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 .
Response to Arguments
Applicant's arguments filed 10/28/25 have been fully considered but they are not persuasive. Regarding the 101 rejections, the Applicant argues that the claims are directed toward the practical application of providing different sensitivity and/or specificity for identifying qualified cardiac events and determining cardiac burden. To support this the Applicant argues that their specification clearly describes using a classification engine configured with a classification model. The Examiner is unable to find any mention of a classification engine in the claims and therefore the Applicant’s line of arguments is moot.
The Applicant further argues that the limitations cannot be practically performed in the human mind because the data acquisition rates required cannot practically be collected and analyzed to effectively determine the value of cardiac burden. The Examiner respectfully disagrees. The claims are silent as to the acquisition rates and do not preclude the data from being sensed and analyzed at a second time. Further the applicant is relying upon the abstract idea itself (i.e., the mentally performable actions which include identifying areas of consistent complexity) for the improvement. The inventive concept cannot be furnished by the abstract idea itself, but must be furnished by the additional elements outside of the abstract idea (MPEP 2106.05, I). The Applicant further argues that Example 4 in the SME examples amount to significantly more just like the current claims. The Examiner respectfully disagrees. Unlike the example, the current claims are directed to the use of a generic arrangement of sensors and processors, all functioning in their usual capacity, is insufficient to show an improvement to the technology. Claim 1 merely requires a complexity assessment and a determination of consistency in the complexity, where the assessment indicates a variation of cardiac burden. The broadest reasonable interpretation of the claims does not limit the assessment of complexity to any particular manner that would preclude a clinician from reviewing the data and mentally assessing a deviation from the expected or normal behavior, and identifying areas where the deviations or abnormalities were consistently appearing. Such an assessment involves the mental processes of comparison, analysis and judgement. Surely a cardiologist is capable of recognizing deviations from the expected or normal heart behavior and the stability/consistency of any recognized abnormal behavior and do a two-part analysis when reviewing presented cardiac data. As stated in MPEP 2106.04(a)(2), Ill, B: The use of a physical aid (e.g., pencil and paper or a slide rule) to help perform a mental step (e.g., a mathematical calculation) does not negate the mental nature of the limitation, but simply accounts for variations in memory capacity from one person to another.
Regarding the 102 rejections, the Applicant argues that Szabados fails to discuss a multi-step process using a first classification engine that then outputs data into a second classification engine. As noted above in the 101 rejections, the claims are silent as to the use of any classification engine or model and therefore, the remarks regarding this are moot. Further the claims are only directed toward the data from one classification being used in the second classification. Szabados clearly discloses this in when the output of one-layer feeds into the input of the second layer (Figs. 19-20 and Column 22). It is noted that the broad claims fail to define any of the data that is measured (including type or values), the data points that are extracted or the qualified events. Based on the broad claims, the data, classification and events as disclosed in Szabados clearly read on the claims. Therefore, the rejections stand.
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-10
Step 1- Claim 1
Claim 1 and dependent claims 2-10 are drawn to a method and thus meet the requirements for step 1.
Step 2a (prong 1) - Claim 1
Claims 1 recites the step of “determining a set of measured data points and determining a value of the cardiac burden” Under the broadest reasonable interpretation, this step covers a concept capable of being performed in the human mind, and thus falls within the mental processes grouping of abstract ideas. Other than reciting the method is “computer-implemented” in the preamble, nothing in the claim precludes the step from practically being performed in the mind.
Accordingly, claim 1 recites an abstract idea.
Step 2a (prong 2) – Claim 1
The judicial exception is not integrated into a practical application. Claim 1 recites the additional elements of:
Collecting a series of cardiac measurements is insignificant extra-solution activity (i.e., data gathering),
Outputting the value of the cardiac burden is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data) is insignificant extra-solution activity (i.e., data output).
These steps do not integrate the abstract idea into a practical application because they are insignificant extra solution activity.
Step 2b- Claim 1
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, providing the value of the cardiac burden is recited at a high level of generality (i.e., as generic devices, a “computer-implemented” method, performing generic computer functions like sending, receiving, and visually displaying data). Further, determining a set of measured data points, classification and generating a set of additional data points is considered generic data gathering/statistics.
The additional elements that were considered insignificant extra solution activity have been re-analyzed and do not amount to anything more than what is well-understood, routine and conventional when considered individually and in combination with evidence provided. Specifically:
Collecting a series of cardiac measurements is well understood, routine, and conventional (i.e., receiving data MPEP 2106.05(d)(II)).
Determining a set of measured data points is well-understood routine and conventional (i.e., gathering data/statistics MPEP 2106.05(d)(II)).
Classification is well-understood routine and conventional (i.e., gathering data/statistics MPEP 2106.05(d)(II)).
Generating additional data points is well-understood routine and conventional (i.e., gathering data/statistics MPEP 2106.05(d)(II)).
Outputting the value of the cardiac burden is considered to be well-understood, routine, and conventional (i.e., presenting data MPEP 2106.05(d)(II)).
Claim 1 is thus consider to be directed to an abstract idea without significantly more.
Claims 2-10 depend from claim 1. The type of data analyzed and generated as stated in claims 2-9 is considered extra solution activity. The devices utilized to collect the data as stated in claim 10 is stated at a high level of generality in applicant’s specification (“a smart watch; a touchpad device; a steering wheel; a smart handheld device; a waveform analysis kiosk; and a connected device”) and are merely used as a tool to carry out the data gathering. Thus, the dependent claims do not change the overall analysis that claims 2-10 are also directed to an abstract idea.
Claims 11-16
Independent claim 11 is directed to a system containing limitations similar to that for claim 1 and further includes a processor with memory. Analyzing the processor and memory of claim 11 under step 2a, prong 1, the processor and memory are recited at a high level of generality and merely use the computer elements (the processor and memory) as a tool. When analyzed under step 2a, prong 2, the processor and memory perform generic computer functions like storing and processing data. Further, when the analysis is extended to step 2b, the processor and memory are considered to use the computer elements as tools, MPEP 2106.05(d)(II). Thus, claim 11 is also considered to be patent ineligible subject matter. Dependent claims 12-16 are similar to dependent claims 2-10 and are rejected on the same grounds.
Claims 17-20
Independent claim 17 is directed to a system containing limitations similar to that for claim 1 and further includes a processor with memory. Analyzing the processor and memory of claim 17 under step 2a, prong 1, the processor and memory are recited at a high level of generality and merely use the computer elements (the processor and memory) as a tool. When analyzed under step 2a, prong 2, the processor and memory perform generic computer functions like storing and processing data. Further, when the analysis is extended to step 2b, the processor and memory are considered to use the computer elements as tools, MPEP 2106.05(d)(II). Thus, claim 17 is also considered to be patent ineligible subject matter. Dependent claims 18-20 are similar to dependent claims 2-10 and are rejected on the same grounds.
Claim Rejections - 35 USC § 102
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)(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) 1-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Szabados et al. (U.S. Pat. 11,083,371 hereinafter “Szabados”).
Regarding claim 1, Szabados discloses a method for determining a cardiac burden of a user (e.g. Col. 22, ll. 24-27; Fig. 19), the method comprising: collecting a series of cardiac measurements at a first set of time points using one or more sensors (e.g. Col. 2, ll. 45-48); determining a set of measured data points, each measured data point comprising: a time value from the first set of time points (e.g. see Fig. 20); and a classification comprising one of an occurrence of a qualified cardiac event or absence of the qualified cardiac event, wherein the classification is selected using a cardiac measurement of the series of cardiac measurements associated with a corresponding time point from the first set of time points generating a set of additional data points associated with a second set of time points different from the first set of time points, each additional data point comprising: a time value from the second set of time points (e.g. 1904); and a classification of one of the occurrence of the qualified cardiac event or the absence of the qualified cardiac event, wherein the classification is selected using one or more measured data points of the set of measured data points (e.g. 1906); determining a value of the cardiac burden for a predefined period of time using the set of measured data points and the set of additional data points (e.g. 1908); and outputting the value of the cardiac burden (e.g. Col. 22, ll. 25-26; “AFIB Burden”).
Regarding claim 2, meeting the limitations of claim 1 above, Szabados further discloses wherein generating the set of additional data points comprises: determining, for each additional data point of the set of additional data points, a closest measured data point; and assigning, for each additional data point of the set of additional data points, the classification of the closest measured data point as the classification of the additional data point (e.g. Col. 22, ll. 22-62).
Regarding claim 7, meeting the limitations of claim 1 above, Szabados further discloses wherein the qualified cardiac event is atrial fibrillation and the cardiac burden is an atrial fibrillation burden (e.g. Col. 22, ll. 24-27).
Regarding claim 8, meeting the limitations of claim 1 above, Szabados further discloses wherein selecting the classification comprises inputting the cardiac measurement of the series of cardiac measurements into a classification model that is trained to detect atrial fibrillation (e.g. Col. 22, ll. 13-27).
Regarding claim 9, meeting the limitations of claim 1 above, Szabados further discloses determining that the set of measured data points, the set of additional data points or both meet a criteria; and in response to the set of measured data points, the set of additional data points or both meeting the criteria determining the value of the cardiac burden (e.g. Col. 22, ll. 22-62).
Regarding claim 10, meeting the limitations of claim 1 above, Szabados further discloses wherein the one or more sensors comprises at least one of a photoplethysmography sensor or an electrocardiogram sensor (e.g. Col. 18, ll. 31).
Regarding claim 11, Szabados discloses a device for measuring cardiac parameters of a user, comprising: one or more sensors configured to collect cardiac measurements of the user (e.g. Col. 22, ll. 24-27; Fig. 19); and a processor (e.g. 1012) configured to operate in a first mode to: cause the one or more sensors to collect a first set of cardiac measurements (e.g. Col. 2, ll. 45-48); input each cardiac measurement of the first set of cardiac measurements as an input cardiac measurement into a classification model to produce a first set of outputs, wherein a first threshold is applied to the first set of outputs for identifying whether the input cardiac measurement is a qualified cardiac event (e.g. 1902); and in response to the first set of outputs meeting a first set of criteria, output an indication of an occurrence of the qualified cardiac event to the user (e.g. Col. 22, ll. 22-62); the processor configured to operate in a second mode to: collect a second set of cardiac measurements (e.g. 1904); input each of the second set of cardiac measurements as an input cardiac measurement into the classification model to produce a second set of outputs (e.g. 1906), wherein a second threshold different than the first threshold is applied to the second set of outputs for identifying whether the input cardiac measurement is the qualified cardiac event (e.g. 1908); determine a value of a cardiac burden for predefined period of time based on the second set of outputs; and output the value of the cardiac burden (e.g. Col. 22, ll. 25-26; “AFIB Burden”).
Regarding claim 12, meeting the limitations of claim 11 above, Szabados further discloses wherein, in the first mode, the processor is further configured to: collect multiple first cardiac measurements; input the multiple first cardiac measurements into the classification model; and in response to the classification model producing a defined number of outputs indicating the occurrence of the qualified cardiac event, output the indication of the occurrence the qualified cardiac event to the user (e.g. Col. 13, l. 60 to Col. 14, l. 2).
Regarding claim 13, meeting the limitations of claim 11 above, Szabados further discloses wherein, in response to outputting an indication of the occurrence of the qualified cardiac event, the device is configured to prompt the user to switch from the first mode to the second mode (e.g. Col. 13, l. 60 to Col. 14, l. 2).
Regarding claim 15, meeting the limitations of claim 11 above, Szabados further discloses wherein: the qualified cardiac event is atrial fibrillation; and the cardiac burden is an atrial fibrillation burden (e.g. Col. 22, ll. 24-27).
Regarding claim 16, meeting the limitations of claim 11 above, Szabados further discloses determining a set of measured data points, each measured data point comprising: a time value from the second set of cardiac measurements; and a classification comprising one of an occurrence of a qualified cardiac event or absence of the qualified cardiac event, wherein the classification is determined from the first set of outputs (e.g. Col. 22, ll. 22-62); and generating a set of additional data points associated with a set of time points, each additional data point comprising: a time value from the set of time points; and a classification of one of the qualified cardiac event or the absence of the qualified cardiac event, wherein the classification is selected using one or more measured data points of the set of measured data points, wherein the value of the cardiac burden is based on the set of measured data points and the set of additional data points (e.g. Col. 22, ll. 22-62).
Regarding claim 17, Szabados discloses a system for measuring cardiac parameters of a user, the system comprising: one or more sensors configured to collect cardiac measurements of the user (e.g. Col. 22, ll. 24-27; Fig. 19); and a processer (e.g. 1012) configured to collect a series of cardiac measurements at a first set of time points using the one or more sensors (e.g. Col. 2, ll. 45-48); determine a set of measured data points, each measured data point comprising: a time value from the first set of time points (e.g. 1902); and a classification comprising one of an occurrence of a qualified cardiac event or absence of the qualified cardiac event, wherein the classification is selected using a cardiac measurement of the series of cardiac measurements associated with the time value (e.g. Col. 22, ll. 22-62); generate a set of additional data points associated with a second set of time points different from the first set of time points, each additional data point comprising (e.g. 1904); a time value from the second set of time points; and a classification of one of the occurrence of the qualified cardiac event or the absence of the qualified cardiac event, wherein the classification is selected using one or more measured data points of the set of measured data points (e.g. 1906); determine a value of a cardiac burden for a predefined period of time using the set of measured data points and the set of additional data points (e.g. 1908); and output the value of the cardiac burden (e.g. Col. 22, ll. 25-26; “AFIB Burden”).
Regarding claim 18, meeting the limitations of claim 17 above, Szabados further discloses wherein the processor is further configured to: determine that the set of measured data points meet a criteria (e.g. Col. 13, l. 60 to Col. 14, l. 2); and the criteria comprises a minimum number of cardiac measurements over the predefined period of time (e.g. Col. 13, l. 60 to Col. 14, l. 2).
Regarding claim 19, meeting the limitations of claim 17 above, Szabados further discloses wherein the value of the cardiac burden indicates an amount of time the user experiences atrial fibrillation over the predefined period of time (e.g. Col. 22, ll. 24-27).
Regarding claim 20, meeting the limitations of claim 17 above, Szabados further discloses wherein the predefined period of time comprises a reoccurring time window comprising one of a weekly time window, a daily time window or an hourly time window (e.g. Col. 33, ll. 26-32).
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3796