with a respective usability indicator indicating that the received section is not usable for diagnosis of the medical condition of the patient; and send[ing] the identified subset.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity by managing interactions between a medical practitioner (user) and patient in order to diagnose the patient as shown in Figure 17. If a claim limitation, under its broadest reasonable interpretation, covers fundamental economic principles or practices and/or managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “medical data acquisition device”, “processing circuitry”, “sensors”, are recited at a high level of generality (e.g., that the calculating and displaying is performed using generic computer components and generic machine learning models with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, Figure 17 and
Paragraph 237, where “While not necessarily so1 system 200 may be a portable unit, a mobile unit1 a handheld unit, etc. System 200 may be a user activated mobile device, which is designed to be operated by a user without medical training (also referred to herein as "a non-medical practitioner"). Optionally, system 200 may be a smartphone, or another computer which optionality includes one or more different types of sensors. Optionally, system 200 may be a dedicated portable handheld device which includes one or more sensors and a processor”
Paragraph 496, where “It is to be noted that in some cases, the medical data acquisition device 1704 can be a handheld device, and at least the processing circuitry1705 and the sensors 1706 can be comprised within a housing of the medical data acquisition device 1704, that can optionally be a handheld device. In some cases, the sensors can be comprised within removably attachable units configured to be attached to the medical data acquisition device 1704. In some cases, the sensors can be external to the medical data acquisition device 1704 and in such cases, it may communicate with the medical data acquisition device 1704 via a wired connection and/or via a wireless connection (e.g. a WIFI connection).”
Paragraph 447, where “Providing the diagnosis-enabling data to the diagnosing entity can include transmitting the diagnosis-enabling data, via a network interface (whether wired or wireless), to a separate device (e.g. a computerized workstation, a smartphone, a tablet, etc.), other than system 200, the separate device operated by a medical practitioner.”
Paragraph 307, where “It is to be noted that in some cases, various machine learning models (such as Support Vector Machine (SVM) or other techniques) can be used for determining presence of diagnosis-enabling data (e.g. existence of specific forms in an image (e.g. tonsil, tympanic membrane, body parts) or specific segments in audio (e.g. S1, S2 in heart) within the physiological data.”
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with route, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claims 2-10 and 12-20 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are directed to an abstract idea without significantly more. Claims 2, 4-10, 12, 14-20 recite measuring, thresholding, and identifying data and do not provide additional elements that would amount to significantly more than the abstract idea. Claims 3 and 13 further recite a sensor which is generically recited in the specification paragraph 250. Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f). These claims fail to remedy the deficiencies of their parent claims above, and therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederick (US 10,028,698 B1) in view of Penders US (10,258,288 B2) and further in view of Soni (US 20140324800 A1).
CLAIM 1-
Frederick teaches the limitations of:
A medical data acquisition device comprising processing circuitry and one or more medical data acquisition sensors, the processing circuitry configured to: (Frederick teaches a patient data acquisition system that includes sensors and processors (col 12 lines 1-35)
receive, during a non-instantaneous physiological measurement process of a patient, a plurality of sections of physiological data acquired by at least one of the medical data acquisition sensors (Frederick teaches that the process of obtaining physiological measurements by using computer-assisted scoring (i.e., non-instantaneous) are collected from the sensors (col 4 lines 1-25)
each of the sections representing a respective time period of the non-instantaneous physiological measurement process (Frederick teaches that in the process of obtaining measurement data (i.e., sections of data of the measurement) it can include over a measurement time period (col 9 line 35-39)
analyze during the non-instantaneous physiological measurement process each received section of physiological data to determine a usability indicator indicating if the received section is usable for diagnosis of a medical condition of the patient or not (Frederick teaches an artifact rejection module, when the process of obtaining the measurement has too much artifact it is well-known in the art that it cannot be used. Frederick teaches that as the data is processed, it is determined if the data can be used when diagnosing the patient or not (col 28 lines 1-16, col 19 lines 1-11, Figure 3))
wherein the analysis comprises transforming the section of physiological data into a frequency domain representation and when determining the usability indicator is based at least in part on the frequency domain representation (Frederick teaches using frequency analysis to remove sections of artifact (i.e., removing unusable bits of data) of the physiological data in order to obtain usable (i.e., transformed) data without artifacts (i.e., data indicated to be without artifact and usable) which is obtained prior to diagnosis (i.e., the transformed data is then analyzed to perform diagnostic processes including frequency analysis (i.e., comparing variance in the frequency domain as recited in the specification paragraph 297) representation of the physiological signals to yield artifact detection) (col 18 63-67- col19 lines 1-21, col 28 lines 1-22, claims 14 and 18, col 19 lines 1-20)
Frederick does not explicitly teach, however Penders teaches:
determine, during the non-instantaneous physiological measurement process, that an accumulated amount of the sections for which the respective usability indicators indicate that the sections are usable for diagnosis satisfies a predetermined criterion; (Penders teaches that the section of data that is continuing to be analyzed (i.e., heartbeat) is sectioned into noise data and artifact data sections, and using a confidence level (i.e., usability indicator) indicates if the data is accurate in order to be used to diagnose heartbeat and the accuracy is dependent on a predetermined level (i.e., usability indicators rely on thresholds of a predetermined nature) (col 11 lines 3-60, col 16 lines 1-30))
identify a subset of the sections wherein (a) the subset includes at least one of the sections associated with the respective usability indicator indicating that the received section is usable for diagnosis of the medical condition of the patient (Penders teaches that the section of data that is continuing to be analyzed (i.e., heartbeat) is sectioned into noise data and artifact data sections, and using a confidence level (i.e., usability indicator) indicates if the data is accurate in order to be used to diagnose heartbeat (col 11 lines 3-60))
and (b) the subset does not include at least one of the sections associated with a respective usability indicator indicating that the received section is not usable for diagnosis of the medical condition of the patient (Penders teaches that if the confidence level indicates that data is unusable, then that section of data is concealed to calculating (col 13 lines 37-51))
and send the identified subset (Figure 13 of Penders shows that the identified subset of the waveform has a lower level of confidence and displays it to the user remotely (col 21 lines 11-25, col 9 lines 17-25, col 6 lines 60-66)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Frederick to integrate the application of having confidence levels of the unusable artifact data of Penders with the motivation of improving collection data to account for human body motion that may interrupt the signal data of a physiological parameter (see: Penders, col 1 lines 15-40).
Frederick in view of Penders does not explicitly teach, however Soni teaches:
in response to determining that the accumulated amount satisfies the predetermined criterion, provide a success indication configured to indicate that the non-instantaneous physiological measurement process can be stopped ( teaches that the collection procedure of patient data can be stopped once successful data acquisition meets adherence criteria (i.e., predetermined criterion) and can be based on entry criteria of amount of data over a predetermined period of time (para [0091-0092, 0097]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system with confidence levels of data of Frederick in view of Penders to integrate the application of stopping the data collection when the criteria is met of Soni with the motivation of improving long-term treatment by monitoring the patient’s condition (see: Soni, col paragraph 2).
CLAIM 2-
Frederick in view of Penders teaches the limitations of claim 1. Regarding claim 2, Penders further teaches:
wherein a length of time represented by the subset exceeds a time-length threshold (confidence indicator and the relevant threshold(s) over a certain time period, a particular color (red, orange, or green) may be selected for display, a waveform for the physiological data may be displayed in a particular manner (col 12 lines 30-34))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Frederick to integrate the application of having confidence levels of the unusable artifact data in time periods of Penders with the motivation of improving collection data to account for human body motion that may interrupt the signal data of a physiological parameter (see: Penders, col 1 lines 15-40).
CLAIM 3-
Frederick in view of Penders and further in view of Soni teaches the limitations of claim 1. Regarding claim 3, Frederick further teaches:
wherein the physiological measurement being conducted by a user using a sensor comprised within the medical data acquisition device (Frederick teaches that the patient data device is portable (col 17 lines 17-21) and that a technician applies the sensors and monitors them remotely (col 16 lines 55-67))
CLAIM 4-
Frederick in view of Penders and further in view of Soni teaches the limitations of claim 1. Regarding claim 4, Frederick further teaches:
wherein the physiological data is obtained during the non-instantaneous physiological measurement process conducted at a first geographical location and sent to a second geographical location of the medical practitioner, the second geographical location being remote from the first geographical location (Frederick teaches that process of obtaining the remote location includes receiving data that is obtained from a separate testing location (col 21 lines 45-66))
CLAIM 5-
Frederick in view of Penders and further in view of Soni teaches the limitations of claim 1. Regarding claim 2, Penders further teaches:
wherein the subset is identified upon the subset being a subset of the sections having a subset length that exceeds the time-length threshold (Filtering of the physiological data to remove unwanted noise and/or artifacts may be done in the time domain, frequency domain, or other domain as appropriate. As an example, a time domain filter may be practical for removal of artifacts when the data has a waveform that is cyclic in nature (col 13 lines 21-26); wherein a time period is a designated threshold)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Frederick to integrate the application of having confidence levels of the unusable artifact data in time periods of Penders with the motivation of improving collection data to account for human body motion that may interrupt the signal data of a physiological parameter (see: Penders, col 1 lines 15-40).
CLAIM 6-
Frederick in view of Penders and further in view of Soni teaches the limitations of claim 1. Regarding claim 6, Frederick further teaches:
wherein the identified subset includes diagnosis-enabling data (Frederick teaches that the subset of data that is identified to be artifact-free can be used in diagnosis of sleep (col 7 lines 5-15, col 18 lines 1-20))
CLAIM 7-
Frederick in view of Penders and further in view of Soni teaches the limitations of claim 1. Regarding claim 7, Frederick further teaches:
wherein the sections of physiological data form an uninterrupted flow of physiological data (The data can be transmitted once, at multiple points during the test. With multiple point data transmission, the sleep test can be remotely monitored from anywhere around the world (col 4 lines 1-4))
CLAIM 8-
Frederick in view of Penders and further in view of Soni teaches the limitations of claim 1. Regarding claim 8, Frederick further teaches:
wherein the subset of the sections of physiological data (Control over the encoding methods may include, but is not limited to selection of a subset of the entire set of signals, target image size, and decimation ratio (col 17 lines 34-37)) forms an uninterrupted flow of physiological data (The data can be transmitted once, at multiple points during the test, or continuously. With continuous data transmission, the sleep test can be remotely monitored from anywhere around the world (col 4 lines 1-4))
CLAIM 9-
Frederick in view of Penders teaches the limitations of claim 1. Regarding claim 9, Frederick further teaches:
wherein the subset of the sections includes one or more pairs of adjacent sections (Figure 10 of Frederick shows that the sections of data are adjacent in pairs to create a corrected EEG from the pair of adjacent continuous sections)
CLAIM 10-
Frederick in view of Penders and further in view of Soni teaches the limitations of claim 1. Regarding claim 10, Frederick further teaches:
and (b) at least one succeeding section of the sections associated with the respective usability indicator indicating that the sections are usable for diagnosis of the medical condition of the patient (Frederick teaches that the section of data that is continuing to be analyzed in sections of an EEG and Motion data in order to create a corrected EEG for diagnosis analysis that removes the artifact sections (Figure 10))
Penders further teaches:
wherein the subset does not include at least one intermediate section of the sections associated with the respective usability indicator indicating that the received section is not usable for diagnosis of the medical condition of the patient (Penders teaches that if the confidence level indicates that data is unusable, then that section of data anytime in the section (which may be an intermediate piece of data) is concealed to calculating (col 13 lines 37-51))
the intermediate section having (a) at least one preceding section of the sections associated with the respective usability indicator indicating that the sections are usable for diagnosis of the medical condition of the patient (Penders teaches that the section of data that (that may have been collected at any time (i.e., intermediate section) is continuing to be analyzed (i.e., heartbeat) is sectioned into noise data and artifact data sections, and using a confidence level (i.e., usability indicator) indicates if the data is accurate in order to be used to diagnose heartbeat (col 11 lines 3-60))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Frederick to integrate the application of having confidence levels of the unusable artifact data of Penders with the motivation of improving collection data to account for human body motion that may interrupt the signal data of a physiological parameter (see: Penders, col 1 lines 15-40).
CLAIMS 11-20-
Claims 11-20 are significantly similar to claims 1-10 and are rejected upon the same art respectively.
Response to Arguments
The arguments filed 7/26/2026 have been fully considered.
The arguments pertaining to the 112(a) and 112(b) rejections are persuasive as the claim limitations that rendered the 112(a) and 112(b) rejections have been removed. However, a new 112(b) rejection has been made in view of the amendments.
Regarding the arguments pertaining to the 101 rejection, these arguments are not persuasive. Applicant argues that the claims are not directed towards “Certain Methods of Organizing Human Activity”. Applicant argues that the processing circuitry and the claimed success indication performs a defined function within the physical measurement process overcome the abstract idea by creating a practical application. Examiner respectfully disagrees and the claimed invention is directed towards a patient and remote provider as evidenced in the specification. Further, the data is being transformed through filtering using statistical models as shown in the specification paragraph 297. The statistical processes are being performed on a generic computing components of the recited medical device comprising processing circuitry and sensors that merely input/output data as shown in the rejection above and do not provide significantly more than the abstract idea. The claims here are not directed to a specific improvement to computer functionality that amount to a practical application. Rather, they are directed to the use of conventional or generic technology in a well-known environment, without any claim that the invention reflects an inventive solution to a technical problem presented by combining the two. In the present case, the claims fail to recite any elements that individually or as an ordered combination transform the identified abstract idea(s) in the rejection into a patent-eligible application of that idea.
Further, not every claim that recites concrete, tangible components escapes the reach of the abstract-idea inquiry. (See, e.g., Alice, 134). It is well-settled that mere recitation of concrete, tangible components that are generic is insufficient to confer patent eligibility to an otherwise abstract idea. In order to amount to an inventive concept, the components must involve more than performance of “’well-understood, routine, conventional activities’ previously known to the industry.” (Alice, 134 S. Ct. at 2359 (quoting Mayo, 132 S.Ct. at 1294)). The originally filed specification was investigated and found to support this conclusion.
Applicant further argues that the claim limitations of performing a non-instantaneous physiological measurement process, transforming raw sensor data into the frequency domain using signal processing techniques, automatically determining usability of data segments in real time and excluding at least one unusable section of data provides a claimed improvement based on the specific sequence of data transmission, similar to BASCOM. Examiner respectfully disagrees. The transmitting and filtering of data using generic computing components does not provide a technological improvement that solves a technical problem and is dissimilar from BASCOM. Transforming data using statistical processes to improve reliability and diagnostic usefulness of diagnosing a patient is part of the abstract idea of Certain Methods of Organizing Human Activity. The algorithmic processing and filtering of useable data does not provide a practical application to overcome the abstract idea.
The dependent claims rely on the arguments of the independent claims and are rejected for the reasons stated above.
Regarding the arguments pertaining to the previously applied prior art, these arguments are not persuasive. Applicant argues that Frederick does not disclose the amendments. However, Frederick does disclose using frequency analysis when determining the usability of the data. Applicant argues that Penders does not disclose time-domain processing, however time-domain processing was not claimed. Applicant argues that Penders does not disclose accumulating across time-based sections an amount of data classified as diagnostically usable, determining that the accumulated amount satisfies a measurement-completion criterion, or providing, a success indication that the measurement can be stopped. Examiner respectfully points out that these claim limitations are not present in the claimed invention. However, Penders does teach “determine, during the non-instantaneous physiological measurement process, that an accumulated amount of the sections for which the respective usability indicators indicate that the sections are usable for diagnosis satisfies a predetermined criterion;” on broadest reasonable interpretation by using heart beat data sectioned into noise data and artifact data sections, and using a confidence level (i.e., usability indicator) indicates if the data is accurate in order to be used to diagnose heartbeat and the accuracy is dependent on a predetermined level (i.e., usability indicators rely on thresholds of a predetermined nature) (col 11 lines 3-60, col 16 lines 1-30)). Further, the new reference of Soni is used to teach that the process can be stopped when the successful indicia are met.
Conclusion
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/KIMBERLY A. SASS/Examiner, Art Unit 3686
