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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/26/2026 has been entered.
Notice to Applicant
This communication is in response to the amendment filed 03/26/2026. Claims 1, 4-5, 9-10, 12-16 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, 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, 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; 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; and the remote computing device comprising: processing circuitry; and a memory comprising instructions). Claim 12 recites additional elements (i.e., a remote computing device of the medical system; an implanted medical device). 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; an implanted medical device). 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; 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 second device for the detected health events; 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). 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; 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, 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. 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, 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. 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 03/26/2026 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 03/26/2026.
In the remarks, Applicant argues in substance that:
Regarding the 101 rejections,
“Amended independent claim 1 as a whole is not a mental process… 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 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 based on removing 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"”;
“Much like the claims in Diehr limited the Arrhenius equation to the practical application of molding rubber products, claim 1 limits the alleged abstract idea into the practical application of adjust[ing] 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 generat[ing] output data indicative of the adjusted longitudinal diagnostic information of the second time period. The claims do not seek to monopolize a method of organizing human activity as executed by a generic computer. Rather, the claims recite specific steps to generate output data comprising an adjusted device history indicative of the adjusted longitudinal diagnostic information of the second time period… As such, as noted by the Examiner, the prior art made of record does not disclose… and therefore amended independent claim 1 recites an improvement to technology or a technical field… As additional evidence that the subject matter of Applicant's claims improves a technical field… Applicant's specification discloses a litany of improvements to the field of health event data handling, such that the improvements would be apparent to one of ordinary skill in the art… Amended independent claim 1 similarly recites features that improve the performance of a medical device… Claim 1, as discussed throughout, solves a specific technical problem rooted in the limited memory capacity of implantable medical devices. Remov[ing] the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record, as recited by claim 1, provides a technical solution that reduces the memory capacity being consumed to store the record, thereby directly improving the technological functioning of the implantable medical device… 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 generat[ing] a device history incorporating the health event data over a second time period that includes a first time period, apply[ing] at least one criterion ... to remove at least a portion of the health event data from the record, and generat[ing] output data comprising an adjusted device history. Removing at least a portion of the health event data from the record not only "reflect[s] a more accurate picture of the patient's health" but also provides a technical solution that reduces consumed memory capacity. Therefore, like the improved medical device in CardioNet, the Office should similarly find that Applicant's claims fit into a class of claims that focus on an improvement in technology… Much like the automated rearrangement of icons in Example 37, the automated removal of health event data from the record provides a specific technical improvement over prior diagnostic monitoring systems by "advantageously enable[ing] improved accuracy in the detection of changes in patient health and, consequently, better evaluation of the condition of the patient" and "reduce[ing] the memory capacity being consumed to store the record, which includes inaccurate health event data"”; and
“a medical system comprising an 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… the specification and claims detail an improvement in the technology field.”
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,
“Amended independent claim 1 as a whole is not a mental process… 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 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 based on removing 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"”:
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, and not the “Mental Processes” grouping, as Applicant now seems to argue. 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 “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 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 based on removing 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."” However, Applicant fails to specify how the “instructions” of “claim 1… are not "rules" as envisioned by the exception” and how “Reducing processing circuitry configured 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 based on removing to being merely "following rules," would directly contradict the MPEP.” Regardless, 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 based on removing” 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. Furthermore, the list of examples for the enumerated sub-groupings is exemplary, and not exhaustive; Appellant’s invention need not be included in the list, as long as the claim recites an abstract idea, which it does, as explained above.
Thus, the claims are directed to an abstract idea.
“Much like the claims in Diehr limited the Arrhenius equation to the practical application of molding rubber products, claim 1 limits the alleged abstract idea into the practical application of adjust[ing] 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 generat[ing] output data indicative of the adjusted longitudinal diagnostic information of the second time period. The claims do not seek to monopolize a method of organizing human activity as executed by a generic computer. Rather, the claims recite specific steps to generate output data comprising an adjusted device history indicative of the adjusted longitudinal diagnostic information of the second time period… As such, as noted by the Examiner, the prior art made of record does not disclose… and therefore amended independent claim 1 recites an improvement to technology or a technical field… As additional evidence that the subject matter of Applicant's claims improves a technical field… Applicant's specification discloses a litany of improvements to the field of health event data handling, such that the improvements would be apparent to one of ordinary skill in the art… Amended independent claim 1 similarly recites features that improve the performance of a medical device… Claim 1, as discussed throughout, solves a specific technical problem rooted in the limited memory capacity of implantable medical devices. Remov[ing] the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record, as recited by claim 1, provides a technical solution that reduces the memory capacity being consumed to store the record, thereby directly improving the technological functioning of the implantable medical device… 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 generat[ing] a device history incorporating the health event data over a second time period that includes a first time period, apply[ing] at least one criterion ... to remove at least a portion of the health event data from the record, and generat[ing] output data comprising an adjusted device history. Removing at least a portion of the health event data from the record not only "reflect[s] a more accurate picture of the patient's health" but also provides a technical solution that reduces consumed memory capacity. Therefore, like the improved medical device in CardioNet, the Office should similarly find that Applicant's claims fit into a class of claims that focus on an improvement in technology… Much like the automated rearrangement of icons in Example 37, the automated removal of health event data from the record provides a specific technical improvement over prior diagnostic monitoring systems by "advantageously enable[ing] improved accuracy in the detection of changes in patient health and, consequently, better evaluation of the condition of the patient" and "reduce[ing] the memory capacity being consumed to store the record, which includes inaccurate health event data"”:
Applicant argues “Much like the claims in Diehr limited the Arrhenius equation to the practical application of molding rubber products, claim 1 limits the alleged abstract idea into the practical application of adjust[ing] 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 generat[ing] output data indicative of the adjusted longitudinal diagnostic information of the second time period.” However, Applicant fails to specify how “the claims in Diehr limited the Arrhenius equation to the practical application of molding rubber products” are similar to the claims to which Applicant seem to refer as “adjust[ing] 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 generat[ing] output data indicative of the adjusted longitudinal diagnostic information of the second time period.” Furthermore, Applicant fails to specify how “adjust[ing] 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 generat[ing] output data indicative of the adjusted longitudinal diagnostic information of the second time period” is a “practical application.” See MPEP § 2106.04(d)(I). Regardless, the claim limitations to which Applicant seem to refer as “adjust[ing] 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 generat[ing] output data indicative of the adjusted longitudinal diagnostic information of the second time period” 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, and not additional elements to be interpreted in Step 2A, Prong Two.
Applicant argues “The claims do not seek to monopolize a method of organizing human activity as executed by a generic computer. Rather, the claims recite specific steps to generate output data comprising an adjusted device history indicative of the adjusted longitudinal diagnostic information of the second time period.” However, evaluating whether the claims monopolize the abstract idea is not a standalone test of subject matter eligibility. Furthermore, the claim limitations to which Applicant seem to refer as “specific steps to generate output data comprising an adjusted device history indicative of the adjusted longitudinal diagnostic information of the second time period” 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, and not additional elements to be interpreted in Step 2A, Prong Two.
Applicant argues “As such, as noted by the Examiner, the prior art made of record does not disclose… and therefore amended independent claim 1 recites an improvement to technology or a technical field.” However, Applicant fails to specify how the prior art not disclosing claim limitations of the present invention “recites an improvement to technology or a technical field.” Per MPEP § 2106.05(I): “the search for an inventive concept should not be confused with a novelty or non-obviousness determination…As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter…a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty…Because [novelty and obviousness] are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101.”
Applicant argues “As additional evidence that the subject matter of Applicant's claims improves a technical field… Applicant's specification discloses a litany of improvements to the field of health event data handling, such that the improvements would be apparent to one of ordinary skill in the art… Amended independent claim 1 similarly recites features that improve the performance of a medical device….Claim 1, as discussed throughout, solves a specific technical problem rooted in the limited memory capacity of implantable medical devices. Remov[ing] the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record, as recited by claim 1, provides a technical solution that reduces the memory capacity being consumed to store the record, thereby directly improving the technological functioning of the implantable medical device… 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 generat[ing] a device history incorporating the health event data over a second time period that includes a first time period, apply[ing] at least one criterion ... to remove at least a portion of the health event data from the record, and generat[ing] output data comprising an adjusted device history. Removing at least a portion of the health event data from the record not only "reflect[s] a more accurate picture of the patient's health" but also provides a technical solution that reduces consumed memory capacity. Therefore, like the improved medical device in CardioNet, the Office should similarly find that Applicant's claims fit into a class of claims that focus on an improvement in technology.” However, “the detection of changes in patient health and, consequently, better evaluation of the condition of the patient” addresses administrative problems, and not a technical problem to any specific devices (i.e., implantable medical devices), technology, or computers for that matter, and thus, the claims do not provide a technical solution. Furthermore, while the claims may include claim limitations which reflect “the processing circuitry reduces the memory capacity being consumed to store the record, which includes inaccurate health event data,” the “processing circuitry” and “memory” associated with “removes the health event data corresponding to the adjudicated health events and the non-adjudicated health events from the record” is the “processing circuitry” and “memory” of the “remote computing device,” and not the “implantable medical device” or “other medical devices that are restricted resource-wise, for example, with a smaller resource footprint.” For example, 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. Unlike in CardioNet, the claims of the present invention do not improve a medical device, but use the implantable medical device 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. Furthermore, the claim limitations to which Applicant seem to refer as “generat[ing] a device history incorporating the health event data over a second time period that includes a first time period, apply[ing] at least one criterion ... to remove at least a portion of the health event data from the record, and generat[ing] 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 “Much like the automated rearrangement of icons in Example 37, the automated removal of health event data from the record provides a specific technical improvement over prior diagnostic monitoring systems by "advantageously enable[ing] improved accuracy in the detection of changes in patient health and, consequently, better evaluation of the condition of the patient" and "reduce[ing] the memory capacity being consumed to store the record, which includes inaccurate health event data."” However, Applicant fails to specify how “the automated removal of health event data from the record provides a specific technical improvement over prior diagnostic monitoring systems” is “Much like the automated rearrangement of icons in Example 37.” Furthermore, Applicant fails to specify how “the automated removal of health event data from the record provides a specific technical improvement over prior diagnostic monitoring systems.” While the specification need not explicitly set forth the 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). Regardless, the claim limitations to which Applicant refer (i.e., "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") 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.
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 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… the specification and claims detail an improvement in the technology field”:
Applicant argues “a medical system comprising an 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… 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, 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. 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.
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
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EMILY HUYNH/Primary Examiner, Art Unit 3683
Prosecution Insights