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 .
Notice to Applicant
Status of Claims
1. Claims 1, 2, 11, 12, and 20 have been amended. Now, claims 1-21 are pending.
Claim Rejections - 35 USC § 101
2. 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.
3. Claims 1-21 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.
4. Claims 1-21 are directed to monitoring a patient, which is considered managing person behavior. Managing personal behavior falls within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain methods of organizing human activity). The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea)
5. Under step 1 of the Alice/Mayo framework, it must be considered whether the claims are directed to one of the four statutory classes of invention. In the instant case, claim 1-10 and 21 recite a system comprising a medical device and a peripheral device, claims 11-19 recite method and at least one step and claim 20 recites a non-transitory computer-readable medium. Therefore, the claims are each directed to one of the four statutory categories of invention (process, apparatus, manufacture).
6. Under step 2A of the Alice/Mayo framework, it must be considered whether the claims are “directed to” an abstract idea. That is, whether the claims recite an abstract idea and fail to integrate the abstract idea into a practical application.
Regarding independent claims 1, 11, and 20, the claim sets forth a process in which monitoring a patient, in the following limitations:
related to at least one physiological parameter of the patient;
receive data collected;
evaluate the data by at least comparing the data to one or more criteria;
based on the evaluation of the data, determine at least one question relating to the data collected;
trigger the at least one question for the patient to answer;
receive at least one answer;
determine based on a combination of the data and the at least one answer, a risk-level of the patient's health associated with at least one of infection, stroke, sepsis, heart failure, chronic obstructive pulmonary disease, heart failure decompensation, cardiac arrhythmia, or myocardial infarction;
based on a comparison of the risk-level to one or more thresholds, determine an alert level of a plurality of alert levels; and
send an alert corresponding to the alert level.
The above-recited limitations monitoring a patient to determine an alert level and sending the alert. This arrangement amounts to managing personal behavior. Such concepts have been considered ineligible certain methods of organizing human activity by the Courts (See MPEP 2106.04(a)).
Claim 1 does recite additional elements:
a medical device configured to collect sensor data;
a peripheral device configured to wirelessly communicate with the medical device;
and processing circuitry configured;
sensor;
by the medical device;
the peripheral device to output for display;
via the peripheral device;
using a machine learning model.
These additional elements merely amount to the general application of the abstract idea to a technological environment (“a medical device configured to collect sensor data”; “a peripheral device configured to wirelessly communicate with the medical device”; “and processing circuitry configured”; “sensor”; “by the medical device”; “the peripheral device to output for display”; “via the peripheral device”; “using a machine learning model”) and insignificant pre-and-post solution activity (receive, evaluate, trigger, determine, comparison, send). The specification makes clear the general-purpose nature of the technological environment. Paragraphs 151 and 155 indicate the functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on or transmitted over as at least one instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media may include computer-readable storage media, which corresponds to a tangible medium such as data storage media, or communication media including any medium that facilitates transfer of a computer program from one place to another, e.g.,according to a communication protocol and The techniques of this disclosure may be implemented in a wide variety of devices or apparatuses, including an integrated circuit (IC) or a set of ICs (e.g.,a chip set). Various components, modules, or units are described in this disclosure to emphasize functional aspects of devices configured to perform the disclosed techniques, but do not necessarily require realization by different hardware units. That is, the technology used to implement the invention is not specific or integral to the claim.
Therefore, considered both individually and as an ordered combination, the additional elements do no more than generally link the use of the abstract idea to a particular technological environment or field of use. That is, given the generality with which the additional limitations are recited, the limitations do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim. Additionally, the claims do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing; and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea. Accordingly, the Examiner concludes that the claim fails to integrate the abstract idea into a practical application, and is therefore “directed to” the abstract idea.
7. Under step 2B of the Alice/Mayo framework, it must finally be considered whether the claim includes any additional element or combination of elements that provide an inventive concept (i.e., whether the additional element or elements are sufficient to amount to significantly more than the abstract idea). As indicated above, considered both individually and as an ordered combination, the additional elements do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim, do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing, and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea
Further, the additional elements (recited above) simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Receiving sensor data, triggering to output for display at least one question, and determining a risk level (i.e., receiving or transmitting data over a network) has been repeatedly considered well-understood, routine, and conventional activity by the Courts (See MPEP 2106.05(d)). Accordingly, the Examiner asserts that the additional elements, considered both individually, and as an ordered combination, do not provide an inventive concept, and the claim is ineligible for patent.
Independent Claims 11 and 20 are parallel in scope to claim 1 and ineligible for similar reasons.
Regarding Claims 3 and 4
Claim 3 and 4 sets forth, in part, wherein the sensor data further comprises data collected.
Such a recitation merely embellishes the abstract idea of monitoring a patient, including facilitating managing personal behavior. While the claim does set forth the additional limitation of “by at least one of the peripheral device”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1.
Regarding Claims 2, 5-10, 13, 14, and 21
Claim 2, 5-10, 13, 14, and 21 sets forth, in part, wherein the processing circuitry is further configured to perform a series of steps.
Such a recitation merely embellishes the abstract idea of monitoring a patient, including facilitating managing personal behavior. While the claim does set forth the additional limitation of “the processing circuitry”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1.
Claim Rejections - 35 USC § 103
8. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
9. Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent Application Publication Number 2008/0162182, Cazares, et al., hereinafter Cazares in view of United States Patent Application Publication Number 2013/0024211, Monteforte, et al., hereinafter Monteforte.
10. Regarding claim 1, Cazares discloses a system for monitoring a patient, the system comprising:
a medical device configured to collect sensor data related to at least one physiological parameter of the patient, (para. 3, modern IMDs also include the capability for bidirectional communication so that information, such as physiological data, can be transmitted to the programmer. Home health care remote monitoring systems can also communicate with the IMD and collect the patient and patient-related data);
a peripheral device configured to wirelessly communicate with the medical device, (para. 3, Implantable medical devices (IMDs), including cardiac rhythm management devices such as pacemakers and implantable cardioverter/defibrillators, typically have the capability to communicate with an external device, such as an external programmer, via wireless telemetry, such as a radio-frequency (RF) or other telemetry link.); and
processing circuitry configured to:
receive sensor data collected by the medical device, (para. 3, some monitoring systems can also collect other objective or subjective data using additional external sensors,);
evaluate the sensor data by at least comparing the sensor data to one or more criteria, (para. 38, means for comparing the received physiological data to the model to derive an index for the patient, para. 77, The measured physiological parameters may be compared to a baseline value to detect changes that exceed a threshold value, and para. 78, Each detector 202 may include hardware or software to evaluate the one or more input signals from the one or more sensors 204, such as to determine a value of an alert status associated with the sensor-detector pair);
receive at least one answer via the peripheral device, (para. 78, Sensors 204 may include implanted or external sensors, such as those described above. Sensors 204 may be configured to automatically collect patient-related data (e.g., a heart rate monitor) or be configured to operate by user commands (e.g., an interrogatory device with a display, or a weight scale). The patient-related data may include sensed physiological data, sensed environmental data, or data collected from a patient in response to a query or request, and para. 111, a patient may be requested to log onto a website daily and answer one or more questions,);
determine, using a machine learning model and based on a combination of the sensor data and the at least one answer, a risk-level of the patient’s health associated with at least one of infection, stroke, sepsis, heart failure, chronic obstructive pulmonary disease, heart failure decompensation, cardiac arrhythmia, or myocardial infarction, (para. 83, patients at high risk of heart failure decompensation may exhibit an unusually low physical activity or heart rate variability (HRV). By increasing the sensitivity of these sensors (e.g., decreasing a threshold value), a lower physical activity value or a lower HRV value may be detected earlier, and para. 161, Parameters may include weights in a weighted function (weighting factors), models used for patient comparison, one or more threshold values, or the like. Parameters may also include variables that control conditional states (e.g., control flow), sample resolution (timing), frequency of assessment, pattern of assessment (e.g., time of day, sequencing of multiple assessments).);
based on a comparison of the risk-level to one or more thresholds, determine an alert level of a plurality of alert levels, (para. 82, Such combinations or permutations of sensors 204 or detectors 202 may be advantageous to provide an alert status value that reflects a more complex decision or determination, and para. 115, The index score and one or more details about the alert state, e.g., whether an alert was generated, to whom it was communicated if there was an alert, etc.); and
send an alert corresponding to the alert level, (para. 91, The alert module 220 may communicate the alert state to a communication module 226, for communication to a user (e.g., a physician or clinician)).
Cazares does not explicitly disclose based on the evaluation of the sensor data, determine at least one question relating to the sensor data collected by the medical device; and
trigger the peripheral device to output for display the at least one question for the patient to answer.
However, Monteforte teaches based on the evaluation of the sensor data, determine at least one question relating to the sensor data collected by the medical device, (para. 196, Intervention alerts instructing the user to perform an activity (e.g., the aforementioned daily exercise reminder, an instruction to take a particular medication, etc) can include a means for the user to provide confirmation feedback that the activity has been completed. User feedback may be collected from data entered on a web page or other graphical display, pressing particular numerical keys on the device's keypad, or directly from a remote device (e.g., pedometer, etc.). In the present weight loss example, user feedback 3022 can confirm that the day's exercise requirement has been completed. If such a confirmation is not received within a defined time frame, notification component 3016 can issue subsequent reminders until confirmation has been received); and
trigger the peripheral device to output for display the at least one question for the patient to answer, (para. 54, the response analysis component 230 can work together with the question generation component 210 to enable intelligent follow-up questions to be asked and/or modification of the form of a question, for instance as a function of responses).
One having ordinary skill in the art at the time the invention was filed would combine the system of Cazares with the health interventions of Monteforte with the motivation of determined health risks associated with the user's known conditions (see Monteforte, para. 8).
11. Regarding claim 2, Cazares discloses the system of claim 1 as described above. Cazares further discloses wherein the processing circuitry is configured to evaluate the sensor data by at least comparing the sensor data to one or more criteria by determining that at least one value of the sensor data is outside a pre-determined range of values, and wherein the processing circuitry is configured to determine the at least one question in response to the determination that the at least one value is outside the pre-determined range, (para. 38, means for comparing the received physiological data to the model to derive an index for the patient, para. 77, The measured physiological parameters may be compared to a baseline value to detect changes that exceed a threshold value, and para. 78, Each detector 202 may include hardware or software to evaluate the one or more input signals from the one or more sensors 204, such as to determine a value of an alert status associated with the sensor-detector pair, para. 111, using sensed patient actions to determine a level of patient compliance. The method 700 illustrated in FIG. 7 detects and monitors patient actions in response to a request. At 702, one or more occurrences of a patient action are detected. Patient actions may be in response to a request for such an action by a clinician, therapist, or physician and para. 113, Threshold values may define a minimum or maximum expected value, such that when the patient falls under a minimum threshold or exceeds a maximum threshold value, a resulting particular action or state (e.g., an alert or alarm) may occur. Threshold values may also be used to define an inner or outer range of expected or accepted values.).
12. Regarding claim 3, Cazares discloses the system of claim 1 as described above. Cazares further discloses wherein the sensor data further comprises data collected by at least one of the peripheral device or one or more other measuring peripheral devices, (see at least paragraphs 70-71).
13. Regarding claim 4, Cazares discloses the system of claims 1 and 3 as described above. Cazares further discloses wherein at least a portion of the sensor data collected by the peripheral device or the one or more other measuring peripheral devices relates to at least one of a location, appearance, or sound of the patient, (para. 71, The external sensors 107 can be placed in a variety of geographic locations (in close proximity to patient or distributed throughout a population) and can record non-patient specific characteristics such as, for example, temperature, air quality, humidity, carbon monoxide level, oxygen level, barometric pressure, light intensity, and sound.).
14. Regarding claim 5, Cazares discloses the system of claim 1 as described above. Cazares further discloses wherein the processing circuitry is further configured to confirm accuracy of the sensor data using the patient’s at least one answer to the at least one question, (para. 72, External sensors 107 can also include devices that measure subjective data from the patient. Subjective data includes information related to a patient's feelings, perceptions, and/or opinions, as opposed to objective physiological data. For example, the "subjective" devices can measure patient responses to inquiries such as "How do you feel?", "How is your pain?" and "Does this taste good?" Such a device may also be adapted to present interrogatory questions related to observational data, such as "What color is the sky?" or "Is it sunny outside?" The device can prompt the patient and record responsive data from the patient using visual and/or audible cues.).
15. Regarding claim 6, Cazares discloses the system of claim 1 as described above. Cazares further discloses wherein the processing circuitry is further configured to determine the risk-level of the patient’s health by inputting the sensor data and the at least one answer to the at least one question into a decision tree algorithm, (para. 177, Patient diagnostic routine file 1612 may include programmatic code or other structures that control or enable the decisional process of an automated patient evaluation. Patient diagnostic routine file 1612 may also include variables, such as threshold values, weighting factors, or other parameters used during the execution of patient diagnostic routines and para. 185, in the context of tachyarrhythmia discrimination and detection, a physician may decide to use a morphology-based discrimination algorithm (e.g., Rhythm ID) over an interval-based discrimination algorithm (e.g., one-button detection enhancement (OBDE)).).
16. Regarding claim 7, Cazares discloses the system of claim 1 as described above. Cazares further discloses wherein the processing circuitry is further configured to monitor, by the processing circuitry, the patient, where at least one of a period or a frequency of monitoring is based on the risk-level of the patient’s health, (para. 101, Non-compliant patients may benefit from closer observation or follow-up by their physician or clinician. The observation or follow-up may assist the physician or clinician in managing an increased medical risk due to non-compliance and increasing the patient's overall compliance. In addition, non-compliant patients may benefit from re-evaluating, modifying, ceasing, or implementing new therapies.).
17. Regarding claim 8, Cazares discloses the system of claim 1 as described above. Cazares further discloses wherein the processing circuitry is further configured to output for display, by the processing circuitry and based on the risk level of the patient’s health, at least one of the at least one question about the patient’s health, an indication of the risk-level of the patient’s health, a notification to maintain status quo, a recommendation to increase monitoring, or an alert to contact a clinician, (para. 101, Non-compliant patients may benefit from closer observation or follow-up by their physician or clinician. The observation or follow-up may assist the physician or clinician in managing an increased medical risk due to non-compliance and increasing the patient's overall compliance. In addition, non-compliant patients may benefit from re-evaluating, modifying, ceasing, or implementing new therapies).
18. Regarding claim 9, Cazares discloses the system of claim 1 as described above. Cazares further discloses wherein the sensor data comprises temperature data, and wherein the processing circuitry is configured to:
determine whether the temperature data is outside a predetermined temperature range, (para. 71, one or more external sensors 107 are adapted to communicate with the transceiver 104 and may transmit and receive information, such as sensed data. External sensors 107 may be used to measure patient physiological data, such as temperature (e.g., a thermometer), blood pressure (e.g., a sphygmomanometer), blood characteristics (e.g., glucose level), body weight, physical strength, mental acuity, diet, or heart characteristics); and
determine a risk-level of infection,( para.156, A between-patient analysis may provide a more long-term indication of a patient's risk compared to a population. In contrast, a within-patient analysis may provide a more short-term indication of acute changes in a patient's health. Thus, it may be advantageous to use one analysis to tune performance of another analysis. For example, a between-patient analysis that includes a large number of patients in the population may provide a sufficient confidence that a particular patient is high or low risk for the occurrence of a particular physiological condition).
19. Regarding claim 10, Cazares discloses the system of claim 1 as described above. Cazares further discloses wherein the sensor data comprises cardiac electrogram data, and wherein the processing circuitry is configured to:
identify one or more atrial fibrillation episodes in the sensor data, (para. 6, wherein the criteria include age, gender, ethnicity, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) heart failure classification, results of a six-minute walk test (6MW), quality of life, heart failure etiology, body mass index (BMI), blood pressure, medication, co-morbidity, arrhythmia history, implant history, treatment compliance, health care system, circadian rhythm, geographic location, patients who have survived for a particular time frame, or patients who have not decompensated in a particular time frame.); and
determine a risk-level of stroke, (para. 83, patients at high risk of heart failure decompensation may exhibit an unusually low physical activity or heart rate variability (HRV). By increasing the sensitivity of these sensors (e.g., decreasing a threshold value), a lower physical activity value or a lower HRV value may be detected earlier).
20. Claims 11-16 are rejected for the same reasons as claims 1, 2, 6, and 8-10 as set forth above.
21. Regarding claim 17, Cazares discloses the method of claim 11 as described above. Cazares further discloses further comprising determining, based on the sensor data, a probability of the patient experiencing heart failure, chronic obstructive pulmonary disease, heart failure decompensation, cardiac arrhythmia, or myocardial infarction, and wherein outputting for display via the peripheral device at least one question comprises outputting the at least one question based on the probability of the patient experiencing at least one of heart failure, chronic obstructive pulmonary disease, heart failure decompensation, cardiac arrhythmia, or myocardial infarction, (para. 83, patients at high risk of heart failure decompensation may exhibit an unusually low physical activity or heart rate variability (HRV). By increasing the sensitivity of these sensors (e.g., decreasing a threshold value), a lower physical activity value or a lower HRV value may be detected earlier).
22. Regarding claim 18, Cazares discloses the method of claims 11 and 17 as described above. Cazares further discloses wherein the probability of the patient experiencing at least one of heart failure, chronic obstructive pulmonary disease, heart failure decompensation, cardiac arrhythmia, or myocardial infarction is determined by comparing the sensor data to a set of thresholds, (para. 83, patients at high risk of heart failure decompensation may exhibit an unusually low physical activity or heart rate variability (HRV). By increasing the sensitivity of these sensors (e.g., decreasing a threshold value), a lower physical activity value or a lower HRV value may be detected earlier).
23. Regarding claim 19, Cazares discloses the method of claim 11 as described above. Cazares further discloses wherein at least a portion of the sensor data is related to at least one of an intra-thoracic impedance, an atrial fibrillation, a burden and rate control information, a night heart rate, a heart rate variability, or a patient activity, (para. 24, physiological data includes one or more of an electrocardiogram, an activity level, a heart rate variability, a heart rate, a heart sound, a blood pressure, an impedance, a body weight, or an O.sub.2 saturation.).
24. Claim 20 are rejected for the same reasons as claim 1 as set forth above. Cazares further discloses a non-transitory computer-readable medium comprising instructions that, when executed, cause processing circuitry to perform a method, (see at least para. 203).
25. Regarding claim 21, Cazares discloses the system of claim 1 as described above. Cazares further discloses wherein the sensor data comprises temperature data, (para. 71, External sensors 107 may be used to measure patient physiological data, such as temperature (e.g., a thermometer)), and wherein the processing circuitry is further configured to:
determine to output the question in response to the sensor data being outside a predetermined range, (Figures 8 and 16, para. 3, Home health care remote monitoring systems can also communicate with the IMD and collect the patient and patient-related data. In addition, some monitoring systems can also collect other objective or subjective data using additional external sensors, such as a blood pressure cuff, a weight scale, or a specialized device that prompts the patient with questions regarding their health state. Some home health care monitoring systems can communicate with a centralized or other remote system, such as directly or using a networked system. Centralized systems, including medical practice systems, provide an efficient mode for physicians and other medical practitioners to manage patient-related data, and para. 114, if the patient index violates a threshold value or condition, for example when a value is outside of a range bounded by one or more threshold values, then an alert is generated. The alert may be communicated to a user, such as a physician, or be used in further processing, such as in determining an alert score or a composite alert score, as described above, and para. 116, When the patient fails to weigh themselves over several days, but continues to report the outdoor temperature using the handheld interrogatory device, it may be inferred by the attending physician that the patient may be physically unable to get to the bathroom to weigh himself. The inference may be supported by a deduced fact that the patient is still capable of reporting the temperature from using the handheld patient monitoring device, which may be situated more conveniently, such as beside the patient's bed. In such a situation, the physician may wish to follow up to ensure that the patient is physically stable. Detecting the presence or absence of data or other trends may be useful to determine or predict patient problems, such as heart failure decompensation, loss of cognitive function, or physical incapacity); and
determine a risk-level of infection based on the sensor data and the at least one answer, (Figures 8 and 16, para. 3, Home health care remote monitoring systems can also communicate with the IMD and collect the patient and patient-related data. In addition, some monitoring systems can also collect other objective or subjective data using additional external sensors, such as a blood pressure cuff, a weight scale, or a specialized device that prompts the patient with questions regarding their health state. Some home health care monitoring systems can communicate with a centralized or other remote system, such as directly or using a networked system. Centralized systems, including medical practice systems, provide an efficient mode for physicians and other medical practitioners to manage patient-related data, para. 80, binary values may indicate whether a patient is more or less likely to experience a health change, such as a change to quality of life, an onset of a disease state (e.g., heart failure decompensation), or death. Discrete values may indicate, for example, a multi-state condition (e.g., low/medium/high) or a scaled value, such as a subjective rating of pain on a scale of one to five).
Response to Arguments
26. Applicant's arguments filed April 27, 2026 have been fully considered but they are not persuasive.
Applicant argues that in claim 1, does not fall under the “certain methods of organizing human activity” groupings of abstract ideas.
In response, Examiner respectfully disagrees. See the 35 U.S.C. 101 rejections above. The claims do not integrate the abstract idea into a practical application, and does not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea). (Digitech Image Tech., LLC v. Electronics for Imaging, Inc. (Fed. Cir. 2014)). The claims do not recite any unconventional computer functions. The structural elements as claimed are for mere convenience and the recited claim elements constitute methods related to “certain methods of organizing human activity”. Claims 1-21 are directed to monitoring a patient to determine an alert level and sending the alert. This arrangement amounts to managing personal behavior. Such concepts have been considered ineligible certain methods of organizing human activity by the Courts (See MPEP 2106.04(a)). The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea). As a result, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, and the claims are properly rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter. The claim is silent on any computer operation and specific technological implementation that would move the claim beyond a general link to a technological environment.
Applicant argues that claim 1 does not merely cite an abstract idea, but applies it in a particular way to solve a specific technological problem in patient monitoring.
In response, Examiner respectfully disagrees. After determining that a claim recites a judicial exception in Step 2A Prong One, examiners should evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception in Step 2A Prong Two. A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception (see MPEP § 2106.04{d) - Integration of a Judicial Exception Into A Practical Application). The court has provided limitations that are indicative that an additional element (or combination of elements) may have integrated the exception into a practical application and limitations that did not integrate a judicial exception into a practical application (see MPEP § 2106.04(d)(I) — Relevant Considerations for Evaluating Whether Additional Elements integrate a Judicial Exception into a Practical Application). Here the instant claims seem more analogous to "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f). Accordingly, the claims do not recite additional limitations that integrate the exception into a Practical Application, and the application of the abstract idea is therefore not eligible.
Applicant argues that the claims are analogous to Bascom and Ex Parte Desjardins, in that the claims reflect a specific improvement that addressed the technical problem.
In response, Examiner respectfully disagrees. With regard to BASCOM, BASCOM was found eligible based on considerations relevant to Part 2B (does the claim as a whole amount to significantly more than the abstract idea) of the two-part framework outlined in MPEP §2106; where claim 1 "carve[s] out a specific location for the filtering system (a remote ISP server) and require the filtering system to give users the ability to customize filtering for their individual network accounts". In contrast, Applicant’s invention aims monitor and/or treat a variety of medical conditions and does not aim to solve a technological problem. The specification is silent in regards to improving the additional elements recited in the claims. Examiner finds, Applicants have not identified anything in the claimed invention that shows or submits the technology is being improved or there was a problem in the technology that the claimed invention solves.
For similar reasons as stated above with BASCOM, the present claims in the instant application are not analogous to Ex Parte Desjardins. The present claims are drawn to monitoring a patient and not to improving system performance. Examiner would also like to note that the decision in Ex Parte Desjardins does not nullify Alice.
Applicant then argues that the combination of elements amounts to significantly more than the alleged judicial exception.
In response, the Examiner respectfully disagrees. The consideration under Step 2B is if the additional elements, alone or in combination, are well-understood, routine and conventional in the field — the novelty of the abstract idea is not considered relevant under the Step 2B analysis. Here, the additional elements, alone or in combination, amount to instruction to implement the abstract idea using a general purpose computer. Alice Corp. Pty. Ltd. V. CLS Bank Int’|, 134 S. Ct. 2347, 1357 (2014). Accordingly, it does not amount to significantly more, and the application of the abstract idea is therefore not eligible.
Applicant argues that Cazares does not disclose or suggest the features of amended independent claim 1.
Applicant’s arguments with respect to claims 1-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
CLINICAL DIAGNOSIS OBJECTS INTERACTION (US 20140122109 A1) teaches diagnosing a patient using a computer system includes, on the computer system: receiving information from the patient, the information including symptoms and symptom history; identifying a first set of diagnoses using the information; presenting the first set of diagnoses and a first set of questions to the patient in accordance with the information; receiving a first set of answers to the first set of questions; and identifying a second set of diagnoses and a second set of questions in accordance with the first set of answers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amber A. Misiaszek whose telephone number is (571) 270-1362. The examiner can normally be reached on M-Th 7:30-5, F 7:30-4, every other Friday Off.
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/AMBER A MISIASZEK/
Primary Examiner, Art Unit 3682
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