The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Invention I in the reply filed on September 16, 2025 is acknowledged. Claims 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
The following claim limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (any paragraphs cited come from PGPUB 2023/0091676, representative of the specification of the instant application):
Claim 1
“An ECG grouping module configured to receive…”
This limitation utilizes the generic placeholder “module”, transitional phrase “configured to” and functional language “to receive the stored one or more episodes” and the last six (6) lines of claim 1. The preceding term “ECG grouping” does not apply specific structure that performs the function.
The specification states the following in paragraph 56: “As shown in FIG. 1, the processor 102 having the EGM 112 may be communicatively coupled with the various components (e.g., monitor electrodes 104). However, in one example, the EGM 112 may be included in a processor that may be communicatively coupled with the various components wirelessly.”
Therefore, the structure from the specification associated with this term is a processor, which may be the same processor as recited in line 4 of claim 1.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more, as exemplified by the following analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, claims 1-8 are directed to a system, which is a machine.
Step 2A, Prong 1: Does the claim recite an abstract idea, law of nature or natural phenomenon?
Yes, in claim 1, the abstract idea is a mental process, such that the following abstract idea can be performed in the mind or on pencil and paper, and relates to the following limitations:
Claim 1: (beginning at line 5) “… conduct an analysis of a plurality of electrocardiogram (ECG) signals from the received electrical signals from the person, the analysis to determine, from the analyzed plurality of ECG signals, that the plurality of ECG signals is indicative of an arrhythmia of a heart of the person; … (beginning at line 14) “analyze the one or more episodes to determine which of the one or more episodes meet at least one pattern matching, associate into a group the one or more episodes that meet at least one pattern matching criterion”
Claims 2-5 do not add additional abstract ideas or modify the abstract ideas identified above. They merely add more additional elements, see below.
Claims 6-8 further define the abstract idea, by providing specific aspects of the ECG signals that are used in the abstract idea (i.e., noise, acceleration and a QRS complex).
The MPEP states, with regard to Voter Verified, Inc. v. Election Systems & Software, LLC, 887 F.3d 1376, 1385, 126 USPQ2d 1498, 1504 (Fed. Cir. 2018), “In this case, the Federal Circuit relied upon the specification in explaining that the claimed steps of voting, verifying the vote, and submitting the vote for tabulation are "human cognitive actions" that humans have performed for hundreds of years” (see MPEP 2106.04(a)(2)(III)(C.1)). Similarly, cardiologists have for many years obtained ECG signals from patients and mentally analyzed these signals to determine if a patient is or has experienced an arrhythmia (see limitations of #2 above). Additionally, and with respect the EGM limitations, cardiologists have analyzed ECG signals and studied common “episodes” with those ECG signals to learn the patterns they might expect to see when performing their job of reading ECG signals for other patients. Cardiologists learn the patterns of ECG signals and what the many variations they could expect to see in such signals mean for the patient. This is how a cardiologist performs their job and has done this for decades.
Step 2A, Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The following limitations of claim 1 is recite additional elements:
“A plurality of electrodes…” as recited in lines 2-3;
“A processor communicatively coupled with the plurality of electrodes” where the processor is configured to perform the abstract idea identified above;
“a storage medium communicatively coupled to the processor…” configured to store data as indicated in lines 9-11;
“an ECG grouping module (EGM)”, which based on the invoking of 35 USC 112(f) is a processor and may be the same processor as recited earlier in claim 1, where the EGM is configured to perform the abstract idea identified above;
“cause the group to be displayed in response to a selection by a user involved with a medical treatment of the person.”
Regarding (1) above, the electrodes relate to pre-solution activity of data gathering, as these collect the ECG data necessary to perform the abstract idea.
Regarding (2) and (4) above, “the Federal Circuit has explained, "[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind." Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015)” (see MPEP 2106.04(a)(2)(III)). The instant claims and indicated limitations are nothing more than performing a mental process on a generic computer (see MPEP 2106.04(a)(2)(III)(C.1)) and/or using a computer as a tool to perform a mental process (see MPEP 2106.04(a)(2)(III)(C.3)). Similar to the analysis in Voter Verified, Inc. v. Election Systems & Software, LLC, 887 F.3d 1376, 1385, 126 USPQ2d 1498, 1504 (Fed. Cir. 2018) (“In this case, the Federal Circuit relied upon the specification in explaining that the claimed steps of voting, verifying the vote, and submitting the vote for tabulation are "human cognitive actions" that humans have performed for hundreds of years” - MPEP 2106.04(a)(2)(III)(C.1)), cardiologists have for many years obtained ECG signals from patients and mentally analyzed these signals to determine if a patient is or has experienced an arrhythmia (see limitations of #2 above). Additionally and with respect the EGM limitations, cardiologists have analyzed ECG signals and studied common “episodes” with those ECG signals to learn the patterns they might expect to see when performing their job of reading ECG signals for other patients. Cardiologists learn the patterns of ECG signals and what the many variations they could expect to see in such signals mean for the patient. This is how a cardiologist performs their job and has done this for decades.
Regarding (3) and (5) above, the storing and/or displaying of the results of the abstract idea are mere post-solution activity. For instance, this is similar to the analysis of the courts with respect to Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016) (see MPEP 2106.04(a)(2)(III)(A)- specifically with regard to displaying data after analysis) and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93 (see MPEP 2106.05(d)(II), specifically regarding “storing and retrieving information in memory”).
In claims 2-4, the same analysis as described above for (2) and (4) applies, as these claims simply define a personal communication device and a server for performing the functions of the EGM.
In claim 5, the same analysis as described above for (1) applies, as the generic name of “wearable cardioverter defibrillator (WCD)” implies electrodes.
Based on the above, there is no additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The discussion claim 1 is above in Step 2A, Prong II of the various additional elements is incorporated herein by reference in its entirety.
In addition to the analysis in Step 2A, Prong II above, it is noted that the specific use of a plurality of electrodes adapted to be in contact with a person and to receive electrical signals from a person is well-understood, routine and conventional in the art, as evidence by Anderson et al. (US Patent No. 4,336,810), which states “It is well known to place electrodes on the patient's skin to sense the ECG signals and to present them for visual analysis either in real time or at a subsequent time for use by a physician or other trained personnel” (see column 1, lines 17-21).
In claims 2-5, the use of a personal communication device being used for analysis of ECG signals is well-known in the art, as evidence by Lange (US Patent Pub. No. 2017/0258406), which states “The components provided in the computer system 600 of FIG. 6 are those typically found in computer systems that may be suitable for use with embodiments of the present disclosure and are intended to represent a broad category of such computer components that are well known in the art. Thus, the computer system 500 can be a personal computer, handheld computing system, telephone, mobile computing system, workstation, tablet, phablet, mobile phone, server, minicomputer, mainframe computer, or any other computing system” (see paragraph 67, emphasis added).
Therefore, the additional elements do not amount to significantly more than the judicial exception.
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.
Claims 1 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Voith (US Patent Pub. No. 2002/0188211) in view of Conley et al. (US Patent No. 6,415,175).
Voith discloses a method and apparatus for processing physiological data (see Abstract). Particularly, Voith teaches a clinical device 12 (see Figure 1). The clinical device 12 comprises:
a plurality of electrodes, the plurality of electrodes adapted to be in contact with a person using the clinical system and to receive electrical signals from the person (see paragraph 28, “The clinical device 12 is connected to a plurality of electrodes 14 attached to a patient 10 to acquire ECG data from the patient 10” and since they are “attached to a patient”, they are wearable);
a processor communicatively coupled to the plurality of electrodes (see paragraph 29, “The clinical device 12 includes an acquisition module 18 coupled to the plurality of electrodes 14… and software 20 coupled to the acquisition module 18”; it is obvious that “software 20” would be stored in memory and run via a processor), the processor configured to conduct an analysis of a plurality of electrocardiogram (ECG) signals from the received electrical signals from the person (see paragraph 29, “The software 20 includes an ECG classification engine 22”; see paragraph 37, “once the ECG data … are divided 114 into segments, the ECG data segments 112 are analyzed 116”), the analysis to determine, from the analyzed plurality of ECG signals, that the plurality of ECG signals is indicative of an arrhythmia of a heart of the person (see paragraph 37, “the ECG data segments 112 are analyzed 116 in order to identify the ECG data segments 112 that are associated with atypical cardiac cycles… The term "atypical" is used to refer to any data segment having a morphology that differs from most of the other data segments. An atypical cardiac cycle may be considered a normal cardiac cycle, i.e. a cardiac cycle may differ from other cardiac cycles, but may not be related to a cardiac disease, malfunction, or abnormality. Several types of normal cardiac cycles may exist within a stream of ECG waveform data. However, each of these normal cardiac cycles differs from the typical cardiac cycles and is thus considered atypical. Cardiac cycles associated with abnormal cardiac cycles are referred to as ectopic or aberrant heart beats”);
a storage medium communicatively coupled with the processor (see paragraph 49, “The data segments may be separated by placing each classification category of data segments into separate memory locations accessible by the software”), the storage medium configured to store one or more episodes comprising the plurality of ECG signals determined to be indicative of an arrhythmia (see the same portion of paragraph 49, which indicates that the different data segments are stored in locations based upon their classification category, which would indicate “one or more episodes” being stored and including the ones that are indicative of an arrythmia); and
an ECG grouping module (EGM) configured to receive the stored one or more episodes (see “ECG Classification engine 22” in Figure 1, the EGM configured to:
analyze the one or more episodes to determine which of the one or more episodes meet at least one pattern matching criterion (see paragraph 38, which states “In order to identify 116 the ECG data segments 112 associated with atypical cardiac cycles, each of the ECG data segments 112 is compared to each one of a plurality of templates stored within the ECG classification engine… To compare an ECG data segment 112 with a stored template, each sample of the ECG data segment 112 is compared with each sample of the template to determine if the ECG data segment 112 is substantially similar to the template”),
associate into a group the one or more episodes that meet at least one pattern matching criterion (see paragraph 39, “If the ECG data segment 112 is substantially similar to one of the plurality of stored templates, the ECG data segment 112 is identified 116 as being associated with the cardiac cycle designated by the template” and paragraph 40, “After being compared to the plurality of stored templates, the ECG data segments 112 are identified 116 as either associated with a typical cardiac cycle or as associated with specific atypical cardiac cycle”).
While Voith teaches and illustrates a display/monitor 24 in Figure 1, and Voith teaches that “As illustrated in FIGS. 2C and 6, four separate sets of representative data may be displayed 148 to a clinician on a display monitor coupled to the clinical device. The display in FIG. 6 includes two ECG waveforms and two continuous blood pressure waveforms. Specifically, representative data for the ECG data in the typical classification category 150 is displayed, and representative data for the ECG data in the PVC classification category 154 is displayed”. However, Voith fails to teach to “cause the group to be displayed in response to a selection by a user involved with a medical treatment of the person.”
Conley teaches “a medical device system having an improved interface and method of operation that more efficiently facilitates interaction with a user. In one aspect the medical device system and method graphically displays a hierarchy of input mechanism that each correspond to a set of arrhythmic episodes having a common data characteristic, such as zone of detection of arrhythmia type. By selecting one of the input mechanisms, the user is able to quickly view detailed information of the set of arrhythmic episodes” (see Abstract). “FIG. 5 illustrates display screen 102 presenting one embodiment of a conversion summary window 500 that presents a graphical summary of the episodes that have occurred” (see column 8, lines 42-54).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide a user interface with the system of Voith that would allow a user to easily view the ECG readings and the classification of them as determined by the system of Voith, which is taught by Conley, “thereby allow[ing] for quick and efficient assessment of the status of the device and of the patient” (see column 9, lines 65-67).
Regarding claim 7, it is noted that Conley teaches that “episodes may be organized by zone of detection such as VF (ventricular fibrillation), VT (ventricular tachycardia), VT-1 (ventricular tachycardia), commanded and accelerated” (see column 8, line 66 through column 9, line 2; emphasis added).
Regarding claim 8, Voith teaches that “In order to identify each heartbeat, the ECG classification engine locates the QRS complex within each heartbeat. Once the ECG data is segmented, each data segment is classified according to the type of heart beat that may have generated the data segment. For example, the data segments may be classified as typical, ventricular, or paced” (see paragraph 5). Also see at least paragraph 41, for instance.
Claims 2-5 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Voith in view of Conley as applied to claim 1 above, and further in view of Cao et al. (US Patent Pub. No. 2022/0225937).
Voith in combination with Conley is described above with respect to claim 1 (and claim 16 below). However, these references do not teach that the ECG grouping module is on a personal device that communicates wirelessly with the processor.
Regarding claims 2 and 17, Cao teaches “A wearable garment and an arrangement of electrodes configured to measure bioelectrical signals from a patient” (see Abstract). As illustrated in Figure 1, the system includes the wearable garment 110, which communicates wirelessly (see lightning bolts 120) with external device(s) 170 directly or through a network 150 (see paragraph 66, “External device 400 may communicate wirelessly with the wearable medical device using telemetry circuitry 446“). Figure 2A also illustrates a personal communication device (see portable computing device 228). Cao teaches that “external device 400 may be a portable computing device, such as portable device 228” (see paragraph 65), and external device 400 is shown in more detail in Figure 4. “Processing circuitry 440 may be configured to perform more complex calculations and analysis functions than performed by the processing circuitry in the wearable medical device” (see paragraph 67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to transmit data to an external device for processing, as taught by Cao, and to utilize this with the system of Voith in order to provide “a processor capable of more complex calculations and analysis than the processor within the wearable garment” (see paragraph 67). Additionally, it would be obvious to separate the functions of a single processor into separately located processors because it has been held that rearranging parts of an invention involves only routine skill in the art (In re Japikse, 86 USPQ 70 – MPEP 214/.04(VI)(C)) as well as to make things separable (In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) – MPEP 2144.04(V)(C)).
Regarding claims 3-4 and 18-19, it is re-iterated that Figure 1 of Cao illustrates that the external device(s) may be communicatively coupled through a network, versus being directly coupled with the wearable garment. “In some examples, external device(s) 170 may include one or more servers, and one or more personal computers, e.g., a computer that a healthcare provider may interact with via a user interface. In some examples, system 100 includes multiple external devices 170 (e.g., a remote patient monitoring system and one or more personal computers). In some examples, external device(s) 170 may comprise a cloud-based computing system” (see paragraph 27).
Regarding claim 5, it is noted that neither Voith nor Conley teach defibrillators. Cao, however, teaches that “When desired, e.g., when processing circuitry 210 receives bioelectrical signals indicating a cardiac arrhythmia… processing circuitry 210 may confirm that the cardiac arrhythmia is treatable by a defibrillation shock and, if necessary, alert patient 208 and deliver the shock” (see paragraph 32). Additionally, the garment of Cao is wearable. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide defibrillating capabilities, as taught by Cao, within the system of Voith because the system of Voith is checking for atypical heartbeats and when life threatening arrhythmias are discovered by the system of Voith, it would be better to treat the patient immediately rather than classifying the episodes without providing assistance, thereby saving the patient’s life.
Specifically regarding claim 16, it is noted that this claim is nearly the same as claim 1. Therefore, the rejection of claim 1 above is incorporated herein as a rejection of claim 16. Claim 16 additionally adds “two therapy electrodes, the two therapy electrodes adapted to be electrical in contact with the person using the WCD system and to provide a therapeutic shock to the person”. Regarding this, it is noted that Cao teaches that “When desired, e.g., when processing circuitry 210 receives bioelectrical signals indicating a cardiac arrhythmia… processing circuitry 210 may confirm that the cardiac arrhythmia is treatable by a defibrillation shock and, if necessary, alert patient 208 and deliver the shock” (see paragraph 32). “Garment 202 also includes processing circuitry 210 and therapy delivery electrodes 230, 232 and 234” (see paragraph 30 of Cao). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to provide defibrillating capabilities, as taught by Cao, within the system of Voith because the system of Voith is checking for atypical heartbeats and when life threatening arrhythmias are discovered by the system of Voith, it would be better to treat the patient immediately rather than classifying the episodes without providing assistance, thereby saving the patient’s life.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Voith in view of Conley as applied to claim 1 above, and further in view of Valiquette et al. (US Patent No. 4,023,564).
Voith in combination with Conley is described above with respect to claim 1. However, these references do not discuss classification in the presence of noise.
Valiquette teaches an arrhythmia detector (see Title), in which “The amplitude of each R wave of an electrocardiogram signal at each of a plurality of sample points is compared with reference values representing amplitudes of a reference template at the sample points” (see Abstract). “R wave complexes tagged as potential arrhythmias by the self-train morphology template 16 are compared with both valid arrhythmias and stored R wave complexes which are noise produced. As previously noted, noise patterns seldom repeat themselves, thereby enabling the digital template memory 20 to distinguish between noise and valid arrhythmias. However, the possibility always exists that a potential arrhythmia produced by noise will be sufficiently close to previously stored noise complexes, particularly if the comparison tolerances happen to be large enough, so as to result in generation of an arrhythmia alarm signal. The ectopic beat classifier 24 avoids this problem by comparing the potential arrhythmias only with R wave complexes which have been determined to be valid arrhythmias by the digital template memory 20” (see column 8, lines 15-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to include a noise determination within the classifying system of Voith, as is taught by Valiquette, in order “to avoid false triggering of an alarm due to waveform complexes which are produced by noise” (see column 2, lines 12-16), thereby reducing falsely determined arrhythmia indications, and reducing the burden of the clinician when reviewing the data or from being alerted unnecessarily.
Conclusion
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/JAMES KISH/ Primary Examiner, Art Unit 3792
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