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 .
Priority
Claims 1-20 are deemed to have an effective filing date of December 1, 2021.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 6 (Fig. 1); 752 (Fig.7).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 114.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 an abstract idea without significantly more.
Step 1:
Claims 1-10 claim a medical device system (product) and claims 11-14 and 16-20 claim a method (process) while claim 15 claims non-transitory computer readable storage media (a product/manufacture) that stores a process. Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Independent claims 1, 11 and 15 recite determining a plurality of signals indicative of physical quantities of a patient (extra-solution activity of data gathering), processing the plurality of signals to determine the physiological parameters of the patient (abstract idea), comparing the plurality of physiological parameters of the patient the N-dimensional model to determine a chronic obstructive pulmonary disease (COPD) risk score (abstract idea), determining whether the COPD-risk score satisfies a threshold (abstract idea) and generating an indication for output based at least in part on the COPD risk score satisfying the threshold (post extra-solution activity of data outputting). The processing of the plurality of signals to determine physiological parameters, comparing the physiological parameters to the N-dimensional model, and determining whether the COPD-risk score satisfies a threshold are drawn to abstract ideas since the steps are mental processes that can be practically performed in the human mind, or with the aid of pen and paper. A person of ordinary skill in the art could reasonably receive an ECG from a patient on a piece of paper, process the ECG signals to identify physiological parameters (circle events), compare the plurality of physiological parameters of the patient to the N-dimensional model (a doctor would compare the circled events to his/her knowledge (information stored in the doctor’s brain) to determine a risk score for the patient), and using his/her knowledge would determine whether the COPD-risk score satisfies a threshold. The middle limitations framed by extra solution activities, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitations in the mind with insignificant extra-solution activity. With respect to claim 15, the non-transitory computer readable storage media implies that a computerized system is performing these limitations and nothing in the claims precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper, to be an abstract idea. In this case, aside from the recitation of the determining signals indicative of physical quantities and generating an indication for output steps (insignificant extra-solution activities), claims 1-20 encompass a user observing the clinical data and making a judgement. There is no additional limitation that suggests an undue level of complexity in the processing, comparing, and determining steps.
Step 2A, Prong 2:
Claim 1 recites a memory for storing an N-dimensional model, where N is a count of physiological parameters and processing circuitry; claim 11 recites a medical device for determining a plurality of signals indicative of physical quantities and processing circuitry. Claim 15 recites a computer readable storage medium that stores instructions.Dependent claim 4 and 14 recite the “the signals … comprise an electrocardiogram”, “the parameters comprise a heart rate”. Claim 5 and 16 recite “the plurality of signals … comprise at least one accelerometer signal and the plurality of physiological parameters include an activity, etc. Claims 6 and 17 recite that the signals comprise an electromyogram and the physiological parameter include a dyspnea score. Claims 7-9 and 19-20 also modify the “signals” and the physiological parameters. These are extra-solution activities of data gathering. The N-dimensional model and the medical device are extra-solution activities of data gathering. The memory and processing circuitry of claim 1, the processing circuitry of claim 11, and computer readable storage medium of claim 15 merely includes instructions to implement the abstract idea on a compute, or use the computer as a tool to perform the abstract idea. This judicial exception is not integrated into a practical application because neither the memory or the medical device integrates the judicial exception of mental process into a practical application as both additional elements are tangential to the extra-solution activity of data gathering and do nothing to integrate the mental processes of comparing data to determine a COPD score and analyzing whether the risk score of the abstract idea satisfies a threshold.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims, taken as a whole, do not integrate the recited judicial exception into a practical application. The memory and processing circuitry of claim 1 do not qualify as significantly more because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, at a high level of generality, to the judicial exception (see applied prior art and Electric Power Group, 830 F.3d 1350 (Fed. Circ. 2016)). The “medical device” of claim 11 does not qualify as significantly more because the limitation is too broad and functions in a similar manner to a sensor. The medical device is simply a tool used to perform the abstract idea, not incorporate the abstract idea into significantly more (see Electric Power Group).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above judicial exception. Thus, the above-identified claims are directed to the judicial exception. Looking at the limitation as an ordered combination (i.e., as a whole) adds nothing that is no already present when looking at the elements individually. There is no indication that he combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation (i.e., the computer is simply a tool to perform the process).
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)(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.
Claims 1-2, 4-5, 9-12, 14-16, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2020/0390403 to Halperin et al. (hereinafter referred to as “Halperin”).
Regarding claim 1, Halperin discloses a medical device system comprising: memory configured to store an N-dimensional model, where N is equal to a count of a plurality of physiological parameters communicatively coupled to the memory (e.g., [0269]: In general, the historical averages and/or data used by the control unit to calculate the estimated times may be stored in computer memory, e.g., in a relational database; and processing circuitry; and [0380]: In general, control unit 14 comprising a random access memory (RAM), non-volatile secondary storage, such as a hard drive or CD ROM drive, network interfaces, and/or peripheral devices where software programs and data are loaded into the RAM for execution and processing by the CPU and results are generated; and control unit 14 is connected to one or more sensors via one or more wired or wireless connections to receive signals from the sensors), the processing circuitry being configured to: determine a plurality of signals indicative of physical quantities of the patient (e.g., paragraph [0380]: sensors receive “motion signals” where such motion may include, for example, respiratory motion, cardiac motion, or other body motion; [0169]: see sensors of Fig. 2, 30, 80, 81, 82, 85, 86, 87); process the plurality of signals indicative of physical quantities of the patient to determine the plurality of physiological parameters of the patient (e.g., paragraph [0181]: pattern analysis module 16 derives a score/parameter for each parameter based on the parameter’s deviation from baseline values (i.e., processes the signals to determine parameters)); compare the plurality of physiological parameters of the patient to the N-dimensional model to determine a chronic obstructive pulmonary disease (COPD)-exacerbation risk score (e.g., paragraph [0181]: pattern analysis module 16 combines the scores determined by comparing the signals to an N-dimensional model where the combination of scores can by computing an average, maximum, standard deviation, or other function of the scores; and [0028]: many chronic diseases, such as chronic obstructive pulmonary disease are direct modifiers of breathing and/or heartbeat patterns – thus, the combined scores of vital signs can determine a chronic obstructive pulmonary disease exacerbation risk score); determine whether the COPD-exacerbation risk score satisfies a threshold (e.g., paragraph [0181]: the combined scores are compared to one or more threshold values to determine whether an episode is predicted (threshold is satisfied), currently occurring (threshold is satisfied), or neither predicted nor occurring, and/or to monitor the severity and progression of an occurring episode); and generate an indication for output that is based at least in part on the COPD-exacerbation risk score satisfying the threshold (e.g., paragraphs [0097]: alert-generation functionality of the apparatus drives the output unit to generate alerts in response to the sensor signals; [0181]: the signal analysis functionality analyzes the signals received from the sensors to determine a condition of the patient and generate an output (e.g., an alert) in response thereto – See Fig. 2, sound generation module 33; and [0375]: signal functionality may determine that there has been a deterioration in a physiological parameter of the patient, and in response thereto, the user interface may generate an output that is indicative of the correlation between lack of improvement in the physiological parameter, or the deterioration of the physiological parameter, and compliance by the patient with the treatment protocol and may include information about the risk impact of changes in vital signs).
Referring to claim 11, Halperin discloses a method for controlling operation of processing circuitry of a medical system (e.g., paragraphs [0026] and [0031]: the present invention related to methods for predicting and monitoring abnormal physiological conditions (a chronic illness) and analysis of characteristics of physiological and/or physical parameters), the method comprising: the steps of the processing circuitry recited in claim 1 (see rejection of claim 1 above).
Regarding claim 15, Halperin discloses a non-transitory computer-readable storage medium storing instructions, which when executed, (e.g., paragraph [0380]: program code including software programs and data are loaded into the RAM for execution and processing by the central computer processing unit (CPU)) cause processing circuitry to provide the functions recited in claim 1 above (see rejection of claim 1 above).
With respect to claims 2 and 12, Halperin discloses the medical device of claim 1 and the method of claim 11, wherein the processing circuitry is further configured to determine the N-dimensional model based on previously determined physiological parameters of the patient (e.g., paragraph [0181]: analyzes sensor data using baseline values for the specific patient).
As to claims 4 and 14, Halperin discloses the medical device of claim 1 and the method of claim 11, wherein the plurality of signals indicative of physical quantities comprise an electrocardiogram and the plurality of physiological parameters comprise a heart rate, and wherein the heart rate is determined based on the electrocardiogram (e.g., paragraphs [0169]: Fig. 2, ECG monitor 62; and [0342]: pattern analysis module 16 of control unit 14 includes cardiac risk-detection functionality and uses a full ECG and/or telemetry monitor to monitor the patient’s heart rate).
With respect to claims 5 and 16, Halperin discloses the medical device of claim 1 and the method of claim 11, wherein the plurality of signals indicative of physical quantities comprise at least one accelerometer signal and the plurality of physiological parameters comprise at least one of an activity, a posture, a respiration rate, or a tidal volume, and wherein the at least one of the activity, the posture, respiration rate, or tidal volume is determined based on the at least one accelerometer signal (e.g., paragraphs [0191]: accelerometer sensing breathing- and heartbeat-related motion of the patient; [0223]: accelerometer worn on the patient’s body detects the body posture of the patient; and [0359]-[0360]: accelerometer is used for detection of parameters such as heart rate, respiration rate, bed-exit (posture/activity) and movement (activity).
As to claims 9 and 20, Halperin discloses the medical device of claim 1 and the method of claim 11, wherein the plurality of signals indicative of physical quantities comprise a temperature sensor signal and the plurality of physiological parameters comprise a temperature of the patient, and wherein the temperature of the patient is based on the temperature sensor signal (e.g., paragraphs [0169]: control unit 14 is coupled to one or more additional sensors including a temperature sensor 80 (Fig. 2); [0175]: temperature sensor 80 measures the body temperature of the patient).
With respect to claim 10, Halperin discloses the medical device of claim 1, comprising an implantable medical device or an insertable medical device (e.g., paragraph [0346]: medical device includes an implantable medical device).
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.
Claims 3, 7, 13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Halperin in view of US Patent Application Publication No. 2020/0353250 to Haddad et al. (hereinafter referred to as “Haddad”).
With respect to claims 3 and 13, Halperin discloses the medical device of claim 1 and the method of claim 11, but does not expressly disclose that the processing circuitry is further configured to update the N-dimensional model to include information indicative of the determined physiological parameters of the patient. However, Haddad, in a related art: adaptive treatment management system including a sensor system, teaches that a risk score generator may be used to generate one or more risk scores based on collected data, such as new or updated patient data (e.g., paragraph [0092] of Haddad); and that the risk score generators may be updated, or trained, on a regular basis using updates or may even be updated in real-time and may be stored on the cloud to generate risk predictions for one or more patients (e.g., paragraph [0106] of Haddad). Accordingly, one of ordinary skill in the risk prediction art would have recognized the benefits of updating the N-dimensional model (stored in the cloud or in the CPU) of Halperin to include information regarding determined physiological parameters of the patient in view of the teachings of Haddad. Consequently, one of ordinary skill in the art would have modified Halperin’s medical device of claim 1 and Halperin’s method of claim 11 to updated the N-dimensional model to include information indicative of the determined physiological parameters of the patient in view of the teachings of Haddad that such was a well-known protocol in the risk prediction systems art for medical patients, and because the combination would have yielded a predictable result.
As to claims 7 and 18, Halperin discloses the medical device of claim 1 and the method of claim 11, wherein the plurality of physiological parameters comprise at least one of a respiration rate (e.g., paragraphs [0184]-[0185]: by combining heart rate or respiratory rates with constant or slower changing information, such as age, gender, or temperature, a dynamic score can be generated), a tidal volume, or a fluid status (e.g., paragraph [0177]: predict an approaching clinical episode such as heart condition-related lung fluid buildup); but does not expressly disclose that the plurality of signals indicative of physical quantities comprise an impedance measurement and that the plurality of physiological parameters comprise at least one of a respiration rate, a tidal volume, or a fluid status, and wherein the at least one of the respiration rate, the tidal volume or the fluid status is determined based on the impedance measurement.
However, Haddad, in a related art, teaches that it was known in the risk prediction art to include an electrical sensor to provide an impedance value (e.g., paragraph [0056] of Haddad), and that various diagnostic metrics that may be used to determine a risk score can be extracted from patient data including an impedance trend index where an impedance index may be an indicator of the amount of fluid congestion experienced by the patient (e.g., paragraphs [0110]-[0113]). Accordingly, one of ordinary skill in the art would have recognized the benefit of determining an impedance measurement of the patient wherein the fluid status is determined based on the impedance measurement in view of the teachings of Haddad. Consequently, one of ordinary skill in the art would have modified Halperin’s medical device of claim 1 and Halperin’s method of claim 11 to determine an impedance measurement of the patient in order to determine the fluid status of the patient in view of the teachings of Haddad that such was a well-known expedient in the risk prediction systems art for medical patients, and because the combination would have yielded a predictable result.
Claims 6, 8, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Halperin in view of US Patent Application Publication No. 29019/01677176 to Annoni et al. (hereinafter referred to as “Annoni”).
With respect to claims 6 and 17, Halperin discloses the medical device of claim 1 and the method of claim 11, wherein the plurality of signals indicative of physical quantities comprise an electromyogram and the plurality of physiological parameters comprise a dyspnea score, and wherein the dyspnea score is determined based on the electromyogram. However, Annoni teaches, in a related art: method and apparatus for monitoring respiratory distress, that signals input to the signal processing circuit can include one or more physiological marker parameters of respiratory distress include an electromyogram (EMG) (e.g., paragraph [0114] of Annoni) and that can allow for detection and/or prediction of exacerbation including a parasternal EMG or a diaphragm EMG (e.g., paragraphs [0073]-[0091] of Annoni) where the plurality of physiological parameters comprise a dyspnea score and the dyspnea score (difficulty or labored breathing score) is determined based on the electromyogram (e.g., Table 1 and paragraph [0144] of Annoni). Accordingly, one of ordinary skill in the art would have recognized the benefit of an electromyogram as one of the sensor outputs of the plurality of signals, determining one of the physiological parameters as dyspnea (difficulty or labored breathing) where dyspnea is measured/based on EMG readings in view of the teachings of Annoni. Consequently, one of ordinary skill in the art would have modified Halperin’s medical device of claim 1 and Halperin’s method of claim 11 one of the patient sensors comprise an electromyogram and one of the physiological parameters is a dyspnea score based on the electromyogram in view of the teachings of Annoni that such was a well-known expedient in the risk prediction systems art for medical patients, and because the combination would have yielded a predictable result.
As to claims 8 and 19, Halperin discloses the medical device of claim 1 and the method of claim 11, wherein the plurality of signals indicative of physical quantities comprise at least one optical sensor signal and the plurality of physiological parameters comprise a blood oxygen level (e.g., paragraph [0169]: blood oxygen monitor (e.g., pulse oximeter/photoplethysmography (optical sensor)), but does not expressly disclose that an oxygen saturation level is determined based on the at least one optical sensor signal. However, Annoni, in a related art, teaches that blood oxygen saturation is a physiological marker for respiratory distress that is measured by a pulse oximeter (e.g., Table 1: measurement Oxygen Saturation). Accordingly, one of ordinary skill in the art would have recognized the benefit of monitoring the blood oxygen level of Halperin so that the patient’s blood oxygen saturation is known via a pulse oximeter or photoplethysmography in view of the teachings of Annoni. Consequently, one of ordinary skill in the art would have modified Halperin’s medical device of claim 1 and Halperin’s method of claim 11 to determine the blood oxygen saturation of the patient in order to oxygen saturation level of the patient in view of the teachings of Annoni that such was a well-known expedient in the risk prediction systems art for medical patients, and because the combination would have yielded a predictable result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2019/0029601 to An et al. is directed to systems and methods for monitoring patient for risk of worsening heart failure where dyspnea is discussed as being often seen with chronic obstructive pulmonary disease patients (e.g., paragraph [0004]), and teaches that a patient management system includes a sensor circuit to receive respiration measurements and an input device to receive patient dyspnea symptom severity (abstract and paragraph [0088]: a comparison of dyspnea symptoms and respiratory rate trend can predict worsening heart failure).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792