DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/05/2026 has been entered.
Status of Claims
This action is in reply to amendments filed on 03/05/2026. Claims 2, 9, and 16 were amended. Claim 1 was cancelled. No claims were added. Therefore, claims 2-21 are currently pending and have been examined.
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 2-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept — i.e. element that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
STEP 1
The claims are directed to method and system which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims recite the abstract idea of:
A method for patient device management, the method comprising:
receiving a plurality of transmissions of interrogation data originating from one or more cardiac monitoring devices corresponding to one or more patients associated with a particular clinic based on a clinic identifier, the interrogation data including device data for the one or more cardiac monitoring devices and patient specific data for the one or more patients, the one or more cardiac monitoring devices being manufactured by one or more manufacturers;
generating manufacturer independent interrogation data by normalizing the interrogation data independent of the one or more manufacturers through a conversion of the interrogation data into a unified format;
generating provider-oriented information for the manufacturer independent interrogation data associated with the particular clinic, the provider-oriented information including at least one metric corresponding to the particular clinic; and
generating at least one metric corresponding to the particular clinic.
The claims, as illustrated by the limitations of Claim 1 above, recite an abstract idea within the “certain methods of organizing human activity” grouping — managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
The claims recite generating and presenting a metric for normalized cardiac monitoring device data associated with a clinic. Generating and presenting a data metric is a process that merely organizes human activity, as it involves following rules and instructions to receive data, generate normalized data, determine data is associated with a particular clinic, generate a clinic metric, and present the metric. It also involves an interaction between a person and a computer. Interaction between a person and computer qualifies as interaction under certain methods of organizing human activity. See MPEP 2106.04(a)(2)(II). As such, the claims recite an abstract idea within the category of certain methods of organizing human activity.
The dependent claims 3-8, 10-15, and 17-21 recite further abstract concepts of organizing human activity because they recite following rules and instructions, such as 3/10/17 generating at least one visual indicator based on the at least one metric, the at least one visual indicator being rendered for display; 4/11/18 the at least one visual indicator is a bar graph, a line graph, a pie chart, or a spreadsheet; 5/12/19 the at least one metric is displayed for a predetermined time period; 6/13/20 the at least one metric includes a change of the at least one metric over a recent time period; 7/14/21 the includes at least one of a number of patients, a number of transmissions per patient, a total number of dockets prepared, a percent of patients remotely monitored by the particular clinic, or a number of transmissions per docket prepared by one or more medical team members; 8/15 the is presented in relation to data pertaining to at least one other clinic.
STEP 2A PRONG TWO
The claims recite additional elements beyond those that encompass the abstract idea above including:
Independent claim 2:
a user interface including the
the user interface being rendered for display
Independent claim 9:
causing at least one display to present the user interface
Independent claim 16:
a server comprising at least one processor and memory comprising instructions that, when executed by the at least one processor, cause the server to:
a user interface including the
the user interface being rendered for display
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with considerations laid out by the Supreme Court or the Federal Circuit. (see MPEP 2106.05 a-c and e) The additional elements integrate the abstract idea into a practical application when they: improve the functioning of a computer or improving any other technology, apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, apply the judicial exception with, or by use of, a particular machine, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. The additional limitations do not integrate the abstract idea into a practical application when they merely serve to link the use of the abstract idea to a particular technological environment or field of use — i.e. merely uses the computer as a tool to perform the abstract idea; or recite insignificant extra-solution activity (see MPEP 2106.05 f - h).
The display, user interface, server, processor, and memory are recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using generic computer components. These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment. Nothing in the claim recites specific limitations directed to an improved display, server, processor, and memory. Similarly, the specification is silent with respect to these kinds of improvements. A general purpose computer that applies a judicial exception to computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a basic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claims do not integrate the abstract transmission overview generation and presentation process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract transmission overview generation and presentation process. The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting basic computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently straightforward such that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination, the limitations recited in the claims add nothing that is not already present when the steps are considered individually.
The limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. For example, limitations 3/10/17 generating at least one visual indicator based on the at least one metric, the at least one visual indicator being rendered for display; 5/12/19 the at least one metric is displayed for a predetermined time period; 6/13/20 the at least one metric includes a change of the at least one metric over a recent time period; 8/15 the is presented in relation to data pertaining to at least one other clinic are directed to the abstract ideas of organizing human activity without integrating into a practical application or amounting to significantly more. Limitations 4/11/18 the at least one visual indicator is a bar graph, a line graph, a pie chart, or a spreadsheet; 7/14/21 the includes at least one of a number of patients, a number of transmissions per patient, a total number of dockets prepared, a percent of patients remotely monitored by the particular clinic, or a number of transmissions per docket prepared by one or more medical team members merely serve to further narrow the abstract idea above. As such, the additional elements do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention. Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-21 are rejected under 35 U.S.C. 103 as being unpatentable over Otto, et al. (US 2013/0110834 A1) in view of Worrell, et al. (US 2013/0317852 A1).
With regards to claim 2, Otto teaches a method for patient device management and a system comprising; a server comprising at least one processor and memory comprising instructions that, when executed by the at least one processor, cause the server to: (see at least ¶ 0007, aggregating CRT performance data for a number of patients in which an IMD is implanted, and generating reports of the aggregated data for review by organizations or individual clinicians treating the patients; at least ¶ 0009, a system includes a processor and a computer-readable storage medium storing instructions. The processor is configured to execute the instructions stored on the computer-readable storage medium to cause the processor to collect cardiac resynchronization therapy (CRT) performance data correlated to cardiac rhythm event data for a first group of patients in which an implantable medical device (IMD) configured to deliver CRT is implanted, aggregate the CRT performance data correlated to the cardiac rhythm event data for a second group of patients from among the first group of patients, and generate a report comprising the aggregation of the CRT performance data correlated to the cardiac rhythm event data for the second group of patients), the method comprising: receiving a plurality of transmissions of interrogation data originating from one or more cardiac monitoring devices corresponding to one or more patients associated with a particular clinic based on a clinic identifier, the interrogation data including device data for the one or more cardiac monitoring devices and patient specific data for the one or more patients, the one or more cardiac monitoring devices being manufactured by one or more manufacturers (see at least figure 7, ¶ 0083, aggregation engine 19 executed on server 18 is configured to generate a report that includes, in one example, the aggregated CRT performance data correlated to AT/AF, PVC, and/or VSEs for all of the patients in the target population of a particular clinic “Clinic 1 – Minneapolis” [patient associated with a particular clinic based on a clinic identifier]; at least ¶ 0023, collecting CRT performance data for a number of IMDs implanted in a number of patients correlated to one or more different types of cardiac rhythm events for those patients, at least ¶ 0087, report 200 includes patient data 202 including patient name, device information for the IMDs implanted within the patients, including device serial number and brand); (see at least figure 7, ¶ 0089, CRT performance data aggregated by aggregation module 22 for a number of patients treated at a particular clinic); generating provider-oriented information for the … interrogation data associated with the particular clinic, the provider-oriented information including at least one metric corresponding to the particular clinic (see at least figure 7, ¶ 0083, aggregation engine 19 executed on server 18 is configured to generate a report that includes, in one example, the aggregated CRT performance data correlated to AT/AF, PVC, and/or VSEs for all of the patients in the target population of a particular clinic “Clinic 1 – Minneapolis” [provider-oriented information for the interrogation data associated with the particular clinic]); and generating a user interface including the at least one metric corresponding to the particular clinic, the user interface being rendered for display (see at least figures 5-7, ¶ 0085, Reports generated by reporting module 24 may be communicated to users, e.g., organizations or individual clinicians, in a number of ways. In one example, electronic reports generated by reporting module 24 may be transmitted electronically to users, e.g., by electronic mail (e-mail), or by publishing such reports on a private or public network to make the reports available for downloading onto a remote computing device).
Otto does not explicitly teach …generating manufacturer independent interrogation data by normalizing the interrogation data independent of the one or more manufacturers through a conversion of the interrogation data into a unified format; …manufacturer independent… Worrell teaches …generating manufacturer independent interrogation data by normalizing the interrogation data independent of the one or more manufacturers through a conversion of the interrogation data into a unified format; …manufacturer independent… (see at least abstract, paragraph 0064, device data presented in uniform fashion irrespective of device manufacturer). It would have been obvious to one of ordinary skill in the art at the time of invention to use the uniform device data presentation of Worrell in the device data reports of Otto with the motivation of allowing healthcare personnel easier interpretation of data (Worrell, paragraph 0004).
Claims 9 and 16 recite similar limitations and are rejected for the same reasons.
With regards to claim 3, Otto teaches the method of claim 2, the method comprising: generating at least one visual indicator based on the at least one metric, the at least one visual indicator being rendered for display (see at least figures 5-7).
Claims 10 and 17 recite similar limitations and are rejected for the same reasons.
With regards to claim 4, Otto teaches the method of claim 3, wherein the at least one visual indicator is a bar graph, a line graph, a pie chart, or a spreadsheet (see at least figures 5-7).
Claims 11 and 18 recite similar limitations and are rejected for the same reasons.
With regards to claim 5, Worrell teaches the method of claim 2, wherein the at least one metric is displayed for a predetermined time period (see at least figure 7(216), “5 Episodes since 01/01/2012” [number of transmissions per patient for predetermined time period]). It would have been obvious to one of ordinary skill in the art at the time of invention to use the uniform device data presentation of Worrell in the device data reports of Otto with the motivation of allowing healthcare personnel easier interpretation of data (Worrell, paragraph 0004).
Claims 12 and 19 recite similar limitations and are rejected for the same reasons.
With regards to claim 6, Worrell teaches the method of claim 5, wherein the at least one metric includes a change of the at least one metric over a recent time period (see at least figure 15, ¶ 0091, the CHF Watch window 248 shows the status of the CHF Watch, the thirty day count, the change in weight, the patient's blood pressure, the CRT pace, Atrial burden, RV pace, and the transthoracic impedance change). It would have been obvious to one of ordinary skill in the art at the time of invention to use the uniform device data presentation of Worrell in the device data reports of Otto with the motivation of allowing healthcare personnel easier interpretation of data (Worrell, paragraph 0004).
Claims 13 and 20 recite similar limitations and are rejected for the same reasons.
With regards to claim 7, Otto teaches the method of claim 2, wherein the user interface includes at least one of a number of patients, a number of transmissions per patient, a total number of dockets prepared, a percent of patients remotely monitored by the clinic, or a number of transmissions per docket prepared by one or more medical team members (see at least figures 5-8, number of patients).
Claims 14 and 21 recite similar limitations and are rejected for the same reasons.
With regards to claim 8, Otto teaches the method of claim 7, wherein the user interface is presented in relation to data pertaining to at least one other clinic (see at least figure 8).
Claim 15 recites similar limitations and is rejected for the same reasons.
Response to Arguments
Applicant's arguments with respect to the 35 USC § 101 rejections set forth in the previous office action have been considered, but are not persuasive. In an effort to advance prosecution, the Examiner has provided a response to applicant's arguments. Applicant argues:
Applicant’s limitations are subject matter eligible because they improve the technology.
In response to Applicant’s argument the limitations are subject matter eligible because they improve the technology, the Examiner respectfully disagrees. The instant application merely uses conventional computer components to convert implantable medical device data into a unified format so a medical provider can “efficiently manage the care of the patients across various device types and manufacturers.” See specification, ¶ 0004. However, making a process more efficient using conventional computer components does not make the process subject matter eligible because “[a]s we have explained, ‘the fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.’ Bancorp Servs., 687 F.3d at 1278.” FairWarning IP, LLC v. Iatric Systems, _ F.3d _, 120 U.S.P.Q.2d 1293 (Fed. Cir. 2016).
Applicant's arguments with respect to the 35 USC § 103 rejections set forth in the previous office action have been considered, but are moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lulias (US 2016/0048660 A1) which discloses a system including a data analytics module that is configured to process aggregated patient data to generate a report comprising relevant patient activities identified using a calculated relevance score. The aggregated patient data for each patient of a plurality of patients comprises historical data associated with a respective patient and recent patient activity associated with the respective patient received from electronic devices associated with a number of healthcare organizations. The recent patient activities are non-claim-based activities from a number of healthcare organizations received from the electronic devices associated with the plurality healthcare organizations. The system also includes a messaging module that is configured to transmit the report to an electronic device associated with one or more of the healthcare organizations responsive to the report generation.
Webb, et al. (US 2004/0088374 A1) which discloses acquisition of physiological data from a medical device, and manipulation and storage of the physiological data in a format that can allows the data to easily be shared between systems and viewed using different applications. Moreover, the techniques provide for the aggregation of the physiological data acquired from a medical device over multiple telemetry sessions. A system, for example, includes a plurality of medical device programmers to collect physiology data via telemetry sessions with medical devices, and a programmer gateway to receive the session data from the medical device programmers and to process the session data for aggregation in one or more data stores. The session data may include metadata that conforms to a data description language, such as XML, and the programmer gateway may execute a translation engine to store portions of the session data within respective data stores based on the metadata.
M. Yang et al., "iCARDEA: Practical data integration for the follow-up of Cardiovascular Implantable Electronic Device patients in cardiology departments," 2011 Computing in Cardiology, Hangzhou, China, 2011, pp. 589-592 which discloses in cardiology departments supporting implantation and follow-up of Cardiovascular Implantable Electronic Devices (CIED), relevant clinical data reside in autonomous healthcare information systems that support different health information technology (HIT) standards and proprietary data formats. Each organization chooses the Electronic Health Record (EHR) integration solutions, underlying technologies, and HIT standards based on their needs, experience and budget. However, without efficient data integration, significant gaps in workflow will continue to hinder immediate availability of critical medical information and limit optimal utilization of clinical and human resources. This paper presents iCARDEA cross-healthcare platform from the view of the cardiology department, driven by the story of fictitious patient with remote CIED monitoring and own Personal Health Record (PHR), supported by personalized care plan and cutting-edge eHealth innovation.
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/JOSEPH D BURGESS/ Primary Examiner, Art Unit 3685
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