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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Determination as to whether a claim satisfies the criteria for subject matter eligibility is a stepwise process (MPEP 2016).
Step 1: Does the claim fall within a statutory category of invention?
Claim 1 recites a method, and claim 11 recites a method, which are within the four statutory categories. Therefore, claims 1 and 11 are directed to a statutory category of invention.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1 and 11 are directed to an abstract idea.
Claim 1 is directed to a method to track cardiac health of a patient, the method comprising:
receiving, via a mobile device, cardiac device data associated with the patient from a cardiac device in communication with the mobile device;
filtering patient health data from the cardiac device based, at least in part, on patient logic rules;
removing patient identification information from the filtered patient health data to anonymize the patient health data; and
transferring the anonymous patient health data to one or more personnel based, at least in part, on the patient logic rules.
Claim 11 is directed to a method to manage cardiac health data of a patient, the method comprising:
receiving, from at least one data storage system, patient data associated with a cardiac device worn by the patient, wherein the patient data is collected by at least one sensor of the cardiac device, and wherein the patient data comprises medical data of the patient and device data of the cardiac device;
filtering a portion of the patient data based, at least in part, on patient logic rules; and
transferring the filtered portion of the patient data to at least one user interface of at least one display device associated with at least one personnel based, at least in part, on the patient logic rules.
The limitations of filtering the data based on patient logic rules and removing patient identification information, as drafted, under their broadest reasonable interpretations, are merely mental processes, because these steps are akin to having a doctor or other human actor performing these operations with pen and paper. For example, “filtering a portion of the data based, at least in part on patient logic rules” encompasses nothing more than a human actor mentally evaluating the data based on certain criteria, and making a conclusion about whether the data should be excluded.
The limitations of “receiving cardiac device data” and “receiving patient data” encompasses nothing more than a human actor collecting these pieces of information by hand.
The limitation “at least one data storage system” indicates that the data may be stored for analysis and display at a later time. Therefore, a human actor can perform the analysis with pen and paper.
Therefore, claims 1 and 11 recite an abstract idea.
Claims 2-10 depend on claim 1, and claims 12-20 depend on claim 11. These dependent claims only recite additional features of the analysis described in claims 1 and 11, which may also be performed by a human actor mentally and using a pen and paper. Claim 2 recites “wherein filtering the patient health data comprises restricting and granting access to portions of the patient health data”, which encompasses nothing more than a human actor evaluating the data according to certain criteria to determine whether access should be granted.
Therefore, claims 1-20 recite an abstract idea.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
This judicial exception is not integrated into a practical application.
Claim 1 recites the additional limitation “receiving, via a mobile device, cardiac device data associated with the patient from a cardiac device in communication with the mobile device”, which amounts to no more than mere pre-solution activity of data gathering. Therefore the claimed generic mobile device and cardiac device elements do not integrate the judicial exception into a practical application.
Claim 11 recites the additional limitation “receiving, from at least one data storage system, patient data associated with a cardiac device worn by the patient, wherein the patient data is collected by at least one sensor of the cardiac device, and wherein the patient data comprises medical data of the patient and device data of the cardiac device”, which amounts to no more than mere pre-solution activity of data gathering. Therefore the claimed generic data storage system, cardiac device, and sensor elements do not integrate the judicial exception into a practical application.
Thus, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea. As described above, dependent claims 2-10 and 12-20 only recite other limitations of data filtering and manipulation, which may be done mentally by a human actor and/or with a pen and paper.
Step 2B: Does the claim include additional elements that are sufficient to amount to significantly more than the judicial exception?
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 recites the additional limitation “receiving, via a mobile device, cardiac device data associated with the patient from a cardiac device in communication with the mobile device”. Claim 11 recites the additional limitation “receiving, from at least one data storage system, patient data associated with a cardiac device worn by the patient, wherein the patient data is collected by at least one sensor of the cardiac device, and wherein the patient data comprises medical data of the patient and device data of the cardiac device”. As discussed above with respect to integration of the abstract idea into a practical application (Step 2A, Prong 2), the additional elements of a mobile device, a cardiac device, at least one data storage system, and at least one sensor to collect data amounts to no more than mere pre-solution activity of data gathering. This pre-solution activity of data gathering using at least one sensor is well-understood, routine, and conventional in the field of wearable cardiac monitoring technology. For example, see Sana et al. (“Wearable Devices for Ambulatory Cardiac Monitoring”, 2020), which describes known methods of wearable cardiac monitoring. Therefore, the claimed generic mobile device, cardiac device, and sensor are all well-understood, routine, and conventional in the field of wearable cardiac monitoring technology.
Therefore, claims 1-20 are not patent-eligible under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 102
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 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 1-4, 7, and 9-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deterding et al. (US 20180325385 A1), hereinafter Deterding.
Regarding claim 1, Deterding discloses a method to track cardiac health of a patient, the method comprising:
receiving, via a mobile device (Figs. 1 and 23, paragraphs [0042] and [0098], reporting device 110A), cardiac device data associated with the patient from a cardiac device (paragraph [0036], "the wearable device will perform real-time measurement of a number of physiological and/or environmental parameters such as, but not limited to, heart rate, pulse oximetry"; paragraph [0050], "sensors 220 may include optical sensors, ... heart rate monitors, pulse oximetry sensors") in communication with the mobile device (paragraph [0042], "monitoring devices worn by users 140 can monitor a variety of physiological parameters which can be transmitted to monitoring and feedback platform 130 and/or reporting devices 110A-110N for analysis");
filtering patient health data from the cardiac device based, at least in part, on patient logic rules (Fig. 2, paragraph [0053], filters 240; paragraph [0055], "FIG. 3 indicates that a wearable device or a mobile device attached to the user monitors physiological data such as a heart rate, a respiratory rate, a blood pressure, a temperature, a body movement, and SpO2 levels to detect the onset of a pulmonary event for the user. Such data is sent to the monitoring and detection platform where the data is analyzed using machine learning methodologies (e.g., fuzzy logic or deep learning) with reference to a baseline health profile of the user)");
removing patient identification information from the filtered patient health data to anonymize the patient health data (paragraph [0064], "monitoring and feedback platform may generate an anonymized set of data"); and
transferring the anonymous patient health data to one or more personnel based, at least in part, on the patient logic rules (paragraph [0064], "the monitoring and feedback platform can send the health report to a reporting device (e.g., a mobile phone running an application, a clinical device, etc.) where a caregiver (e.g., parent, medical professional, etc.) can evaluate the data").
Regarding claim 2, Deterding discloses the method of claim 1, as explained above. Deterding further discloses that filtering the portion of the patient data comprises restricting and granting access to portions of the medical data and the device data (paragraph [0052], "Identification module 235 may be able to provide a unique identifier to external devices and/or securely identify remote devices which wearable device 200 may communicate with. ... if the identification module 235 fails to authenticate an external device, then the identification module terminates communications with the external device. In some embodiments, the identification module 235 maintains a white list of allowable external devices and a blacklist of external devices that have failed authentication a certain number of times"; paragraph [0102], "The firewall may additionally manage and/or have access to an access control list which details permissions including, for example, the access and operation rights of an object by an individual, a machine, and/or an application, and the circumstances under which the permission rights stand").
Regarding claim 3, Deterding discloses the method of claim 1, as explained above. Deterding further discloses that the one or more personnel comprise one or more medical personnel (paragraph [0039], "Depending on the end user, varying information may be displayed on the reporting device, e.g., the caregiver's device. For the at-home user, a parent may see a dashboard indicating the child's health score (1-100) with a Red/Yellow/Green (R/Y/G) indicator. A physician may see a readout of the physiological parameters in addition to the health score and the R/Y/G indicator"; paragraph [0055], "After the analysis is complete, the outcome of the analysis is sent to the parents, the doctor, or a school of the user").
Regarding claim 4, Deterding discloses the method of claim 1, as explained above. Deterding further discloses that the cardiac device data comprises the patient health data and device data, the patient health data being associated with a health of the patient (paragraph [0043], "the wearable monitoring devices worn by users 140 may measure a set of physiological parameters") and the device data being associated with parameters of the cardiac device (paragraph [0051], "the status module can monitor when the sensors associated with the wearable device are malfunctioning or exhibiting anomalous behavior. In some embodiments, the status module 230 can report the health of the sensors associated with the wearable device to the monitoring and feedback platform").
Regarding claim 7, Deterding discloses the method of claim 1, as explained above. Deterding further discloses that the patient health data is transferred to the one or more personnel upon detection of a cardiac event associated with the patient (paragraph [0055], "a wearable device or a mobile device attached to the user monitors physiological data such as a heart rate, a respiratory rate, a blood pressure, a temperature, a body movement, and SpO2 levels to detect the onset of a pulmonary event for the user. Such data is sent to the monitoring and detection platform where the data is analyzed ... After the analysis is complete, the outcome of the analysis is sent to the parents, the doctor, or a school of the user"; paragraph [0064], "monitoring and feedback platform may generate an anonymized set of data which can be used by analytics engine to generate various analytics").
Regarding claim 9, Deterding discloses the method of claim 1, as explained above. Deterding further discloses mirroring the cardiac device data on a second device that is remote from the mobile device, wherein the second device is associated with professional personnel (paragraph [0039], "Depending on the end user, varying information may be displayed on the reporting device, e.g., the caregiver's device. For the at-home user, a parent may see a dashboard indicating the child's health score (1-100) with a Red/Yellow/Green (R/Y/G) indicator. A physician may see a readout of the physiological parameters in addition to the health score and the R/Y/G indicator").
Regarding claim 10, Deterding discloses the method of claim 1, as explained above. Deterding further discloses:
receiving a message from the one or more personnel (paragraph [0058], "interactive survey questions may be sent back to the portable device from the caregiver's electronic device"); and
displaying the received message to the patient (paragraph [0068], "The interface displays several questions in connection with a daily questionnaire for the user. In some embodiments, these questions can be predetermined beforehand in time or they can be framed in real time").
Regarding claim 11, Deterding discloses a method to manage cardiac health data of a patient, the method comprising:
receiving, from at least one data storage system (Fig. 1, paragraph [0046], database 160; paragraph [0054], "the data may be stored locally until wearable device 200 is in transmittable range. ... After the physiological information is received by the remote server, this information is stored on the server"; Fig. 23, paragraphs [0103]-[0105], storage devices 2390), patient data associated with a cardiac device worn by the patient, wherein the patient data is collected by at least one sensor of the cardiac device, and wherein the patient data comprises medical data of the patient and device data of the cardiac device;
filtering a portion of the patient data based, at least in part, on patient logic rules (Fig. 2, paragraph [0053], filters 240; paragraph [0055], "FIG. 3 indicates that a wearable device or a mobile device attached to the user monitors physiological data such as a heart rate, a respiratory rate, a blood pressure, a temperature, a body movement, and SpO2 levels to detect the onset of a pulmonary event for the user. Such data is sent to the monitoring and detection platform where the data is analyzed using machine learning methodologies (e.g., fuzzy logic or deep learning) with reference to a baseline health profile of the user)"); and
transferring the filtered portion of the patient data to at least one user interface of at least one display device associated with at least one personnel based, at least in part, on the patient logic rules (paragraph [0064], "the monitoring and feedback platform can send the health report to a reporting device (e.g., a mobile phone running an application, a clinical device, etc.) where a caregiver (e.g., parent, medical professional, etc.) can evaluate the data"; paragraph [0039], "Depending on the end user, varying information may be displayed on the reporting device, e.g., the caregiver's device"; paragraph [0061]).
Regarding claim 12, Deterding discloses the method of claim 11, as explained above. Deterding further discloses that filtering the portion of the patient data comprises restricting and granting access to portions of the medical data and the device data (paragraph [0052], "Identification module 235 may be able to provide a unique identifier to external devices and/or securely identify remote devices which wearable device 200 may communicate with. ... if the identification module 235 fails to authenticate an external device, then the identification module terminates communications with the external device. In some embodiments, the identification module 235 maintains a white list of allowable external devices and a blacklist of external devices that have failed authentication a certain number of times"; paragraph [0102], "The firewall may additionally manage and/or have access to an access control list which details permissions including, for example, the access and operation rights of an object by an individual, a machine, and/or an application, and the circumstances under which the permission rights stand").
Regarding claim 13, Deterding discloses the method of claim 11, as explained above. Deterding further discloses allowing the at least one personnel to access predetermined categories of the medical data and the device data using the at least one user interface (paragraph [0061], "Depending on the end user, varying information may be displayed on the electronic device of the caregivers. For the at-home user, a parent would see a dashboard indicating the child's health score (1-100) as a percentage of baseline with a Red/Yellow/Green indicator or a gas tank display of full-to-empty. A physician may see readouts of the physiological parameters in addition to the health score and R/Y/G indicator").
Regarding claim 14, Deterding discloses the method of claim 11, as explained above. Deterding further discloses that the patient logic rules are implemented using a medical logic module (paragraph [0055], "Such data is sent to the monitoring and detection platform where the data is analyzed using machine learning methodologies (e.g., fuzzy logic or deep learning) with reference to a baseline health profile of the user). The machine learning methodologies, the baseline health profile, and the outcome of the analysis of the physiological data can be stored in a database. After the analysis is complete, the outcome of the analysis is sent to the parents, the doctor, or a school of the user").
Regarding claim 15, Deterding discloses the method of claim 14, as explained above. Deterding further discloses that the care station logic module is a centralized storage database that controls communication between the patient and the at least one personnel (paragraph [0046], "Data from the wearable monitoring devices and external monitors 150 may be stored in database 160. ... the system provide access to a large data set and provides a consistent, rapid way to incorporate the data into a meaningful value for feedback from families and healthcare providers").
Regarding claim 16, Deterding discloses the method of claim 14, as explained above. Deterding further discloses that the medical logic module filters the medical data for transferring to medical personnel (paragraph [0055], "the outcome of the analysis is sent to the parents, the doctor, or a school of the user"; paragraph [0064], "The sensor data (or a filter version) may be transmitted to a monitoring and feedback platform where an analysis is generated. In accordance with some embodiments, the analysis generated by the monitoring and feedback platform may be based on individualized baseline profiles that have been previously generated").
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5-6 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Deterding et al. (US 20180325385 A1), hereinafter Deterding, in view of Reiner (US 20170068792 A1).
Regarding claim 5, Deterding discloses the method of claim 4, as explained above.
filtering the device data from the cardiac device data based, at least in part, on the patient logic rules (paragraph [0051], "the status module can monitor when the sensors associated with the wearable device are malfunctioning or exhibiting anomalous behavior"); and
removing the patient identification information from the filtered device data to anonymize the device data (paragraph [0064], "monitoring and feedback platform may generate an anonymized set of data").
Deterding does not explicitly disclose transferring the anonymous device data to one or more customer service personnel based, at least in part, on the patient logic rules.
However, Reiner teaches a method for medical device security, data tracking and outcomes analysis (paragraph [0022]) comprising transferring anonymous device data to one or more customer service personnel based, at least in part, on the patient logic rules (paragraph [0199], "the program 110 will collect all device related data and share anonymized data with authorized parties (e.g., regulatory agencies, manufacturers, researchers)").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Deterding with the teachings of Reiner so that the method further comprises transferring the anonymous device data to one or more customer service personnel based, at least in part, on the patient logic rules, because doing so provides an effective method of objectively analyzing both device and manufacture performance, allowing healthcare consumers direct access to comparative medical device data and device manufacturers the ability to identify technical deficiencies at an earlier point in time along with the ability to proactively intervene (Reiner, paragraph [0200]).
Regarding claim 6, the method of claim 5 is obvious over Deterding and Reiner, as explained above. Reiner further teaches that the anonymous device data is transferred to the one or more customer service personnel when an equipment issue occurs with the cardiac device (paragraph [0199], "While the program 110 will collect all device related data and share anonymized data with authorized parties (e.g., regulatory agencies, manufacturers, researchers) to ensure patient safety standards are maintained, it is valuable for the program 110 to have the ability for direct data communication with the vendor to troubleshoot and offer guidance when device malfunction occurs").
Regarding claim 17, Deterding discloses the method of claim 14, as explained above. Deterding does not explicitly disclose that the customer service logic module filters the device data for transferring to customer service personnel.
However, Reiner teaches a method for medical device security, data tracking and outcomes analysis (paragraph [0022]) comprising:
filtering device data (paragraph [0110], "the program 110 will collect all device related data") for transferring to customer service personnel (paragraph [0199], "the program 110 will...share anonymized data with authorized parties (e.g., regulatory agencies, manufacturers, researchers) ... it is valuable for the program 110 to have the ability for direct data communication with the vendor to troubleshoot and offer guidance when device malfunction occurs. In effect, this would lead to the creation of 'device hotlines' with vendors which provides patients and providers with the option to directly communicate and share device related data with the device manufacturer")
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Deterding with the teachings of Reiner so that the at least one personnel comprises customer service personnel, and so that the customer service logic module filters the device data for transferring to customer service personnel, because doing so provides an effective method of objectively analyzing both device and manufacture performance, allowing healthcare consumers direct access to comparative medical device data and device manufacturers the ability to identify technical deficiencies at an earlier point in time along with the ability to proactively intervene (Reiner, paragraph [0200]).
Regarding claim 18, Deterding discloses the method of claim 14, as explained above. Deterding does not explicitly disclose that the CRM logic module filters the device data for transferring to CRM personnel or providers of the cardiac device, to investigate issues related to wear time and device alerts associated with the cardiac device.
However, Reiner teaches a method for medical device security, data tracking and outcomes analysis (paragraph [0022]) comprising:
filtering device data (paragraph [0110], "the program 110 will collect all device related data"),
anonymizing the collected data and transferring the anonymized data to CRM personnel (paragraph [0199], "the program 110 will...share anonymized data with authorized parties (e.g., regulatory agencies, manufacturers, researchers)"), and
allowing investigation of issues related to wear time and device alerts associated with the cardiac device (paragraph [0101], "The ability of the program 110 to standardize methods for medical device quality control are a unique feature of the invention and provides important (and currently unavailable) data for determining device longevity and clinical utility of medical devices over prolonged periods of time"; paragraph [0169], "The analysis and feedback of this device positional and functionality data can be automatically transferred by the program 110 at predefined time intervals (e.g., weekly) to authorized providers, along with the ability to automate data alerts and prompts when predefined data thresholds are exceeded, thereby requiring receipt notification, acknowledgement, follow-up, and potential intervention").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Deterding with the teachings of Reiner so that the CRM logic module filters the device data for transferring to CRM personnel or providers of the cardiac device, to investigate issues related to wear time and device alerts associated with the cardiac device, because doing so provides an effective method of objectively analyzing both device and manufacture performance, allowing healthcare consumers direct access to comparative medical device data and device manufacturers the ability to identify technical deficiencies at an earlier point in time along with the ability to proactively intervene (Reiner, paragraph [0200]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Deterding et al. (US 20180325385 A1), hereinafter Deterding, in view of Arora et al. (US 20210082551 A1), hereinafter Arora.
Regarding claim 8, Deterding discloses the method of claim 1, as explained above. Although Deterding further discloses providing anonymous health data (paragraph [0064], "monitoring and feedback platform may generate an anonymized set of data which can be used by analytics engine to generate various analytics"), Deterding does not explicitly disclose providing the anonymous patient health data to researchers for studying cardiac health trends.
However, Arora teaches methods for providing real-time/near-real-time/periodic health updates for patients and generating a health report associated with a patient (paragraph [0018]) comprising providing the anonymous patient health data to researchers for studying cardiac health trends (paragraph [0021], "systems and methods described herein provide for anonymizing patient data that allows for anonymous research and analysis results to be correlated by a healthcare professional. ... The monitoring system has the capability of processing a patient data to allow multiple healthcare professional to view and analyze either independently or in a collaborated manner to identify and monitor health characteristics (e.g., blood pressure, diabetes, thyroid issues, etc.)").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Deterding with the teachings of Arora so that the method further comprises providing the anonymous patient health data to researchers for studying cardiac health trends, because doing so maintains an appropriate level of anonymization within the data or a subset of the anonymized data without compromising the privacy of the patients associated with the anonymized data (Arora, paragraph [0035]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Deterding et al. (US 20180325385 A1), hereinafter Deterding, in view of LePendu (US 20170091391 A1).
Regarding claim 19, Deterding discloses the method of claim 11, as explained above. Deterding further discloses prior to transferring the filtered portion of the patient data to the at least one user interface, removing patient identification information from the filtered portion of the patient data to anonymize the patient data (paragraph [0064], "monitoring and feedback platform may generate an anonymized set of data which can be used by analytics engine to generate various analytics").
Deterding does not explicitly disclose maintaining an anonymous identifier within the anonymous patient data to allow the at least one personnel to anonymously reach the patient.
However, LePendu teaches a computerized method of removing protected health information from a patient's medical record (Abstract) comprising:
removing patient identification information from the filtered portion of the patient data to anonymize the patient data (paragraph [0035], "HIPAA regulations currently lists 18 identifiers that are considered protected health information ... scrubbing a patient's medical record means the removal and/or replacement of these 18 identifiers"; paragraph [0039], "The data integration logic module 32 further includes a de-identification/re-identification process 10 that is adapted to remove and replace all protected health information (PHI) according to HIPAA standards"); and
maintaining an anonymous identifier within the anonymous patient data to allow the at least one personnel to anonymously reach the patient (paragraph [0056], "Once a piece of protected information is identified, then a replacement value is determined as a substitute for the original value of the protected information, as shown in block 66. In block 68, the original value of the protected information in the medical record is then replaced with the selected replacement value"; paragraph [0057] discloses methods of determining replacement values).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Deterding with the teachings of LePendu so that the method further comprises maintaining an anonymous identifier within the anonymous patient data to allow the at least one personnel to anonymously reach the patient, because doing so ensures that medical information that has been de-identified, even if accessed by unauthorized persons or entities, cannot be easily linked back to the patient's identity, thus protecting the patient's privacy (LePendu, paragraph [0059]) and so that the anonymization cannot be easily detected (LePendu, paragraph [0062]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Deterding et al. (US 20180325385 A1), hereinafter Deterding, in view of LePendu (US 20170091391 A1), and further in view of Reiner (US 20170068792 A1).
Regarding claim 20, the method of claim 19 is obvious over Deterding and LePendu, as explained above. Neither Deterding nor LePendu explicitly discloses that the at least one personnel comprises customer service personnel, and wherein the anonymous patient data is utilized by the customer service personnel to study heart rate data for troubleshooting readings.
However, Reiner teaches a method for medical device security, data tracking and outcomes analysis (paragraph [0022]) comprising:
collecting cardiac data (paragraph [0094], cardiac rate and rhythm),
anonymizing the collected data and transferring the anonymized data to customer service personnel (paragraph [0199], "the program 110 will collect all device related data and share anonymized data with authorized parties (e.g., regulatory agencies, manufacturers, researchers)"), and
allowing the customer service personnel to troubleshoot readings and reach the patient (paragraph [0199], "it is valuable for the program 110 to have the ability for direct data communication with the vendor to troubleshoot and offer guidance when device malfunction occurs. In effect, this would lead to the creation of 'device hotlines' with vendors which provides patients and providers with the option to directly communicate and share device related data with the device manufacturer").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Deterding and LePendu with the teachings of Reiner so that the at least one personnel comprises customer service personnel, and so that the anonymous patient data is utilized by the customer service personnel to study heart rate data for troubleshooting readings, because doing so provides an effective method of objectively analyzing both device and manufacture performance, allowing healthcare consumers direct access to comparative medical device data and device manufacturers the ability to identify technical deficiencies at an earlier point in time along with the ability to proactively intervene (Reiner, paragraph [0200]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Mason (US 20200275886 A1) discloses a method of remote assistance (paragraph [0070]) wherein access to patient information is different depending on the type of personnel (paragraph [0071])
Raduchel et al. (WO 2018152410 A1) discloses methods for providing a healthcare provider with an electronic medical record of a patient, a recommendation, or an alert relating to the patient, based on an analysis of the patient's health data, wherein medical record aggregation may be performed relatively anonymously (Fig. 7)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINE SISON/Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights