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 .
DETAILED ACTION
In the amendment filed 17 February 2026:
Claims 23-27 are new
Claims 1,5, 7, 9, 14-15, 19, 22 are amended
Claims 1,2,4-9,14-16,18-27 are pending
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 1,2,4-9,14-16,18-27 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.
Claims 1, 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a device, non-transitory computer readable storage medium and method, which are within a statutory category.
Step 2A1
The limitations of:
Claims 1, 14-15 (Claim 1 being representative)
receive patient parametric data […of internal data of…] a patient;
determine based on the patient parametric data that a clinical event of interest has occurred in the patient;
responsive to the clinical event of interest, automatically generate and display a notification, to prompt the patient to complete a survey;
receive input from the patient in response to the survey;
and cause the input from the patient to be sent […to a storage location…],
as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to detect clinical events and prompt the patient to complete a survey in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “receiving, generating, displaying and determining” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a method implemented by a computing device, the claimed invention amounts to managing personal behavior or interaction between people. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a computing device, non-transitory computer-readable storage medium, processor and memory that implements the identified abstract idea. The server is not described by the applicant and is recited at a high-level of generality (i.e., a generic server performing generic computer functions) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claims further recite the additional elements of a user interface, implantable medical device and database. The user interface, implantable medical device and database merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a computing device, non-transitory computer-readable storage medium, processor and memory to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a user interface, implantable medical device and database was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such the claim is not patent eligible.
Claims 2,4-9,16,18-27 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claim(s) 2,16 merely describe(s) the implantable medical device, which further defines the abstract idea.
Claim(s) 4, 18 merely describe(s) the clinical event, which further defines the abstract idea.
Claim(s) 5, 19 merely describe(s) generating and displaying prompts for patient to complete based on a threshold, which further defines the abstract idea.
Claim(s) 6, 20 merely describe(s) the threshold, which further defines the abstract idea.
Claim 7 merely describe(s) generating and displaying data, which further defines the abstract idea.
Claim 8 merely describe(s) the threshold, which further defines the abstract idea.
Claim(s) 21-22 merely describe(s) the survey including a question or prompt from a clinical study, which further defines the abstract idea.
Claim 23 merely describe(s) the survey, which further defines the abstract idea.
Claim 24 merely describe(s) the event day, which further defines the abstract idea.
Claim 25 merely describe(s) the notification day, which further defines the abstract idea.
Claim 26 merely describe(s) the notification day, which further defines the abstract idea.
Claim 27 merely describe(s) the implantable medical device, which further defines the abstract idea.
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.
The Examiner notes that the rejection will reference the translated documents (attached) corresponding to any foreign documents recited in the rejection.
Claim 1-2, 4, 14-16, 18, 23-27 is/are rejected under 35 U.S.C. 103(a) as being unpatentable over Hresko et al (US Publication No. 20170300653) in view of Stahmann et al (US Publication No. 20160287091) in view of Ujhelyi et al (US Publication No. 20030050566).
Regarding Claim 1
Hresko A device configured to process patient data, the device comprising:
a memory [Hresko at Para. 0068 teaches the processor 32 is also in electronic communication with transitory or non-transitory computer readable memory 34 for storing information received from the sensors];
a user interface [Hresko at Para. 0079 teaches in some implementations, the patient can interact with a user interface of the patient monitor to identify one or more patient symptoms. The user interface may include a touchscreen that provides a drop down menu or check list which, in turn, allows the patient to select a particular symptom from a list of alternatives];
and one or more processors in communication with the memory and the user interface, the one or more processors configured to [Hresko at Para. 0068]:
responsive to the clinical event of interest, automatically generate and display a notification, via the user interface, to prompt the patient to complete a survey [Hresko at Para. 0054 teaches in other examples, the device controller 10 may provide survey questions to be answered by the patient when a cardiac event is identified based on analysis of sensed cardiac information. In either case, patient symptom information 56 is recorded along with, and often in response to, recording of cardiac data by the medical device];
receive, via the user interface, input from the patient in response to the survey [Hresko at Para. 0054];
and cause the input from the patient to be sent to a database [Hresko at Para. 0054].
Hresko does not teach receive patient parametric data from an implantable medical device in a patient;
determine based on the patient parametric data that a clinical event of interest has occurred in the patient;
Stahmann teaches receive patient parametric data from an implantable medical device in a patient [Stahmann at Para. 0055 teaches in the figure, the system 200 is shown to include an IMD 202. In various embodiments, the IMD includes an implantable cardiac device (ICD), cardiac rhythm management (CRM) device, pulse generator, or other implanted medical device that provides therapy to a patient or an organ of a patient, and/or that provides data derived from measurements internal to a patient];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine processor of Hresko with the data of Stahmann with the motivation to improve patient’s condition.
Hresko/Stahmann does not teach determine based on the patient parametric data that a clinical event of interest has occurred in the patient [Stahmann at Para. 0055 teaches in the figure, the system 200 is shown to include an IMD 202. In various embodiments, the IMD includes an implantable cardiac device (ICD), cardiac rhythm management (CRM) device, pulse generator, or other implanted medical device that provides therapy to a patient or an organ of a patient, and/or that provides data derived from measurements internal to a patient];
Ujhelyi teaches determine based on the patient parametric data that a clinical event of interest has occurred in the patient [Ujhelyi at Para. 0031 teaches FIG. 2 is a block diagram depicting an implantable medical device system 50 incorporating an internal arrhythmia notification module 52, according to one embodiment of the invention. Notification module 52 may be implemented as microprocessor 128 of FIG. 3, optionally in conjunction with a speaker or vibration module (not shown in FIG. 3). A detection module 54 detects atrial fibrillation (AF) using any of a variety of conventional techniques. Accordingly, the arrhythmia notification features of the present invention may be incorporated into any implantable arrhythmia monitoring device that is capable of detecting AF, either with or without leads];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Hresko, Stahmann with the clinical event of Ujhelyi with the motivation to improve the effectiveness of AF management [Ujhelyi at Para. 0009]
Regarding Claim 2
Hresko/Stahmann/Ujhelyi teach the device of claim 1,
Hresko/Stahmann/Ujhelyi further teach wherein the implantable medical device is an implantable cardiac monitor [Ujhelyi at Para. 0031 teaches Accordingly, the arrhythmia notification features of the present invention may be incorporated into any implantable arrhythmia monitoring device that is capable of detecting AF, either with or without leads].
Regarding Claim 4
Hresko/Stahmann/Ujhelyi teach the device of claim 1,
Hresko/Stahmann/Ujhelyi further teach wherein the clinical event of interest is an atrial fibrillation event [Ujhelyi at Para. 0032 teaches when detection module 54 detects the onset of an AF episode, a duration counter 56 begins timing the duration of the episode. If this duration exceeds a threshold, notification module 52 issues a notification to the patient or to another person. The threshold may be adjustable, for example, within a range of one minute to 48 hours, and may be set by a physician].
Regarding Claim 14
Hresko teaches a non-transitory computer-readable storage medium storing instructions that, when executed, cause one or more processors of a device configured to process patient data to perform:
responsive to the clinical event of interest, automatically generating and displaying a notification, by the device, to prompt the patient to complete a survey [Hresko at Para. 0054 (see Claim 1 for explanation)];
receiving, by the device, input from the patient in response to the survey [Hresko at Para. 0054 (see Claim 1 for explanation)];
and sending, by the device, the input from the patient to a database [Hresko at Para. 0054 (see Claim 1 for explanation)].
Hresko does not teach receiving, by the device, patient parametric data from an implantable medical device in a patient;
determining, by the device, based on the patient parametric data that a clinical event of interest has occurred in the patient;
Stahmann teaches receiving, by the device, patient parametric data from an implantable medical device in a patient [Stahmann at Para. 0055 (see Claim 1 for explanation)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine processor of Hresko with the data of Stahmann with the motivation to improve patient’s condition.
Hresko/Stahmann does not teach determining, by the device, based on the patient parametric data that a clinical event of interest has occurred in the patient;
Ujhelyi teaches determining, by the device, based on the patient parametric data that a clinical event of interest has occurred in the patient [Ujhelyi at Para. 0031 (see Claim 1 for explanation)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Hresko, Stahmann with the clinical event of Ujhelyi with the motivation to improve the effectiveness of AF management [Ujhelyi at Para. 0009]
Regarding Claim 15
Hresko teaches a method for processing patient data, the method comprising:
responsive to the clinical event of interest, automatically generating and displaying a notification, by the computing device, to prompt the patient to complete a survey [Hresko at Para. 0054 (see Claim 1 for explanation)];
receiving, by the computing device, input from the patient in response to the survey [Hresko at Para. 0054 (see Claim 1 for explanation)];
and sending, by the computing device, the input from the patient to a database [Hresko at Para. 0054 (see Claim 1 for explanation)].
Hresko does not teach receiving, by a computing device, patient parametric data from an implantable medical device in a patient;
determining, by the computing device, based on the patient parametric data that a clinical event of interest has occurred in the patient;
Stahmann teaches receiving, by a computing device, patient parametric data from an implantable medical device in a patient [Stahmann at Para. 0055 (see Claim 1 for explanation)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine processor of Hresko with the data of Stahmann with the motivation to improve patient’s condition.
Hresko/Stahmann do not teach determining, by the computing device, based on the patient parametric data that a clinical event of interest has occurred in the patient;
Ujhelyi teaches determining, by the computing device, based on the patient parametric data that a clinical event of interest has occurred in the patient [Ujhelyi at Para. 0031 (see Claim 1 for explanation)];
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Hresko, Stahmann with the clinical event of Ujhelyi with the motivation to improve the effectiveness of AF management [Ujhelyi at Para. 0009]
Regarding Claim 16
Claim(s) 16 is/are analogous to Claim(s) 2, thus Claim(s) 16 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 2.
Regarding Claim 18
Claim(s) 18 is/are analogous to Claim(s) 4, thus Claim(s) 18 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 4.
Regarding Claim 23
Hresko/Stahmann/Ujhelyi teach the device of claim 1,
Hresko/Stahmann/Ujhelyi further teach wherein the survey includes at least one question related to the patient parametric data [Hresko at Para. 0054 teaches in some examples, the medical device or medical device controller 10 can obtain a recording of cardiac information 52 (e.g., a short duration ECG recording) when the patient identifies symptoms with the device controller 10 (e.g., in response to survey questions). In other examples, the device controller 10 may provide survey questions to be answered by the patient when a cardiac event is identified based on analysis of sensed cardiac information. In either case, patient symptom information 56 is recorded along with, and often in response to, recording of cardiac data by the medical device.].
Regarding Claim 24
Hresko/Stahmann/Ujhelyi teach the device of claim 1,
Hresko/Stahmann/Ujhelyi further teach wherein the one or more processors are further configured to:
determine that the clinical event of interest has occurred on an event day; and automatically generate and display the notification on a notification day that is within a predetermined number of days of the event day [Ujhelyi at Para. 0040 teaches Notification module 52 may also incorporate a repeat alert function. In this mode, an arrhythmia state that triggers an additional alert may be defined as the persistence of an AF episode beyond a threshold duration. For example, notification module 52 may be programmed to alert the patient upon onset of an AF episode and to issue another alert every 60 minutes as long as the AF episode persists].
Regarding Claim 25
Hresko/Stahmann/Ujhelyi teach the device of claim 24,
Hresko/Stahmann/Ujhelyi further teach wherein the notification day is the event day [Ujhelyi at Para. 0040 (see Claim 14 for explanation; interpreted as notification day is event day)].
Regarding Claim 26
Hresko/Stahmann/Ujhelyi teach the device of claim 24,
Hresko/Stahmann/Ujhelyi further teach wherein the notification day is a random day within the predetermined number of days of the event day [Ujhelyi at Para. 0040 (see Claim 14 for explanationy)].
Regarding Claim 27
Hresko/Stahmann/Ujhelyi teach the device of claim 1,
Hresko/Stahmann/Ujhelyi further teach wherein the implantable medical device is an implantable cardiac monitor configured to sense physiological signals, and wherein the patient parametric data comprises one of:
heart rate, heart rate variability, ECG morphological features, intrabeat intervals, atrial fibrillation (AF) burden, respiratory rate, or activity levels [Ujhelyi at Para. 0053 teaches cardiac information 52 received from the medical device can include, without limitation, ECG data (e.g., long-duration or short-duration ECG recordings, along with associated annotations and/or fiducial data of interest), premature ventricular contraction (PVC) count, heart rate information, heart sounds information (e.g., data received from Audiocor® sensors manufactured by Inovise Medical, Inc. of Beaverton, Oreg.), and cardiac ultrasound data].
Claims 5-8.19-20 rejected under 35 U.S.C. 103(a) as being unpatentable over Hresko, Stahmann, Ujhelyi as applied to claim 1,14-15 above, and further in view of SPENCER et al (US Publication No. 20210007621).
Regarding Claim 5
Hresko/Stahmann/Ujhelyi teach the device of claim 4,
Hresko/Stahmann/Ujhelyi do not teach wherein to generate and display the notification, via the user interface, to prompt the patient to complete the survey the one or more processors are configured to: generate and display the notification, via the user interface, to prompt the patient to complete the survey based on a single atrial fibrillation event lasting longer than a predetermined threshold.
SPENCER teaches wherein to generate and display the notification, via the user interface, to prompt the patient to complete the survey the one or more processors are configured to: generate and display the notification, via the user interface, to prompt the patient to complete the survey based on a single atrial fibrillation event lasting longer than a predetermined threshold [SPENCER at Para. 108 teaches an approach of using of movable or ‘rolling’ time ‘windows’ of varying sizes may be used to detect periods of distinct activity for the above analyses. For example, the interval data may be analyzed in multiple overlapping windows of 1 hour, which would allow for the identification of rhythmic disturbances lasting at least an hour (interpret to combine with SURVEY of Hresko)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Hresko, Stahmann, Ujhelyi with the threshold of SPENCER with the motivation to improve the accuracy of cardiac monitoring.
Regarding Claim 6
Hresko/Stahmann/Ujhelyi/SPENCER teach the device of claim 5,
Hresko/Stahmann/Ujhelyi/SPENCER further teach wherein the predetermined threshold is one hour [Ujhelyi at Para. 0032 (see Claim 4 for explanation; range interpreted to include the hour threshold)].
Regarding Claim 7
Hresko/Stahmann/Ujhelyi teach the device of claim 4,
Hresko/Stahmann/Ujhelyi do not teach wherein to generate and display the notification, via the user interface, to prompt the patient to complete the survey the one or more processors are configured to: generate and display the notification, via the user interface, to prompt the patient to complete the survey based on a cumulative daily atrial fibrillation burden being greater than a predetermined threshold.
SPENCER teaches wherein to generate and display the notification, via the user interface, to prompt the patient to complete the survey the one or more processors are configured to: generate and display the notification, via the user interface, to prompt the patient to complete the survey based on a cumulative daily atrial fibrillation burden being greater than a predetermined threshold [SPENCER at Para. 0110 teaches these plots and analysed data are compared to previous recordings, in order to detect any change. Over time, such as months or years, the atrial fibrillation burden may increase to 2% or higher, which can be detected by these retroactive comparisons. Other changes can be detected, such as an increase in the heart rate exhibited during the episodes. Recordal of data during this time will thus be able to track this increase and alert the patient or a medical practitioner to any increases without repeated diagnostic visits, and may inform treatment changes, such as the necessity of providing medicine to lower heart rate, as well as anticoagulants (interpret to combine with survey of Hresko)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Hresko, Stahmann, Ujhelyi with the threshold of SPENCER with the motivation to improve the accuracy of cardiac monitoring.
Regarding Claim 8
Hresko/Stahmann/Ujhelyi/SPENCER teach the device of claim 7,
Hresko/Stahmann/Ujhelyi/SPENCER further teach wherein the predetermined threshold is 5% [SPENCER at Para. 0110 (see Claim 7 for explanation; threshold of 2 percent or higher is within the 5 percent threshold)].
Regarding Claim 19
Claim(s) 19 is/are analogous to Claim(s) 5, thus Claim(s) 19 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 5.
Regarding Claim 20
Claim(s) 20 is/are analogous to Claim(s) 6, thus Claim(s) 20 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 6.
Claim 9 rejected under 35 U.S.C. 103(a) as being unpatentable over Hresko, Stahmann, Ujhelyi as applied to claim 1,14-15 above, and further in view of Tierney et al (US Publication No. 20180040002).
Regarding Claim 9
Hresko/Stahmann/Ujhelyi teach the device of claim 1,
Hresko/Stahmann/Ujhelyi further teach wherein to generate and display the notification, via the user interface, to prompt the patient to complete the survey the one or more processors are configured to:
generate and display the notification to prompt the patient to complete the survey based on both the patient parametric data received from the implantable medical device indicating a clinical event of interest has occurred in the patient [Hresko at Para. 0054 (see Claim 1 for explanation)]… [ …]
Hresko/Stahmann/Ujhelyi do not teach [ … ] … and a detection of the patient in a geofenced area.
Tierney teaches [ … ] … and a detection of the patient in a geofenced area [Tierney at Para. 0025 teaches as noted above, the electronic survey system (or simply “survey system”) uses geolocation information associated with a client device to determine whether to provide an electronic survey to the client device].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Hresko, Stahmann, Ujhelyi with the geofencing of Tierney with the motivation to improve the efficiency of survey systems [Tierney at Para. 0029].
Claim 12-22 rejected under 35 U.S.C. 103(a) as being unpatentable over Hresko, Stahmann, Ujhelyi as applied to claim 1,14-15 above, and further in view of St. Ores et al (US Publication No. 20060224326).
Regarding Claim 21
Hresko/Stahmann/Ujhelyi teach the device of claim 1,
Hresko/Stahmann/Ujhelyi do not teach wherein the survey includes at least one question or prompt for a clinical study related to the implantable medical device.
St. Ores teaches wherein the survey includes at least one question or prompt for a clinical study related to the implantable medical device [St. Ores at para. 0083 teaches each patient provides his or her patient input 230 to the health data collection system 16. This includes the remotely collected sensor data (implanted and external), the collection of which is often transparent to the patient 30. The patient 30 provides other types of information through the intermediary device 100 to the host data collection system 16. For example, the central server 16 on an automated bases, the investigator on a global basis, or the investigator on a patient specific or subgroup basis, may generate questionnaires regarding, e.g., quality of life issues. Thus, responses to such questionnaires are submitted to the host data collection system 16; St. Ores at Para. 0089 teaches in addition to determining whether specific data is provided and provided correctly at a specific time, the protocol compliance module 325 evaluates all data related to the clinical study and identifies various irregularities or discrepancies].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Hresko, Ujhelyi with the clinical study of St. Ores with the motivation to improve post-market surveillance capability.
Regarding Claim 22
Hresko/Stahmann/Ujhelyi teach the device of claim 1,
Hresko/Stahmann/Ujhelyi do not teach wherein the survey includes at least one question or prompt for a clinical study related to the clinical event of interest.
St. Ores teaches wherein the survey includes at least one question or prompt for a clinical study related to the clinical event of interest [St Ores at Para. 0083, 0089 (see Claim 21 for explanation; interpret to combine with clinical event of Ujhelyi)].
It would have been prima facie obvious skill in the art, at the time of effective filing, to combine the references of Hresko, Ujhelyi with the clinical study of St. Ores with the motivation to improve post-market surveillance capability.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1,2,4-9,14-16,18-27, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
The recitations of claim 1 are not directed to fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people. The Office Action attempts to categorize the recitations of claim 1 as being directed to "managing personal behavior including following rules or instructions;"12 however, MPEP 2106.04(a)(2)(II)(C) clarifies that this sub-grouping covers concepts like "social activities, teaching, and following rules or instruction."13 This includes examples such as a method of playing a dice game,14 assigning hair designs to balance head shape,15 or a series of instructions of how to hedge risk.16 Although the processing circuitry of claim 1 does execute instructions, these are not "rules" as envisioned by the exception. Claim 1 is not directed to managing personal behavior such as following rules or instructions. Reducing processing circuitry configured to determine based on the patient parametric data that a clinical event of interest has occurred and responsive to the clinical event of interest, automatically generate and display a notification to being merely "following rules," would directly contradict the MPEP which requires that the organizing human activity group "not [] be expanded beyond these enumerated sub-groupings except in rare circumstances."17 As such, claim 1 is not directed to organizing human activity or any abstract idea and therefore is patent eligible under step 2A prong 1 of 35 U.S.C. § 101.
But even if the claims recite an abstract idea, which Applicant does not acquiesce, the claims as a whole integrate the alleged abstract idea into a practical application of the alleged abstract idea. A claim that integrates an abstract idea into a practical application of the abstract idea, applies the abstract idea in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim amounts to more than monopolizing the abstract idea“…monopolizing the abstract idea [citing to Diehr and CardioNet and listing various “problems” addressed by the claimed invention].
Applicant submits that, with respect to claim 1 for example, receiving patient parametric data from an implantable medical device, determining based on the patient parametric data that a clinical event of interest has occurred in the patient, and responsive to the clinical event of interest, automatically generating and displaying a notification, via the user interface to prompt the patient to complete a survey represents an inventive concept that improves the functioning of a medical device, and therefore does not represent mere data manipulation by generic computing components.
Regarding (a), the Examiner respectfully disagrees. The Examiner has not expanded the categories of abstract ideas as is plainly evident in the basis of rejection. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that the identified claim elements represent a series of rules or instructions for a person or persons, with or without the aid of a computer, to follow to detect clinical events and prompt the patient to complete a survey. Furthermore, the Examiner submits that healthcare itself is inherently represents the organization of human activity. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a series of rules or instructions for a person or persons to follow to detect clinical events and prompt the patient to complete a survey, the claimed invention is directed to an abstract idea.
Regarding (b), the Examiner respectfully disagrees. The claims are unlike Diehr or CardioNet. The claims are unlike Diehr because there is no improvement to “another technology,” the only technology claimed is a computer, which is not improved either. The claims are unlike CardioNet because the claims are confined to a general-purpose computer, not a specific medical device, and there is no improvement to the computer. The claim does not recite that the abstraction is performed on a medical device, it is performed on a computer. Furthermore, the problems argued are not problems caused by the computer, but are instead administrative problems, which do not represent technical problems.
Regarding (c), the Examiner respectfully disagrees. The implantable medical device is not being improved because the implantable medical device is claimed to operate as it normally would. Collecting and transmitting data are operations that implantable medical devices normally perform. As recited in (b), the computing device is performing operations computer are designed to do, which is receiving, processing, transmitting and displaying data. Furthermore, there is no improvement to the medical device claimed. All the claim is reciting, is outputting data to a database.
Rejection under 35 U.S.C. § 103
Regarding the rejection of Claims 1,2,4-9,14-16,18-27, the Examiner has considered the Applicant’s arguments; however, these arguments are moot given the new grounds of rejection as necessitated by amendment.
Conclusion
The prior art made of record and not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Bornzin et al (US Publication No. 7606618) discloses an implantable medical device with a notification system to conveniently and efficiently notify the patient of certain conditions.
Perschbacher et al (US Publication No. 10765379) discloses systems and methods for managing machine-generated medical alerts associated with physiological events detected from one or more patients
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN C EDOUARD whose telephone number is (571)270-0107. The examiner can normally be reached M-F 730 - 430.
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/JONATHAN C EDOUARD/Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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