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 .
Status of claims
This final office action on merits is in response to the communication received on 11/25/2025. Claims 1-24 are pending and considered below.
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 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Under step 1, the analysis is based on MPEP 2106.03, and claims 1-6 are drawn to a renal therapy apparatus, claims 7-20 are drawn to a medical device apparatus, claims 21-24 are drawn to a medical device method. Thus, each claim, on its face, is directed to one of the statutory categories (i.e., useful process, machine, manufacture, or composition of matter) of 35 U.S.C. 101.
Step 2A Prong One
Claim 1 recites the limitation of determining that at least one of an alarm or an event has been generated by the therapy operations processor. This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or by using a pen and paper. But for the “a control processor communicatively coupled to the memory device and the therapy operations processor, the control processor configured to” language, the claim encompasses a user simply recognizing or identifying the occurrence of an alarm or event in their mind or by using a pen and paper. The mere nominal recitation of a control processor does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process which is an abstract idea.
Claim 7 recites the limitation of identifying as a first stream, the first subset of the received medical device data, identifying as a second stream, the second subset of the received medical device data, detecting an occurrence of an alarm or event, and creating a record that includes an identifier of the alarm or event. This limitation, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind or by using a pen and paper. But for the “a control processor communicatively coupled to the memory device and the therapy operations processor, the control processor configured to” language, the claim encompasses a user simply reviewing received data, categorizing portions into two groups, noting when an event or alarm has occurred, and writing down the categorized data with the associated identifier in their mind or by using a pen and paper. The mere nominal recitation of a control processor does not take the claim limitation out of the mental processes grouping. Thus, the claim recites a mental process which is an abstract idea.
Independent claim 21 recites identical or nearly identical steps with respect to claim 7 (and therefore also recite limitations that fall within this subject matter grouping of abstract ideas), and this claim is therefore determined to recite an abstract idea under the same analysis.
Under Step 2A Prong Two
The claimed limitations, as per claim 1, include:
a memory device configured as a circular buffer;
a therapy operations processor configured to generate (i) alarms, (ii) events, and (iii) high fidelity medical device data, (i), (ii), and (iii) being related to operation of the renal therapy apparatus for performing a renal therapy treatment, the medical device data including at least two of first data generated at a 1 Hz rate, second data generated at a 5 Hz rate, third data generated at a 10 Hz rate, fourth data generated at a 20 Hz rate, fifth data generated at a 60 Hz rate, and sixth data generated at an asynchronous rate;
a control processor communicatively coupled to the memory device and the therapy operations processor, the control processor configured to
receive the medical device data at the specified data rates from the therapy operations processor,
store a first stream of the medical device data to the memory device in a circular buffer configuration such that previous medical device data stored to the memory device is overwritten after being in the memory device for a first specified time duration,
determine that at least one of an alarm or an event has been generated by the therapy operations processor,
store, for a second specified time duration after the occurrence of the at least one of the alarm or the event, a second stream of the medical device data to the memory device in the circular buffer configuration such that previous medical device data stored to the memory device is overwritten after being in the memory device for the first specified time period, and
after the second specified time duration has elapsed, create a file that includes the medical device data in the circular buffer and information indicative of the at least one of the generated alarm or event.
The claimed limitations, as per claim 7 include:
a therapy operations processor configured to generate alarms, events, and high fidelity medical device data that are related to an operation of the medical device apparatus for performing a medical treatment;
a memory device including a first circular buffer configured to store a first duration of medical device data and a second circular buffer configured to store a second duration of medical device data, the first circular buffer configured to store a first subset of the medical device data and the second circular buffer configured to store a second subset of the medical device data;
a control processor communicatively coupled to the memory device and the therapy operations processor, the control processor configured to
receive a stream of medical device data from the therapy operations processor,
identify as a first stream, the first subset of the received medical device data,
identify as a second stream, the second subset of the received medical device data,
write the first stream to the first circular buffer such that a most recent first duration of the first stream is stored,
write the second stream to the second circular buffer such that a most recent second duration of the second stream is stored,
detect an occurrence of an alarm or event, and
create a record that includes an identifier of the alarm or event and at least the first subset of the medical device data that is stored in the first circular buffer.
Examiner Note: underlined elements indicate additional elements of the claimed invention identified as performing the steps of the claimed invention.
The judicial exception expressed in claim 1 is not integrated into a practical application. The claim as a whole merely describes how to generally “apply” the concept of collecting, recognizing, and storing event related data for later analysis in a computer environment. The claimed computer components (i.e., a memory device configured as a circular buffer, a therapy operations processor, a control processor communicatively coupled to the memory device and the therapy operations processor, the control processor) are recited at a high level of generality and are merely invoked as tools to perform an existing process of observing and recording information associated with an event. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea. Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application.
The judicial exception expressed in claim 1 is not integrated into a practical application. The abstract idea is merely carried out in a technical environment or field (i.e., renal therapy), however fails to contain meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment (see MPEP 2106.05(h)). The additional elements that are carried out in a technical environment includes the renal therapy apparatus for performing a renal therapy treatment. Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application.
The judicial exception expressed in claim 1 is not integrated into a practical application. The claim recites the additional elements of receiving the medical device data at the specified data rates from the therapy operations processor, storing a first stream of the medical device data to the memory device, storing a second stream of the medical device data to the memory device, and creating a file that includes the medical device data in the circular buffer and information indicative of the at least one of the generated alarm or event. This limitation is recited at a high level of generality (i.e., as a general means of collecting and recording information for later use), and amounts to merely data gathering and storage, which is a form of insignificant extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
The judicial exception expressed in claim 7 is not integrated into a practical application. The claim as a whole merely describes how to generally “apply” the concept of collecting, categorizing, and recording data associated with an event or an alarm in a computer environment. The claimed computer components (i.e., a therapy operations processor, a memory device including a first circular buffer configured to store a first duration of medical device data and a second circular buffer configured to store a second duration of medical device data, a control processor communicatively coupled to the memory device and the therapy operations processor, the control processor configured, writing the first stream to the first circular buffer such that a most recent first duration of the first stream is stored, and writing the second stream to the second circular buffer such that a most recent second duration of the second stream is stored) are recited at a high level of generality and are merely invoked as tools to perform an existing process of segregating data into groups, tracking when a triggering event occurs, and associating the data with the event. Simply implementing the abstract idea on a generic computer is not a practical application of the abstract idea. Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application.
The judicial exception expressed in claim 7 is not integrated into a practical application. The abstract idea is merely carried out in a technical environment or field (i.e., a medical environment for a medical treatment), however fails to contain meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment (see MPEP 2106.05(h)). The additional elements that are carried out in a technical environment includes an operation of the medical device apparatus for performing a medical treatment. Accordingly, alone and in combination, these additional elements do not integrate the abstract idea into a practical application.
The judicial exception expressed in claim 7 is not integrated into a practical application. The claim recites the additional elements of receiving a stream of medical device data from the therapy operations processor. This limitation is recited at a high level of generality (i.e., as a general means of obtaining information for subsequent processing), and amounts to merely data gathering, which is a form of insignificant extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Therefore, under step 2A, the claims are directed to the abstract idea, and require further analysis under Step 2B.
Under step 2B
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A, the claim as a whole merely describes how to generally “apply” the concept of collecting, recognizing, and storing event related data for later analysis in a computer environment. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A, the abstract idea is merely carried out in a technical environment or field, however fails to contain meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
Claim 1 does not include an additional element that are sufficient to amount to significantly more than the judicial exception. For the providing limitation that was considered extra-solution activity in Step 2A, this has been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the field. The specification does not provide any indication that the limitation of collecting and recording information for later use is anything other than a conventional action that simply comes before and after the occurrence of an alarm event in the operation of a medical device (see [0002] and Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)). For these reasons, there is no inventive concept. The claim is not patent eligible.
Claim 7 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A, the claim as a whole merely describes how to generally “apply” the concept of collecting, categorizing, and recording data associated with an event or an alarm in a computer environment. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
Claim 7 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A, the abstract idea is merely carried out in a technical environment or field, however fails to contain meaningful limitations beyond generally linking the use of an abstract idea to a particular technological environment. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea.
Claim 7 does not include an additional element that are sufficient to amount to significantly more than the judicial exception. For the providing limitation that was considered extra-solution activity in Step 2A, this has been re-evaluated in Step 2B and determined to be well-understood, routine, conventional activity in the field. The specification does not provide any indication that the limitation of obtaining information for subsequent processing is anything other than a conventional action that simply comes before and after identifying data subsets, detecting an event, and recording associated information (see [0002] and Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)). For these reasons, there is no inventive concept. The claim is not patent eligible.
Claims 2-3, 9-16, 22, and 24 recite no further additional elements, and only further narrow the abstract idea. The previously identified additional elements, individually and as a combination, do not integrate the narrowed abstract idea into a practical application for reasons similar to those explained above, and do not amount to significantly more than the narrowed abstract idea for reasons similar to those explained above.
Claims 4-6, 8, 17-19, 20, and 23 recite the additional element of a portable memory device (claim 4), the control processor is configured to transmit the file to the portable memory device after detecting that the portable memory device is communicatively coupled to the port (claim 4), the control processor (claim 5, 8, 17-19), to enable a server to recreate conditions of the renal therapy apparatus (claim 6), to transmit the record via at least one of (i) a network to a server, or (ii) a port to a portable memory device (claim 17), to display on a display screen in a time-series graph at least some of the first subset of the medical device data included within the record (claim 19), a renal therapy machine (claim 20), to receive medical device data (claim 23). However, this additional element amounts to implementing an abstract idea on a generic computing device, mere linking to a particular environment or mere data gathering (i.e., an insignificant extra-solution activity)). As such, these additional elements, when considered individually or in combination with the prior devices, do not integrate the abstract idea into a practical application or amount to significantly more than the abstract idea.
Thus, as the dependent claims remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, the dependent claims are not patent eligible.
Therefore, the claims here fail to contain any additional element(s) or combination of additional elements that can be considered as significantly more and the claim is rejected under 35 U.S.C. 101 for lacking eligible 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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-24 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (U.S. Patent Publication 2013/0310726 A1), referred to hereinafter as Miller, in view of Drew et al. (U.S. Patent Publication 2007/0255147 A1), referred to hereinafter as Drew.
Regarding claim 1, Miller teaches a renal therapy apparatus (Miller [0017] “The present system and method involve a medical device infrastructure that integrates many aspects of providing home renal therapy.”) comprising:
a memory device (Miller [0162] “System 110, including any or all of devices or subsystems 100, 102, 104, 106, 108, 118, 120, 122, 130, 140, 150, and 160, includes a main unit 170 which preferably includes one or more processors 176 electrically coupled by an address/data bus 178 to one or more memory devices 174, other computer circuitry 172, and one or more interface circuits 180”),
a therapy operations processor configured to generate (i) alarms, (ii) events, and (iii) high fidelity medical device data, (i), (ii), and (iii) being related to operation of the renal therapy apparatus for performing a renal therapy treatment (Miller [0162] “System 110, including any or all of devices or subsystems 100, 102, 104, 106, 108, 118, 120, 122, 130, 140, 150, and 160, includes a main unit 170 which preferably includes one or more processors 176 electrically coupled by an address/data bus 178 to one or more memory devices 174, other computer circuitry 172, and one or more interface circuits 180”, Miller [0141] “The water treatment device 108 can inform the renal therapy machine 100 of its status, such as an alarm situation, and send any other pertinent data to ACPU 112. Renal therapy machine 100 stores and acts upon the data, e.g., decides whether to raise an alarm. Water treatment device 108 in an embodiment include a small user interface and display.” Miller [0293] “In FIG. 34A, the clinician has selected and may enter values into fields in the time tab 3406. Here, the clinician can select and enter values for either a night therapy time 3416 or a night dwell time per cycle 3418. The clinician enters values for the displayed hours and minutes fields. The clinician also has the ability to enable a treatment option, such as smart dwells option 3420, which provides more control over the dwell time during the night portion of peritoneal dialysis therapy. Enabling smart dwells 3420 allows a clinician to select parameters that comport with the patient's lifestyle. When smart dwells is set to "Enabled", the renal therapy machine 100 adjusts the dwell time to accommodate changes in the fill and drain times, so that the treatment ends as scheduled. When smart dwells is set to "Disabled", the therapy dwell times are not changeable, therefore, the treatment may end at a different time then scheduled.”, Miller [0249] “During a renal treatment, a large number of events take place, which machine 100 stores in its log files. Home medical device system 110 provides a proficient way to notify clinicians regarding pertinent treatment events and conditions. The clinicians can specify the events or conditions that are of most concern. When these events occur or when the conditions are met or not met, system 110 triggers and displays relevant notifications to the clinician who reviews the patient's treatment data.”, and Miller [0239] “FIG. 16F illustrates the backflush option tab 1614 of device program screen 1600 displayed on a clinician's display device 192, which allows the clinician to specify the backflush volume at drop-down menus 1676 and the backflush frequency at drop-down menu 1678. Backflush volume at drop-down menu 1676 is the volume of dialysate that is sent to the dialyzer to prevent clotting of the dialyzer. This volume is also given to the patient. The renal therapy machine automatically compensates its UF rate to remove this fluid, so from the fluid management standpoint there is a net zero fluid transfer. Backflush frequency at drop-down menu 1678 is how often (in minutes) a backflush bolus is given, which allows automating the delivery of the programmed backflush volume at the backflush frequency rate throughout the treatment.”),
a control processor communicatively coupled to the memory device and the therapy operations processor, the control processor configured to (Miller [0139] “The blood pressure monitor 104 may be provided with a blood pressure module that plugs into the renal therapy machine 100. For example, the blood pressure module of monitor 104 may include a printed circuit board controller that plugs into a controller bus of machine 100. The module of monitor 104 communicates thereafter via data bus communication with a primary control processor ("ACPU") 112.”)
receive the medical device data at the specified data rates from the therapy operations processor (Miller [0141] “The water treatment device 108 connects to the renal therapy machine 100 through an Ethernet cable in one embodiment. The water treatment device 108 is normally powered. The renal therapy machine 100 can request water as needed from water treatment device 108. Water treatment device 108 is configured to supply, on an online basis, any amount of water that machine 100 needs. Renal therapy machine 100 controls and receives data from the water treatment device 108.”),
store a first stream of the medical device data to the memory device (Miller [0144] “For example, the renal therapy machine 100 may record how much water treatment device 108 has made and delivered to machine 100 and add that information to the machine's own log files. Data stored on water treatment device 108 that is not sent to machine 100 may otherwise be obtained via the Ethernet data connection to water treatment device 108. For example, a service person can access the additional data via a laptop connection to water treatment device 108 via the Ethernet connection.”)
determine that at least one of an alarm or an event has been generated by the therapy operations processor (Miller [0141] “Renal therapy machine 100 controls and receives data from the water treatment device 108. In one embodiment, the tablet 122 does not control water treatment device 108. Instead, water treatment device 108 is a slave to the programmed ACPU 112. The water treatment device 108 can inform the renal therapy machine 100 of its status, such as an alarm situation, and send any other pertinent data to ACPU 112. Renal therapy machine 100 stores and acts upon the data, e.g., decides whether to raise an alarm. Water treatment device 108 in an embodiment include a small user interface and display.”),
store a second stream of the medical device data to the memory device (Miller [0144] “The water treatment device 108, which provides water to the renal therapy machine 100 as needed, also records and maintains its own log files that document the actions taken by the water treatment device 108 and any alarm or alert events that occur over a treatment. The water treatment device 108 in one embodiment does not write directly to the log files of renal therapy machine 100 log files. Renal therapy machine 100 may however include some data or parameters sent from water treatment device 108 that machine 100 records in its own log files.” and Miller [0249] “During a renal treatment, a large number of events take place, which machine 100 stores in its log files. Home medical device system 110 provides a proficient way to notify clinicians regarding pertinent treatment events and conditions. The clinicians can specify the events or conditions that are of most concern. When these events occur or when the conditions are met or not met, system 110 triggers and displays relevant notifications to the clinician who reviews the patient's treatment data.”)
create a file that includes the medical device data and information indicative of the at least one of the generated alarm or event (Miller [0249] “During a renal treatment, a large number of events take place, which machine 100 stores in its log files. Home medical device system 110 provides a proficient way to notify clinicians regarding pertinent treatment events and conditions. The clinicians can specify the events or conditions that are of most concern. When these events occur or when the conditions are met or not met, system 110 triggers and displays relevant notifications to the clinician who reviews the patient's treatment data.”).
Miller fails to explicitly teach a circular buffer; the medical device data including at least two of first data generated at a 1 Hz rate, second data generated at a 5 Hz rate, third data generated at a 10 Hz rate, fourth data generated at a 20 Hz rate, fifth data generated at a 60 Hz rate, and sixth data generated at an asynchronous rate; in a circular buffer configuration such that previous medical device data stored to the memory device is overwritten after being in the memory device for a first specified time duration; for a second specified time duration after the occurrence of the at least one of the alarm or the event, in the circular buffer configuration such that previous medical device data stored to the memory device is overwritten after being in the memory device for the first specified time period; and after the second specified time duration has elapsed.
Drew teaches a circular buffer (Drew [0012] “A first recording includes pre-event data from a signal set that may be stored in an active buffer. The active buffer may be a circular buffer. Upon detection of a first event, pre-event data may be copied into a data block having lowest priority data. Post-event data associated with the first event may also be saved in the data block having the pre-event data of the first event.”);
the medical device data including at least two of first data generated at a 1 Hz rate, second data generated at a 5 Hz rate, third data generated at a 10 Hz rate, fourth data generated at a 20 Hz rate, fifth data generated at a 60 Hz rate, and sixth data generated at an asynchronous rate (Drew “[0094] In FIG. 11, an event is not currently detected so pointers such as those used in copying data from the active to the fixed buffer area as shown in FIG. 11 may not be currently utilized. Furthermore, as illustrated in FIG. 11 each of the configurations maybe assigned a different number of memory blocks to store data associated with that particular configuration. This allows them to support varying amounts of data with a common block-size divisor. Note that recording 3 is using both block 2504 and block 2508 which may be separated by one or more blocks from another recording as shown with 2506. Moreover, each configuration may have Start pointers such as pointers 2580 to be used with that configuration. Finally, FIG. 11 also indicates that active buffers 2110 may be sized in accordance with a formula such as: Active Buffer Size=(Maximum number of channels)*(Maximum Pre-event time)*(Sample rate). Where Maximum Pre-event Time is in seconds and Sample rate is in words per second.”);
in a circular buffer configuration such that previous medical device data stored to the memory device is overwritten after being in the memory device for a first specified time duration (Drew [0084] “In an aspect of the invention, loop recording memory 2106 may be separated into active buffers 2110 and a fixed record buffer 2112. The active buffers 2110 as further illustrated in FIG. 8 may be circular buffers that store pre-event data. Active buffers 2110 may overwrite older data as new data is recorded. As those skilled in the art will realize, the size of active buffers 2110 may determine the number and size of recording that may be stored.”),
for a second specified time duration after the occurrence of the at least one of the alarm or the event, in the circular buffer configuration such that previous medical device data stored to the memory device is overwritten after being in the memory device for the first specified time period (Drew [0090] “FIG. 10 further illustrates the breakdown of fixed record buffer 2112 and active buffers 2110. In FIG. 10, the abbreviations of A for active buffers 2110 and F for fixed record buffer 2112 are used for illustrative purposes. As illustrated in FIG. 10, active buffers 2110 continues to record 2410 data before, after, and during event detection”, Drew [0078] In accordance with an aspect of the invention, an implantable medical device stores loop recordings of waveform data having specified pre-event and post-event times. The implantable medical device may also include a multitude of sense channels to process numerous signal types. Overlaps as discussed below occur when the storing of data related to a second event overlaps the storing of data from a first event. Because data relating to both events may be stored redundantly, memory capacity for additional events is diminished.”, and Drew [0084] “In an aspect of the invention, loop recording memory 2106 may be separated into active buffers 2110 and a fixed record buffer 2112. The active buffers 2110 as further illustrated in FIG. 8 may be circular buffers that store pre-event data. Active buffers 2110 may overwrite older data as new data is recorded. As those skilled in the art will realize, the size of active buffers 2110 may determine the number and size of recording that may be stored.”)
and after the second specified time duration has elapsed (Drew [0012] “A first recording includes pre-event data from a signal set that may be stored in an active buffer. The active buffer may be a circular buffer. Upon detection of a first event, pre-event data may be copied into a data block having lowest priority data. Post-event data associated with the first event may also be saved in the data block having the pre-event data of the first event.”).
It would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the renal therapy apparatus of Miller to incorporate the circular buffer based data retention techniques taught by Drew. Miller teaches a renal therapy apparatus that generates alarms and events and medical device data during treatment and stores such information in log files for clinician review and diagnosis, but does not specify retaining a rolling window of pre-event, post-event, and high-resolution data. Drew teaches using an active circular buffer to continuously store pre-event data by overwriting older data after a specified duration, and upon event detection, copying the buffered pre-event data and saving post-event data associated with the detected event, including sizing buffers based on sample rate and pre-event time.
A PHOSITA would have been motivated to combine Miller and Drew because both references address medical devices that detect clinically relevant events and retain associated data for troubleshooting and analysis, and Drew provides a known technique for preserving sufficient high-resolution context around alarms and events without requiring unlimited memory. Applying Drew’s circular buffer event-recording approach to Miller’s renal therapy apparatus would have been a substitution of one known data storage and retention technique for another to improve event diagnostic capture, yielding predictable results.
Regarding claim 2, Miller and Drew teach the invention in claim 1, as discussed above, and further teach wherein the medical device data includes at least one of pump rate data, pressure data, temperature data, scale data, or diagnostic data (Miller [0234] “FIG. 16C illustrates the dialysate tab 1608 of device program screen 1600 displayed on a clinician's display device 192. Tab 1608 allows the clinician to specify dialysate flowrate at entries 1638 and the dialysate prescription at drop-down menu 1640. Dialysate flowrate is the flowrate at which dialysate is pumped to and from a dialyzer (for hemodialysis) or the patient (for peritoneal dialysis). Dialysate prescription relates to the chemical makeup of the dialysate used for treatment, which is generally measured by measuring the conductivity of the dialysate.”, Miller [0311] “FIG. 36D illustrates an example screen shot of a general tab 3610 in system settings screen 3600 displayed on a clinician's display device 192. On the general tab 3610, a clinician can specify fluid temperature 3640, a user mode 3642 and the language 3644. Fluid temperature 3640 controls the temperature of the fluid warmer and the temperature of the fluid that will be infused into the patient.”, Miller [0139] “The blood pressure monitor 104 may be provided with a blood pressure module that plugs into the renal therapy machine 100. For example, the blood pressure module of monitor 104 may include a printed circuit board controller that plugs into a controller bus of machine 100.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to include pump rate, temperature, pressure, and diagnostic data in the stored subsets of medical device data, since Miller teaches monitoring these conventional parameters in renal therapy machines and their inclusion would have been a routine choice.
Regarding claim 3, Miller and Drew teach the invention in claim 1, as discussed above, and further teach wherein the first specified time duration is between ten seconds and two minutes and the second time duration is between zero seconds and thirty seconds (Miller [0181] “In an alternative embodiment, the connectivity agent 114 may remain on during treatment and may report information about the renal therapy machine 100 and the treatment in real-time. For example, in one embodiment, system 110 may allow a clinician to remotely and simultaneously view screens being viewed by the patient on user interface 122.” and Miller [0218] “From treatment summary screen 1400, a clinician can see a description of the flag symbols at chart 1401. The clinician can also see the date, start time and total dialysis time at chart 1402, the prescribed device program at chart 1404 and overall treatment summary log in table format showing exact times for various treatment events at chart 1406).”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to select time durations such as 10 seconds to 2 minutes of data and 0 to 30 seconds of pre and post-event data, because Drew teaches storing event-related time windows and Miller teaches logging treatment times, making the claimed durations an obvious optimization of result effective variables.
Regarding claim 4, Miller and Drew teach the invention in claim 1, as discussed above, and further teach further comprising a port to receive a portable memory device, wherein the control processor is configured to transmit the file to the portable memory device after detecting that the portable memory device is communicatively coupled to the port (Miller [0162] “A block diagram of the electrical systems of any of the devices or subsystems of the home medical device system (e.g., machine 100, modem 102, blood pressure monitor 104, scale 106, water treatment device 108, server 118, system hub 120, user interface 122, service portal 130, enterprise resource planning system 140, web portal 150, business intelligence portal 160) is illustrated in FIG. 1B. System 110, including any or all of devices or subsystems 100, 102, 104, 106, 108, 118, 120, 122, 130, 140, 150, and 160, includes a main unit 170 which preferably includes one or more processors 176 electrically coupled by an address/data bus 178 to one or more memory devices 174, other computer circuitry 172, and one or more interface circuits 180. Processor 176 may be any suitable processor, such as a microprocessor from the INTEL PENTIUM.RTM. family of microprocessors. The memory 174 preferably includes volatile memory and non-volatile memory. Memory 174 can store a software program that interacts with the other devices in the system 110 as described below. This program may be executed by the processor 176 in any suitable manner. The memory 174 may also store digital data indicative of documents, files, programs, web pages, etc. retrieved from another computing device and/or loaded via an input device 194.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to provide a port for receiving a portable memory device and configure the control processor to transmit files to it, because Miller discloses memory and interface circuits including USB ports, and portable data transfer was a well-known and predictable solution for exporting patient treatment data.
Regarding claim 5, Miller and Drew teach the invention in claim 1, as discussed above, and further teach wherein the control processor is configured to transmit the file to a server via a network after the file is created (Miller [0021] “The connectivity agent sends the log files to a connectivity server after treatment is completed” and Miller [0163] “The interface circuit 180 may be implemented using any suitable interface standard, such as an Ethernet interface and/or a Universal Serial Bus ("USB") interface. One or more input devices 194 may be connected to the interface circuit 180 for entering data and commands into the main unit 170. For example, the input device 194 may be a keyboard, mouse, touch screen, track pad, track ball, isopoint, and/or a voice recognition system. The interface circuit 180 may be connected to any type of network 182, such as an Internet, a local area network ("LAN"), a telephone network ("POTS"), and/or other networks.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to configure the apparatus to transmit the file to a server via a network connection, since Miller teaches transmitting log files to a server for clinician access and recordkeeping.
Regarding claim 6, Miller and Drew teach the invention in claim 1, as discussed above, and further teach wherein the file includes at least a portion of the first stream of the medical device data before the at least one of the alarm or the event and the second stream of the medical device data after the at least one of the alarm or the event to enable a server to recreate conditions of the renal therapy apparatus for identifying a cause of the at least one of the alarm or the event (Miller [0144] “The water treatment device 108, which provides water to the renal therapy machine 100 as needed, also records and maintains its own log files that document the actions taken by the water treatment device 108 and any alarm or alert events that occur over a treatment. The water treatment device 108 in one embodiment does not write directly to the log files of renal therapy machine 100 log files. Renal therapy machine 100 may however include some data or parameters sent from water treatment device 108 that machine 100 records in its own log files.” and Miller [0249] “During a renal treatment, a large number of events take place, which machine 100 stores in its log files. Home medical device system 110 provides a proficient way to notify clinicians regarding pertinent treatment events and conditions. The clinicians can specify the events or conditions that are of most concern. When these events occur or when the conditions are met or not met, system 110 triggers and displays relevant notifications to the clinician who reviews the patient's treatment data.”and Drew [0090] “FIG. 10 further illustrates the breakdown of fixed record buffer 2112 and active buffers 2110. In FIG. 10, the abbreviations of A for active buffers 2110 and F for fixed record buffer 2112 are used for illustrative purposes. As illustrated in FIG. 10, active buffers 2110 continues to record 2410 data before, after, and during event detection”, Drew [0078] In accordance with an aspect of the invention, an implantable medical device stores loop recordings of waveform data having specified pre-event and post-event times. The implantable medical device may also include a multitude of sense channels to process numerous signal types. Overlaps as discussed below occur when the storing of data related to a second event overlaps the storing of data from a first event. Because data relating to both events may be stored redundantly, memory capacity for additional events is diminished.”, Drew [0076] “Discussed herein are techniques for storing recordings of event data in an implanted medical device for subsequent reporting and analysis.”, Drew [0082] “Events may be triggered automatically by various algorithms or by other inputs, for example telemetry commands from a patient device. In one aspect of the invention, other inputs may include manual triggers issued by a patient. In an embodiment of the invention, various types of triggers may cause the implantable device to store waveform data. Triggers may include an implantable seizure detection algorithm which monitors EEG channels for seizure activity. In addition, triggers may include cardiac arrhythmia detection logic to monitor ECG signals.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to generate files that include both pre-event and post-event data for reconstructing the event, because Drew teaches capturing data from before and after alarms in a circular buffer and Miller teaches storing event records for diagnostic purposes, making the combination a predictable improvement.
Regarding claim 7, Miller teaches A medical device apparatus (Miller [0018] “In one embodiment, a home medical device system includes a plurality of home medical devices including a renal therapy machine”) comprising:
a therapy operations processor configured to generate alarms, events, and high fidelity medical device data that are related to an operation of the medical device apparatus for performing a medical treatment (Miller [0162] “System 110, including any or all of devices or subsystems 100, 102, 104, 106, 108, 118, 120, 122, 130, 140, 150, and 160, includes a main unit 170 which preferably includes one or more processors 176 electrically coupled by an address/data bus 178 to one or more memory devices 174, other computer circuitry 172, and one or more interface circuits 180”, Miller [0141] “The water treatment device 108 can inform the renal therapy machine 100 of its status, such as an alarm situation, and send any other pertinent data to ACPU 112. Renal therapy machine 100 stores and acts upon the data, e.g., decides whether to raise an alarm. Water treatment device 108 in an embodiment include a small user interface and display.” Miller [0293] “In FIG. 34A, the clinician has selected and may enter values into fields in the time tab 3406. Here, the clinician can select and enter values for either a night therapy time 3416 or a night dwell time per cycle 3418. The clinician enters values for the displayed hours and minutes fields. The clinician also has the ability to enable a treatment option, such as smart dwells option 3420, which provides more control over the dwell time during the night portion of peritoneal dialysis therapy. Enabling smart dwells 3420 allows a clinician to select parameters that comport with the patient's lifestyle. When smart dwells is set to "Enabled", the renal therapy machine 100 adjusts the dwell time to accommodate changes in the fill and drain times, so that the treatment ends as scheduled. When smart dwells is set to "Disabled", the therapy dwell times are not changeable, therefore, the treatment may end at a different time then scheduled.”, Miller [0249] “During a renal treatment, a large number of events take place, which machine 100 stores in its log files. Home medical device system 110 provides a proficient way to notify clinicians regarding pertinent treatment events and conditions. The clinicians can specify the events or conditions that are of most concern. When these events occur or when the conditions are met or not met, system 110 triggers and displays relevant notifications to the clinician who reviews the patient's treatment data.”, and Miller [0239] “FIG. 16F illustrates the backflush option tab 1614 of device program screen 1600 displayed on a clinician's display device 192, which allows the clinician to specify the backflush volume at drop-down menus 1676 and the backflush frequency at drop-down menu 1678. Backflush volume at drop-down menu 1676 is the volume of dialysate that is sent to the dialyzer to prevent clotting of the dialyzer. This volume is also given to the patient. The renal therapy machine automatically compensates its UF rate to remove this fluid, so from the fluid management standpoint there is a net zero fluid transfer. Backflush frequency at drop-down menu 1678 is how often (in minutes) a backflush bolus is given, which allows automating the delivery of the programmed backflush volume at the backflush frequency rate throughout the treatment.”);
a memory device configured to store a first duration of medical device data configured to store a second duration of medical device data, configured to store a first subset of the medical device data and configured to store a second subset of the medical device data (Miller [0162] “System 110, including any or all of devices or subsystems 100, 102, 104, 106, 108, 118, 120, 122, 130, 140, 150, and 160, includes a main unit 170 which preferably includes one or more processors 176 electrically coupled by an address/data bus 178 to one or more memory devices 174, other computer circuitry 172, and one or more interface circuits 180” and Miller [0144] “For example, the renal therapy machine 100 may record how much water treatment device 108 has made and delivered to machine 100 and add that information to the machine's own log files. Data stored on water treatment device 108 that is not sent to machine 100 may otherwise be obtained via the Ethernet data connection to water treatment device 108. For example, a service person can access the additional data via a laptop connection to water treatment device 108 via the Ethernet connection.” and Miller [0249] “During a renal treatment, a large number of events take place, which machine 100 stores in its log files. Home medical device system 110 provides a proficient way to notify clinicians regarding pertinent treatment events and conditions. The clinicians can specify the events or conditions that are of most concern. When these events occur or when the conditions are met or not met, system 110 triggers and displays relevant notifications to the clinician who reviews the patient's treatment data.”);
a control processor communicatively coupled to the memory device and the therapy operations processor, the control processor configured to (Miller [0139] “The blood pressure monitor 104 may be provided with a blood pressure module that plugs into the renal therapy machine 100. For example, the blood pressure module of monitor 104 may include a printed circuit board controller that plugs into a controller bus of machine 100. The module of monitor 104 communicates thereafter via data bus communication with a primary control processor ("ACPU") 112.”)
receive a stream of medical device data from the therapy operations processor (Miller [0147] “In one embodiment, tablet 122 serves as a user interface to the renal therapy machine 100 in the sense that the user can send data to and receive data from machine 100 via tablet 122. Data entered into the user interface is securely sent to the renal therapy machine 100 and processed in ACPU 112, which actually controls the machine. In one embodiment, all treatment data is stored in the renal therapy machine 100, not the tablet 122. Storing no treatment data in the tablet 122 is advantageous because if the tablet 122 is disconnected or lost no sensitive or important data is lost.”),
detect an occurrence of an alarm or event (Miller [0141] “The water treatment device 108 can inform the renal therapy machine 100 of its status, such as an alarm situation, and send any other pertinent data to ACPU 112. Renal therapy machine 100 stores and acts upon the data, e.g., decides whether to raise an alarm. Water treatment device 108 in an embodiment include a small user interface and display.”),
create a record that includes an identifier of the alarm or event and at least the first subset of the medical device data that is stored (Miller [0249] “During a renal treatment, a large number of events take place, which machine 100 stores in its log files. Home medical device system 110 provides a proficient way to notify clinicians regarding pertinent treatment events and conditions. The clinicians can specify the events or conditions that are of most concern. When these events occur or when the conditions are met or not met, system 110 triggers and displays relevant notifications to the clinician who reviews the patient's treatment data.” and Miller [0144] “For example, the renal therapy machine 100 may record how much water treatment device 108 has made and delivered to machine 100 and add that information to the machine's own log files. Data stored on water treatment device 108 that is not sent to machine 100 may otherwise be obtained via the Ethernet data connection to water treatment device 108. For example, a service person can access the additional data via a laptop connection to water treatment device 108 via the Ethernet connection.”).
Miller fails to explicitly teach a first circular buffer and a second circular buffer; identify as a first stream, the first subset of the received medical device data; identify as a second stream, the second subset of the received medical device data; write the first stream to the first circular buffer such that a most recent first duration of the first stream is stored; write the second stream to the second circular buffer such that a most recent second duration of the second stream is stored;
Drew teaches a first circular buffer and a second circular buffer (Drew [0012] “A first recording includes pre-event data from a signal set that may be stored in an active buffer. The active buffer may be a circular buffer. Upon detection of a first event, pre-event data may be copied into a data block having lowest priority data. Post-event data associated with the first event may also be saved in the data block having the pre-event data of the first event.”);
identify as a first stream, the first subset of the received medical device data (Drew [0012] “In accordance with another aspect of the invention, a method and apparatus is provided for handling multiple recording and their associated overlaps in a limited memory device. The method provides a mechanism for deciding what and how much information to store for events. The handling of recording includes prioritization of data stored in data blocks of a fixed buffer. A first recording includes pre-event data from a signal set that may be stored in an active buffer. The active buffer may be a circular buffer. Upon detection of a first event, pre-event data may be copied into a data block having lowest priority data. Post-event data associated with the first event may also be saved in the data block having the pre-event data of the first event.”),
identify as a second stream, the second subset of the received medical device data (Drew [0064] “Thus, the concept of storage of data records in first and second data structures envisions possibilities of storage of the sensed physiological data and the storage of their associated pointers. As an example, summary information data may be stored in the first and second data structures wherein the more detailed and more space consuming waveform data (pre-detection data, post-detection data, etc.) may be stored, and pointed to, in an associated memory (such as a loop record buffer).”),
write the first stream to the first circular buffer such that a most recent first duration of the first stream is stored (Drew [0012] “In accordance with another aspect of the invention, a method and apparatus is provided for handling multiple recording and their associated overlaps in a limited memory device. The method provides a mechanism for deciding what and how much information to store for events. The handling of recording includes prioritization of data stored in data blocks of a fixed buffer. A first recording includes pre-event data from a signal set that may be stored in an active buffer. The active buffer may be a circular buffer. Upon detection of a first event, pre-event data may be copied into a data block having lowest priority data. Post-event data associated with the first event may also be saved in the data block having the pre-event data of the first event.”),
write the second stream to the second circular buffer such that a most recent second duration of the second stream is stored (Drew [0064] “Thus, the concept of storage of data records in first and second data structures envisions possibilities of storage of the sensed physiological data and the storage of their associated pointers. As an example, summary information data may be stored in the first and second data structures wherein the more detailed and more space consuming waveform data (pre-detection data, post-detection data, etc.) may be stored, and pointed to, in an associated memory (such as a loop record buffer).”).
It would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the medical device apparatus of Miller to incorporate the multibuffer, streaming data storage techniques taught by Drew. Miller teaches a medical device apparatus that generates alarms, events, and medical device data during treatment and stores such information in memory and log files for clinician review and analysis. However, Miller does not specify segregating different subsets of medical device data into separate buffers or retaining different time durations of data based on data type or relevance to an event.
Drew teaches identifying different subsets (streams) of sensed medical device data and storing those subsets in separate circular buffers, so that each buffer retains a most recent time window of data. Additionally, the circular buffer overwrites older data as new data is received, and buffered data associated with detected events are used to create a corresponding record. A person of ordinary skill in the art would have been motivated to apply Drew’s circular buffer and stream segregation techniques to Miller’s medical device apparatus in order to improve retention and organization of event diagnostic data, which would yield predictable results. The combination applies a known data management technique to a known medical device system to improve event data capture and does not change the operation of either reference.
Regarding claim 8, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the control processor is configured to additionally include in the record the second subset of the medical device data that is stored in the second circular buffer (Miller [0139] “The blood pressure monitor 104 may be provided with a blood pressure module that plugs into the renal therapy machine 100. For example, the blood pressure module of monitor 104 may include a printed circuit board controller that plugs into a controller bus of machine 100. The module of monitor 104 communicates thereafter via data bus communication with a primary control processor ("ACPU") 112.”, Miller [0249] “During a renal treatment, a large number of events take place, which machine 100 stores in its log files. Home medical device system 110 provides a proficient way to notify clinicians regarding pertinent treatment events and conditions. The clinicians can specify the events or conditions that are of most concern. When these events occur or when the conditions are met or not met, system 110 triggers and displays relevant notifications to the clinician who reviews the patient's treatment data.” and Miller [0144] “For example, the renal therapy machine 100 may record how much water treatment device 108 has made and delivered to machine 100 and add that information to the machine's own log files. Data stored on water treatment device 108 that is not sent to machine 100 may otherwise be obtained via the Ethernet data connection to water treatment device 108. For example, a service person can access the additional data via a laptop connection to water treatment device 108 via the Ethernet connection.” And Drew [0084] “In an aspect of the invention, loop recording memory 2106 may be separated into active buffers 2110 and a fixed record buffer 2112. The active buffers 2110 as further illustrated in FIG. 8 may be circular buffers that store pre-event data. Active buffers 2110 may overwrite older data as new data is recorded. As those skilled in the art will realize, the size of active buffers 2110 may determine the number and size of recording that may be stored.”)
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to include in the record both the first and second subsets of data from the respective circular buffers, as taught by Drew’s handling of multiple data structures and Miller’s log file recording of different treatment parameters, in order to provide a more complete clinical record.
Regarding claim 9, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the first duration and the second duration have a same time duration (Drew [0075] “Furthermore, in another aspect of the invention, all pre-event and post-event times may be the same for all events. However, as those skilled in the art will realize both pre-event and post-event times may be adjusted such that the total time saved for each event remains the same”.)
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to configure the first and second buffer durations to be the same, in view of Drew’s teaching that all pre-event and post-event times may be equal for simplifying memory management.
Regarding claim 10, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the first duration has a time duration that is longer than the second duration (Drew [0110] “Moreover, data compression may be used to store an additional number of loop recording or a longer record time for the same number of loop recording.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to make the first buffer duration longer than the second, consistent with Drew’s disclosure that data compression may be used to allow longer record times for some recordings relative to others.
Regarding claim 11, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the first duration and the second duration are each between ten seconds and two minutes (Miller [0181] “In an alternative embodiment, the connectivity agent 114 may remain on during treatment and may report information about the renal therapy machine 100 and the treatment in real-time. For example, in one embodiment, system 110 may allow a clinician to remotely and simultaneously view screens being viewed by the patient on user interface 122.” and Miller [0218] “From treatment summary screen 1400, a clinician can see a description of the flag symbols at chart 1401. The clinician can also see the date, start time and total dialysis time at chart 1402, the prescribed device program at chart 1404 and overall treatment summary log in table format showing exact times for various treatment events at chart 1406).”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to set both the first and second durations to between ten seconds and two minutes, as Miller discloses precise time based logging of dialysis treatment events within that range for clinical review.
Regarding claim 12, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the first subset of the medical device data is generated at a first data rate and the second subset of medical device data is generated at a second, different data rate (Drew [0094] “Finally, FIG. 11 also indicates that active buffers 2110 may be sized in accordance with a formula such as: Active Buffer Size=(Maximum number of channels)*(Maximum Pre-event time)*(Sample rate). Where Maximum Pre-event Time is in seconds and Sample rate is in words per second.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to configure the first and second subsets of data to be generated at different data rates, consistent with Drew’s teaching that buffer size depends on sample rate and that different channels or signals may operate at different frequencies.
Regarding claim 13, Miller and Drew teach the invention in claim 12, as discussed above, and further teach wherein the first data rate and the second data rate are each between 1 Hz and 100 Hz (Drew [0094] “Finally, FIG. 11 also indicates that active buffers 2110 may be sized in accordance with a formula such as: Active Buffer Size=(Maximum number of channels)*(Maximum Pre-event time)*(Sample rate). Where Maximum Pre-event Time is in seconds and Sample rate is in words per second.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to select data rates within 1 Hz to 100 Hz, as Drew discloses examples that support that range for medical device sampling and buffer allocation.
Regarding claim 14, Miller and Drew teach the invention in claim 12, as discussed above, and further teach wherein at least one of the first data rate or the second data rate includes an asynchronous data rate (Drew [0094] “Finally, FIG. 11 also indicates that active buffers 2110 may be sized in accordance with a formula such as: Active Buffer Size=(Maximum number of channels)*(Maximum Pre-event time)*(Sample rate). Where Maximum Pre-event Time is in seconds and Sample rate is in words per second.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to include asynchronous data rates alongside regular periodic sampling, as Drew discloses buffer configurations that accommodate both periodic and irregular sample rates.
Regarding claim 15, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the detected alarm or event is a first alarm or event, and wherein the first subset of the medical device data is associated with the first alarm or event and the second subset of the medical device data is associated with a second, different alarm or event (Miller [0162] “System 110, including any or all of devices or subsystems 100, 102, 104, 106, 108, 118, 120, 122, 130, 140, 150, and 160, includes a main unit 170 which preferably includes one or more processors 176 electrically coupled by an address/data bus 178 to one or more memory devices 174, other computer circuitry 172, and one or more interface circuits 180”, Miller [0141] “The water treatment device 108 can inform the renal therapy machine 100 of its status, such as an alarm situation, and send any other pertinent data to ACPU 112. Renal therapy machine 100 stores and acts upon the data, e.g., decides whether to raise an alarm. Water treatment device 108 in an embodiment include a small user interface and display.” Miller [0293] “In FIG. 34A, the clinician has selected and may enter values into fields in the time tab 3406. Here, the clinician can select and enter values for either a night therapy time 3416 or a night dwell time per cycle 3418. The clinician enters values for the displayed hours and minutes fields. The clinician also has the ability to enable a treatment option, such as smart dwells option 3420, which provides more control over the dwell time during the night portion of peritoneal dialysis therapy. Enabling smart dwells 3420 allows a clinician to select parameters that comport with the patient's lifestyle. When smart dwells is set to "Enabled", the renal therapy machine 100 adjusts the dwell time to accommodate changes in the fill and drain times, so that the treatment ends as scheduled. When smart dwells is set to "Disabled", the therapy dwell times are not changeable, therefore, the treatment may end at a different time then scheduled.”, Miller [0249] “During a renal treatment, a large number of events take place, which machine 100 stores in its log files. Home medical device system 110 provides a proficient way to notify clinicians regarding pertinent treatment events and conditions. The clinicians can specify the events or conditions that are of most concern. When these events occur or when the conditions are met or not met, system 110 triggers and displays relevant notifications to the clinician who reviews the patient's treatment data.”, and Miller [0239] “FIG. 16F illustrates the backflush option tab 1614 of device program screen 1600 displayed on a clinician's display device 192, which allows the clinician to specify the backflush volume at drop-down menus 1676 and the backflush frequency at drop-down menu 1678. Backflush volume at drop-down menu 1676 is the volume of dialysate that is sent to the dialyzer to prevent clotting of the dialyzer. This volume is also given to the patient. The renal therapy machine automatically compensates its UF rate to remove this fluid, so from the fluid management standpoint there is a net zero fluid transfer. Backflush frequency at drop-down menu 1678 is how often (in minutes) a backflush bolus is given, which allows automating the delivery of the programmed backflush volume at the backflush frequency rate throughout the treatment.” and Drew [0103] “In another aspect of the invention, a second event may be detected while the first event is being recorded. For example, if the first event was an ISDA detection trigger and the second event was the end of a seizure cluster. (The ISDA trigger may be considered more important than the end of seizure event. In this case, at some time the second loop recording may get overwritten before the first if memory is filled and a block is needed for a new loop recording).”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to associate the first subset of data with a first alarm or event and the second subset with a different alarm or event, combining Miller’s disclosure of renal machine alarms or events with Drew’s disclosure of overlapping recordings for different event triggers.
Regarding claim 16, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the alarm or event includes at least one of an occlusion alarm, a pressure alarm, a low fluid volume alarm, a flow rate alarm, a syringe alarm, a fluid leak detection alarm, a blood leak detection alarm, an air bubble detection alarm, a power supply alarm, a treatment pause event, a treatment stoppage event, or a treatment parameter change event (Miller [0143] “In one embodiment, ACPU 112 and user interface 122 of renal therapy machine 100 walk the patient through the entire treatment process and instruct the patient on a step-by-step basis to perform the treatment. The user interface screens are standardized but are populated with data that machine 100 receives from clinicians (as described in detail below). The instructions are according to a doctor's prescription and provide parameters by which machine 100 operates, such as the blood flowrate, dialysate flowrate and ultrafiltrate volume. Renal therapy machine 100 performs a treatment and records that the treatment has been performed according to the parameters. Errors, alerts, alarm conditions and whether or not treatment steps have been successfully performed are recorded. The renal therapy machine 100 records this information by creating the log files that document each treatment.”, Milller [0264] “FIG. 25 illustrates an example device prescription history report 2500 displayed on a clinician's display device 192. The device prescription history report allows the clinicians to view when the settings for a renal therapy machine 100 were last modified 2502, who made the modification 2504. The device prescription history report 2500 then lists the history of the various settings on different dates. The device prescription history report lists, for each date under 2502, the dialyzer model 2506, the treatment type 2508, the treatment duration 2512, blood flowrate 2514, maximum positive and negative pump pressures 2516 and 2518, maximum dialysate flowrate 2520, dialysate prescription 2522, prime method 2524 and rinseback volume 2526.” and Miller [0265] “FIG. 26 illustrates an example operator interventions report 2600 displayed on a clinician's display device 192 that allows a clinician to view when and why alarms were raised during renal treatment, such as alarm timestamps 2602, the type of alert that was raised 2604, when an operator acted 2606 and what the operator requested 2608.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to include specific types such as occlusion, pressure, or flow rate alarms, because Miller teaches a wide variety of alarms and treatment event notifications during dialysis operations.
Regarding claim 17, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the control processor is configured to transmit the record via at least one of (i) a network to a server, or (ii) a port to a portable memory device for diagnosis of a cause of the alarm or event (Miller [0139] “The blood pressure monitor 104 may be provided with a blood pressure module that plugs into the renal therapy machine 100. For example, the blood pressure module of monitor 104 may include a printed circuit board controller that plugs into a controller bus of machine 100. The module of monitor 104 communicates thereafter via data bus communication with a primary control processor ("ACPU") 112.”, Miller [0162] “A block diagram of the electrical systems of any of the devices or subsystems of the home medical device system (e.g., machine 100, modem 102, blood pressure monitor 104, scale 106, water treatment device 108, server 118, system hub 120, user interface 122, service portal 130, enterprise resource planning system 140, web portal 150, business intelligence portal 160) is illustrated in FIG. 1B. System 110, including any or all of devices or subsystems 100, 102, 104, 106, 108, 118, 120, 122, 130, 140, 150, and 160, includes a main unit 170 which preferably includes one or more processors 176 electrically coupled by an address/data bus 178 to one or more memory devices 174, other computer circuitry 172, and one or more interface circuits 180. Processor 176 may be any suitable processor, such as a microprocessor from the INTEL PENTIUM.RTM. family of microprocessors. The memory 174 preferably includes volatile memory and non-volatile memory. Memory 174 can store a software program that interacts with the other devices in the system 110 as described below. This program may be executed by the processor 176 in any suitable manner. The memory 174 may also store digital data indicative of documents, files, programs, web pages, etc. retrieved from another computing device and/or loaded via an input device 194.” and Miller [0021] “The connectivity agent sends the log files to a connectivity server after treatment is completed” and Miller [0163] “The interface circuit 180 may be implemented using any suitable interface standard, such as an Ethernet interface and/or a Universal Serial Bus ("USB") interface. One or more input devices 194 may be connected to the interface circuit 180 for entering data and commands into the main unit 170. For example, the input device 194 may be a keyboard, mouse, touch screen, track pad, track ball, isopoint, and/or a voice recognition system. The interface circuit 180 may be connected to any type of network 182, such as an Internet, a local area network ("LAN"), a telephone network ("POTS"), and/or other networks.” and Drew [0076] “Discussed herein are techniques for storing recordings of event data in an implanted medical device for subsequent reporting and analysis.” and Drew [0082] “Events may be triggered automatically by various algorithms or by other inputs, for example telemetry commands from a patient device. In one aspect of the invention, other inputs may include manual triggers issued by a patient. In an embodiment of the invention, various types of triggers may cause the implantable device to store waveform data. Triggers may include an implantable seizure detection algorithm which monitors EEG channels for seizure activity. In addition, triggers may include cardiac arrhythmia detection logic to monitor ECG signals.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to either a networked server or a portable memory device, as Miller teaches transmission of log files over Ethernet or USB and Drew teaches storing event data for subsequent reporting and analysis.
Regarding claim 18, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the control processor is configured to model or analyze at least the first subset of the medical device data that is included within the record for diagnosis of a cause of the alarm or event (Miller [0139] “The blood pressure monitor 104 may be provided with a blood pressure module that plugs into the renal therapy machine 100. For example, the blood pressure module of monitor 104 may include a printed circuit board controller that plugs into a controller bus of machine 100. The module of monitor 104 communicates thereafter via data bus communication with a primary control processor ("ACPU") 112.”, and Drew [0076] “Discussed herein are techniques for storing recordings of event data in an implanted medical device for subsequent reporting and analysis.” and Drew [0082] “Events may be triggered automatically by various algorithms or by other inputs, for example telemetry commands from a patient device. In one aspect of the invention, other inputs may include manual triggers issued by a patient. In an embodiment of the invention, various types of triggers may cause the implantable device to store waveform data. Triggers may include an implantable seizure detection algorithm which monitors EEG channels for seizure activity. In addition, triggers may include cardiac arrhythmia detection logic to monitor ECG signals.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to analyze the subset of recorded medical data for diagnosing the cause of alarms or events, in view of Miller’s processor based analysis of treatment data and Drew’s disclosure of stored event data being analyzed for diagnosis.
Regarding claim 19, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the control processor is configured to display on a display screen in a time-series graph at least some of the first subset of the medical device data included within the record (Miller [0139] “The blood pressure monitor 104 may be provided with a blood pressure module that plugs into the renal therapy machine 100. For example, the blood pressure module of monitor 104 may include a printed circuit board controller that plugs into a controller bus of machine 100. The module of monitor 104 communicates thereafter via data bus communication with a primary control processor ("ACPU") 112.”, Miller [0164] “The display 192 generates visual displays of data generated during operation of the device or subsystem 100, 102, 104, 106, 108, 118, 120, 122, 130, 150, 140, 160. For example, the display 192 may be used to display information received from the system hub 120. The visual displays may include prompts for human input, run time statistics, calculated values, data, etc.”, Miller [0286] “For example, the graph for each day indicates a pre-treatment pulse indicated by a diamond-shaped icon and a post-treatment pulse as indicated by the square icon. The blood pressure and pulse readouts may be instantaneous readouts indicating a single sample taken at a single point in time or be an average readout taken and averaged over multiple points in time.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to display the recorded data in a time series graph, as Miller discloses displaying medical data in graphical format (i.e., blood pressure graphs, treatment parameters) for clinician review.
Regarding claim 20, Miller and Drew teach the invention in claim 7, as discussed above, and further teach wherein the medical device apparatus includes at least one of a renal therapy machine or an infusion pump (Miller [0018] “In one embodiment, a home medical device system includes a plurality of home medical devices including a renal therapy machine, such as, but not limited to, a home hemodialysis ("HD") machine, a home peritoneal dialysis ("PD") machine, a home hemofiltration ("HF") machine, a home hemodiafiltration ("HDF") machine, and a home continuous renal replacement ("CRRT") machine.”).
Therefore, it would be obvious to a PHOSITA before the effective filing date of the invention to apply the claimed apparatus to renal therapy machines or infusion pumps, as Miller teaches the use of the described system in renal therapy and infusion related devices.
Claim 21 is analogous to claim 7, thus claim 21 is similarly analyzed and rejected in a manner consistent with the rejection of claim 7.
Claim 22 is analogous to claim 8, thus claim 22 is similarly analyzed and rejected in a manner consistent with the rejection of claim 8.
Claim 23 is analogous to claim 12, thus claim 23 is similarly analyzed and rejected in a manner consistent with the rejection of claim 12.
Claim 24 is analogous to claims 10 and 11, thus claim 24 is similarly analyzed and rejected in a manner consistent with the rejection of claims 10 and 11.
Response to Arguments
Applicant’s arguments and amendments, see Remarks/Amendments submitted on 11/25/2025 with respect to the rejection of the claims have been carefully considered and is addressed below.
Claim Rejections - 35 USC § 101
Applicant’s arguments have been fully considered but are not persuasive. Applicant states that the Office Action is silent about how the claim limitations interact and impact each other when evaluating whether the exception is integrated into a practical application (from the USPTO memo regarding Step 2A, Prong Two), however, the argument is not persuasive. The memo does not require a different outcome where the interaction of the claim elements, even when considered together, implements an abstract idea using generic computing components. Here, the claimed processors and memory devices interact to collect, selectively retain, and store information associated with alarms or events, which does not integrate the judicial exception into a practical application.
Applicant’s reliance on Ex parte Desjardins and Enfish is not persuasive. In those cases, the claims recited specific technical improvements to how a computer or model itself operated. In this application, the present claims do not modify how the renal therapy apparatus performs treatment, generates alarms, or controls therapy parameters. However, the claims specify when high-resolution data is stored and associated with an alarm or event for later review. Improving the availability of information for diagnostic purposes reflects an improvement in how information is collected and retained, not an improvement to the operation, control, or functionality of the medical device itself.
Applicant further relies on advantages described in the specification regarding improved diagnostic resolution. However, subject matter eligibility is based on the claim language, not on unclaimed benefits that are described in the specification. The claims do not recite a new memory structure, a new alarm detection mechanism, or any change to therapy control. Instead, the claims recite applying high-level data storage techniques, including circular buffers and event triggered record creation, to carry out the abstract idea using conventional computing functionality.
Lastly, even when the claim limitations are considered together, the judicial exception is not integrated into a practical application under Step 2A. The claims apply the abstract idea of recognizing an event and recording associated information in a medical environment, which is an insufficient limitation under MPEP § 2106.05(h). Also, the claims do not recite significantly more under Step 2B. The additional elements amount to well-understood, routine, and conventional activities of receiving data, consistent with Electric Power Group v. Alstom. Therefore, the rejection of Claims 1-24 under 35 U.S.C. § 101 is maintained.
Claim Rejections - 35 USC § 103
Applicant’s arguments have been considered but are not persuasive. Although Miller does not explicitly disclose a circular buffer, the rejection properly relies on Drew for teaching circular buffer storage of pre-event and post-event medical device data, and relies on Miller for teaching alarm and event detection, logging, and record generation in a renal therapy apparatus. The combination is proper because both references are directed to medical devices that detect events and retain diagnostic data, and Drew’s buffering techniques are readily applicable to Miller’s renal therapy system to achieve predictable results.
Applicant states that Drew fails to disclose “after a second specified time duration has elapsed, create a file that includes medical device data in a circular buffer and information indicative of at least one of the generated alarm or event,” stating that Drew stores data only in a fixed record buffer rather than a separate file. However, under the broadest reasonable interpretation, the claimed file or record is not limited to a filesystem object or non overwritable storage area. Drew discloses copying pre-event and post-event data from a circular buffer into a fixed record buffer upon event detection, which constitutes creating a record that includes buffered medical device data associated with an event. The claims do not require that the record be permanently retained or stored outside the loop recording memory.
Applicant’s reliance on Drew’s use of an implantable medical device with limited memory is not persuasive. The claims do not recite any minimum memory capacity or permanent storage requirement. Also, claim 1 recites overwriting older data after specified time durations. Therefore, Drew’s priority-based overwriting of event records does not teach away from, but instead aligns with, the claimed invention.
Applicant’s arguments for independent claims 7 and 21 are unpersuasive for the same reasons as listed above. Drew teaches storing different subsets of medical device data in circular buffers and associating those subsets with detected events, while Miller teaches generating alarms and creating records tied to treatment events. Combining these teachings would have been obvious to a person of ordinary skill in the art seeking to improve diagnostic data capture in a medical device. The claims do not require any additional structural or functional limitation that would distinguish over the combined teachings of Miller and Drew.
Accordingly, Applicant has not identified any claim limitation that is incompatible with the combined disclosures of Miller and Drew. Therefore, the rejection of claims 1-24 under 35 U.S.C. § 103 is therefore maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure.
Anderson (U.S. Patent Publication 2013/0090853) teaches a system that provides high frequency diagnostic data capture by storing device data in a dynamic circular buffer with real time resolution tapering, maintaining high resolution for recent data and progressively lower resolution for older data, so that only low bandwidth information is transmitted during normal operation. However, upon a trigger event, the system transmits the entire lean buffer data record and subsequently streams incoming diagnostic data at high resolution before tapering transmission resolution over time.
Handler (U.S. Patent Publication 2017/0043089 A1) teaches a vital sign monitor that integrates data from a renal therapy machine and an infusion pump, displaying both treatment parameters in aligned timelines within a single user interface for the same patient.
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.
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/K.R.L./Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685