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 .
Election/Restrictions
Applicant's election with traverse of Group I, Claims 1-11, in the reply filed on 9 March 2026 is acknowledged. The traversal is on the ground(s) that the office failed to describe a materially different apparatus for practicing the method and a materially different process when distinguishing between groups I and II and I and III. This is not found persuasive because the MPEP does not require showing both – case law specifies “or”, and further the restriction indicated a materially different apparatus in the restriction dated 9 January 2026. With regard to groups II and III applicant asserts that the restriction fails to show a search burden; however, the restriction is clear in stating both the differences and further that the differences result in varying search classes/subclasses. Accordingly, the requirement is still deemed proper and is therefore made FINAL.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/group, there being no allowable generic or linking claim.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are determined to be directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1
The claimed inventions in claims 1-11 are directed to statutory subject matter as the claim(s) recite(s) a method and a system of detecting QRS complexes in an ECG signal.
Step 2A, Prong One
Claim 1 recites the following steps or instructions for “receiving electrocardiogram data…”, “identifying an abnormality…”, “ordering the set of lead rhythm graphs..”, and “outputting for display a subset of lead rhythm graphs…”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III). These limitations concern data collection, data analysis and recording the results of data analysis which could be done mentally or by hand with pen and paper. For example, these limitations are nothing more than a medical professional receiving a pre-recorded or ECG data and lead rhythm graphs on paper, identifying abnormalities, ordering the graphs based on a set criterion, and providing an output of the result of the identification and analysis.
Accordingly, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
In addition, Claim 1 recites additional elements of a display device of a mobile device.
Step 2A, Prong Two
The above-identified abstract idea in independent Claim 1 (and respective dependent claims 2-11) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements (identified above in independent Claim 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) and appear to be extra solution activity where data to be analyzed by the abstract idea is acquired or obtained.
More specifically, the additional elements of: a display device of a mobile device, is a generically recited computer element in independent Claim 1 (and respective dependent claims) which does not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claim 1 (and its respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g. display device of a mobile device, as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and the respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claim 1 (and the respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2B
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons:
The claim requires the additional elements of: a display device of a mobile device.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Additionally, the claimed “a display device of a mobile device” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for a display device of a mobile device. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
The recitation of the above-identified additional limitations in Claim 1 and the respective dependent claims, amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method of claims 1-11 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1 and the respective dependent claims, do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
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 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 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spencer et al. (US 2021/0007621; hereinafter “Spencer”).
Regarding claim 1, Spencer teaches a method, comprising: receiving electrocardiogram (ECG) data, including a set of lead rhythm graphs (e.g. ¶¶ 36, 116, etc.; Figs. 1-10 – the 12.5 sec Rhythm strips are considered the lead rhythm graphs); identifying an abnormality in one or more lead rhythm graphs of the set of lead rhythm graphs (e.g. ¶¶ 63-66 – “onset of the atrial fibrillation episodes is rapid…confirmed by ‘zooming in’ on the onset point of the atrial fibrillation and obtaining the ECG trace associated with the beginning of the fibrillation episode, as shown in the rhythm strip”); ordering the set of lead rhythm graphs based on the abnormality to form an ordered set of lead rhythm graphs, such that a first lead rhythm graph of the ordered set of lead rhythm graphs includes a first waveform which includes the abnormality (e.g. ¶¶ 104, 107-109 - “a stored template could be second cardiac data corresponding to an episode of atrial fibrillation, which again may be from the same or a different subject, or could be artificially generated. Similarity of any portion of the second cardiac data to this template would indicate that the portion should be categorised accordingly. Multiple templates could be stored, corresponding to different rhythmic categories.”); and outputting for display a subset of lead rhythm graphs of the ordered set of lead rhythm graphs to a display device of a mobile device (e.g. ¶¶ 101 – ‘smartphone’), wherein the subset of lead rhythm graphs includes at least the first lead rhythm graph (e.g. ¶¶ 116 – “This information can then be provided to a user of the system in conjunction with the R-R plots and/or ECG data gathered at the same time. In this way, when a user zooms in on a particular time point, all available data can be reviewed, potentially including: ECG waves (such as recorded by 1-12 Lead ECG); pulse waves (from single or multiple locations); central blood pressure, and any other data”).
Regarding claim 2, Spencer discloses the ECG data further includes a set of analysis results generated by an analysis of the set of lead rhythm graphs, wherein the analysis of the set of lead rhythm graphs includes comparing ECG data of the set of lead rhythm graphs to nominal ECG waveforms, identifying discrepancies among compared ECG data and nominal ECG waveforms as abnormalities, and indicating one or more identified abnormalities in the ECG data of the set of lead rhythm graphs, and outputting the set of analysis results, the set of analysis results including indication of the abnormality (e.g. ¶¶ 106-107 – “compared to a standard profile of a ‘normal’ heart rhythm”; “categorised into one or more rhythmic categories by comparing to stored templates corresponding to said categories”).
Regarding claim 3, Spencer discloses ordering the set of lead rhythm graphs based on the abnormality further includes positioning a second lead rhythm graph directly after the first lead rhythm graph in the ordered set of lead rhythm graphs, wherein the second lead rhythm graph includes a second waveform that also includes the abnormality included in the first waveform (e.g. ¶¶ 107-109 – where the plurality of lead rhythm graph ECGs are stored in the categories continuously and consecutively).
Regarding claim 4, Spencer discloses in response to receiving a first user input, outputting for display the second lead rhythm graph and not outputting the first lead rhythm graph (e.g. ¶¶ 56 – “display plots produced are intended to be interactive, such that the pertinent information may be selected with ease by a user of the invention”).
Regarding claim 5, Spencer discloses in response to receiving a first user input, outputting for display a lead rhythm graph of the ordered set of lead rhythm graphs which directly follows the lead rhythm graph in the ordered set of lead rhythm graphs which is being displayed prior to receiving the first user input, and not displaying the lead rhythm graph being displayed prior to receiving the first user input (e.g. ¶¶ 56 – “display plots produced are intended to be interactive, such that the pertinent information may be selected with ease by a user of the invention”).
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claims 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Spencer in view of Soosalu et al. (US 2019/0125278; hereinafter “Soosalu”).
Regarding claim 6, Spencer fails to expressly disclose the first user input is a swipe from a left side of the display device to a right side of the display device. The use of swipes as inputs is common in the art of mobile devices with touchscreens. In the same field of endeavor, Soosalu discloses the use of swipes in first and second directions (left to right and right to left) in order to provide inputs for controlling the data on the display (e.g. ¶¶ 91). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of swiping from a left side of the display device to a right side of the display device, as taught by Soosalu, to improve the similar device of Spencer, in the same way by controlling the data displayed on the mobile phone easily and through well known gestures.
Regarding claim 7, Spencer indicates that the interface for controlling the graphical data is interactive and selectable (¶¶ 56); however, it is unclear whether in response to receiving a second user input, outputting for display a lead rhythm graph of the ordered set of lead rhythm graphs which directly precedes the lead rhythm graph in the ordered set of lead rhythm graphs which is being displayed prior to receiving the second user input, and not displaying the lead rhythm graph being displayed prior to receiving the second user input. The examiner notes it would have been obvious to one of ordinary skill in the art, to control specific display plots, as is shown in Figs. 1-10, as that would be an obvious and expected interactive and selectable feature for any user interface.
Regarding claims 8 and 10, Spencer indicates that the interface for controlling the graphical data is interactive and selectable (¶¶ 56); however, it is unclear when receiving a third user input, when a single lead rhythm graph of the ordered set of lead rhythm graphs is displayed, whether the prior art outputs for displaying or not displaying an array of two or more lead rhythm graphs of the ordered set of lead rhythm graphs, wherein the array displays each lead rhythm graph of the ordered set of lead rhythm graph simultaneously. The examiner notes it would have been obvious to one of ordinary skill in the art, to control specific display plots to have an ordered set of graphs simultaneously, as simply displaying more than one graph would be recognized as a feature that any display in the art would be capable of.
Regarding claim 9, Spencer fails to expressly disclose the third user input is a tap on the display device. In the same field of endeavor, Soosalu discloses the use of user in put taps in order to control how data is displayed on the display (e.g. ¶¶ 49-50). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of tapping on the display device, as taught by Soosalu, to improve the similar device of Spencer, in the same way to control how the data displayed on the mobile phone easily and through well known gestures.
Regarding claim 11, Spencer fails to expressly disclose identifying an orientation of the display device and outputting for display on the display device the subset of lead rhythm graphs, such that a time axis of each lead rhythm graph of the subset of lead rhythm graphs is parallel to a horizontal width of the display device. In the same field of endeavor, Soosalu teaches the identification of the orientation of the mobile phone device and based off that controlling the horizontal and vertical axes (e.g. ¶¶ 70-71, 90, etc.) in order to effectively display the data. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of adjusting graphical axes based on the device orientation, as taught by Soosalu, to improve the similar device of Spencer, in the same way by improving the data display for review.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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