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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Following is an analysis of subject matter eligibility according to MPEP 2106:
Step 1:
Independent claims 1 and 13 recite at least one step or act of accessing data, and thus the claim is directed to a process, which is one of the statutory categories of invention.
Step 2A Prong 1:
Claim 1 recites the following limitations:
after receiving a package of data comprising strips of electrocardiogram (ECG) data and metadata, which includes an initial maximum heart rate of the patient study;
display on the user interface at least some of the strips of ECG data, including a first strip of ECG data associated with the initial maximum heart rate and a second strip of ECG data; receive a user selection of the second strip, the second strip of ECG data associated with a lower maximum heart rate;
and override the initial maximum heart rate in response to the user selection.
Claim 13 recites the following limitations:
receiving a package of data comprising strips of electrocardiogram (ECG) data and metadata, the metadata including an initial maximum heart rate of the patient study;
displaying, on a user interface, at least some of the strips of ECG data, including a strip of ECG data associated with the initial maximum heart rate;
and overriding the initial maximum heart rate in response to selecting a strip of ECG data associated a lower maximum heart rate.
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind, i.e., using pen and paper. A human could receive and reasonably evaluate and/or compare two sets of data (i.e. “strips of ECG data”) with a “first strip has an initial maximum heart rate” and an additional or second strip has a “lower maximum heart rate” that is selected to override the “initial maximum heart rate”.
This concept aligns with MPEP 2106.04(a)(2). Mental process where claims reciting: “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)”, were determined to comprise “a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions.” Thus, the present claims recite limitations which fall within the 'mental processes’ grouping of abstract ideas. For example, these limitations are nothing more than receiving a ECG strip, reviewing the data of the strip to identify an initial maximum heart rate, then selecting the a secondary or additional strip of ECG data with a lower maximum heart rate.
Step 2A Prong 2:
The judicial exception is not integrated into a practical application.
Claim 1 recites the following limitations:
a remote computing system comprising: a user interface, one or more processors, and computer-readable media having computer-executable instructions embodied thereon;
display on the user interface at least some of the strips of ECG data
receive a user selection of the second strip, the second strip of ECG data associated with a lower maximum heart rate;
and override the initial maximum heart rate in response to the user selection.
Claim 13 recites the following limitations:
displaying, on a user interface, at least some of the strips of ECG data, including a strip of ECG data associated with the initial maximum heart rate;
and overriding the initial maximum heart rate in response to selecting a strip of ECG data associated a lower maximum heart rate.
The “display on the user interface” amount to nothing more than the pre-solution activity of data gathering. The display and “a remote computing system comprising: a user interface, one or more processors, and computer-readable media having computer-executable instructions embodied thereon” are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
The limitations of “evaluating” data and “recommending or implementing” an updated data set comprise method steps that are merely implementation of a method on a generic system, such as a processor. The implementation of a mental process on a generic computer (in this case, displaying on a user interface data is performed, one can readily ascertain how the mentally determine “electing a strip of ECG data associated a lower maximum heart rate”) provide no improvement to the functioning of a computer system as known in the medical art, thus as noted in MPEP 2106.05(a) the limitations do not amount to an improvement in the functioning of a computer. Similarly, these limitations comprises well-understood, routine and conventional activity with a processor, where it is common to have computer devices receive, evaluate and make “recommendations” or “implement” a change based on the data. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application. Accordingly, even in combination, the additional element noted above (display and processor) do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claim does 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 a user interface, display and processor(s) amount to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. The additional elements recited above are well known in the field of electronics and medical devices. Moreover, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, is discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984. See MPEP § 2106.05(d).
There is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a); Or applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). Thus, the limitations of updating data, by a processor in a closed-loop manner (without human intervention) is considered executing a mental process by using a generic computer component (processor). As discussed with respect to Step 2A Prong Two, the additional element in the claim are mere instructions to apply the exception using a generic computer component (processor). The same analysis applies here in 2B and does not provide an inventive concept.
Dependent claims:
Claims 2-12 and 14-20 are dependent claims that further limit the method into steps relating to monitoring and revising the data through a mental process. Accordingly, these claims do not integrate the abstract idea into a practical application for similar reason to claims 1 and 13. These limitations comprise well-understood, routine and conventional activity in electronics and medical diagnostic and treatment devices, where it is common to have computer devices evaluate and present data. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 6-8, 13-14, 16-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MacIver et al. (US 20210401316 A1).
As to claim 1, MacIver et al. discloses a remote computing system comprising: a user interface (graphical user interface, GUI; Abstract, [0008, 0014-0017, 0099]), one or more processors ([0008, 0030]), and computer-readable media having computer-executable instructions embodied thereon ([0008, 0030]), the instructions configured to be executed to cause the remote computing system to: after receiving a package of data comprising strips of electrocardiogram (ECG) data and metadata (Figures 2A-3; [0030-0033, 0099-0100]), which includes an initial maximum heart rate of the patient study ([0099]; Figure 2A): display on the user interface at least some of the strips of ECG data ([0099]; Figure 2A), including a first strip of ECG data associated with the initial maximum heart rate and a second strip of ECG data ([0099, 0106-0115]; Figure 2A); receive a user selection of the second strip, the second strip of ECG data associated with a lower maximum heart rate ([0099, 0106-0127, 0133]; Figure 2A-3; “the module 140 further enables the user to manually re-shift or reposition (on the GUI) the automatically established end point of analysis, to a different position, if the user does not agree with the automatically determined end point of analysis. To do so, in some embodiments, the user can click on and select the end point of analysis highlighted on the ECG waveform, in the GUI, and drag the selected end point of analysis to the different position/point on the ECG waveform” [0157]. Therefore, as seen in Figures 2A-3, the Max HR can be determined through the selected data strip. As such, the user can adjust the “second strip of ECG data to be associated with a lower maximum heart rate”, see Figure 3); and override the initial maximum heart rate in response to the user selection (Figure 3, [0157] Figures 2A-2B; adjusting the ECG segment used to determine the maximum heart rate will alter the data used to calculation the maximum heart rate and thus “override” the initial maximum heart rate determination).
As to claim 3, MacIver et al. discloses the overriding includes inserting a noisy signal flag into the strip of ECG data associated with the initial maximum heart rate ([0096]).
As to claim 6, MacIver et al. discloses the metadata includes an initial minimum heart rate ([0099]; Figure 2A-2B), wherein the instructions are configured to be executed by the one or more processors ([0099]) to cause the remote computing system to: override the initial minimum heart rate in response to selecting a strip of ECG data comprising a higher minimum heart rate (“the module 140 further enables the user to manually re-shift or reposition (on the GUI) the automatically established end point of analysis, to a different position, if the user does not agree with the automatically determined end point of analysis. To do so, in some embodiments, the user can click on and select the end point of analysis highlighted on the ECG waveform, in the GUI, and drag the selected end point of analysis to the different position/point on the ECG waveform” [0157]. Therefore, as seen in Figures 2A-3, the Min HR can be determined through the selected data strip. As such, the user can adjust the strip of ECG data to be associated with a higher minimum heart rate, see Figure 3. And as such, adjusting the ECG segment used to determine the minimum heart rate will alter the data used to calculation the minimum heart rate and thus “override” the initial minimum heart rate determination).
As to claim 7, MacIver et al. discloses the initial maximum heart rate and the lower maximum heart rate are heart rates calculated during respective most acute sections of the ECG data ([0099]; Figure 2A-2B).
As to claim 8, MacIver et al. discloses the heart rates are average heart rates of the most acute sections ([0099]; Figure 2A-2B).
As to claim 13, MacIver et al. discloses receiving a package of data comprising strips of electrocardiogram (ECG) data and metadata (Figures 2A-2B), the metadata including an initial maximum heart rate of the patient study ([0099]; Figure 2A-2B); displaying, on a user interface (graphical user interface, GUI; Abstract, [0008, 0014-0017, 0099]), at least some of the strips of ECG data (Figures 2A-3; [0030-0033, 0099-0100]), including a strip of ECG data associated with the initial maximum heart rate (Figures 2A-2B; [0099]); and overriding the initial maximum heart rate in response to selecting a strip of ECG data associated a lower maximum heart rate (“the module 140 further enables the user to manually re-shift or reposition (on the GUI) the automatically established end point of analysis, to a different position, if the user does not agree with the automatically determined end point of analysis. To do so, in some embodiments, the user can click on and select the end point of analysis highlighted on the ECG waveform, in the GUI, and drag the selected end point of analysis to the different position/point on the ECG waveform” [0157]. Therefore, as seen in Figures 2A-3, the Max HR can be determined through the selected data strip. As such, the user can adjust the strip of ECG data to be associated with a lower maximum heart rate, see Figure 3, by adjusting the ECG segment used to determine the maximum heart rate. Adjusting the segments will alter the data used to calculation the maximum heart rate and thus “override” the initial maximum heart rate determination).
As to claim 14, MacIver et al. discloses in Figures 2A-3, the Max HR can be determined through the selected data strip. As such, the user can adjust the strip of ECG data to be associated with a lower maximum heart rate, see Figure 3, by adjusting the ECG segments used to determine the maximum heart rate. Adjusting the segments used will alter the data used to calculation the maximum heart rate and thus “override” the initial maximum heart rate determination. Therefore, MacIver et al. discloses “the overriding the initial maximum heart rate is performed in response to: receiving, via the user interface, a user selection of the strip of ECG data comprising the lower maximum heart rate”.
As to claim 16, MacIver et al. discloses the metadata includes an initial minimum heart rate ([0099]; Figure 2A-2B), and to override the initial minimum heart rate in response to selecting a strip of ECG data comprising a higher minimum heart rate (“the module 140 further enables the user to manually re-shift or reposition (on the GUI) the automatically established end point of analysis, to a different position, if the user does not agree with the automatically determined end point of analysis. To do so, in some embodiments, the user can click on and select the end point of analysis highlighted on the ECG waveform, in the GUI, and drag the selected end point of analysis to the different position/point on the ECG waveform” [0157]. Therefore, as seen in Figures 2A-3, the Min HR can be determined through the selected data strip. As such, the user can adjust the strip of ECG data to be associated with a higher minimum heart rate, see Figure 3. And as such, adjusting the ECG segment used to determine the minimum heart rate will alter the data used to calculation the minimum heart rate and thus “override” the initial minimum heart rate determination).
As to claim 17, MacIver et al. discloses the initial maximum heart rate and the lower maximum heart rate are heart rates calculated during respective most acute sections of the ECG data ([0099]; Figures 2A-3).
As to claim 18, MacIver et al. discloses the respective most acute sections comprise no more than 10 seconds of the ECG data (Figures 2A-2B).
As to claim 20, MacIver et al. discloses the heart rates are average heart rates of the most acute sections (Figures 2A-2B).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 4-5, 9, 12, 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over MacIver et al. (US 20210401316 A1).
As to claim 2, MacIver et al. discloses the invention substantially as claimed with employing a strip of ECG data associated with the initial maximum heart rate ([0096]) but does not explicitly disclose “the strip of the ECG data associated with the initial maximum heart rate is associated with a noisier signal than the strip of ECG data comprising the lower maximum heart rate”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to filter and modify the data used to determine the heart rate data in order to provide the predictable results of optimizing the parameter determinations to meet specific patient therapeutic needs and requirements. Furthermore, it is extremely well known in the medical device arts to filter noise from data.
As to claim 4, MacIver et al. discloses the invention substantially as claimed with employing a strip of ECG data associated with the initial maximum heart rate ([0096]) but does not explicitly disclose “the noisy signal flag causes the strip of ECG data associated with the initial maximum heart rate to be removed as a candidate for containing a maximum heart rate”. It is extremely well known in the medical device arts to filter noise from collected data signals and exclude noisy signal data. As such, it would have been obvious to one having ordinary skill in the art at the time the invention was made to filter and modify the data used to determine the heart rate data in order to provide the predictable results of optimizing the parameter determinations to meet specific patient therapeutic needs and requirements.
As to claims 5 and 15, MacIver et al. discloses the invention substantially as claimed with the override the initial maximum heart rate but does not explicitly disclose “overriding all calculated maximum heart rates that are greater than the lower maximum heart rate”. However, modifying data with a threshold value, such as the threshold of “lower maximum heart rate” and disregarding data that is outside the threshold, is extremely well known in data computations. As such, it would have been obvious to one having ordinary skill in the art at the time the invention was made to filter and modify the data used to determine the heart rate data in order to provide the predictable results of optimizing the parameter determinations to meet specific patient therapeutic needs and requirements.
As to claims 9 and 19, MacIver et al. discloses the invention substantially as claimed with the respective most acute sections comprising no more than 10 seconds of ECG data (Figures 2A-2B) and selecting a number of beats (Figure 2A-2B), but does not explicitly disclose “no more than 6 beats within the ECG data”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the beat number data used to determine the heart rate data in order to provide the predictable results of optimizing the parameter determinations to meet specific patient therapeutic needs and requirements.
As to claim 12, MacIver et al. discloses the invention substantially as claimed with employing a strip of ECG data associated with the initial maximum heart rate ([0096]) but does not explicitly disclose “exclude the strips of ECG data associated with a noisy signal as a candidate for containing a maximum heart rate”. It is extremely well known in the medical device arts to filter noise from collected data signals and exclude noisy signal data. As such, it would have been obvious to one having ordinary skill in the art at the time the invention was made to filter and modify the data used to determine the heart rate data in order to provide the predictable results of optimizing the parameter determinations to meet specific patient therapeutic needs and requirements.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over MacIver et al. (US 20210401316 A1) in view of Bardy et al. (US 20190357794 A1).
MacIver et al. discloses the invention substantially as claimed but does not explicitly disclose wireless communications with a “web browser” or a server for “a first set of instructions are part of the package of data received from a server”. Bardy et al. discloses a network with a web browser ([0086-0090]; Figure 14) and a server ([0079-0081]; Figure 14) for providing wireless communication and transmission of ECG data. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the communications and transmission of ECG data in MacIver et al. with the wireless network with a web browser and server as disclosed by Bardy et al. in order to provide the predictable results of providing ECG monitoring in an ambulatory patient (Figure 14). Additionally, wireless transmission of diagnostic data to a server or clinician at remote location is extremely well known in the medical device arts.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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