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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 8, 2026 has been entered.
Response to Amendment
In the amendment filed on January 8, 2026, the following has occurred: claim(s) 1, 16 have been amended. Now, claim(s) 1-5 and 16-20 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-5 and 16-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-5: Step 2A Prong One
Claim 1 recite(s)
dividing the data into a plurality of data blocks, wherein each one of the plurality
of data blocks is associated with a time;
assigning a sample number to each one of the plurality of data blocks, wherein the sample number represents an order of occurrence in which each one of the plurality of data blocks was captured;
transmitting the plurality of data blocks from the ECG monitor; and
ordering the plurality of data blocks based on the time at which the each one of the plurality of data blocks was captured and the sample number of each one of the plurality of data blocks for each time.
These limitations as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people (including following rules or instructions), which is a subgrouping of Certain Methods of Organizing Human Activity. For example, these limitations encompass a user following instructions to divide data into a plurality of data blocks, a user following instructions to assign a sample number to each one of the plurality of data blocks, a user following instructions to send the plurality of data blocks from the ECG monitor, and a user following instructions to order the plurality of data blocks based on time at which the each one of the plurality of data blocks was captured and the sample number of each one of the plurality of data blocks for each time. But for the recitation of generic computer components, such steps could be accomplished by a person following instructions to make determinations from data, and therefore encompass Certain Methods of Organizing Human Activity.
Claims 2-5 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. For example, claim 2 includes the abstract idea identified above and further describes the plurality of data blocks. Similarly, claim 3 includes the abstract idea identified above and describes adding data to the plurality of data blocks. Similarly, claim 4 includes the abstract idea identified above and describes tracking the plurality of data blocks. Finally, claim 5 includes the abstract idea identified above and describes determining a number of plurality of data blocks that meet a criteria. Therefore, these claims merely further describe a mental process in a computer environment to observe, evaluate, and judge information. Therefore, these claims recite limitations that fall into the Certain Methods of Organizing Human Activity grouping of abstract ideas.
Claims 1-5: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining
elements amount to no more than general purpose computer components programmed to perform
the abstract idea along with generally linking the abstract idea to a particular technical environment and insignificant extra-solution data gathering activity.
Claims 1-5, directly or indirectly, recite the following generic computer components configured to implement the abstract idea: “…a server, wherein the server receives the sample number assigned to each one of the plurality of data blocks;”, ““the ECG monitor including a housing configured to house a memory and a microcontroller”, “on the server”. The written description discloses that the recited computer components encompass generic computer components “In turn, the download station 145 can be operated through user controls 149 to execute a communications or data download program 146 ("Download") or similar program that interacts with the monitor recorder 144 via the physical interface to retrieve the stored ECG data 166. The download station 145 could alternatively be a server, personal computer, tablet or handheld computer, smart mobile device, or purpose-built device designed specific to the task of interfacing with a monitor recorder 144. Still other forms of download station 145 are possible” (See pages 23-24), “Each diagnostic composite plot 151 is based on ECG data 166 that has either been recorded by a conventional electrocardiograph (not shown) or retrieved or obtained from some other type of ECG monitoring and recording device. Following completion of the ECG monitoring, the ECG data is assembled into a diagnostic composite plot 151, which can be used by a physician to diagnosis and, if required, treat a cardiac rhythm disorder, or for other health care or related purposes.” (See page 22). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “via electrodes included in an ECG monitor”, “using the microcontroller” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “capturing electrocardiogram (ECG) data” at a high degree of generality, amount no more than receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information). As set forth in MPEP 2106.05(d)(II), computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, is an example of when an abstract idea has not been integrated into a practical application.
Claims 1-5: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.")
Additionally, receiving data that is utilized in the dividing, assigning, and transmitting steps amounts to insignificant extra-solution data gathering activity (Mayo, 566 U.S. at 79, 101
USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d
1960, 1966 (Fed. Cir. 2012)).
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2016.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application. The claims are not patent eligible.
Claims 16-20: Step 2A Prong One
Claim 16 recite(s)
dividing the data into a plurality of data blocks, wherein each one of the plurality
of data blocks is associated with a time;
assigning a sample number to each one of the plurality of data blocks, wherein the sample number represents an order of occurrence in which each one of the plurality of data blocks was captured;
transmitting the plurality of data blocks from the ECG monitor; and
ordering the plurality of data blocks based on the time at which the each one of the plurality of data blocks was captured and the sample number of each one of the plurality of data blocks for each time.
These limitations as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer component, encompass managing interactions between people
(including following rules or instructions), which is a subgrouping of Certain Methods of Organizing Human Activity. For example, these limitations encompass a user following instructions to divide data into a plurality of data blocks, a user following instructions to assign a sample number to each one of the plurality of data blocks, a user following instructions to send the plurality of data blocks from the ECG monitor, and a user following instructions to order the plurality of data blocks based on time at which the each one of the plurality of data blocks was captured and the sample number of each one of the plurality of data blocks for each time. But for the recitation of generic computer components, such steps could be accomplished by a person following instructions to make determinations from data, and therefore encompass Certain Methods of Organizing Human Activity.
Claims 17-20 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea, but for the recitation of generic computer components. For example, claim 17 includes the abstract idea identified above and further describes the plurality of data blocks. Similarly, claim 18 includes the abstract idea identified above and further describes the sample numbers. Similarly, claim 19 includes the abstract idea identified above and further describes the plurality of data blocks. Finally, claim 20 includes the abstract idea identified above and further describes the data. Therefore, these claims merely further describe a mental process in a computer environment to observe, evaluate, and judge information. Therefore, these claims recite limitations that fall into the Certain Methods of Organizing Human Activity grouping of abstract ideas.
Claims 16-20: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining
elements amount to no more than general purpose computer component programmed to perform
the abstract idea along with generally linking the abstract idea to a particular technical environment and insignificant extra-solution data gathering activity.
Claims 16-20, directly or indirectly, recite the following generic computer component configured to implement the abstract idea: “the ECG monitor including a housing configured to house a memory and a microcontroller”. The written description discloses that the recited computer component encompass generic computer components “In turn, the download station 145 can be operated through user controls 149 to execute a communications or data download program 146 ("Download") or similar program that interacts with the monitor recorder 144 via the physical interface to retrieve the stored ECG data 166. The download station 145 could alternatively be a server, personal computer, tablet or handheld computer, smart mobile device, or purpose-built device designed specific to the task of interfacing with a monitor recorder 144. Still other forms of download station 145 are possible” (See pages 23-24), “Each diagnostic composite plot 151 is based on ECG data 166 that has either been recorded by a conventional electrocardiograph (not shown) or retrieved or obtained from some other type of ECG monitoring and recording device. Following completion of the ECG monitoring, the ECG data is assembled into a diagnostic composite plot 151, which can be used by a physician to diagnosis and, if required, treat a cardiac rhythm disorder, or for other health care or related purposes.” (See page 22). As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “via electrodes included in an ECG monitor”, “using the microcontroller” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “capturing electrocardiogram (ECG) data” at a high degree of generality, amount no more than receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information). As set forth in MPEP 2106.05(d)(II), computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity, is an example of when an abstract idea has not been integrated into a practical application.
Claims 16-20: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.")
Additionally, receiving data that is utilized in the dividing, assigning, and transmitting steps amounts to insignificant extra-solution data gathering activity (Mayo, 566 U.S. at 79, 101
USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d
1960, 1966 (Fed. Cir. 2012)).
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2016.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application. The claims are not patent eligible.
Accordingly, claims 1-5 and 16-20 are directed to an abstract idea without significantly more. Therefore claims 1-5 and 16-20 are rejected under 35 U.S.C. § 101.
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, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nakajima (U.S. Patent Pre-Grant Publication No. 2020/0397346) in view of Saripalli et al. (U.S. Patent Pre-Grant Publication No. 2020/0337648).
As per independent claim 1, Nakajima discloses a method of transmitting data, comprising:
dividing the data into a plurality of data blocks using the microcontroller, wherein each one of the plurality of data blocks is associated with a time (See Paragraphs [0060]-[0061]: The annotation device according to the present embodiment generates labelled sensor data by assigning a plurality of labels to the acquired sensor data, a plurality of time segments set in the sensor data include a first time segment and a second time segment that are adjacent to each other in time series, which the Examiner is interpreting a plurality of time segments to encompass a plurality of data blocks, and the Examiner is interpreting the processor can be implemented by one or more integrated circuits, logic circuits, microprocessors, GPUs, DSPs, or controllers from any desired family or manufacturer to encompass using the microcontroller);
assigning a sample number to each one of the plurality of data blocks using the microcontroller, wherein the sample number represents an order of occurrence in which each one of the plurality of data blocks was captured (See Paragraphs [0060]-[0061]: Each labelled time segment is a segment set in the time series (time axis) by the start time and the end time in the sensor data, the start time of the first time segment is set to be earlier than the start time of the second time segment, and the end time of the first time segment is set to be earlier than the end time of the second time segment, whereas the end time of the first time segment is set to be later than the start time of the second time segment, which the Examiner is interpreting the first time segment before the second segment to encompass the sample number represents an order of occurrence in which each one of the plurality of data blocks was captured as the labelled time segment is interpreted to encompass sample numbers, and the Examiner is interpreting the processor can be implemented by one or more integrated circuits, logic circuits, microprocessors, GPUs, DSPs, or controllers from any desired family or manufacturer to encompass using the microcontroller);
transmitting the plurality of data blocks from the ECG monitor to a server, wherein the server receives the sample number assigned to each one of the plurality of data blocks (See Paragraphs [0223]-[0224]: The control unit may transmit the labelled sensor data after the width of the overlapping segment is changed to the learning device via a network (See Paragraphs [0093]-[0094]: The learning device may be a general-purpose server device).)
While Nakajima teaches the method as described above, Nakajima may not explicitly teach capturing electrocardiogram (ECG) data via electrodes included in an ECG monitor, the ECG monitor including a housing configured to house a memory and a microcontroller;
ordering the plurality of data blocks on the server based on the time at which the each one of the plurality of data blocks was captured and the sample number of each one of the plurality of data blocks for each time.
Saripalli teaches a method for capturing electrocardiogram (ECG) data via electrodes included in an ECG monitor (See Paragraphs [0054]-[0057]: One or more medical devices administer to a patient, while one or more monitoring devices (e.g., electrocardiogram (ECG) sensor) gather data regarding patient vitals, patient activity, medical device operation, which the Examiner is interpreting the monitoring device (e.g., ECG sensor) to encompass via electrodes included in an ECG monitor as an ECG sensor includes electrodes), the ECG monitor including a housing configured to house a memory and a microcontroller (See Fig. 1, Paragraphs [0057], [0096]-[0097]: Certain examples gather 1D time series data from one or more medical devices (e.g., ECG) and a patient via one or more monitoring devices, which the Examiner is interpreting the medical device (e.g., ECG) to encompass the ECG monitor including a housing configured to house a memory and a microcontroller);
ordering the plurality of data blocks on the server based on the time at which the each one of the plurality of data blocks was captured and the sample number of each one of the plurality of data blocks for each time (See Paragraphs [0031], [0051], [0182]: A framework including a) a computer executing one or more deep learning (DL) models and hybrid deep reinforcement learning (RL) models trained on aggregated machine timeseries data converted into the single standardized data structure format and in an ordered arrangement per patient to predict one or more future events and summarize pertinent past machine events related to the predicted one or more future machine events on a consistent input time series data of a patient having the standardized data structure format, which the Examiner is interpreting the timeseries data to encompass based on the time at which the each one of the plurality of data blocks was captured, and when combined Saripalli with Nakajima’s disclosure of labelled time segments to encompass the sample number of each one of the plurality of data blocks for each time.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nakajima to include capturing electrocardiogram (ECG) data via electrodes included in an ECG monitor, the ECG monitor including a housing configured to house a memory and a microcontroller as taught by Saripalli. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nakajima with Saripalli with the motivation of improving patient outcomes (See Detailed Description of Certain Embodiments of Saripalli in Paragraph [0055]).
As per independent claim 16, Nakajima discloses a method of transmitting data, comprising:
dividing the data into a plurality of data blocks using the microcontroller, wherein each one of the plurality of data blocks is associated with a time (See Paragraphs [0060]-[0061]: The annotation device according to the present embodiment generates labelled sensor data by assigning a plurality of labels to the acquired sensor data, a plurality of time segments set in the sensor data include a first time segment and a second time segment that are adjacent to each other in time series, which the Examiner is interpreting a plurality of time segments to encompass a plurality of data blocks, and the Examiner is interpreting the processor can be implemented by one or more integrated circuits, logic circuits, microprocessors, GPUs, DSPs, or controllers from any desired family or manufacturer to encompass using the microcontroller);
assigning a sample number to each one of the plurality of data blocks using the microcontroller, wherein the sample number represents an order of occurrence in which each one of the plurality of data blocks was captured (See Paragraphs [0060]-[0061]: Each labelled time segment is a segment set in the time series (time axis) by the start time and the end time in the sensor data, the start time of the first time segment is set to be earlier than the start time of the second time segment, and the end time of the first time segment is set to be earlier than the end time of the second time segment, whereas the end time of the first time segment is set to be later than the start time of the second time segment, which the Examiner is interpreting the first time segment before the second segment to encompass the sample number represents an order of occurrence in which each one of the plurality of data blocks was captured as the labelled time segment is interpreted to encompass sample numbers, and the Examiner is interpreting the processor can be implemented by one or more integrated circuits, logic circuits, microprocessors, GPUs, DSPs, or controllers from any desired family or manufacturer to encompass using the microcontroller);
transmitting the plurality of data blocks from the ECG monitor (See Paragraphs [0223]-[0224]: The control unit may transmit the labelled sensor data after the width of the overlapping segment is changed to the learning device via a network.)
While Nakajima teaches the method as described above, Nakajima may not explicitly teach capturing electrocardiogram (ECG) data via electrodes included in an ECG monitor, the ECG monitor including a housing configured to house a memory and a microcontroller;
ordering the plurality of data blocks based on the time at which the each one of the plurality of data blocks was captured and the sample number of each one of the plurality of data blocks for each time.
Saripalli teaches a method for capturing electrocardiogram (ECG) data via electrodes included in an ECG monitor (See Paragraphs [0054]-[0057]: One or more medical devices administer to a patient, while one or more monitoring devices (e.g., electrocardiogram (ECG) sensor) gather data regarding patient vitals, patient activity, medical device operation, which the Examiner is interpreting the monitoring device (e.g., ECG sensor) to encompass via electrodes included in an ECG monitor as an ECG sensor includes electrodes), the ECG monitor including a housing configured to house a memory and a microcontroller (See Fig. 1, Paragraphs [0057], [0096]-[0097]: Certain examples gather 1D time series data from one or more medical devices (e.g., ECG) and a patient via one or more monitoring devices, which the Examiner is interpreting the medical device (e.g., ECG) to encompass the ECG monitor including a housing configured to house a memory and a microcontroller);
ordering the plurality of data blocks based on the time at which the each one of the plurality of data blocks was captured and the sample number of each one of the plurality of data blocks for each time (See Paragraphs [0031], [0051], [0182]: A framework including a) a computer executing one or more deep learning (DL) models and hybrid deep reinforcement learning (RL) models trained on aggregated machine timeseries data converted into the single standardized data structure format and in an ordered arrangement per patient to predict one or more future events and summarize pertinent past machine events related to the predicted one or more future machine events on a consistent input time series data of a patient having the standardized data structure format, which the Examiner is interpreting the timeseries data to encompass based on the time at which the each one of the plurality of data blocks was captured, and when combined Saripalli with Nakajima’s disclosure of labelled time segments to encompass the sample number of each one of the plurality of data blocks for each time.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nakajima to include capturing electrocardiogram (ECG) data via electrodes included in an ECG monitor, the ECG monitor including a housing configured to house a memory and a microcontroller; ordering the plurality of data blocks based on the time at which the each one of the plurality of data blocks was captured and the sample number of each one of the plurality of data blocks for each time as taught by Saripalli. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nakajima with Saripalli with the motivation of improving patient outcomes (See Detailed Description of Certain Embodiments of Saripalli in Paragraph [0055]).
As per claim 17, Nakajima/Saripalli discloses the method of claim 16 as described above. Nakajima further teaches wherein the plurality of data blocks is associated with a device identifier corresponding to the ECG monitor (See Paragraphs [0060]-[0061]: The annotation device according to the present embodiment generates labelled sensor data by assigning a plurality of labels to the acquired sensor data, which the Examiner is interpreting the labelled sensor data to encompass a device identifier corresponding to the ECG monitor.)
As per claim 18, Nakajima/Saripalli discloses the method of claim 16 as described above. Nakajima further teaches wherein the sample number is a consecutive number assigned in increasing order (See Paragraphs [0060]-[0061]: The start time of the first time segment is set to be earlier than the start time of the second time segment, and the end time of the first time segment is set to be earlier than the end time of the second time segment, whereas the end time of the first time segment is set to be later than the start time of the second time segment, which the Examiner is interpreting the first time segment and second time segment to encompass assigned in increasing order.)
As per claim 19, Nakajima/Saripalli discloses the method of claim 16 as described above. Nakajima further teaches wherein the plurality of data blocks overlap (See Paragraphs [0061]-[0062]: The first time segment and the second time segment are set to have an overlapping segment in which the first time segment and the second time segment partially overlap each other in the time series.)
As per claim 20, Nakajima/Saripalli discloses the method of claim 16 as described above. Nakajima further teaches wherein the data includes different types of physiological data (See Paragraphs [0057]-[0058]: The sensor may be, for example, a biosensor (a sensor capable of measuring heartbeat, body temperature, myoelectricity, electrocardiogram, brain waves, and the like), an activity sensor (a sensor capable of measuring vibration, acceleration, and the like), a motion sensor, a camera, a microphone, a load cell, and the like, which the Examiner is interpreting the biosensor to encompass different types of physiological data.)
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Nakajima (U.S. Patent Pre-Grant Publication No. 2020/0397346) in view of Saripalli et al. (U.S. Patent Pre-Grant Publication No. 2020/0337648) in further view of Soni et al. (U.S. Patent Pre-Grant Publication No. 2020/0342362).
As per claim 2, Nakajima/Saripalli discloses the method of claim 1 as described above. Nakajima/Saripalli may not explicitly teach wherein, based on the sample number, the server identifies a time at which the ECG monitor fails to transmit the plurality of data blocks.
Soni teaches a method wherein, based on the sample number, the server identifies a time at which the ECG monitor fails to transmit the plurality of data blocks (See Paragraphs [0029]-[0030], [0056], [0060]-[0062]: The generative model is already trained and operates in an inferencing mode to fill in missing data and/or events when possible, which the Examiner is interpreting the generative model operated in inferencing mode to encompass the server identifies a time at which the ECG monitor fails to transmit the plurality of data blocks ([0056]: ECG monitoring devices can be used to gather data regarding a patient.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nakajima/Saripalli to include based on the sample number, the server identifies a time at which the ECG monitor fails to transmit the plurality of data blocks as taught by Soni. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nakajima/Saripalli with Soni with the motivation of lower healthcare costs and improve quality of care by using synthetic data/events for data augmentation, imputation of missing data (See Detailed Description of Certain Embodiments of Soni in Paragraph [0028]).
As per claim 3, Nakajima/Saripalli discloses the method of claim 1 and Nakajima/Saripalli/Soni discloses the method of claim 2 as described above. Nakajima/Saripalli may not explicitly teach wherein the server inserts a flat signal to represent the time at which the ECG monitor fails to transmit the plurality of data blocks.
Soni further teaches wherein the server inserts a flat signal to represent the time at which the ECG monitor fails to transmit the plurality of data blocks (See Paragraphs [0029]-[0030], [0056], [0060]-[0062], [0074]: The generative model is already trained and operates in an inferencing mode to fill in missing data and/or events when possible, and Fig. 4 describes a portion of missing data that is filled by imputation with synthetic data generated by one or more generative model, which the Examiner is interpreting portion of missing data that is filled by imputation with synthetic data to encompass the server inserts a flat signal to represent the time at which the ECG monitor fails to transmit the plurality of data blocks when combined with Nakajima.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Nakajima/Saripalli to include the server inserts a flat signal to represent the time at which the ECG monitor fails to transmit the plurality of data blocks as taught by Soni. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nakajima/Saripalli with Soni with the motivation of lower healthcare costs and improve quality of care by using synthetic data/events for data augmentation, imputation of missing data (See Detailed Description of Certain Embodiments of Soni in Paragraph [0028]).
As per claim 4, Nakajima/Saripalli discloses the method of claim 1 and Nakajima/Saripalli/Soni discloses the method of claim 2 as described above. Nakajima further teaches wherein the server is configured to track the sample number that is assigned to each one of the plurality of data blocks (See Paragraphs [0143]-[0144]: The control unit operates as the label assignment unit and sets a plurality of time segments in the acquired sensor data, which the Examiner is interpreting the control unit's operation as a label assignment unit to encompass track the sample number that is assigned to each one of the plurality of data blocks.)
As per claim 5, Nakajima/Saripalli discloses the method of claim 1 and Nakajima/Saripalli/Soni discloses the method of claim 2 as described above. Nakajima further teaches wherein, based on the sample number, the server determines a number of the plurality of data blocks that the ECG monitor failed to transmit (See Paragraphs [0101]-[0103]: The data can be cleaned by the processor to interpolate missing data in the time series, which the Examiner is interpreting the processor would be able to identify missing data in the time series if the processor is to clean the data to encompass determines a number of the plurality of data blocks that the ECG monitor failed to transmit.)
Response to Arguments
In the Remarks filed on January 8, 2026, the Applicant argues that the newly amended and/or added claims overcome the 35 U.S.C. 101 rejection(s) and 35 U.S.C. 103 rejection(s). The Examiner does not acknowledge that the newly added and/or amended claims overcome the 35 U.S.C. 101 rejection(s) and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) on August 4, 2025, the USPTO mailed a memo titled "Reminders on evaluating subject matter eligibility of claims under 35 U.S.C. 101". Regarding Step 2A, Prong Two, the memo states that examiners should identify the way in which additional elements use or interact with an exception to integrate the judicial exception into a practical application. The memo cautions that "the additional limitations should not be evaluated in a vacuum, completely separate from the recited judicial exception." Instead, the analysis should take into consideration all the claim limitations and how these limitations interact and impact each other when evaluating whether the exception is integrated into a practical application. In contrast to this guidance, the Office Action highlights most of the claim elements as additional elements. The Office Action argues that the claim elements are not integrated into a practical application other than an abstract idea per se. The Office Action then summarily concludes that the additional elements amount to no more than mere instructions to apply an exception and cannot provide an inventive concept. The Office Action is missing the analysis that is spelled out in the memo from August 4, 2025. Namely, 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. Merely underlying the claim elements and then making a subject matter eligibility conclusion is not a sufficient analysis. The memo emphasizes that a "rejection of a claim should not be made simply because an examiner is uncertain as to the claim's eligibility. In order to make a rejection of a claim under any of the statutory bases (i.e., 35 U.S.C. 101, 102, 103, 112), unpatentability must be established by a preponderance of the evidence." Here, the conclusory analysis provided in the Office Action does not establish the lack of a practical application or the integration of a judicial application into a practical application. Applicant respectfully submits that a preponderance of the evidence has not been provided in the Office Action to justify the rejection. For at least this reason, present Claims 1-5 and 16-20 are patentable;
(2) Applicant respectfully submits that the claims are directed to a technical improvement. Currently amended independent Claims 1 and 16 recite a technology-based solution that, when the claim elements are combined, provides for improved patient care by the collection of ECG data over long periods of time, which can be difficult and costly. Additionally, currently amended Independent Claims 1 and 16 further recite pre-processing the captured ECG data with a microcontroller housed within a housing included in the ECG monitor. Pre-processing ECG data on the ECG monitor is a technical improvement. This pre-processing provides for improved computer efficiency with respect to processing the ECG data because the data is already pre-processed before being transmitted to a server for further processing. By sharing the data processing load between the ECG monitor's microcontroller and the server, power consumption and memory usage across both the ECG monitor and server is improved. The unique process of continuous ECG data gathering, pre-processing, and transmission to a server for further processing improves computer efficiency with respect to processing ECG data, thereby improving patient care which provides a technology-based solution. In view thereof, currently amended independent Claims 1 and 16 recite an improvement in technology, as defined in MPEP Chapter 2105.05(a). Accordingly, under Step 2B of the Alice test, currently amended independent Claims 1 and 16 and dependent Claims 2-5 and 17-20 recite statutory subject matter;
(3) Claims 1 and 16 disclose that the ECG monitor includes a housing configured to house a memory and a microcontroller. Support for amended Claims 1 and 16 can be found in U.S. Patent No. 9,345,414, the disclosure of which is incorporated by reference, and specifically in at least FIG. 9 and col. 12, Ins. 9-19. Respectfully, the cited art fails to teach or suggest an ECG monitor including a housing configured to house a memory and a microcontroller. Applicant submits that the references of Nakajima and Saripalli are not cited for the newly added claim features as identified above, nor do these references disclose the ECG monitor including a housing configured to house a memory and a microcontroller in non-cited portions. Thus, for at least these reasons, Applicant respectfully submits that currently amended independent Claims 1 and 16 are patentably distinguished from the cited prior art and are currently in condition for allowance. Therefore, Applicant respectfully requests withdrawal of the present rejections of independent Claims 1 and 16. Additionally, Applicant respectfully submits that Claims 2-5 and 17-20, which depend from independent Claims 1 and 16, are also allowable.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the claimed limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer component, encompass managing interactions between people (including following rules or instructions), which is a subgrouping of Certain Methods of Organizing Human Activity. The Examiner maintains that independent claim 1’s additional elements of “the ECG monitor including a housing configured to house a memory and a microcontroller” and “a server” recite generic computer components and are merely instructions to implement an abstract idea on a computer, “via electrodes included in an ECG monitor” and “using the microcontroller” amount no more than generally linking the abstract idea to a particular technical environment and are also similar to adding the words “apply it” to the abstract idea, and “capturing electrocardiogram (ECG) data”, recites at a high degree of generality, amount no more than receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information). The Examiner does not acknowledge that most of the claim elements are additional elements as four steps (“dividing”, “assigning”, “transmitting”, “ordering”) are included in the abstract idea. The additional elements that do not integrate the abstract idea into a practical application makes up 34% of the overall claim language. The Examiner maintains that the judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer component programmed to perform the abstract idea along with generally linking the abstract idea to a particular technical environment and insignificant extra-solution data gathering activity. The Examiner maintains that the additional elements do not integrate the judicial exception into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the claims are similar to “iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48” (See MPEP 2106.05(a)(II)), which the courts have indicated may not be sufficient to show an improvement to technology. The Examiner does not acknowledge that the “pre-processing” by using the microcontroller does not show a clear technical improvement as the microcontroller is analyzing information using a conventional technique (data pre-processing is a crucial step in data analysis). The 35 U.S.C. 101 rejection(s) stand.
In response to argument (3), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Nakajima and Saripalli encompass the newly amended independent claims 1 and 16 as described above in the 35 U.S.C. 103 rejection(s). The 35 U.S.C. 103 rejection(s) stand.
Conclusion
Fujihashi et al. (U.S. Patent Pre-Grant Publication No. 2008/0243012), describes a data acquirer is operable to acquire electrocardiogram data, a data compressor is operable to compress the electrocardiogram data with either a wavelet transform, a Huffman coding, or an arithmetic coding, thereby generating compressed electrocardiogram data adapted to be transmitted to a remote receiver which is configured to reconstruct the electrocardiogram data.
Sato et al. (U.S. Patent Pre-Grant Publication No. 2009/0198475), describes an analysis sever capable of performing analysis among a large amount of sensor data in order to obtain an analysis result that a reader desires and outputting the result instantaneously.
Delano et al. (“A Long-Term Wearable Electrocardiogram Measurement System”), describes a low-power, wearable electrocardiogram (ECG) monitor for long-term data acquisition and analysis.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683