DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
As detailed on the Filing Receipt filed 1/10/2025, the instant application claims priority to as early as 8/5/2022. At this point in prosecution, all claims are accorded the earliest claimed priority date.
Information Disclosure Statement
The Information Disclosure Statement filed on 10/10/2023 is in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of the IDS is included with this Office Action.
Claim Status
Claims 1-20 are pending, and under examination.
Claim Rejections - 35 USC § 101
35 USC § 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 USC § 101 because the claimed invention is directed to an abstract idea without significantly more (i.e., non-statutory subject matter).
"Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I).
Abstract ideas include mathematical concepts (including formulas, equations and calculations), and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)).
The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea.
Step 1: The Four Categories of Statutory Subject Matter (MPEP 2106.03)
The claims are directed to computing systems (claims 1-19) and a method (claim 20), which fall under categories of statutory subject matter.
Step 2A, Prong One: Whether the Claims Set Forth or Describe a Judicial Exception (MPEP 2106.04 § II.A.1)
‘Mathematical concepts’ are relationships between variables and numbers, numerical formulas or equations, or acts of calculation, which need not be expressed in mathematical symbols (MPEP 2106.04(a)(2) § I). The claims recite elements which encompass mathematical concepts, at least under their broadest reasonable interpretation, including:
determining a time-between event (TBE) value for a first plurality of detected events (claims 1, 12 and 20), i.e., calculating a value.
The recited acts of calculation constitute mathematical concepts.
‘Mental processes’ are processes that can be performed in the human mind at least with use of a physical aid, e.g., a slide rule or pen and paper (MPEP 2106.04(a)(2) § III). The claims recite elements that encompass processes that are practicably performable in the human mind, at least under their broadest reasonable interpretation, including:
determining a classification condition based on the determined TBE value and reference data comprising information corresponding to prior detected events (claims 1, 12 and 20);
determining a change in the TBE value over time for a second plurality of detected events (claims 1, 12 and 20;
based on the determined change in the TBE value, applying the classification condition to a plurality of detected events, wherein the plurality of detected events comprises the first plurality of events and the second plurality of events (claims 1, 12 and 20); and
determining whether one or more of the plurality of detected events satisfies the classification condition (1, 12 and 20).
The recited steps of evaluating information, which are practicably performable in the human mind, constitute mental processes.
Hence, the claims recite elements that, individually and in combination, constitute an abstract idea. The claims must therefore be examined further to determine whether they integrate this abstract idea into a practical application (MPEP 2106.04(d)).
Step 2A, Prong Two: Whether the Claims Contain Additional Elements that Integrate the Judicial Exception(s) into a Practical Application (MPEP 2106.04 § II.A.2)
The claims further recite additional elements that constitute computer hardware for performing claimed functions and/or require performance of claimed functions on a computer, including:
a computing system comprising: memory; processing circuitry coupled to the memory, configured to perform claimed functions; and communications circuity configured to communicate results to another device via a network (claims 1 and 12); and
processed data represents events or symptom occurrences detected by a computing device (claims 1, 12 and 20).
The claims do not describe any specific computational steps by which a computer performs or carries out functions drawn to the abstract idea, nor do they provide any details of how specific structures of a computer are used to implement these functions. The claims state nothing more than that a generic computer performs functions drawn to the abstract idea, and are therefore mere instructions to apply the abstract idea using a computer. As such, the claims do not integrate the abstract idea into a practical application (see MPEP 2106.04(d) § I and 2106.05(f)).
When the claims are considered as a whole: they do not improve the functioning of a computer, other technology, or technical field (MPEP 2106.04(d)(1) and 2106.05(a)); they do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition (MPEP 2106.04(d)(2)); they do not implement the abstract idea with, or in conjunction with, a particular machine (MPEP 2106.05(b)); they do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)); and they do not apply or use the abstract idea in some other meaningful way beyond linking the use of the abstract idea to a particular technological environment and/or field of use (e.g., clinical analysis; MPEP 2106.05(e) and 2106.05(h)).
Hence, the recited abstract idea is not integrated into a practical application. See MPEP 2106.04(d) § I.
Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are directed to the abstract idea. Claims that are directed to an abstract idea must be examined further to determine whether the additional elements besides the abstract idea render the claims significantly more than the abstract idea. Additional elements besides the abstract idea may constitute inventive concepts that are sufficient to render the claims significantly more (MPEP 2106.05).
Step 2B: Whether the Claims Contain Additional Elements that Amount to an Inventive Concept (MPEP 2106.05)
Mere instructions to implement an abstract idea using a computer are, when considered individually, insufficient to constitute an inventive concept that would render the claims significantly more than said abstract idea (see MPEP 2106.05(f)).
When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a
particular technology; they do not improve a technology by allowing the technology to
perform a function that it previously was not capable of performing; and they do not apply or use the abstract idea in some other meaningful way beyond linking the use of the abstract idea to a particular technological environment and/or field of use (e.g., clinical analysis; MPEP 2106.05(e) and 2106.05(h)).
Hence, the claims do not include additional elements that are sufficient to amount to significantly more than the recited abstract idea. See MPEP 2106.05.
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not constitute significantly more than the abstract idea, so the claims are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 USC §§ 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 USC § 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.
Claims 1-3, 9-10, 12-14 and 19-20 are rejected under 35 USC §§ 102(a)(1) and 102(a)(2) as being anticipated by Sarkar (US 2010/0030293; filed 7/31/2008).
Claim 1 recites a computing system comprising: a memory; processing circuitry coupled to the memory, the processing circuitry configured to: determine a time-between-event (TBE) value for a first plurality of events detected by a computing device; determine a classification condition based on the determined TBE value and reference data stored in the memory, the reference data comprising information corresponding to prior detected events; determine a change in the TBE value over time for a second plurality of events detected by the computing device; based on the determined change in the TBE value, apply the classification condition to a plurality of detected events, wherein the plurality of detected events comprises the first plurality of events and the second plurality of events; and determine whether one or more of the plurality of detected events satisfies the classification condition; and communications circuitry configured to: communicate to another device via a network that the one or more of the plurality of detected events satisfies the classification condition.
With respect to claim 1, Sarkar discloses techniques for using multiple physiological parameters to provide an early warning for worsening heart failure (Abstract), and implementation as a medical device comprising: a processor, including discrete or integrated logic circuitry; memory including computer-readable instructions that, when executed by the processor, cause the processor to perform disclosed functions; and a telemetry module, including any suitable hardware, firmware, software or combination thereof for communicating with another device (paras. 0060, 0063 and 0081; Fig. 1).
Sarkar discloses functions including: storing digitized cardiac signals in memory, measuring durations of time intervals between various detected cardiac events/waveforms (e.g., A-V intervals and R-R intervals), analyzing measured series of intervals to determine whether the patient’s heart is presently exhibiting tachyarrhythmia (paras. 0070-75); and providing an alert when worsening heart failure is detected (para. 0103).
Measuring durations of time intervals as disclosed is considered to read on determining time-between event values as claimed. Sarkar also characterizes the detection of arrythmia as classification of the patient’s heart rhythm based on measured intervals (para. 0070), and further describes detecting worsening heart failure when the value of an index, representing changes in a diagnostic parameter over time, is greater than an upper threshold value and/or when a secondary diagnostic parameter satisfies a corresponding condition (para. 0008). In this way, the disclosure of Sarkar is considered to read on applying a classification condition based on a determined change in TBE value as claimed.
With respect to claim 2, Sarkar discloses application of the device to identify instances of worsening heart failure, and provide an alert that enables a patient to seek medical attention before experiencing a heart failure event (para. 0006). In other words, application of the device to predict a future detected event based on the application of the classification condition.
With respect to claim 3, Sarkar discloses that the alert may be communicated through a computerized communication network (para. 0006). Sarkar also describes embodiments wherein the alert is transmitted to a server and relayed to a physician via a computing device (para. 0035).
With respect to claim 9, Sarkar discloses update modules that may update the threshold values (i.e., adjust the classification condition) based on changes in patient condition observed via one or more monitored diagnostic parameters (para. 0124).
With respect to claim 10, Sarkar discloses analyzing measured series of intervals (para. 0075), i.e., periods between two or more events.
Claim 12 recites a computing system having limitations of substantive similarity to those in claim 1, the only difference being that the system of claim 12 operates upon data representing symptom occurrences experienced by a patient detected by a medical device (rather than upon data representing events detected by a computing device, as in claim 1).
With respect to claim 12, the disclosure of Sarkar is considered to read on the claim in the same manner as outlined above with respect to claim 1.
With respect to claim 13, the disclosure of Sarkar is considered to read on the claim in the same manner as outlined above with respect to claim 2.
With respect to claim 14, the disclosure of Sarkar is considered to read on the claim in the same manner as outlined above with respect to claim 3.
With respect to claim 19, the disclosure of Sarkar is considered to read on the claim in the same manner as outlined above with respect to claim 10.
Claim 20 recites a method for operating processing circuitry of a computing device, comprising performance of steps via the processing circuitry of substantive similarity to configured functions of the processing circuitry of claim 1.
With respect to claim 20, the disclosure of Sarkar is considered to read on the claim in the same manner as outlined above with respect to claim 1.
In this way, the disclosure of Sarkar anticipates the limitations of claims 1-3, 9-10, 12-14 and 19-20. Thus, the claimed invention is anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 USC § 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 USC § 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.
Claims 4-8, 11 and 15-18 are rejected under 35 USC § 103 as being unpatentable over Sarkar, as applied to claims 1 and 12 above, and further in view of Doğu (International Journal for Quality Research 6(2): 151-157; published 2012).
With respect to claims 4-5, Sarkar discloses calculation of threshold values including a lower threshold value (paras. 0008 and 0124). However, the disclosed lower threshold is not equivalent to (i.e., not applied in the manner of) a lower control limit as claimed.
Doğu discusses statistical surveillance methods for monitoring time between medical errors (pg. 151, Abstract), and presents an exemplary analysis of an obtained dataset comprising dates of omission medication errors in a hospital during a considered time period (pg. 152, l. column). Doğu discusses calculating time to next event for each observation (pg. 152, l. column), i.e., determining a time-between-event value for a first plurality of detected events; plotting the time-between-events values and calculating upper and lower control limits, according to various control chart models, including the exponential CUSUM chart which compares the mean TBE (Xt) to reference values (k1 and k2), to classify process state (pg. 152, r. column – pg. 154, r. column and Table 1).
Doğu further teaches evaluating state of the modeled medical process based on the location of the plotted points relative to the control limits, which indicate thresholds for change over time in the mean TBE, wherein the process is considered to be ‘out-of-control’ when a point plotted is less than the lower control limit or greater than the upper control limit (pg. 152, r. column – pg. 153, l. column).
Doğu discusses prior application of statistical process control techniques to monitoring industrial processes, and consideration that said techniques ensure high-quality production and reduce costs in the business environment (pg. 151, l. column; pg. 156, l. column). Doğu also discusses prior application of statistical process control techniques to health care adverse event monitoring, and applicability of variable TBE control charts to timely analysis of health care data with complex event distributions (pg. 151, r. column).
With respect to claim 6, Doğu teaches calculating the mean of the TBE values, and calculating the control limits based on the mean TBE (pg. 152, r. column). The mean TBE is considered to read on a baseline value as claimed.
With respect to claim 7, Doğu teaches analysis of medical occurrence data according to various control chart models, including the exponential CUSUM chart which calculates control limits based on the difference between the mean TBE (Xt) and reference values (k1 and k2) to classify process control (pg. 152, r. column – pg. 154, r. column and Table 1). In other words, plotting and analyzing medical occurrence data as an exponential CUSUM chart involves determining the lower control limit based on the mean TBE (i.e., the baseline value) and reference data.
With respect to claim 8, Doğu teaches that if a plotted point falls below the lower control limit, this indicates that the mean TBE may have decreased and process deterioration may have occurred (pg. 153, l. column).
With respect to claim 11, Sarkar discloses that interval durations may be determined in response to stored data in memory (para. 0072). Sarkar discloses storing received heart signals within memory, retrieval of stored heart signals from memory, generating and storing marker codes indicative of different detected cardiac events (para. 0082). In this way, Sarkar discloses storage and analysis of reference data comprising information corresponding to prior events detected by the computing device as claimed.
With respect to claim 15, the combined teachings of Sarkar and Doğu are considered to read on the claim in the same manner as outlined above with respect to claim 4.
With respect to claim 16, the combined teachings of Sarkar and Doğu are considered to read on the claim in the same manner as outlined above with respect to claim 5.
With respect to claim 17, the combined teachings of Sarkar and Doğu are considered to read on the claim in the same manner as outlined above with respect to claim 6.
With respect to claim 18, the combined teachings of Sarkar and Doğu are considered to read on the claim in the same manner as outlined above with respect to claim 8.
An invention would have been obvious to one of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, said practitioner would have implemented the disclosed control chart techniques of Doğu to analyze and classify the measured interval durations of Sarkar, because Doğu teaches that statistical process control techniques have previously been applied to health care adverse event monitoring, and variable TBE control charts are able to efficiently implement analyses of data following a wide range of distributions such as those found in real healthcare data (pg. 151, r. column). Said practitioner would have had a reasonable expectation of success because Sarkar and Doğu both concern statistical analysis of medical occurrence data based on determined time intervals between events and observed change in parameters over time relative to determined upper and lower bounds.
In this way the disclosure of Sarkar, in view of Doğu, makes obvious the limitations of claims 4-8, 11 and 15-18. Thus, the claimed invention is prima facie obvious.
Conclusion
At this point in prosecution, no claim is allowed.
The following prior art, made of record and not relied upon, is considered pertinent to applicant's disclosure:
Alemi (The Joint Commission Journal on Quality and Safety 30(2): 95-102; published February 2004) discusses analysis of peak expiratory flow rate data, via time-between control charts, for monitoring of asthma attacks and trends;
Costa (International Journal of Computational Intelligence Systems 13(1): 1567-1577; published 10/6/2020) discloses modeling determined time between, and length of, atrial fibrillation episodes according to a given distribution and classifying subject cardiac condition (pg. 1571, l. column).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore C. Striegel whose telephone number is (571)272-1860. The examiner can normally be reached Mon-Fri 12pm-8pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Olivia M. Wise can be reached at (571)272-2249. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.C.S./Examiner, Art Unit 1685
/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 August 4, 2026
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