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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/31/2026 has been entered.
Notice to Applicant
This communication is in response to the amendment filed 07/31/2026. Claims 1, 8, 12-15 have been amended. Claims 1-20 are presented for examination.
Subject Matter Free of Prior Art
Claim(s) 1-20 are allowable over prior art because the prior art of record fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims, in particular: “apply at least one criterion to the health event data stored in the record for the patient for determining whether to remove at least a portion of the health event data from the record, wherein the health event data comprises one or more adjudicated health events and one or more non-adjudicated health events over the first time period, wherein the one or more adjudicated health events comprise the samples and the one or more non-adjudicated health events do not comprise the samples, and wherein the one or more adjudicated health events are adjudicated as true detections of the health event or false detections of the health event; based on a determination that the health event data satisfies the at least one criterion, remove the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record; adjust longitudinal diagnostic information of the second time period based on removing the adjudicated health events and the non-adjudicated health events from longitudinal diagnostic information of the first time period; and generate output data comprising an adjusted device history indicative of the adjusted longitudinal diagnostic information of the second time period.” Because the prior art does not teach or disclose the above features in the specific manner and combinations recited in independent claims 1, 12-15, claims 1, 12-15 are hereby deemed to be allowable over prior art. Originally numbered dependent claims 2-11, 16-20 incorporate the allowable features of originally numbered independent claims 1, 12, through dependency, respectively.
However, the claims are still rejected under 101.
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 (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 1 is drawn to a system which is within the four statutory categories (i.e., machine). Claim 12 is drawn to a method which is within the four statutory categories (i.e., method). Claim 13 is drawn to a non-transitory computer readable storage medium which is within the four statutory categories (i.e., manufacture). Claim 14 is drawn to a system which is within the four statutory categories (i.e., machine). Claim 15 is drawn to a system which is within the four statutory categories (i.e., machine).
Independent claim 1 (which is representative of independent claims 12-15) recites… store the health event data received…in a record for the patient; generate a device history incorporating the health event data over a second time period that includes a first time period; apply at least one criterion to the health event data stored in the record for the patient for determining whether to remove at least a portion of the health event data from the record, wherein the health event data comprises one or more adjudicated health events and one or more non-adjudicated health events over the first time period, wherein the one or more adjudicated health events comprise the samples and the one or more non-adjudicated health events do not comprise the samples, and wherein the one or more adjudicated health events are adjudicated as true detections of the health event or false detections of the health event; based on a determination that the health event data satisfies the at least one criterion, remove the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record; adjust longitudinal diagnostic information of the second time period based on removing the adjudicated health events and the non-adjudicated health events from longitudinal diagnostic information of the first time period; and generate output data comprising an adjusted device history indicative of the adjusted longitudinal diagnostic information of the second time period.
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the 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 collect patient data, analyze the collected data, and output determinations regarding patient health based on the analysis accordingly in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps as indicated supra. That is, other than reciting generic computer components (discussed infra), the claim amounts to managing personal behavior or relationships or interactions between people following rules or instructions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships 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 claims recite an abstract idea.
Claim 1 recites additional elements (i.e., an implantable medical device comprising: sensing circuitry configured to sense patient activity including one or more of a cardiac electrical signal, impedance, or motion of a patient; communication circuitry configured to communicate with a remote computing device; a storage device configured to store a portion of the patient activity; and processing circuitry configured to: analyze the sensed patient activity; detect health events of the patient based on the analysis; select, based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events; store the one or more waveforms as samples in the storage device of the implantable medical device; and transmit health event data comprising the samples and the detected health events to the remote computing device; and the remote computing device comprising: processing circuitry; and a memory comprising instructions). Claim 12 recites additional elements (i.e., a medical system; selecting, by an implantable medical device of the medical system based on health events, one or more waveforms of patient activity for retention for a limited subset of the health events; storing, by the implantable medical device, the one or more waveforms as samples in a storage device of the implantable medical device; transmitting, by the implantable medical device, health event data comprising the samples and the detected health events to a remote computing device of the medical system). Claim 13 recites additional elements (i.e., a non-transitory computer readable storage medium comprising program instructions configured to cause processing circuitry of a remote computing device of a medical system; receiving health event data transmitted from an implanted medical device, wherein the health event data comprises detected health events and samples, and wherein the samples comprise the one or more waveforms of the patient activity selected for retention for a limited subset of the detected health events and stored in a storage device of the implanted medical device; storing the received health event data in a record for the patient). Claim 14 recites additional elements (i.e., a medical system comprising: a first device comprising: sensing circuitry configured to sense patient activity including one or more of a cardiac electrical signal, impedance, or motion of a patient; communication circuitry configured to communicate with a second, remote device; a storage device configured to store a portion of the patient activity; and processing circuitry configured to: analyze the sensed patient activity; detect health events of the patient based on the analysis; and select, based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events; store the one or more waveforms as samples in the storage device of the first device; transmit health event data comprising the samples and the detected health events to the second device; and the second device comprising: processing circuitry; and memory comprising programming instructions). Claim 15 recites additional elements (i.e., a medical system comprising: processing circuitry; and memory comprising programming instructions; an implanted medical device having a storage device). Looking to the specifications, a remote computing device having processing circuitry, memory comprising programming instructions, non-transitory computer readable storage medium comprising program instructions is described at a high level of generality (¶ 0025; ¶ 0058-0060; ¶ 0064-0066; ¶ 0068-0069), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, “an implantable medical device comprising: sensing circuitry configured to sense patient activity including one or more of a cardiac electrical signal, impedance, or motion of a patient; communication circuitry configured to communicate with a remote computing device; a storage device configured to store a portion of the patient activity; and processing circuitry configured to: analyze the sensed patient activity; detect health events of the patient based on the analysis; select, based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events; store the one or more waveforms as samples in the storage device of the implantable medical device; and transmit health event data comprising the samples and the detected health events to the remote computing device” only invokes the implantable medical device merely as a tool in its ordinary capacity to perform an existing process (i.e., sensing, analyzing, storing, providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The 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. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a remote computing device having processing circuitry, memory comprising programming instructions, non-transitory computer readable storage medium comprising program instructions) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, “an implantable medical device comprising: sensing circuitry configured to sense patient activity including one or more of a cardiac electrical signal, impedance, or motion of a patient; communication circuitry configured to communicate with a remote computing device; and processing circuitry configured to: analyze the sensed patient activity; detect health events of the patient based on the analysis; and transmit health event data to the remote computing device for the detected health events” only invokes the implantable medical device merely as a tool in its ordinary capacity to perform an existing process (i.e., sensing, analyzing, storing, providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-11, 16-20 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 2-9, 13-18 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claim 10 further recites the additional elements of “wherein the computing device receives the health event data from the implanted medical device via a network,” which only provides the input data for the performance of the abstract idea, and as such, amounts to insignificant extrasolution activity (i.e., mere data gathering), which does not impose meaningful limits on the scope of the claim. Furthermore, the “network” is described at a high level of generality, such that it amounts to no more than mere instructions to apply the exception using generic computer components. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application. Reevaluated under step 2B, receiving or transmitting data over a network has been recognized by the courts as well-understood, routine, and conventional elements/functions. See: MPEP § 2106.05(d)(II). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not provide “significantly more.”
Claim 11 further recites the additional elements of “wherein the implantable medical device comprises at least one of a pacemaker/defibrillator or a ventricular assist device (VAD) that comprises one or more sensors and sensing circuitry,” which still only invokes the “pacemaker/defibrillator or a ventricular assist device (VAD) that comprises one or more sensors and sensing circuitry” merely as a tool in its ordinary capacity to perform an existing process (i.e., sensing, analyzing, and providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claims as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Certain Methods of Organizing Human Activity,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Response to Arguments
Applicant's arguments filed 07/31/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 07/31/2026.
In the remarks, Applicant argues in substance that:
Regarding the 101 rejections,
“the instructions recited in claim 1 are program instructions executed by hardware, which is structurally distinct from the rules or instructions envisioned by the judicial exception. The rules or instructions of the judicial exception are directed to governing, regulating, or managing human behavior, human choices, or human conduct. In contrast, claim 1 recites program instructions executed by hardware. For example, claim 1 recites a memory comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to remove the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record and then adjust longitudinal diagnostic information of a second time period that includes the first time period. These steps do not manage human activity or personal behavior, as neither a clinician nor a patient is involved in or following these steps. Instead, the claim recites hardware removing health event data and adjusting longitudinal diagnostic information. This is a technical sequence of operations performed within the bounds of computer architecture, entirely removed from human activity or personal behavior”;
“Amended independent claim 1 similarly recites features that improve the performance of a medical device…Likewise, the present claims are directed to a specific technological improvement in how an implantable medical device and its remote computing system manage limited memory and diagnostic output. For example, amended independent claim 1, recites select[ing], based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events and stor[ing] the one or more waveforms as samples in the storage device of the implantable medical device. Selecting waveforms of the patient activity for retention for a limited subset of the detected health events provides a technical solution that reduces consumed memory capacity on the implantable medical device. Additionally, removing the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record and adjusting longitudinal diagnostic information of a second time period that includes the first time period based on removing the adjudicated health events and the non-adjudicated health events provides a technical solution to complement the retention of the limited subset of the detected health events facilitate "improved accuracy in the detection of changes in patient health and, consequently, better evaluation of the condition of the patient"”; and
“a medical system comprising an implantable medical device with processing circuitry configured to select, based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events and store the one or more waveforms as samples in the storage device of the implantable medical device and a remote computing device, where a memory of the remote computing device comprises programming instructions that, when executed by the processing circuitry, cause the processing circuitry to generate a device history incorporating the health event data over a second time period that includes a first time period, apply at least one criterion to the health event data stored in the record for the patient for determining whether to remove at least a portion of the health event data from the record, remove the health event data corresponding to the adjudicated health events and the non- adjudicated health events from the record, adjust longitudinal diagnostic information of a second time period that includes the first time period based on removing the adjudicated health events and the non-adjudicated health events, and generate output data comprising an adjusted device history represents an inventive concept that improves the functioning of a medical system, and specifically improves the functioning of an implantable medical device…the specification and claims detail an improvement in the technology field…claim 1 recites a medical device system that comprises a combination of recitations that are not well- understood, routine or conventional activity. Specifically, claim 1 recites a technical solution to "allow[] for removal of inaccurate health event data and retaining of accurate health event data without requiring more memory resources on IMD 10 to store additional samples of related patient data."39 Much like the remote ISP server coupled to the client computer, where the remote ISP server had the filtering tool in Example 34, the non- conventional distribution of claim 1 provides a technology-based solution to a technology-based problem. Therefore, when viewed as an ordered combination, the recitations of claim 1 provide an inventive concept that improves the functioning of medical system, for analogous reasons as discussed with respect to Example 34.”
It is respectfully submitted that Examiner has considered Applicant’s arguments and does not find them persuasive. Examiner has attempted to address all of the arguments presented by Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
In response to Applicant’s argument that (a) regarding the 101 rejections,
“the instructions recited in claim 1 are program instructions executed by hardware, which is structurally distinct from the rules or instructions envisioned by the judicial exception. The rules or instructions of the judicial exception are directed to governing, regulating, or managing human behavior, human choices, or human conduct. In contrast, claim 1 recites program instructions executed by hardware. For example, claim 1 recites a memory comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to remove the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record and then adjust longitudinal diagnostic information of a second time period that includes the first time period. These steps do not manage human activity or personal behavior, as neither a clinician nor a patient is involved in or following these steps. Instead, the claim recites hardware removing health event data and adjusting longitudinal diagnostic information. This is a technical sequence of operations performed within the bounds of computer architecture, entirely removed from human activity or personal behavior”:
It is respectfully submitted that per broadest reasonable interpretation of the claim in light of the specification, the claims of the present invention encompass the activity of (to paraphrase) rules or instructions followed to collect patient data, analyze the collected data, and output determinations regarding patient health based on the analysis accordingly, which covers the sub-grouping of managing personal behavior or relationships or interactions between people in the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Put another way, the claimed invention amounts to a series of rules or steps that a user (i.e., doctor) would follow to collect patient data, filter the collected data, and generate confirmed data (i.e., health events of a medical device) accordingly. This is an abstract idea. That the steps are performed on a well-known, general purpose computer (i.e., a remote computing device having processing circuitry, memory comprising programming instructions, non-transitory computer readable storage medium comprising program instructions) does not remove the invention from being directed to an abstract idea.
Applicant argues “the instructions recited in claim 1 are program instructions executed by hardware, which is structurally distinct from the rules or instructions envisioned by the judicial exception. The rules or instructions of the judicial exception are directed to governing, regulating, or managing human behavior, human choices, or human conduct. In contrast, claim 1 recites program instructions executed by hardware. For example, claim 1 recites a memory comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to remove the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record and then adjust longitudinal diagnostic information of a second time period that includes the first time period. These steps do not manage human activity or personal behavior, as neither a clinician nor a patient is involved in or following these steps. Instead, the claim recites hardware removing health event data and adjusting longitudinal diagnostic information. This is a technical sequence of operations performed within the bounds of computer architecture, entirely removed from human activity or personal behavior.” However, the claim limitations to which Applicant seem to refer as “remove the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record and then adjust longitudinal diagnostic information of a second time period that includes the first time period” are interpreted as rules or instructions to analyze the collected data and output determinations regarding patient health based on the analysis accordingly, which is the abstract idea, but for the recitation of generic computer components. Furthermore, the ”hardware” and “computer architecture” to which Applicant refer (i.e., memory comprising programming instructions, processing circuitry) is not interpreted as part of the abstract idea, but as additional elements to be interpreted in Step 2A, Prong Two, which are described at a high level of generality, such that it amounts to no more than mere instructions to apply the exception using generic computer components. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Furthermore, per MPEP § 2106.04(a)(2)(II), “It is noted that the number of people involved in the activity is not dispositive as to whether a claim limitation falls within [the "certain methods of organizing human activity"] grouping, as long as the claim recites an abstract idea, which it does, by managing personal behavior or relationships or interactions between people following rules or instructions, as explained above.
Thus, the claims are directed to an abstract idea.
“Amended independent claim 1 similarly recites features that improve the performance of a medical device…Likewise, the present claims are directed to a specific technological improvement in how an implantable medical device and its remote computing system manage limited memory and diagnostic output. For example, amended independent claim 1, recites select[ing], based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events and stor[ing] the one or more waveforms as samples in the storage device of the implantable medical device. Selecting waveforms of the patient activity for retention for a limited subset of the detected health events provides a technical solution that reduces consumed memory capacity on the implantable medical device. Additionally, removing the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record and adjusting longitudinal diagnostic information of a second time period that includes the first time period based on removing the adjudicated health events and the non-adjudicated health events provides a technical solution to complement the retention of the limited subset of the detected health events facilitate "improved accuracy in the detection of changes in patient health and, consequently, better evaluation of the condition of the patient"”:
Applicant argues “Amended independent claim 1 similarly recites features that improve the performance of a medical device…Likewise, the present claims are directed to a specific technological improvement in how an implantable medical device and its remote computing system manage limited memory and diagnostic output. For example, amended independent claim 1, recites select[ing], based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events and stor[ing] the one or more waveforms as samples in the storage device of the implantable medical device. Selecting waveforms of the patient activity for retention for a limited subset of the detected health events provides a technical solution that reduces consumed memory capacity on the implantable medical device. Additionally, removing the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record and adjusting longitudinal diagnostic information of a second time period that includes the first time period based on removing the adjudicated health events and the non-adjudicated health events provides a technical solution to complement the retention of the limited subset of the detected health events facilitate "improved accuracy in the detection of changes in patient health and, consequently, better evaluation of the condition of the patient."” However, the claim limitations of the present invention are different from the claim limitations of the aforementioned case law. Even if the claim limitations of the present invention are similar to that of the claims found eligible (and they are not similar), the claimed inventions are fundamentally different in scope and examples should be interpreted based on the asserted fact patterns; as previously stated above, other fact patterns may have different eligibility outcomes, as is the case with the claims of the present invention. The claims found eligible in CardioNet are directed to an improvement of a medical device; unlike in CardioNet, the claims of the present invention to which Applicant refer as “select[ing], based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events and stor[ing] the one or more waveforms as samples in the storage device of the implantable medical device” do not recite any technological computational efficiency, solution, or improvement, but only invokes the implantable medical device merely as a tool in its ordinary capacity to perform an existing process (i.e., sensing, analyzing, storing, providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Furthermore, there is no nexus between the functionality of the claims and the aforementioned problems and thus, the claims do not reflect the alleged improvements. Furthermore, the claim limitations to which Applicant seem to refer as “removing the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record and adjusting longitudinal diagnostic information of a second time period that includes the first time period based on removing the adjudicated health events and the non-adjudicated health events” are interpreted as rules or instructions to analyze the collected data and output determinations regarding patient health based on the analysis accordingly, which is the abstract idea, and not additional elements to be interpreted in Step 2A, Prong Two. Even if the claims provide the alleged improvements of “improved accuracy in the detection of changes in patient health and, consequently, better evaluation of the condition of the patient, any alleged benefits of the invention are at best, an improvement to rules or instructions to collect patient data, analyze the collected data, and output determinations regarding patient health based on the analysis accordingly, which is the abstract idea. However, an improved abstract idea is still an abstract idea and the claims do not provide a technical improvement.
The disclosure does not provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing any technical improvement or any physical improvement to the computer. See MPEP § 2106.04(d)(1) and 2106.05(a). Furthermore, the computing system (i.e., “remote computing device”) did not cause the argued problem and thus it is not a technical problem caused by the technological environment to which the claims are confined and the claims do not provide a technical improvement.
Thus, the claim as a whole does not integrate the recited judicial exception into a practical application.
“a medical system comprising an implantable medical device with processing circuitry configured to select, based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events and store the one or more waveforms as samples in the storage device of the implantable medical device and a remote computing device, where a memory of the remote computing device comprises programming instructions that, when executed by the processing circuitry, cause the processing circuitry to generate a device history incorporating the health event data over a second time period that includes a first time period, apply at least one criterion to the health event data stored in the record for the patient for determining whether to remove at least a portion of the health event data from the record, remove the health event data corresponding to the adjudicated health events and the non- adjudicated health events from the record, adjust longitudinal diagnostic information of a second time period that includes the first time period based on removing the adjudicated health events and the non-adjudicated health events, and generate output data comprising an adjusted device history represents an inventive concept that improves the functioning of a medical system, and specifically improves the functioning of an implantable medical device…the specification and claims detail an improvement in the technology field…claim 1 recites a medical device system that comprises a combination of recitations that are not well- understood, routine or conventional activity. Specifically, claim 1 recites a technical solution to "allow[] for removal of inaccurate health event data and retaining of accurate health event data without requiring more memory resources on IMD 10 to store additional samples of related patient data."39 Much like the remote ISP server coupled to the client computer, where the remote ISP server had the filtering tool in Example 34, the non- conventional distribution of claim 1 provides a technology-based solution to a technology-based problem. Therefore, when viewed as an ordered combination, the recitations of claim 1 provide an inventive concept that improves the functioning of medical system, for analogous reasons as discussed with respect to Example 34”:
Applicant argues “a medical system comprising an implantable medical device with processing circuitry configured to select, based on the detected health events, one or more waveforms of the patient activity for retention for a limited subset of the detected health events and store the one or more waveforms as samples in the storage device of the implantable medical device and a remote computing device, where a memory of the remote computing device comprises programming instructions that, when executed by the processing circuitry, cause the processing circuitry to generate a device history incorporating the health event data over a second time period that includes a first time period, apply at least one criterion to the health event data stored in the record for the patient for determining whether to remove at least a portion of the health event data from the record, remove the health event data corresponding to the adjudicated health events and the non- adjudicated health events from the record, adjust longitudinal diagnostic information of a second time period that includes the first time period based on removing the adjudicated health events and the non-adjudicated health events, and generate output data comprising an adjusted device history represents an inventive concept that improves the functioning of a medical system, and specifically improves the functioning of an implantable medical device…the specification and claims detail an improvement in the technology field.” However, as stated previously above, the computing system (i.e., “remote computing device”) did not cause the argued problem and thus it is not a technical problem caused by the technological environment to which the claims are confined and the claims do not provide a technical improvement. The claims of the present invention do not improve any specific devices (i.e., implantable medical devices), technology, or computers for that matter, but use the implantable medical device merely as a tool in its ordinary capacity to perform an existing process (i.e., sensing, analyzing, storing, providing data), which amounts to no more than a recitation of the words "apply it" (or an equivalent) and only generally links the claimed invention to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Furthermore, the claim limitations to which Applicant seem to refer as “generate a device history incorporating the health event data over a second time period that includes a first time period, apply at least one criterion to the health event data stored in the record for the patient for determining whether to remove at least a portion of the health event data from the record, remove the health event data corresponding to the adjudicated health events and the non- adjudicated health events from the record, adjust longitudinal diagnostic information of a second time period that includes the first time period based on removing the adjudicated health events and the non-adjudicated health events, and generate output data comprising an adjusted device history” are interpreted as rules or instructions to collect patient data, analyze the collected data, and output determinations regarding patient health based on the analysis accordingly, which is the abstract idea, but for the recitation of generic computer components, and not additional elements to be interpreted in Step 2A, Prong Two. Looking at the limitations as an ordered combination with the additional elements adds nothing that is not already present when looking at the elements individually.
Applicant argues “claim 1 recites a medical device system that comprises a combination of recitations that are not well- understood, routine or conventional activity. Specifically, claim 1 recites a technical solution to "allow[] for removal of inaccurate health event data and retaining of accurate health event data without requiring more memory resources on IMD 10 to store additional samples of related patient data."39 Much like the remote ISP server coupled to the client computer, where the remote ISP server had the filtering tool in Example 34, the non- conventional distribution of claim 1 provides a technology-based solution to a technology-based problem. Therefore, when viewed as an ordered combination, the recitations of claim 1 provide an inventive concept that improves the functioning of medical system, for analogous reasons as discussed with respect to Example 34.” However, per MPEP § 2106.05(I)(A), evaluating whether a claim limitation is “well-understood, routine, conventional activity” is not a standalone test for determining eligibility, but only one consideration “For Evaluating Whether Additional Elements Amount To An Inventive Concept.” Furthermore, as stated previously above, there is no nexus between the functionality of the claims of the present invention and the aforementioned problems and thus, the claims do not reflect the alleged improvements (i.e., “allow[] for removal of inaccurate health event data and retaining of accurate health event data without requiring more memory resources on IMD 10 to store additional samples of related patient data”).
Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Thus, Examiner maintains the 101 rejections of claims 1-20, which have been updated to address Applicant’s remarks and to comply with the 2019 Revised Patent Subject Matter Eligibility Guidance and the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence in the above Office Action.
Conclusion
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571)272-8317. The examiner can normally be reached on M-Th 8-5 PM.
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, Robert Morgan can be reached on (571) 272-6773.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY HUYNH/Primary Examiner, Art Unit 3683
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