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 Arguments
Applicant's arguments filed July 8, 2026 have been fully considered but they are not persuasive.
Applicant argues “that there is no human or pen-and-paper analog to the above-recited claim features and the claim combination of features. Moreover, the claims provide a technical solution to a technical problem”(page 6 of Remarks). However, this is not found to be persuasive.
The claimed subject matter is still directed towards concepts that can be practically performed in the human mind or 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”. As such, the claims remain rejected under 35 U.S.C. 101 as detailed below.
Additionally the Applicant argues that ”mere adjustment of a boundary of a segment of ECG is plainly not a selection of a second strip of ECG as claimed and clearly does not automatically result in overriding an initial maximum heart rate” (page 6 of Remarks). However, the examiner respectfully disagrees. MacIver et al. discloses “In various embodiments, the first duration may be up to 30 days. In one embodiment, as an example, the HR range 214 being displayed corresponds to a period of 7 days. The HR range 214 is followed by a textual portion 215 that provides auto-generated notes such as, for example, maximum and minimum heart rates as well as the date and time of occurrence of the maximum and minimum heart rates. The user may select a checkbox 216 to enable printing of the textual portion 215 which may include printed strips of the maximum and/or minimum heart rates, for example” ([0099]). Thus strip(s) of ECG data can be displayed and printed whereby the selection of data sets enables “automatically overriding the initial maximum heart rate in response to the user selection” but removing the first strip as a “candidate” and selecting an alternative data set or second strip.
Therefore, for the reasons stated above and previously made of record, the claims remain rejected under MacIver et al. as further detailed below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 5-9, 11-15, 17-18 and 21-24 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 display on the user interface at least some of the strips of ECG data,
wherein the strips displayed include a first strip and a second strip of ECG data, wherein the first strip is associated with an initial maximum heart rate of a patient study, wherein the second strip is associated with a lower maximum heart rate than the initial maximum heart rate;
receive, via a user interface, a user selection of the second strip; and
automatically override the initial maximum heart rate in response to the user selection by associating the first strip with metadata that removes the first strip as a candidate for containing a maximum heart rate.
Claim 13 recites the following limitations:
receiving a package of data comprising strips of electrocardiogram (ECG) data;
displaying, on a 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 associated with a lower maximum heart rate than the initial maximum heart rate; and
in response to a selection of the second strip, automatically overriding the initial maximum heart rate by associating the first strip with metadata that removes the first strip as a candidate for containing a 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;
displaying, on a user interface, at least some of the strips of ECG data,
receive, via a user interface, a user selection of the second strip;
and automatically override the initial maximum heart rate in response to the user selection by associating the first strip whin metadata that removes the first strip as a candidate for containing a maximum heart rate.
Claim 13 recites the following limitations:
displaying, on a 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 associated with a lower maximum heart rate than the initial maximum heart rate; and
in response to a selection of the second strip, automatically overriding the initial maximum heart rate by associating the first strip with metadata that removes the first strip as a candidate for containing a 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 3, 5-9, 11-12, 14-15, 17-18 and 21-24 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 reasons 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 comprise integration of the mental process into practical application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 recites “associating the metadata for any of the strips with calculated maximum heart rates that are greater than the lower maximum heart rate.” However, claim 1 only recites a first strip as containing a maximum heart rate and “and automatically override the initial maximum heart rate in response to the user selection by associating the first strip with metadata that removes the first strip as a candidate for containing a maximum heart rate”. Therefore, since claim 5 depends from claim 1, claim 5 fails to further limit claim 1 since “any of the strips” recited in claim 5 only refers to the “first strip” as recited in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 3, 5-9, 13-14, 17-18 and 21-24 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 (Figures 2A-3; [0030-0033, 0099-0100]), display on the user interface at least some of the strips of ECG data ([0099]; Figure 2A), wherein the strips displayed include a first strip and second strip of ECG data ([0099, 0106-0115]; Figure 2A), wherein the first strip is associated with an initial maximum heart rate of a patient study ([0099]; Figure 2A), wherein the second strip is 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) than the initial maximum heart rate; receive, via the user interface, a user selection of the second strip ([0099]); and automatically 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) by associating the first strip with metadata that removes the first strip as a candidate for containing a maximum heart rate (“The HR range 214 is followed by a textual portion 215 that provides auto-generated notes such as, for example, maximum and minimum heart rates as well as the date and time of occurrence of the maximum and minimum heart rates. The user may select a checkbox 216 to enable printing of the textual portion 215 which may include printed strips of the maximum and/or minimum heart rates, for example”[0099]. Thus strips of ECG data can be selected, displayed and printed. Furthermore, the selection of data enables “automatically overriding the initial maximum heart rate in response to the user selection” but removing the first strip as a “candidate” and selecting an alternative data set or second strip).
As to claim 3, MacIver et al. discloses the metadata is a noisy signal flag ([0096]).
As to claim 3, MacIver et al. discloses the automatically override the initial maximum heart rate comprises associating the metadata for any of the strips (i.e. the first strip since the first strip has the initial maximum heart rate) with calculated maximum heart rates that are greater than the lower maximum heart rate [of the second strip] ([0099]).
As to claim 6, MacIver et al. wherein the instructions are configured to be executed by the one or more processors ([0099]) to cause the remote computing system to: automatically override an initial minimum heart rate in response to a selection, via the user interface of one of the strips 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 strips of ECG data ([0099]; Figure 2A-2B).
As to claim 8, MacIver et al. discloses the heart rates are average heart rates of the most respective acute sections ([0099]; Figure 2A-2B).
As to claim 9, 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 13, MacIver et al. discloses receiving a package of data comprising strips of electrocardiogram (ECG) data; 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 first strip of ECG data associated with the initial maximum heart rate (Figures 2A-2B; [0099]) and a second strip of ECG data associated with a lower maximum heart rate than the initial 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); and in response to selection of the second strip of ECG, automatically overriding the initial maximum heart rate by associating the first strip with metadata (Figures 2A-2B) that removes the first strip as a candidate for containing a maximum heart rate (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) by associating the first strip with metadata that removes the first strip as a candidate for containing a maximum heart rate (“The HR range 214 is followed by a textual portion 215 that provides auto-generated notes such as, for example, maximum and minimum heart rates as well as the date and time of occurrence of the maximum and minimum heart rates. The user may select a checkbox 216 to enable printing of the textual portion 215 which may include printed strips of the maximum and/or minimum heart rates, for example”[0099]. Thus strips of ECG data can be selected, displayed and printed. Furthermore, the selection of data enables “automatically overriding the initial maximum heart rate in response to the user selection” but removing the first strip as a “candidate” and selecting an alternative data set or second strip).
As to claim 14, MacIver et al. discloses wherein the selection is a user selection of the second strip via a user interface ([0099]).
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 21, MacIver et al. discloses displaying strips of data (Figures 2A-2B). Since the lower maximum heart rate from the second strip is then selected to override the initial maximum heart rate, the examiner considers, under the broadest reasonable interpretation, that MacIver et al. to disclose “displaying the strips of ECG in descending order based on calculated maximum heart rates”. Furthermore, since the first strip is the initial strip which includes the initial maximum heart rate, the first strip is “initially displayed” or displayed prior “above all other strips” (i.e. prior to the second strip).
As to claim 22, MacIver et al. discloses displaying a respective button adjacent to each of the strips (Figures 2A-2B), wherein the selection is made in response to a user selecting the button adjacent to the second strip (Figures 2A-2B).
As to claim 23, MacIver et al. discloses displaying strips of data (Figures 2A-2B). Since the lower maximum heart rate from the second strip is then selected to override the initial maximum heart rate, the examiner considers, under the broadest reasonable interpretation, that MacIver et al. to disclose “displaying the strips of ECG in descending order based on calculated maximum heart rates”. Furthermore, since the first strip is the initial strip which includes the initial maximum heart rate, the first strip is “initially displayed” or displayed prior “above all other strips” (i.e. prior to the second strip).
As to claim 24, MacIver et al. discloses displaying a respective button adjacent to each of the strips (Figures 2A-2B), wherein the selection is made in response to a user selecting the button adjacent to the second strip (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 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over MacIver et al. (US 20210401316 A1).
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.
As to claim 15, MacIver et al. discloses the invention substantially as claimed with the automatically override the initial maximum heart rate but does not explicitly disclose “automatically overriding all calculated maximum heart rates that are greater than the lower maximum heart rate by associating the metadata with any of the strips with the 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.
Claim 11 is 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
