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 .
Response to Amendment
In the amendment filed on May 14, 2026, the following has occurred: claim(s) 1, 16 have been amended and claim(s) 2 have been canceled. Now, claim(s) 1, 3-5 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, 3-5 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, 3-5: Step 2A Prong One
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;
identify, based on the sample number, a time at which the ECG monitor fails to transmit the plurality of data blocks; and
determining, based on a lack of sample numbers for at least one expected data block, a loss of battery life in the ECG monitor
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, 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, a user following instructions to identify, based on the sample number, a time at which the ECG monitor has failed to transmit the plurality of data blocks, and a user following instructions to make a determination, based on a lack of sample numbers for at least one expected data block, a loss of battery life in the ECG monitor. 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 3-5 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 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, 3-5: 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, 3-5, 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”, “via 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 clock time, and wherein each of the plurality of data blocks includes a plurality of samples;
assigning a sample number to each one of the plurality of samples, 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 based on a clock time, 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, 3-5, and 16-20 are directed to an abstract idea without significantly more. Therefore claims 1, 3-5, 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 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 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 clock 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), and wherein each of the plurality of data blocks includes a plurality of samples (See Paragraphs [0148]-[0149]: The control unit may set the time width of the overlapping segment based on the sampling cycle of the sensor so that the overlapping segment includes a plurality of sample points for sampling the outputs of the sensor respectively, which the Examiner is interpreting a time width to encompass the plurality of data blocks, and interpreting a plurality of sample points to encompass a plurality of samples);
assigning a sample number to each one of the plurality of samples 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], [0148]-[0149]: 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 samples 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.)
Distinguishing Subject Matter
The following is a statement of reasons for the indication of distinguishing subject matter: Claims 1, 3-5 distinguish over the prior art. The closest prior art (Nakajima (U.S. Patent Pre-Grant Publication No. 2020/0397346), Saripalli et al. (U.S. Patent Pre-Grant Publication No. 2020/0337648), Soni et al. (U.S. Patent Pre-Grant Publication No. 2020/0342362)), describes a step of acquiring sensor data in which the outputs of a sensor are arrayed in time series; and a step for providing a plurality of labels to the acquired sensor data, the plurality of labels includes a first label and a second label, wherein the first label is provided to a first time segment, and the second label is provided to a second time segment that comes after the first time segment in the time series, combined with execute artificial intelligence model(s) trained on aggregated time series data to at least one of a) predict a future medical machine event, b) detect a medical machine event, or c) classify the medical machine event using the one-dimensional time series healthcare-related data; when the artificial intelligence model(s) are executed to predict the future medical machine event, output an alert related to the predicted future medical machine event to trigger a next action, combined with synthetic time series data generation apparatus is to generate a synthetic data set including multi-channel time-series data and associated annotation using a first artificial intelligence network model, and analyze the synthetic data set with respect to a real data set using a second artificial intelligence network model. However, the prior art does not describe the step of “determining, based on a lack of sample numbers for at least one expected data block, a loss of battery life in the ECG monitor”, the prior art does not describe capturing ECG data via electrodes, dividing the data into a plurality of data blocks, assigning a sample number to each of the plurality of the plurality of data blocks, to finally determine a loss of battery life in the ECG monitor based on a lack of sample numbers for at least one expected data block.
Response to Arguments
In the Remarks filed on May 14, 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. 103 rejection(s) concerning claims 1, 3-5. 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) concerning claims 16-20.
The Applicant argues that:
(1) in instant Claim 1, Applicant respectfully maintains that at least the above-quoted elements of Claim I show that the claim does not recite an abstract idea, even if abstract ideas are involved. For instance, the method organizes the data blocks by the time associated with the data blocks and the sample numbers assigned. The data blocks are transmitted from the ECG to a server where the ordering occurs. Even if, arguendo, the claim involves certain abstract ideas, the claim is not directed to the abstract idea. In the same way as the cited MPEP example, Claim I rearranges (organizes, in the instance of Claim 1), the data blocks at the server based on received input of the labels, which is a non-abstract act having observable effect;
(2) Applicant respectfully submits that the claimed elements of ''electrodes included in an ECG monitor'' recite specific architecture which is not abstract or at least integrates any abstract ideas involved into a practical application. For instance, the claims are not merely directed to ''a user following instructions to assign a sample number to each one of the plurality of data blocks''. Nor are the recited elements generic computer components, at the least because an ECG monitor (a claimed element including ECG electrodes) is not a generic computer. Rather, the claimed apparatus defines a specific data-capturing architecture for an ECG apparatus, wherein high-fidelity data are captured and labeled, transmitted to an external server, and processed to reconstruct a data set intelligible to a caregiver. The claims, when read as a whole, cannot be said to be directed to merely the labelling of information. Even beyond the fact that these operations cannot be performed by a human because they require continuous sampling, real-time device-side numbering, and server-side inference across thousands to millions of physiological samples, the claims provide a practical application and a technical improvement at least in how the method saves high-frequency medical device data in a way that maintains continuity despite the associated constraints on labeling the data with time when time frames are close together. Applicant respectfully notes that this further conclusory remark still fails to fulfill the requirements of the August 4, 2025 memo. A simple statement that these elements do not integrate the judicial exception into a practical application squarely contradicts the noted findings under MPEP 2106.04(a)(l) and is antithetical to the spirit of the August 4, 2025 memo. Further, the Office Action does not explicitly address the recitation of an ECG monitor, nor how such an element interacts with the claims as a whole. As noted above, an ECG monitor is not a ''generic'' computer component, it is a central technology to the disclosure. The claimed element of electrodes included in an ECG monitor is not ''generally linking the abstract idea to a particular technical environment'' (a conclusory statement antithetical to the August 4, 2025 memo), but rather shows that the claim, when viewed as a whole with the elements dealing with the data collected by such electrodes, is integrated into a practical application. Further yet, and as disclosed in further detail below, the claims when viewed as a whole disclose a technical improvement over conventional systems which are not optimized to maintaining proper timeline information in data packets which are captured at a same time or near a same time. Against this background, Applicant notes here that Director Squires more recently co-authored an Appeals Review Panel (ARP) decision. Ex parte Desjardins. The ARP decision overturned a PTAB decision that concluded certain claim terms related to artificial intelligence did not constitute statutory subject matter. Similar to the Office Action, the PTAB panel had found ''no additional element (or combination of elements) [in the claims] that may have integrated the judicial exception into a practical application." Id. The ARP decision cited the Federal Circuit's 2016 Enfish, LLC v. Microsoft Corp. decision, which recognized that technical improvements can be found solely in software. Id. Here, the ARP determined that such an improvement was recited by the claim and supported by the specification, explaining ''[w]e are persuaded that constitutes an improvement to how the machine learning model itself operates, and not, for example, the identified mathematical calculation." The Office Action directly contradicts the principle of Enfish that technical improvements can be found solely in software. Applicant has previously noted that the claimed features, especially when viewed as a whole, and even if they could be said to relate to a software, recite a technical improvement over conventional systems. As noted in previous Responses, Claims 1-5 and 16-20 recite an improvement in the effective time of ECG data as a tool for diagnosing cardiac arrhythmia patterns that only become apparent over an extended time frame, such as 30 minutes or longer. P. 1, ln. 28-p.3, ln. 7 of Applicant's Specification as filed highlight issues with prior art ECG systems failing to store data with enough resolution to enable a cardiac condition to be detected. Applicant maintains that the improvement over conventional systems is indicative of a technical improvement achieved by the methods as claimed. Applicant respectfully submits that no Office Action has properly addressed this argument in light of the above-noted ARP. Rather, the Office Actions have only made conclusory remarks stating that the claims do not concern a technical problem. Claim 16 recites equivalent subject matter to that discussed above in regards to Claim 1. Applicant respectfully submits that present independent Claims 1 and 16 recite non- abstract subject matter under either of Step 2A, Prong One or Prong Two of the Alice/Mayo test, and thereby overcome all of the rejections under 35 U.S.C. § 101. Dependent Claims 3-5 and 17-20 do not recite any features that change the analysis of independent Claims 1 and 16. Applicant submits that Claims 3-5 and 17-20 are allowable based at least on their dependence on an allowable base claim. Claim 2 has been canceled as a result of this Response and the separate rejection of Claim 2 under 35 U.S.C. § 101 is therefore obviated. Applicant respectfully requests that the rejection of Claims 1-5 and 16-20 under 35 U.S.C. § 101 be favorably reconsidered and withdrawn;
(3) Claim 1 has been amended herein, in part, to incorporate the subject matter of canceled Claim 2. Applicant respectfully submits that the cited portions of Nakajima, Saripalli, and Soni fail to disclose, teach, or suggest each of the features of the presently amended claims;
(4) Applicant respectfully submits that the cited portions of the references fail to teach or suggest each of the features of amended Claim 16. Nakajima at [0060]-[0061] and Saripalli at [0031], [0051], and [O182] were cited against the previous version of these portions of Claim 16. Office Action, 16-18. Claim 16 as currently amended clarifies that the data blocks are associated with a clock time, that each data block includes a plurality of samples, and that each of the samples is assigned a sample number. The instant Specification discloses that if relatively small blocks of data are being transmitted continuously, that associating each sample with a clock time is difficult when multiple samples are taken at a same time or near a same time. Specification as filed, p. 45, ln. 19-29. To remedy this, the claimed method utilizes clock time with the start of a data block and sample numbers for each of the samples included in the data blocks to reconstruct the timeline, which can be done based on the sample rate of the ECG monitor. See id at p. 45, ln. 19-p. 46, ln. 21. The cited portions of Nakajima and Saripalli, on the other hand, capture each time segment as a block labeled with the time it was taken (start time and end time in Nakajima and as a time series in Saripalli), as opposed to the claimed method of labelling samples with sample numbers which overcomes the problems disclosed with conventional systems when time frames are too close together. The cited portions of Nakajima and Saripalli therefore fail to teach or suggest each and every feature of amended Claim 16. The cited portions of Soni fail to remedy the shortcomings of Nakajima and Saripalli, having been cited for different reasons. 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. Additionally, Applicant respectfully submits that Claims 3-5 and 17-20, which depend from independent Claims 1 and 16, are also allowable at least for their dependency on an allowable base claim and for further patentably distinct features therein. Claim 2 has been canceled by this Response, obviating the separate rejection of this claim. Therefore, Applicant respectfully requests withdrawal of each of the rejections under 35 U.S.C. § 103.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner does not acknowledge that the Applicant’s claims are similar to Subject Matter Eligibility Example 37. The abstract idea of Example 37 is integrated into a practical application at Step 2A Prong Two by recited additional elements that recite a specific manner of automatically displaying icons to the user based on the which provides a specific improvement over prior systems, resulting in an improved user interface for electronic devices. The Applicant’s claims are not similar to Example 37’s claims as the plurality of data blocks are ordered based on the occurrence of the time at which the each one of the plurality of data blocks was captured, this ordering does not appear to recite a clear improvement as a timestamp would accomplish the task. 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 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 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 of the “via electrodes included in an ECG monitor” is recited at a level of generality that amounts to a device that acquires data and can communicate the data to another device, the ECG monitor is recited at a level of generality that amounts to generally linking the abstract idea to a particular technical environment. 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 find the decision of Ex parte Desjardins to be similar to the Applicant’s claims as the Applicant’s claims are not identifying an improvement to the generic computer components of the server, the microcontroller, or particular captured data. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (3), the Examiner has withdrawn the 35 U.S.C. 103 rejection(s) that were applied to claims 1-5 in the previous Office Action.
In response to argument (4), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Nakajima describes the newly amended claimed portions as Nakajima describes in Paragraphs [0148]-[0149] that “The control unit may set the time width of the overlapping segment based on the sampling cycle of the sensor so that the overlapping segment includes a plurality of sample points for sampling the outputs of the sensor respectively”. The Examiner maintains that Nakajima’s general disclosure of “time” encompasses the Applicant’s newly amended claim limitation of “clock time” as the outputs of a sensor are arranged in time series on the time axis (Paragraph [0012]). The 35 U.S.C. 103 rejection(s) stand.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
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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/Bennett Stephen Erickson/ Primary Examiner, Art Unit 3683
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