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
Newly submitted claims 48-51 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Independent claims 48 and 49 are directed to distinct inventions to claim 25.
Claim 25 is directed to a device for intraoperative monitoring new onset conduction disturbances using an ECG interface and the processor and memory are configured to determine the existence of a heart conduction block based on ECG and calculating a metric characterized from ECG waves indicative of a level of partial heart conduction block by comparing the obtained ECG to a baseline.
Claim 48 is directed to a device for intraoperative monitoring new onset conduction disturbances during transcatheter heart procedure using an ECG interface and the processor and memory are configured to identify P and R wave onset time during tissue-manipulating phase, calculating PR interval and comparing to a PR baseline to generate a threshold percentage for determining alarm signal.
Claim 49 is directed to a method of detecting intraoperative conduction disturbances during heart disease intervention procedure that calculates a baseline and current vector electrogram , the baseline comprises a loop traced by an electrical vector having magnitude and direction components, and determining a deviation metric representing a spatial distance in vector space between the baseline and current for generating an alarm.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 48-51 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
This Office Action is responsive to the amendment filed on 12/11/2025. As directed by the amendment: claims 25-34, 36-42, and 47 have been amended, claims 1-24, 35, and 45 have been cancelled, and claims 52-56 have been added. Thus, claims 25-34, 36-44, 46-47, and 52-56 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see page 10, filed 12/11/2025, with respect to claim objections have been fully considered and are persuasive. The objection of the claims has been withdrawn.
Applicant's arguments, see pages 11-17, filed 12/11/2025, under 35 U.S.C. 112(a) for written description have been fully considered. Applicant, on pages 11-14, cites portions of the instant specification to assert support of the amendments to the claim. Applicant then argues on pages 14-15 that calculating a metric is disclosed and that the metric is calculated by comparing ongoing ECG with baseline ECG and stored criteria outlined in [0082], [0137], [0243], and [0337]-[0358].
Examiner disagrees because although the metric is calculated using Euclidian distance of peak and base amplitudes for ECG, noted in [0151] and [0154], and that the metric calculation is relating to and indicative of signal features [0245]-[0255], the calculation of the metric by “comparing the portion of the ongoing ECG recording with baseline ECG data…and stored criteria” is not disclosed in the specification. Furthermore, the “metric” is still not clearly defined in the instant specification because [0249] also discloses “a variety of metrics” can also be calculated relating to temporal onset, temporal offset, and peak times (which would require additional support/disclosure for either template matching or phase space) which is different than the feature extraction described in [0154]. Looking at Fig. 2 (216), it appears that the comparison of baseline ECG and ongoing ECG occurs between the calculated metrics of both the ongoing ECG and the baseline ECG. While the instant specification also fails to disclose how this calculated metric extracted from the comparison is also related to the clinical/stored criteria, Applicant admits on the record that comparing clinical criteria to the baseline ECG measurement and ongoing ECG recording is well-known.
Applicant then argues on pages 15-16 that “The amended Claims 28-29 directly address this by clarifying that "the criteria define range parameters corresponding to one or more clinical criteria" and that "the baseline value is derived from the ECG data." This eliminates the confusing "transformation" language and makes clear that:
Clinical criteria define what ranges are significant
Baseline values come from the patient's ECG
The range spans from baseline to the threshold defined by clinical criteria.”
Examiner notes that although the amendments clarify the range, the range being used to calculate the metric is new matter and the limitation cannot be found in the instant specification.
In regards to the genus 112a rejection, Applicant argues on page 16 that “the specification provides extensive identifying characteristics.
Paragraphs [0337]-[0358] describe clinical criteria for multiple species of heart
conduction blocks including LAFB, LBBB, RBBB, and AV block. These sections
teach specific ECG features associated with each type of block. This provides the
"blaze marks" that allow a person skilled in the art to recognize how the claimed
invention would be applied across different types of heart conduction blocks.
Moreover, the amended claims no longer require covering "every and all types
of heart conductance blocks." The claims now focus on detecting "partial heart
conduction block" using metrics that characterize standard ECG waveform features (P
waves, R waves, T waves, QRS complexes). These features are present in ECG
recordings regardless of the specific type of conduction block, and the specification
teaches how alterations in these features indicate partial block (e.g., paragraph [0137]
teaching sub-threshold detection of partial block).”
Examiner disagrees because none of the heart conduction block species discloses the criteria for a partial heart conduction block. The closest disclosure is found in [0356] relating to RBBB relating to an incomplete RBBB at 110-120 msec, which is still not a partial heart conductance block. Therefore, the rejections are maintained.
Applicant’s arguments, see pages 17-23, filed 12/11/2025, under 35 U.S.C. 112(a) enablement with respect to claim objections have been fully considered and are persuasive. Applicant argues on page 18 that “The claims do not purport to cover exotic or unknown measurement techniques – they cover the application of well-established ECG analysis to detect partial heart conduction block during transcatheter procedures.” Applicant also argues on page 19 that “The existence of published, peer-reviewed clinical criteria demonstrates that the field has established methods for diagnosing various types of heart conduction blocks. Moreover, ECG analysis is a mature field with well-established techniques. Measuring P waves, R waves, T waves, and QRS complexes from ECG recordings is routine practice. Comparing these measurements to baseline values and clinical thresholds is standard clinical methodology… The invention is directed to intraoperative monitoring during transcatheter heart procedures - sophisticated medical procedures performed by trained cardiac electrophysiologists. These practitioners have extensive training in interpreting ECG signals, understanding heart conduction physiology, and applying clinical diagnostic criteria.” Applicant then argues on page 20 that “enablement does not require separate instructions for every possible application. As the Supreme Court recently explained in Amgen V. Sanofi, "what is important is that the specification teach those in the art to make and use the invention as claimed." 598 U.S. at 611. Here, the specification teaches how to measure ECG features, compare them to baseline and clinical criteria, and detect partial heart conduction block.” Applicant then asserts on page 21 that “the specification provides sufficient detail about the methodology that a person skilled in the art could implement the invention using their own ECG data and established clinical criteria… None of these steps requires inventive effort or extensive experimentation They involve applying well-established techniques to achieve the claimed result.” Examiner agrees with Applicants assertions. The rejection of the claims has been withdrawn.
Applicant’s arguments, see pages 23-25, filed 12/11/2025, with respect to 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of the claims has been withdrawn.
Applicant's arguments, see pages 25-32, filed 12/11/2025, under 35 U.S.C. 101 have been fully considered but they are not persuasive. Applicant argues on page 27 that “Here, the claimed device provides a specific technological solution (automated ECG monitoring and alarm generation) to a specific problem (detecting heart conduction disturbances during transcatheter procedures). This is analogous to the patent-eligible subject matter in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117 (Fed. Cir. 2018), where claims directed to a method of treating patients with a specific genetic profile were held patent-eligible because they were directed to a specific treatment regimen, not an abstract idea.” Examiner disagrees because the instant claims fail to recite a technological improvement or a practical application. No treatment is recited in the claim and the alarm signal is extra-solution activity that does not integrate the judicial exception into practical application.
Applicant then argues on page 28 that “This is fundamentally a technological process that relie on ECG acquisition hardware, signal processing, and automated analysis. It cannot be performed in the human mind.” Examiner disagrees because the characterizing of waveforms can be done by a human, as it is well-known in the art, and comparing the features and calculating metric is can be done by pen and paper.
Applicant then argues on page 28 that “The claimed invention improves the functioning of intraoperative monitoring systems by providing automated detection of heart conduction disturbances. As described in the specification (paragraphs [0022]-[0036]), the problem with current monitoring approaches is that they rely on manual visual monitoring by operators and technical staff, which is slow (reaction times of 1-4 seconds) and inconsistent. The claimed invention solves this technological problem by providing automated, real-time analysis of ECG signals with automatic alarm generation. This represents an improvement to medical monitoring technology similar to the technological improvements found patent-eligible in Enfish (improvement to database systems) and Visual Memory LLC V. NVIDIA Corp., 867 F.3d 1253 (Fed. Cir. 2017) (improvement to memory systems).” Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application.
Applicant then argues on page 29 that “These are not generic computer components used for generic purposes. The are specific medical monitoring components configured for a specific application -
acquiring ECG signals from electrodes placed on a patient during transcatheter surgery, processing those signals to detect heart conduction disturbances, and generating alarms… The claim is explicitly limited to "a device for intraoperative monitoring of new onset conduction disturbances" where the patient is "undergoing transcatheter heart procedure." This is not a generic monitoring claim - it is specifically directed to monitoring during cardiac surgery.” Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity.
Applicant then argues on page 30-31 that “This ordered combination provides a specific solution (automated intraoperative monitoring with alarm generation) to a specific problem (detecting
heart conduction disturbances during cardiac surgery). The specification explains that
this combination solves the problem of slow and inconsistent human reaction times
(paragraphs [0135], [0176]-[0184]). The claim elements are not simply generic computer components performing generic functions. The ECG interface is "adapted to receive from ECG circuitry
comprising body surface electrodes configured to be placed on a patient undergoing a
transcatheter heart procedure." The processor is "adapted to convert the received ECG
signals into ECG data." The metric calculation is specifically configured to characterize P waves, R waves, T waves, and QRS complexes and detect heart conduction disturbances.” Applicant further asserts that the claims are analogous to BASCOM. Examiner disagrees because BASCOM is directed to filtering internet content and the instant claims are directed to transcatheter heart procedure. Examiner further disagrees because the combination of additional elements of generic computer components, ECG interface, and the extra-solution activity is well-understood, routine, and conventional.
Applicant then argues on page 31 that “The processor is "adapted to convert the received ECG signals into ECG data"
- a specific signal processing function
The memory stores "criteria for determining existence of a heart conduction
block based on ECG data" - specific medical diagnostic criteria
The indicator device is "configured to present an alarm responsive to alarm
instruction" in an intraoperative setting
These components work together in a specific configuration to provide
automated intraoperative monitoring, which is a concrete practical application.” Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity.
Applicant then argues on page 31 that “The Examiner characterized electrodes as "data gathering structures for the
insignificant extra-solution activity of data gathering." This is incorrect. The
electrodes are not peripheral to the solution - they are integral to it. The claim is
directed to intraoperative monitoring, which necessarily requires acquiring ECG
signals from the patient during surgery. Without the electrodes configured to be
placed on a patient undergoing transcatheter procedure, the claimed invention could
not function.” Examiner disagrees because the claim fails to recite electrodes in a specific configuration that would not make them well-understood, routine, and convention.
Applicant then argues on page 32 that “the claim does not merely invoke the surgical environment as a field of use - the intraoperative monitoring is the essence of the claimed invention. The device is specifically configured for use during surgery, with real-time acquisition of ECG signals from electrodes on the patient and automatic alarm generation. This is distinguishable from cases where claims merely recite performing a
generic process "on a computer" or "over the internet." Here, the intraoperative
context is integral to the claim - the device monitors for "new onset" conduction
disturbances during the procedure, accesses "ongoing" ECG recordings during
performance of the procedure, and provides alarms to enable real-time surgical
decisions.” Examiner disagrees because the real-time acquisition of the surgical environment is done on generic computer components. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity. Therefore, the rejection of record is maintained.
Applicant’s arguments, see pages 32-36, filed 12/11/2025, with respect to 35 U.S.C. 102/103 have been fully considered and are persuasive. The amendments to the claim obviate the rejection of record. The rejection of the claims has been withdrawn. See updated rejection below.
Claim Objections
Claim 25 is objected to because of the following informalities: line 3 recitation “an electrocardiogram, ECG, interface…” should be amended to recite “an electrocardiogram (ECG) interface…” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25-34, 36-44, 46-47, and 52-56 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 25 has been added to include the limitation, "calculating a metric…by comparing the portion of the ongoing ECG recording with baseline ECG data recorded from the patient and the stored criteria". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for the metric calculated using Euclidian distance of peak and base amplitudes for ECG, noted in [0151] and [0154], and that the metric calculation is relating to and indicative of signal features [0245]-[0255], the calculation of the metric by “comparing the portion of the ongoing ECG recording with baseline ECG data…and stored criteria” is not disclosed in the specification. Furthermore, the “metric” is still not clearly defined in the instant specification because [0249] also discloses “a variety of metrics” can also be calculated relating to temporal onset, temporal offset, and peak times (which would require additional support/disclosure for either template matching or phase space) which is different than the feature extraction described in [0154]. Looking at Fig. 2 (216), it appears that the comparison of baseline ECG and ongoing ECG occurs between the calculated metrics of both the ongoing ECG and the baseline ECG. There is no clear recitation in the instant specification that discloses how the metrics are calculated, and what calculations are required. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " calculating a metric…by comparing the portion of the ongoing ECG recording with baseline ECG data recorded from the patient and the stored criteria”. Therefore, the new claim limitations introduce new matter.
Claim 52 has been added to include the limitation, " wherein calculating the metric comprises:
measuring a duration of the QRS complex in the portion of the ongoing ECG signal;
comparing the measured duration to a baseline QRS duration derived from the baseline ECG data;
determining a difference between the measured duration and the baseline QRS duration; and
wherein the metric is based on the determined difference ". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for analyzing template ECG signal “to calculate a variety of metrics characterizing temporal features of the single-beat template ECG signal timecourse, including, for example, the onset (e.g., time of rise to at least 10% above baseline 301), offset (e.g., time of return to less than 10% above baseline 301), and/or peak times of any one or more of the P, R, and T waves. Other landmarks include, for example, the times of the onset peak and/or offset of the negative-going Q and S waves, although since these waves blend with the positive-going R wave, some offset/onset times may be considered to coincide.” ([0249]) . However, the specification does not provide support for calculating a metric by determining a difference between measured duration of QRS and baseline QRS. There is no clear recitation in the instant specification that discloses how the metrics are calculated, and what calculations are required. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " wherein calculating the metric comprises:
measuring a duration of the QRS complex in the portion of the ongoing ECG signal;
comparing the measured duration to a baseline QRS duration derived from the baseline ECG data;
determining a difference between the measured duration and the baseline QRS duration; and
wherein the metric is based on the determined difference”. Therefore, the new claim limitations introduce new matter.
Claim 53 has been added to include the limitation, " wherein the criteria comprise clinical diagnostic criteria selected from the group consisting of: MEANS criteria for left anterior fascicular block, … MEANS criteria for right bundle branch block, and MEANS criteria for atrioventricular block". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for LBBB MEANS . However, the specification does not provide support for MEANS for LAFB. Applicant’s remarks filed 12/11/2025 recites [0349] and referenced preliminary amendments, however, this cannot be found. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " wherein the criteria comprise clinical diagnostic criteria selected from the group consisting of: MEANS criteria for left anterior fascicular block, … MEANS criteria for right bundle branch block, and MEANS criteria for atrioventricular block”. Therefore, the new claim limitations introduce new matter.
Claim 54 has been added to include the limitation, " wherein each range parameter is defined by:
a first endpoint corresponding to the baseline value of a respective criterion parameter measured from the baseline ECG data; and a second endpoint corresponding to a threshold value specified in the clinical criteria for indicating existence of heart conduction block;
wherein calculating the metric comprises normalizing a current measured value of the respective criterion parameter to a scale extending from the first endpoint to the second endpoint". The limitation does not have support in the instant specification nor in the parent application.
The specification does not provide support for a first and second end point and the normalization of the current measured value. Applicant’s remarks filed 12/11/2025 recites [0338]-[0348] and [0802] (which does not exist), however, this cannot be found. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " wherein each range parameter is defined by:
a first endpoint corresponding to the baseline value of a respective criterion parameter measured from the baseline ECG data; and a second endpoint corresponding to a threshold value specified in the clinical criteria for indicating existence of heart conduction block;
wherein calculating the metric comprises normalizing a current measured value of the respective criterion parameter to a scale extending from the first endpoint to the second endpoint”. Therefore, the new claim limitations introduce new matter.
Claim 56 has been added to include the limitation, " wherein the memory stores instructions that cause the processor to:
continuously monitor the ongoing ECG signal recording during the transcatheter heart procedure by calculating updated metric values at intervals of no more than one heartbeat cycle;
detect a rate of change of the metric by comparing metric values calculated from successive heartbeat cycles;
determine that the rate of change exceeds a predefined rate threshold indicative of acute conduction system damage; and
generate the alarm signal in response to determining that the rate of change exceeds the predefined rate threshold;
wherein the alarm signal is generated within two seconds of detecting the rate of change exceeding the predefined rate threshold". The limitation does not have support in the instant specification nor in the parent application.
The specification provides support for monitoring ongoing ECG signal . However, the specification does not provide support for detecting a rate of change by comparing metric values from heartbeat cycles, and the alarm generated with 2 seconds . Applicant’s remarks filed 12/11/2025 recites [0212], [0214], [0135], and [0218], however, this cannot be found. Applicant has not indicated where the disclosure provides adequate written description support for the instant claim limitation, " wherein the memory stores instructions that cause the processor to:
continuously monitor the ongoing ECG signal recording during the transcatheter heart procedure by calculating updated metric values at intervals of no more than one heartbeat cycle;
detect a rate of change of the metric by comparing metric values calculated from successive heartbeat cycles;
determine that the rate of change exceeds a predefined rate threshold indicative of acute conduction system damage; and
generate the alarm signal in response to determining that the rate of change exceeds the predefined rate threshold;
wherein the alarm signal is generated within two seconds of detecting the rate of change exceeding the predefined rate threshold”. Therefore, the new claim limitations introduce new matter.
Claims 25-34, 36-44, 46-47, and 52-56 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
Merely recite a description of the problem to be solved while claiming all solutions to it, leaving the industry to “complete an unfinished invention.” See Ariad, 598 F.3d at 1353
Disclosure of function alone is little more than a wish possession. See MPEP 2163(II)(A)(3)(a).
The written description requirement is not satisfied by merely outlining the goals or results one hopes to achieve with the invention. See MPEP 2163(II)(A)(3)(a).
Claim 25 fails to sufficiently describe the calculation of the metric and its calculation in regards to the level of partial heart conduction block in enough detail for one skilled in the art to show possession of the claimed invention. The mere statement and recitation of the term “metric” in claim 25, Fig. 2 (214, 206) and [0283], [0360]-[0362] of the instant specification PB Pub (US 20240032843) provides insufficient guidance as to what is a “metric” due to multiple definitions provided by the instant specification. The metric may be calculated using Euclidian distance of peak and base amplitudes for ECG, noted in [0151] and [0154], and that the metric calculation is relating to and indicative of signal features [0245]-[0255], while [0249] also discloses “a variety of metrics” can also be calculated relating to temporal onset, temporal offset, and peak times (which would require additional support/disclosure for either template matching or phase space) which is different than the feature extraction described in [0154]. Additionally, the calculation of the metric by “comparing the portion of the ongoing ECG recording with baseline ECG data…and stored criteria” is not disclosed in the specification. The instant specification provides insufficient detail about what the metric of “the level of partial heart conduction block” is. [0137] of the instant specification PG Pub distinguishes the partial heart conduction block using a sub-threshold, but it is unknown how this “metric” establishes the partial heart conduction block. [0243] of the instant specification PG pub merely state that the metrics are calculated from blocks 206, 208, 210, 212, and 214, but these calculations appear to calculate metrics for ongoing ECG and baseline ECG separately, that are then compared to one another at 216. There is also no clear connection in which the metric is calculated for either the partial or full heart conductance block and for which species of heart conductance blocks (e.g. SA block, SV block, RBBB, His block, LAFB). Nor is there a way in which the criteria are used to calculate the metric. Although Applicant outlines what the heart block criteria may be for 3 representative species in [0337]-[0358] of the instant specification PG Pub, the instant specification fails to distinguish what within the criteria allows one skilled in the art to identify a partial and full heart conductance block used in the calculation for the metric and how the criteria is converted into block or partial block. Furthermore, the instant specification PG Pub, in [0349]-[0358] the different criteria for LAFB, LBBB, RBBB, and AV block but provides no way in which these criteria are used to calculate the metric. Additionally, none of the heart conduction block’s (His block, SA block, RBBB, LBBB, and LAFB) discloses the criteria for a partial heart conduction block. The closest disclosure is found in [0356] relating to RBBB relating to an incomplete RBBB at 110-120 msec, which is still not a partial heart conductance block. Therefore, claims 25-34, 36-44, 46-47, and 52-56 do not provide sufficient detail for one to replicate and understand the intended function that’s being performed to show that Applicant has possession of the claimed invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25-34, 36-44, 46-47, and 52-56 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 25, it is unclear how the metric is calculated when the step requires the comparing of the ongoing ECG and baseline ECG data and criteria, which are both mutually distinct from one another. A calculation requires the use of an equation or arithmetic involved, whereas the recited comparing of ongoing ECG and baseline ECG data is a judgement that is determined.
Regarding claim 28, it remains unclear how the metric is calculated based on range parameters when a calculation requires an equation or arithmetic while the independent claim compares ongoing ECG with criteria, that makes up the range parameters, and baseline ECG data.
Claim 31 recites the limitation "the instructions" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the heart conduction block" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "the instructions" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 54 recites the limitation "the clinical criteria" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 26-34, 36-44, 46-47, and 52-56 are rejected by way of dependency to claim 25.
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 25-34, 36-44, 46-47, and 52-56 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Each of independent claim 25 recites a step calculate a metric…by comparing the portion of the ongoing ECG recording with baseline ECG data recorded from the patient and the stored criteria, which is a mental process and mathematical concept. This judicial exception is not integrated into a practical application because the generically recited computer elements (ie. a processor and memory), determining values, and calculating a metric do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are to receiving data, processing data, and calculating a metric, which are all well-understood, routine, and conventional computer functions. See MPEP § 2106.05(d).
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 25 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claim 25, the following step is an abstract idea:
“calculate a metric…by comparing the portion of the ongoing ECG recording with baseline ECG data recorded from the patient and the stored criteria”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could calculate a metric by comparing features from ongoing ECG and baseline ECG.
“calculate a metric” , which is a mathematical concept when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(I), the mathematical concepts grouping is defined as mathematical relationships, mathematical formulas or equations, and mathematical calculations. In this case, the metric is calculated using a Euclidian distance to extract features, as noted in [0154], which is a mathematical concept.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claim 25, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “processor”, “indicator device”, and “memory” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “electrodes” and “ECG interface” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “metric”, “alarm”, “criteria”, “heart conduction block”, “ECG data/signal”, “test value”, “P wave, an R wave, a T wave, and a QRS complex of the portion of the ongoing ECG signal”, “metric indicative of a level of partial heart conduction block”, and “baseline ECG data” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “transcatheter heart procedure” is generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “processor”, “indicator device”, and “memory” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “electrodes” and “ECG interface” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “metric”, “alarm”, “criteria”, “heart conduction block”, “ECG data/signal”, “test value”, “P wave, an R wave, a T wave, and a QRS complex of the portion of the ongoing ECG signal”, “metric indicative of a level of partial heart conduction block”, and “baseline ECG data” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)];
- “transcatheter heart procedure” is generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
The additional elements of claim 25, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the processor, memory, and indicator device, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The ECG sensor is claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Zhao et al (US 20170258356) teaches the use of ECG/EKG sensors to collect ECG signals ([0006]), and Shuros et al. (US 20200376280) teaches surface electrodes for collecting ECG ([0053]).
Dependent claims 26-34, 36-44, 46-47, and 52-56 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to the type of data (claims 26-34, 42-44, 46-47, and 52-56) and to generic gathering structure (claims 36-41, and 55), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 25-34, 36-44, 46-47, and 52-56 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Interpretation
Claim 25 recites the phrase “comprising”, which is an open-ended term, and would open up the claim to include any additional material recited in the prior art. Although claim 37 and 55 uses the phrase “consisting of”, the claim is not limited to only 4 electrodes due to the open-ended term “comprising” used in the independent claim 25.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 25-27, 30, 33, 46, and 52 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shuros et al. (US 20200376280)(IDS)(Hereinafter Shuros).
Regarding claim 25, Shuros teaches A device for intraoperative monitoring of new onset conduction disturbances (Abstract “An exemplary medical system includes an AV conduction monitor to detect an indication of either a presence or an absence of intermittent or rate-related AV conduction disturbance using physiologic information of the subject.”), the device comprising:
an indicator device configured to present an alarm responsive to alarm instruction ([0058] “the external device 120 or the remote device 124 may include a respective display unit for displaying the physiological signals, stimulation parameters, capture verification, or AV conduction status, among other intermediate analyses and computations. Alerts, alarms, emergency calls, or other forms of warnings to signal the detected medical event may also be generated.”);
an electrocardiogram, ECG, interface adapted to receive from ECG circuitry comprising body surface electrodes configured to be placed on a patient undergoing a transcatheter heart procedure, the ECG circuitry configured to acquire ECG signals from the body surface electrodes ([0081] “The QRS width information 322 may be derived from a surface ECG signal” [0053] “surface ECG signal sensed using skin electrodes [ECG interface] attached to the body surface.” Examiner notes that the patient undergoing transcatheter heart procedure is the manner intended for the electrodes to be used, which is functional language. “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.” See MPEP 2114. Examiner notes the surface electrodes are taught by Shuros, and therefore contains the claimed structure.);
a processor coupled to the indicator device and adapted to convert the received ECG signals into ECG data ([0100] “The machine (e.g., computer system) 700 may include a hardware processor 702 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 704” [0081] “The QRS width information 322 may be derived from a surface ECG signal”); and
a digital memory accessible to the processor and storing criteria for determining existence of a heart conduction block based on the EGG data ([0100] “The machine (e.g., computer system) 700 may include a hardware processor 702 (e.g., a central processing unit (CPU), a graphics processing unit (GPU), a hardware processor core, or any combination thereof), a main memory 704” [0082] “The AV conduction monitor 230 can detect an indication of a presence of intermittent AV conduction disturbance in response to the AVI exceeding an AVI threshold (AVI.sub.block) [criteria], and detect an indication of an absence of intermittent AV conduction disturbance in response to the AVI falling below the AVI.sub.block.”);
wherein the memory also stores instructions instructing the processor to:
access in the ECG data a portion of an ongoing ECG signal recording recorded from the patient during the performance of the transcatheter heart procedure ([0081] “The QRS width information 322 may be derived from a surface ECG signal” Examiner notes that the patient undergoing transcatheter heart procedure is the manner intended for the electrodes to be used, which is functional language. “A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.” See MPEP 2114. Examiner notes the surface electrodes are taught by Shuros, and therefore contains the claimed structure.);
calculate a of a metric characterizing one or more of a P wave, an R wave, a T wave, and a QRS complex of the portion of the ongoing ECG signal and indicative of a level of partial heart conduction block from the portion of the ongoing ECG recording by comparing the portion of the ongoing ECG recording with baseline ECG data recorded from the patient and the stored criteria ([0042] “AV conduction disturbance can include different degrees of obstruction, varying from a mild delay in conduction (first-degree AV block)” [0091] “patient QRS width may be compared to a QRS width threshold (QRS.sub.block) [baseline ECG data]. At 420, an intermittent AV conduction disturbance is decided to be present if the patient QRS width exceeds the QRS.sub.block, or to be absent if the QRS width falls below the QRS.sub.block. In an example, patient AVI [metric] may be compared to an AVI threshold (AVI.sub.block) [stored criteria].”); and
generate an alarm signal to instruct to the indicator device based on the calculated metric ([0058] “the external device 120 or the remote device 124 may include a respective display unit for displaying the physiological signals, stimulation parameters, capture verification, or AV conduction status, among other intermediate analyses and computations. Alerts, alarms, emergency calls, or other forms of warnings to signal the detected medical event may also be generated.”).
Regarding claim 26, Shuros teaches further comprising ECG circuitry configured to record the ECG signal recording ([0053] “surface ECG signal sensed using skin electrodes [ECG interface] attached to the body surface.”).
Regarding claim 27, Shuros teaches wherein the digital memory stores the baseline ECG data ([0091] “patient QRS width may be compared to a QRS width threshold (QRS.sub.block) [baseline ECG data].”).
Regarding claim 30, Shuros teaches wherein the alarm is indicative of the existence of the partial heart conduction block in a heart of the patient based on the EGG data ([0042] “AV conduction disturbance can include different degrees of obstruction, varying from a mild delay in conduction (first-degree AV block)” [0091] “patient QRS width may be compared to a QRS width threshold (QRS.sub.block) [baseline ECG data]. At 420, an intermittent AV conduction disturbance is decided to be present if the patient QRS width exceeds the QRS.sub.block, or to be absent if the QRS width falls below the QRS.sub.block. In an example, patient AVI [metric] may be compared to an AVI threshold (AVI.sub.block) [stored criteria].”).
Regarding claim 33, Shuros teaches wherein the alarm instruction is indicative of heart conduction block at a specific structure of a heart conduction system ([0058] “the external device 120 or the remote device 124 may include a respective display unit for displaying the physiological signals, stimulation parameters, capture verification, or AV conduction status, among other intermediate analyses and computations. Alerts, alarms, emergency calls, or other forms of warnings to signal the detected medical event may also be generated.”).
Regarding claim 46, Shuros teaches wherein an interval between the portion of the ongoing EGG recording and the baseline EGG data is a single heartbeat ([0081] “The QRS [single heartbeat] width information 322 may be derived from a surface ECG signal”).
Regarding claim 52, Shuros teaches wherein calculating the metric comprises:
measuring a duration of the QRS complex in the portion of the ongoing ECG signal;
comparing the measured duration to a baseline QRS duration derived from the baseline ECG data;
determining a difference between the measured duration and the baseline QRS duration; and
wherein the metric is based on the determined difference ([0042] “AV conduction disturbance can include different degrees of obstruction, varying from a mild delay in conduction (first-degree AV block)” [0091] “patient QRS width may be compared to a QRS width threshold (QRS.sub.block) [baseline ECG data]. At 420, an intermittent AV conduction disturbance is decided to be present if the patient QRS width exceeds the QRS.sub.block, or to be absent if the QRS width falls below the QRS.sub.block. In an example, patient AVI [metric] may be compared to an AVI threshold (AVI.sub.block) [stored criteria].”).
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.
Claim(s) 34, 38, 43, and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shuros et al. (US 20200376280)(IDS)(Hereinafter Shuros) in view of Hooks et al. (EP3318210A1)(IDS)(Hereinafter Hooks).
Regarding claim 34, Shuros teaches the invention of claim 25. However, Shuros does not teach the indicator device displays a visual representation of a heart conduction system with the mark presented at the specific structure of the heart conduction system and with a visual characteristic indicative of the alarm instruction. Hooks, in the same field of endeavor, teaches the determination of a level of heart block based on ECG from electrodes (Abstract), and further teaches wherein the indicator device displays a visual representation of a heart conduction system with the mark presented at the specific structure of the heart conduction system and with a visual characteristic indicative of the alarm instruction (Fig. 7 shows 3D mapping of intracardiac image, which marks the heart. [0071] “a first Risk Index RI1 may activate one visual alarm with an appropriated display,”) to alert a user about a heart blockage ([0071]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the indicator device displays a visual representation of a heart conduction system with the mark presented at the specific structure of the heart conduction system and with a visual characteristic indicative of the alarm instruction of Hooks, because such a modification would allow to alert a user about a heart blockage.
Regarding claim 38, Shuros teaches the invention of claim 25. However, Shuros does not teach the baseline EGG data is collected using standard 12- lead ECG. Hooks, in the same field of endeavor, teaches the determination of a level of heart block based on ECG from electrodes (Abstract), and further teaches wherein the baseline EGG data is collected using standard 12- lead ECG ([0179] “The timing of individual atrial and ventricular depolarisations (total of 30,754 EGM and ECG complexes), and the cardiac rhythm at each beat, was assessed manually by an experienced clinician, to act as a gold-standard comparison to the algorithm. Database signals were fed to the device with real-time sampling to simulate a 'live' electrophysiologic study. The device signal interpretations and alarm conditions were stored and later analysed.” [0116] “Voltage signals are also recorded from the body surface in the form of an electrocardiogram (ECG) 14, typically of 12 leads in standard locations (only 3 leads shown in FIG. 1).”) to alert a user about a heart blockage ([0071]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the baseline EGG data is collected using standard 12- lead ECG of Hooks, because such a modification would allow to alert a user about a heart blockage.
Regarding claim 43, Shuros teaches the invention of claim 25. However, Shuros does not teach the indicator device presentation of the alarm in response to the alarm instruction comprises display of a vector electrogram, and a change thereto. Hooks, in the same field of endeavor, teaches the determination of a level of heart block based on ECG from electrodes (Abstract), and further teaches wherein the indicator device presentation of the alarm in response to the alarm instruction comprises display of a vector electrogram, and a change thereto ([0094] “the monitoring system comprises a screen displaying pulse markers in real time, the pulse markers corresponding to a onset or a peak of each electrophysiology recording acquired by the IEGM electrode and the ECM electrodes.” [0111] “FIG. 14 shows real-time or near real-time display of pulsed signals output from the Risk Monitoring Device to the EP recording system, for the purposes of a visual check that the Risk Monitoring Device is accurately detecting atrial and ventricular depolarisations [change].”) to alert a user about a heart blockage ([0071]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the indicator device presentation of the alarm in response to the alarm instruction comprises display of a vector electrogram, and a change thereto of Hooks, because such a modification would allow to alert a user about a heart blockage.
Regarding claim 44, Shuros teaches the invention of claim 25. However, Shuros does not teach the indicator device presentation of the alarm in response to the alarm instruction is indicative of a potential to halt or reverse the partial heart conduction block. Hooks, in the same field of endeavor, teaches the determination of a level of heart block based on ECG from electrodes (Abstract), and further teaches wherein the indicator device presentation of the alarm in response to the alarm instruction is indicative of a potential to halt or reverse the partial heart conduction block ([0135] “allowing automatic generation of a sensorial alert when conditions indicating risk of heart block occur. The system disclosed is able to react to risk conditions faster than the human reaction, and in a more consistent manner.”) to alert a user about a heart blockage ([0071]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the indicator device presentation of the alarm in response to the alarm instruction is indicative of a potential to halt or reverse the partial heart conduction block of Hooks, because such a modification would allow to alert a user about a heart blockage.
Claim(s) 36-37 and 39-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shuros et al. (US 20200376280)(IDS)(Hereinafter Shuros) in view of Chien (US 20160143553)(Hereinafter Chien).
Regarding claim 36, Shuros teaches the invention of claim 25. Shuros does not teach a set of electrodes for collecting a 12-lead ECG with an interface containing less than 10 ports. Chien, in the same field of endeavor, teaches the collection of ECG signal used in the diagnosing of heat blockage (bundle branch block) (Abstract), and further teaches wherein the ongoing ECG signal recording is obtained using a set of electrodes having less electrodes than defined for performing a standard 12-lead ECG, and the device comprises an interface connecting to electrodes with fewer electrode attachment ports than ten ([0022] “The illustrative embodiment employs a conventional 12-lead ECG in which six chest electrodes V1, . . . , V6 are connected to the chest, a left arm electrode LA is connected to the left arm, a right arm electrode RA is connected to the right arm, and a left leg electrode LL is connected to the left leg. A ground electrode is also connected, in the illustrative example as a right leg electrode RL…the illustrative 12-lead ECG is a standard ECG configuration, various modified electrode configurations may alternatively be employed, such as the Mason-Likar ECG in which the limb electrodes are moved off the limbs toward the body center-of-mass, e.g. onto the torso, or a reduced-electrodes configuration such as the EASI system (where the leads of the 12-lead ECG can be computed using suitable mathematical transforms).”) to reduce the number of electrodes/leads/wires, which significantly reduces cable bulk and tangling on a user ([0022]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the set of electrodes for collecting a 12-lead ECG with an interface containing less than 10 ports of Chien, because such a modification would allow to reduce the number of electrodes/leads/wires, which significantly reduces cable bulk and tangling on a user.
Although Chien does not explicitly use less than 10 attachment ports, for a person of ordinary skill in the art, making such modifications would have required nothing more than a predictable application of a known technique to a known device ready for improvement. See KSR, 550 U.S. at 416-417. A skilled artisan would have understood how to modify Chien to use less leads (as shown in [0022]) to reduce the number of electrodes/leads/wires, which significantly reduces cable bulk and tangling on a user. The use of less than 10 attachment ports would not have been “uniquely challenging or difficult for one of ordinary skill in the art” or “represented an unobvious step over the prior art” to modify Hooks in view of Chien as discussed above. Leapfrog Enters., Inc. v. Fisher- Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR, 550 U.S. at 418-19).
Regarding claim 37, Shuros teaches the invention of claim 25. Shuros does not teach 4 electrodes corresponding to an arm, a leg, and chest electrode. Chien, in the same field of endeavor, teaches the collection of ECG signal used in the diagnosing of heat blockage (bundle branch block) (Abstract), and further teaches wherein the body surface electrodes consists of four electrodes ([0022] “The illustrative embodiment employs a conventional 12-lead ECG in which six chest electrodes V1, . . . , V6 are connected to the chest, a left arm electrode LA is connected to the left arm, a right arm electrode RA is connected to the right arm, and a left leg electrode LL is connected to the left leg. A ground electrode is also connected, in the illustrative example as a right leg electrode RL” As noted under the claim interpretation, the claim will be interpreted as consisting at least 4 electrodes due to the use of “comprising” in the independent claim.) to reduce the number of electrodes/leads/wires, which significantly reduces cable bulk and tangling on a user ([0022]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the 4 electrodes corresponding to an arm, a leg, and chest electrode of Chien, because such a modification would allow to reduce the number of electrodes/leads/wires, which significantly reduces cable bulk and tangling on a user.
Regarding claim 39, Shuros teaches the invention of claim 25. Shuros does not teach 4 electrodes corresponding to an arm, a leg, and chest electrode. Chien, in the same field of endeavor, teaches the collection of ECG signal used in the diagnosing of heat blockage (bundle branch block) (Abstract), and further teaches wherein the four electrodes correspond to arm and leg electrodes of the standard 12-lead ECG, and one or more chest electrodes ([0022] “The illustrative embodiment employs a conventional 12-lead ECG in which six chest electrodes V1, . . . , V6 are connected to the chest, a left arm electrode LA is connected to the left arm, a right arm electrode RA is connected to the right arm, and a left leg electrode LL is connected to the left leg. A ground electrode is also connected, in the illustrative example as a right leg electrode RL”) to reduce the number of electrodes/leads/wires, which significantly reduces cable bulk and tangling on a user ([0022]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Hooks, with the 4 electrodes corresponding to an arm, a leg, and chest electrode of Shuros, because such a modification would allow to reduce the number of electrodes/leads/wires, which significantly reduces cable bulk and tangling on a user.
Regarding claim 40, Shuros teaches the invention of claim 25. Shuros does not teach V6 chest electrode. Chien, in the same field of endeavor, teaches the collection of ECG signal used in the diagnosing of heat blockage (bundle branch block) (Abstract), and further teaches wherein the chest electrodes are one or more V6 electrodes ([0022] “The illustrative embodiment employs a conventional 12-lead ECG in which six chest electrodes V1, . . . , V6 are connected to the chest, a left arm electrode LA is connected to the left arm, a right arm electrode RA is connected to the right arm, and a left leg electrode LL is connected to the left leg. A ground electrode is also connected, in the illustrative example as a right leg electrode RL”) to reduce the number of electrodes/leads/wires, which significantly reduces cable bulk and tangling on a user ([0022]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the V6 chest electrode of Chien, because such a modification would allow to reduce the number of electrodes/leads/wires, which significantly reduces cable bulk and tangling on a user.
Regarding claim 41, Shuros teaches the invention of claim 25. Shuros does not teach transform ECG data into standard ECG data referring to the leads. Chien, in the same field of endeavor, teaches the collection of ECG signal used in the diagnosing of heat blockage (bundle branch block) (Abstract), and further teaches wherein the instructions instruct the processor to transform the ECG data into a standard ECG data referring to a set of leads corresponding to a standard 12-lead ECG ([0025] “The ECG recorder 18 records voltage samples as a function of time for each lead of the 12-lead ECG. To this end, the ECG recorder 18 acquires the potentials on the two electrodes of the lead (for example, electrodes LA and RA for Lead I) for each time interval and computes the lead voltage for the time interval as the difference (e.g. the voltage of Lead I equals LA-RA).”) to visualize the extracted physiological data ([0023]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the transform ECG data into standard ECG data referring to the leads of Chien, because such a modification would allow visualize the extracted physiological data.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shuros et al. (US 20200376280)(IDS)(Hereinafter Shuros) in view of Chien (US 20160143553)(Hereinafter Chien), Anderson (US 20110184692)(Hereinafter Anderson), and Dawson et al. (“Linear affine transformations between 3-lead (Frank XYZ leads) vectorcardiogram and 12-lead electrocardiogram signals” Journal of Electrocardiology Volume 42, Issue 6, November–December 2009, Pages 622-630) (Hereinafter Dower).
Regarding claim 42, Shuros teaches the invention of claim 25. However, Shuros in view of Chien fail to teach performing a modified inverse Dower transform to produce a set of leads corresponding to Frank vector cardiography leads. Anderson, in the same field of endeavor, teaches analyzing vector leads from recorded ECG (Abstract) and further teaches wherein the processor transforms the EGG data by performing a modified inverse Dower transform to produce a set of leads corresponding to Frank vector cardiography leads ([0021] “One approach to obtain the XYZ signals for the vectorcardiographic display is the Frank lead configuration, where orthogonal XYZ leads are recorded directly from the patient. This lead configuration requires the placement of an electrode on the back of the patient, making it unsuited for emergency care. Another approach to obtain the XYZ signals is through mathematical transformation from the 12-lead recording to XYZ signals, e.g. the inverse Dower transformation (5).”) to optimize the transformation with the best accuracy for less lead usage. It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the performing a modified inverse Dower transform to produce a set of leads corresponding to Frank vector cardiography leads of Anderson, because such a modification would allow to optimize the transformation with the best accuracy for less lead usage.
Although Chien uses the EASI method for yielding the 12-lead ECG, Shuros in view of Chien do not teach the Dower transform. Dawson, in the same field of endeavor, teaches using a conventional 12-lead ECG recording for medical diagnostics (Abstract), and further uses the Dower transform (Abstract-Results “the statistical affine transform presented here maps 3-lead VCG to12-lead ECG more accurately than Dower or other lead transformation matrices of the ECG recordings.”) to use few leads to determine the conventional 12-lead ECG (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the performing a Dower transform of Dawson, because such a modification would allow to use few leads to determine the conventional 12-lead ECG.
Claim(s) 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shuros et al. (US 20200376280)(IDS)(Hereinafter Shuros) in view van den Berg et al. (“Normal Values of QT Variability in 10-s Electrocardiograms for all Ages” Front. Physiol., 03 October 2019 Sec. Cardiac Electrophysiology, Volume 10 - 2019) (Hereinafter VDB).
Regarding claim 53, Shuros teaches the invention of claim 25. However, Shuros fail to teach criteria comprise clinical diagnostic criteria selected from the group consisting of: MEANS criteria for left anterior fascicular block, MEANS criteria for left bundle branch block, MEANS criteria for right bundle branch block, and MEANS criteria for atrioventricular block. VDB, in the same field of endeavor, teaches using QT variability, from ECG, to determine an AV block (Abstract) and further teaches wherein the criteria comprise clinical diagnostic criteria selected from the group consisting of: MEANS criteria for left anterior fascicular block, MEANS criteria for left bundle branch block, MEANS criteria for right bundle branch block, and MEANS criteria for atrioventricular block (Pg 3 left col. lines 15-19“The ECGs were processed by our Modular ECG Analysis System (MEANS), an ECG computer program that has been evaluated extensively (van Bemmel et al., 1990; Willems et al., 1991). MEANS signals excessive noise and baseline wander, recognizes ectopic beats and the various forms of AV block.”) to correlate fiducial points of segments for heart blocks (Pg 3 left col. lines 25-27). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the criteria comprise clinical diagnostic criteria selected from the group consisting of: MEANS criteria for left anterior fascicular block, MEANS criteria for left bundle branch block, MEANS criteria for right bundle branch block, and MEANS criteria for atrioventricular block of VBD, because such a modification would allow to correlate fiducial points of segments for heart blocks.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shuros et al. (US 20200376280)(IDS)(Hereinafter Shuros) in view Jaros et al. (“Comparison of Different Electrocardiography with Vectorcardiography Transformations” Sensors (Basel). 2019 Jul 11;19(14):3072.) (Hereinafter Jaros).
Regarding claim 55, Shuros teaches the invention of claim 25. However, Shuros fail to teach the ECG circuitry comprises body surface electrodes consisting of four electrodes positioned to correspond to arm electrodes, leg electrodes, and a chest electrode of a standard twelve-lead ECG configuration; the processor is configured to transform ECG signals from the four electrodes into twelve-lead ECG data by: (a) applying a modified inverse Dower transform to produce Frank vector cardiography lead data, and (b) applying a Dower transform to the Frank vector cardiography lead data to generate the twelve-lead ECG data; and the stored criteria reference lead designations of the standard twelve-lead ECG configuration. Jaros, in the same field of endeavor, teaches obtain QRS complexes via ECG transformation (Abstract) and further teaches wherein:
the ECG circuitry comprises body surface electrodes consisting of four electrodes positioned to correspond to arm electrodes, leg electrodes, and a chest electrode of a standard twelve-lead ECG configuration (Pg. 5 lines 30-32 “To transform the 12-lead ECG into 3 lead VCG, only the values of 6 thoracic leads, lead I and lead II, i.e., 8 linearly independent leads are used.”);
the processor is configured to transform ECG signals from the four electrodes into twelve-lead ECG data by: (a) applying a modified inverse Dower transform to produce Frank vector cardiography lead data (Pg 4 lines 1-3 “This method is based on the mathematical pseudoinversion of the Dower’s method of deriving ECG from VCG.”), and (b) applying a Dower transform to the Frank vector cardiography lead data to generate the twelve-lead ECG data (Pg. 5 lines 30-32 “To transform the 12-lead ECG into 3 lead VCG, only the values of 6 thoracic leads, lead I and lead II, i.e., 8 linearly independent leads are used.” Pg 8 lines 24-25v “The test was performed on the recordings from the PTB database and the MSE and R result vector in relation to the reference Frank’s leads was obtained for each method.”); and
the stored criteria reference lead designations of the standard twelve-lead ECG configuration (Pg 7 lines 6-8 “The individual recordings contain 15 simultaneously measured leads. The leads measured comprise of 12 ECG leads (Eithoven, Goldberg, and Wilson leads) and 3 VCG leads (Frank’s leads).”) to obtain the most accurate transformation (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Shuros, with the ECG circuitry comprises body surface electrodes consisting of four electrodes positioned to correspond to arm electrodes, leg electrodes, and a chest electrode of a standard twelve-lead ECG configuration; the processor is configured to transform ECG signals from the four electrodes into twelve-lead ECG data by: (a) applying a modified inverse Dower transform to produce Frank vector cardiography lead data, and (b) applying a Dower transform to the Frank vector cardiography lead data to generate the twelve-lead ECG data; and the stored criteria reference lead designations of the standard twelve-lead ECG configuration of Jaros, because such a modification would allow to obtain the most accurate transformation.
Conclusion
Claims 28-29, 31, 32, 47, 54, and 56 are free from prior art but remain rejected under 35 U.S.C. 101, 112(a), and 112(b), and are dependent on rejected claim 25 under 35 U.S.C. 102(a)(2).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Aufferet (“Conduction Disturbances After Transcatheter Aortic Valve Replacement: Current Status and Future Perspectives” Circulation Volume 136, Number 11 Sept. 12, 2017)
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 MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796