DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “providing an electrocardiogram (ECG) and a processor” at Ln. 3, but should recite -- an electrocardiogram (ECG) and a processor--. Appropriate correction is required.
Claims 2 and 26 are objected to because of the following informalities: Claims 2 and 26 recite “compute windowed HRV” at Ln. 18, but should recite -- compute windowed heart rate variability (HRV) --. Appropriate correction is required.
Claims 20 and 30 are objected to because of the following informalities: Claims 20 and 30 recite “ATTR amyloidoisis” at Ln. 3, but should recite -- Amyloid transthyretin (ATTR) amyloidoisis--. 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.
Claims 2, 3 and 26 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.
Regarding Claim 2:
Claim 2 recites “wherein the software, when executed, is configured to … synthesize the measured VAT, the measured P-wave terminal velocity, the measured Global QRS derivation, and the measured vector of beat and rhythm burdens into an Ejection Fraction (EF) biomarker value.” The Present Specification does not describe the manner in which the measured elements are “synthesized” in a manner sufficient to convey to a person of ordinary skill in the art what is being done. Relatedly, the Present Specification does not provide sufficient details of the “Ejection Fraction (EF) biomarker value” to apprise a person of ordinary skill in the art of its scope. Accordingly, the Present Specification does not provide sufficient details regarding the output of “the software” as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Claim 2 recites “wherein the software, when executed, is configured to … assess the subject's ejection fraction percentage status through comparing the subject's synthesized EF biomarker value with established EF biomarker value norms correlated with specific ejection fraction percentages.” The Present Specification does not describe the recited “synthesized EF biomarker” or the recited “established EF biomarker” in sufficient detail to apprise a person of ordinary skill in the art of what they entail. Accordingly, the Present Specification does not provide sufficient details regarding the input of “the software” as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Regarding Claim 3, Claim 3 recites “wherein the software is configured to implement artificial intelligence (AI) based predictive analysis in assessing the subject's ejection fraction percentage status through comparing the subject's synthesized EF biomarker value with established EF biomarker value norms correlated with specific ejection fraction percentages.”
For similar reasons to those explained above with respect to Claim 2, the Present Specification does not provide sufficient details regarding the input of “the software” as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
The Present Specification provides no details regarding the recited “artificial intelligence (AI) based predictive analysis.” One of ordinary skill in the art would be unable to discern what the recited “artificial intelligence (AI) based predictive analysis” entails, as the Present Specification provides no guidance with respect to the particular AI algorithm or type of AI algorithm employed. As such, the Present Specification does not describe in what sense “the software is configured to implement artificial intelligence (AI) based predictive analysis” in such a manner as to reasonably convey to one skilled in the relevant art that the inventor had possession of the claimed invention at the time the application was filed.
Regarding Claim 26, Claim 26 is similar to Claim 2 and is rejected as failing to comply with the written description requirement for the same reasons as explained above with respect to Claim 2.
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 1 and 25, and Claims 2-4, 17, 19-20, 22-24, 26-27, 29-30 and 44-47 by dependency, 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 Independent Claim 1, Claim 1 recites “an extended period of time” at Ln. 7, Ln. 9, Ln. 14 and Ln. 17. It is unclear whether the “an extended period of time” of Ln. 7, Ln. 9, Ln. 14 and Ln. 17 are the same or different extended periods of time.
For purposes of this Office Action, the term “an extended period of time” at Ln. 9, Ln. 14 and Ln. 17 is being interpreted to be the same “an extended period of time” as that recited at Ln. 7.
The Examiner notes that the Present Specification lists over twenty examples of what “an extended period of time” may entail at Pg. 5-7. These examples span from as narrow a range as “between a 1-second … and less than or equal to a 2-second period of time” to as broad a range as “between a 0.00001 second … and less than or equal to a 6-month period of time.” Absent such specifics as listed in the Present Specification, the broadest reasonable interpretation of the term “an extended period of time” is that it includes almost any period of time. The term “an extended period of time” is so-interpreted herein.
Regarding Claim 25, Claim 25 recites “an extended period of time” in a manner similar to Claim 1, and is indefinite for the same reasons. Claim 25 is being interpreted similarly to 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 1-4, 17, 19-20, 22-27, 29-30 and 44-47 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Eligibility Step 1 – The Four Categories of Statutory Subject Matter
Claims 1-4, 17, 19-20, 22-27, 29-30 and 44-47 each fall within one of the four categories of statutory subject matter.
Eligibility Step 2A, Prong One
Claims 1-4, 17, 19-20, 22-27, 29-30 and 44-47 recite abstract ideas:
Regarding Independent Claim 1:
“assess the subject’s ejection fraction percentage status” recites a mental process when afforded its broadest reasonable interpretation. Such assessing is practically performable in the human mind, and is an evaluation. See MPEP 2106.04(a)(2) (III).
Regarding Claim 2, Claim 2 recites several additional functions in the alternative. Although only a single such function is required by the claim, each is addressed in furtherance of compact prosecution.
“utilize the derived LI waveform and resampled LII and LIII waveform data to derive the following other bipolar frontal leads: aVF, aVR and aVL” recites a mental process when afforded its broadest reasonable interpretation. Such deriving is practically performable in the human mind, and is an evaluation. See MPEP 2106.04(a)(2) (III).
“estimate a Wilson Cental Terminal Reference Potential with a spatial vector cardiography transform” recites a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2).
“approximate a beat-by-beat maxima for pre-cordial leads V1 thru V6 with the spatial vector cardiography transform” recites a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2).
“filter the derived LI waveform data, LII waveform data, LIII waveform data, aVF data, aVR data, aVL data, Wilson Central Terminal Reference potential, and V1 thru V6 data to remove motion (and other) artifacts” recites a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2).
“calculate a spectral entropy for each heartbeat over the time period and remove all heartbeats above a pre-set threshold model” recites a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2).
“compute PR, QT, ST interval for remaining stable heart-beats” recites a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2).
“compute windowed HRV” recites a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2).
“synthesize the measured VAT, the measured P-wave terminal velocity, the measured Global QRS derivation, and the measured vector of beat and rhythm burdens into an Ejection Fraction (EF) biomarker value” recites a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2).
“assess the subject's ejection fraction percentage status through comparing the subject's synthesized EF biomarker value with established EF biomarker value norms correlated with specific ejection fraction percentages” recites a mental process when afforded its broadest reasonable interpretation. Such assessing is practically performable in the human mind, and is an evaluation. See MPEP 2106.04(a)(2) (III).
Regarding Claim 3:
“implement artificial intelligence (AI) based predictive analysis in assessing the subject's ejection fraction percentage status through comparing the subject's synthesized EF biomarker value with established EF biomarker value norms correlated with specific ejection fraction percentage” recites a mathematical calculation when afforded its broadest reasonable interpretation. See MPEP 2106.04(a)(2).
Regarding Claims 4, 17, 19-20, and 22-24, Claims 4, 17, 19-20, and 22-24 depend from and further limit Claim 1 and recite abstract ideas for the same reasons as does Claim 1.
Regarding Claim 25:
“assess the subject's ejection fraction percentage status” recites a mental process for the same reasons as explained above with respect to the similar limitation of Claim 1.
Regarding Claim 26, Claim 26 is similar to Claim 2. Claim 26 recites mental processes for the same reasons as explained above with respect to Claim 2.
Regarding Claims 27 and 29-30, Claims 27 and 29-30 depend from and further limit Claims 1 and 25 and recite abstract ideas for the same reasons as do Claims 1 and 25.
Regarding Claim 44:
“assessing the ejection fraction percentage status for the subject as normal, mildly abnormal, moderately abnormal, or severely abnormal” recites a mental process when afforded its broadest reasonable interpretation. Such assessing is practically performable in the human mind, and is an evaluation. See MPEP 2106.04(a)(2) (III).
Regarding Claims 45-47, Claims 45-47 depend from and further limit Claims 1, 25 and 44 and recite abstract ideas for the same reasons as do Claims 1, 25 and 44.
Eligibility Step 2A, Prong Two:
Claims 1-4, 17, 19-20, 22-27, 29-30 and 44-47 do not amount to significantly more than the abstract ideas recited therein.
Regarding Independent Claim 1:
“an electrocardiogram (ECG) device and a processor: wherein the ECG device is wearable, wherein the ECG device has LII and LIII leads, wherein the ECG device is configured upon placement onto a subject to capture LII and LIII electrical signal waveform data from the subject via the LII and LIII leads over an extended period of time, wherein the ECG device is configured to wirelessly transmit LII and LIII electrical signal waveform data from the subject captured over an extended period of time to a processor” amounts to mere data gathering in conjunction with implementing the recited abstract idea (i.e., data upon which the abstract idea of “assessing” is based is gathered by the ECG), and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“wherein the processor comprises software that, when executed, causes the processor to manually or automatically” recites generic computer structures for performing generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
“provide a report to a user of the assessed ejection fraction percentage for the subject” amounts to mere data outputting in conjunction with implementing the recited abstract idea (i.e., the result of the abstract idea of “assessing” is output), and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Regarding Claim 2:
“resample the LII and LIII electrical signal waveform data captured over an extended period of time to 250Hz” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“derive LI waveform with resampled LI and LII waveform data” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“measure ventricular activation time (VAT) for derived lead aVR, wherein the VAT is measured from the onset of the QRS complex to the peak of the R wave” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“measure P-wave terminal velocity, wherein the P-wave terminal velocity is measured by multiplying the amplitude of the derived V2 in millimeters (mm) and the time duration of the derived V2 negative deflection in milliseconds (ms)” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“measure Global QRS derivation, wherein measuring the Global QRS derivation comprises looking at the direction and magnitude of the QRS complexes in the derived LI waveform data, LII waveform data, LIII waveform data” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“measure a vector of beat and rhythm burdens that includes quantified beat-type and rhythm with ST, PR, QT attributes” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“provide a report to a user of the assessed ejection fraction percentage for the subject” amounts to mere data outputting in conjunction with implementing the recited abstract idea (i.e., the result of the abstract idea of “assessing” is output), and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Regarding Claims 3-4, 17, 19-20 and 22-24, Claims 3-4, 17, 19-20 and 22-24 do not recite any additional elements.
Regarding Claim 25:
“placing the ECG device onto the subject” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“obtaining LII and LIII electrical signal waveform data captured over an extended period of time; wirelessly transmitting the obtained LII and LIII electrical signal waveform data captured over an extended period of time to the processor via the ECG device” amounts to mere data gathering in conjunction with implementing the recited abstract idea, and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
“provide a report to a user of the assessed ejection fraction percentage for the subject” amounts to mere data outputting in conjunction with implementing the recited abstract idea (i.e., the result of the abstract idea of “assessing” is output), and is thus insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Regarding Claim 26, Claim 26 is similar to Claim 2. Claim 26 does not integrate the recited abstract ideas into a practical application for the same reasons as explained above with respect to Claim 2.
Regarding Claims 27 and 29-30, Claims 27 and 29-30 do not recite any additional elements.
Regarding Claim 44:
“administering to the subject a therapeutic agent…” is extra-solution activity insufficient to integrate the abstract idea into a practical application.
Regarding Claims 45-47, Claims 45-47 do not recite any additional elements.
Eligibility Step 2B:
Claims 1-4, 17, 19-20, 22-27, 29-30 and 44-47 do not recite additional elements that integrate the recited judicial exception into a practical application.
Regarding Independent Claim 1:
“an electrocardiogram (ECG) device and a processor: wherein the ECG device is wearable, wherein the ECG device has LII and LIII leads, wherein the ECG device is configured upon placement onto a subject to capture LII and LIII electrical signal waveform data from the subject via the LII and LIII leads over an extended period of time, wherein the ECG device is configured to wirelessly transmit LII and LIII electrical signal waveform data from the subject captured over an extended period of time to a processor” does not contribute an inventive concept. The claimed electrocardiogram is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 20140276161 A1 at Para. [0002] (“Electrocardiogram (EKG, also known as ECG) devices are well-known in the prior art. They measure the electrical activity of the human heart using electrodes and create tracings of the activity on paper or on a visual display.”).
“wherein the processor comprises software that, when executed, causes the processor to manually or automatically” does not contribute an inventive concept. The claimed processor is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 20220343475 A1 at Para. [0015] (“As is well-known machine learning processors use a data processing algorithm to produce target output data from input data…”).
“provide a report to a user of the assessed ejection fraction percentage for the subject” does not contribute an inventive concept. Providing such a report is recited a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 20020133062 A1 at Para. [0024].
Regarding Claim 2:
“resample the LII and LIII electrical signal waveform data captured over an extended period of time to 250Hz” does not contribute an inventive concept. Such resampling amounts to gathering ECG signals. This is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 20140276161 A1 at Para. [0002]; IHARA, Z.; "Design and Performance of lead Systems for the Analysis of Atrial signal Components in the ECG;" THÈSE NO 3565 (2006), ÉCOLE POLYTECHNIQUE FÉDÉRALE DE LAUSANNE POUR L'OBTENTION DU GRADE DE DOCTEUR ÈS SCIENCES at Pg. xvii, First Paragraph (“For over a century, electrocardiology has been observing human cardiac activity through recordings of electrocardiograms (ECG). The potential differences derived from the nine electrodes of the standard 12-lead ECG, placed at their designated positions, are the expression of electric dynamics of which the heart is the source.”)
“derive LI waveform with resampled LI and LII waveform data” does not contribute an inventive concept. Such deriving is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., HARA, Z.; "Design and Performance of lead Systems for the Analysis of Atrial signal Components in the ECG;" THÈSE NO 3565 (2006), ÉCOLE POLYTECHNIQUE FÉDÉRALE DE LAUSANNE POUR L'OBTENTION DU GRADE DE DOCTEUR ÈS SCIENCES at Pg. xvii, First Paragraph.
“measure ventricular activation time (VAT) for derived lead aVR, wherein the VAT is measured from the onset of the QRS complex to the peak of the R wave” does not contribute an inventive concept. Measurement of ventricular activation time is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 6445950 B1 at Col. 4, Ln. 50-51.
“measure P-wave terminal velocity, wherein the P-wave terminal velocity is measured by multiplying the amplitude of the derived V2 in millimeters (mm) and the time duration of the derived V2 negative deflection in milliseconds (ms)” does not contribute an inventive concept. Such measurement of P-wave terminal velocity is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., L. Wolder et al., "Electrocardiographic P terminal force in lead V1, its components, and the association with stroke and atrial fibrillation or flutter," Heart Rhythm, 2022; 20, 354-362 (Abstract Only) at Abstract, “Background” Heading (“The electrocardiographic (ECG) marker P terminal force V1 (PTFV1) is generally perceived as a marker of left atrial pathology…”).
“measure Global QRS derivation, wherein measuring the Global QRS derivation comprises looking at the direction and magnitude of the QRS complexes in the derived LI waveform data, LII waveform data, LIII waveform data” does not contribute an inventive concept. Such measurement is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., Curtin AE, Burns KV, Bank AJ, Netoff TI. QRS Complex Detection and Measurement Algorithms for Multichannel ECGs in Cardiac Resynchronization Therapy Patients. IEEE J Transl Eng Health Med. 2018 Jun 5;6:1900211 at Pg. 1, Left Column, First Paragraph.
“measure a vector of beat and rhythm burdens that includes quantified beat-type and rhythm with ST, PR, QT attributes” does not contribute an inventive concept. The recited measurement is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., G. Marcus, "Evaluation and Management of Premature Ventricular Complexes," Circulation, Volume 141, Issue 17, 28 April 2020; Pages 1404-1418 at Pg. 1405, Left Column, First Paragraph.
“provide a report to a user of the assessed ejection fraction percentage for the subject” does not contribute an inventive concept. Providing such a report is recited a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 20020133062 A1 at Para. [0024].
Regarding Claims 3-4, 17, 19-20 and 22-24, Claims 3-4, 17, 19-20 and 22-24 do not recite any additional elements.
Regarding Claim 25:
“placing the ECG device onto the subject” does not contribute an inventive concept. The placed ECG device is recited and a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 20140276161 A1 at Para. [0002].
“obtaining LII and LIII electrical signal waveform data captured over an extended period of time; wirelessly transmitting the obtained LII and LIII electrical signal waveform data captured over an extended period of time to the processor via the ECG device” does not contribute an inventive concept for the same reasons as explained above with respect to the similar Claim 1 limitation.
“provide a report to a user of the assessed ejection fraction percentage for the subject” does not contribute an inventive concept for the same reasons as explained above with respect to the similar Claim 1 limitation.
Regarding Claim 26, Claim 26 is similar to Claim 2. Claim 26 does not contribute an inventive concept for the same reasons as explained above with respect to Claim 2.
Regarding Claims 27 and 29-30, Claims 27 and 29-30 do not recite any additional elements.
Regarding Claim 44:
“administering to the subject a therapeutic agent…” does not contribute an invention concept. Administration of such a therapeutic agent is recited at a high level of generality, and is well-understood, routine and conventional in the art. See, e.g., US 20200305734 A1 at Para. [0118].
Regarding Claims 45-47, Claims 45-47 do not recite any additional elements.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 17, 19-20, 24, 25-26 and 29-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2020/0397313 A11 to Attia et al. (“Attia”) as evidenced by ECG Learning Center, "The Standard 12 Lead ECG," https://ecg.utah.edu/lesson/1, accessed via WaybackMachine on 9/22/2026 via https://web.archive.org/web/20230425093325/ https://ecg.utah.edu/lesson/1; publication date April 25, 2023 (“Standard 12 Lead ECG”).
Regarding Independent Claim 1, Attia discloses:
A system for characterizing a subject's Ejection Fraction (EF) percentage status, comprising: (Abstract, “Systems, methods, devices, and techniques for estimating an ejection-fraction characteristic of a mammal.”);
providing an electrocardiogram (ECG) device and a processor: (Para. [0046], “FIG. 1 is a conceptual diagram of an example system 100 for recording and processing ECG data, and using the ECG data to estimate an ejection-fraction…;” Fig. 1, “electrodes 104,” and “ECG Processing System 110”);
wherein the ECG device is wearable, (Para. [0073], “…the electrodes may be provided in a wearable patch for continuous monitoring over a period of time.”);
wherein the ECG device has LII and LIII leads, (Para. [0006], “For the purposes of this specification, an electrocardiogram may include the traditional 12 leads, additional leads, or any number of leads to as few as a single lead.”);
Attia’s “traditional 12 lead” electrocardiogram “has LII and LIII leads.” See Standard 12 Lead ECG at Pg. 2 of 2, “Bipolar limb leads (frontal plane)” Heading, listing “Lead I,” “Lead II” and “Lead III” as included in a standard 12 lead ECG.
wherein the ECG device is configured upon placement onto a subject to capture LII and LIII electrical signal waveform data from the subject via the LII and LIII leads over an extended period of time, (Para. [0073], “…the electrodes may be provided in a wearable patch for continuous monitoring over a period of time;” Para. [0073], “An ejection-fraction prediction model can be trained and implemented based on data from any number of ECG leads, including a single lead, any multi lead configuration and a standard 12-lead ECG;” Para. [0058], “The ECG data may span a single cardiac cycle of the patient, a portion of a cardiac cycle, or multiple cardiac cycles.”);
Attia’s “traditional 12 lead” electrocardiogram “capture[s] LII and LIII electrical signal waveform data from the subject via the LII and LIII leads.” See Standard 12 Lead ECG at Pg. 2 of 2, “Bipolar limb leads (frontal plane)” Heading, listing “Lead I,” “Lead II” and “Lead III” as included in a standard 12 lead ECG.
For brevity, this interpretation is not reiterated in Claim 1, but applies to Claim 1 limitations wherein LII and LIII are recited. Attia’s “traditional 12 lead” ECG includes LII and LIII by virtue of being a “traditional 12 lead” ECG.
The Examiner notes that this interpretation is supported by the contrast in breadth between Claim 1 and Claim 4. Claim 4 recites “wherein the ECG has only two leads: LII and LIII, or wherein the ECG has three leads including at least LII and LIII” (emphasis added). Claim 1 does not limit the recited ECG to “only” LII and LIII.
In the interest of compact prosecution and given the inventive concept, the Examiner addresses the manner in which Claim 1 would be rejected were it to be so-limited below in the “Art Made of Record Although Not Relied Upon” section of this Office Action.
As noted above, the Present Specification lists over twenty examples of what “an extended period of time” may entail at Pg. 5-7. These examples span from as narrow a range as “between a 1-second … and less than or equal to a 2-second period of time” to as broad a range as “between a 0.00001 second … and less than or equal to a 6-month period of time.” Absent such specifics as listed in the Present Specification, the broadest reasonable interpretation of the term “an extended period of time” is that it includes almost any period of time. The term “an extended period of time” is so-interpreted herein. Attia’s “multiple cardiac cycles” is such an “extended period of time.”
wherein the ECG device is configured to wirelessly transmit LII and LIII electrical signal waveform data from the subject captured over an extended period of time to a processor, (Para. [0050], describing transmission of ECG data to “ECG processing system 110” which “may or may not be in the same physical location as the patient 102 and the data recorder;” data transmission to a processing system that is in a different physical location than the patient from whom data is gathered is wireless; see Paras. [0080], [0083], and [0084] detailing various such wireless communication means; Para. [0073]);
and wherein the processor comprises software that, when executed, causes the processor to manually or automatically: (Paras. [0051] through [0055]; Paras. [0090] through [0091], describing the models of Paras. [0051] through [0055] as “computer programs” which include “machine instructions for a programmable processor”);
- receive LII and LIII electrical signal waveform data captured over an extended period of time from a subject wirelessly transmitted from the ECG device; and (Para. [0073]; Fig. 2, “Obtain ECG Date 202;” Para. [0058]);
- utilize the received LII and LIII electrical signal waveform data captured over an extended period of time to: assess the subject's ejection fraction percentage status; (Para. [0073]; Para. [0058], “ At stage 210, the ejection-fraction prediction model processes the predictive inputs that represent the patient's ECG result to generate an estimated (predicted) ejection-fraction characteristic. In some implementations (212), the ejection-fraction characteristic is an absolute estimate of the patient's ejection fraction that identifies a specific value for the ejection fraction;” Fig. 2, “Process Predictive Inputs With EF-Prediction Model to Generate EF Prediction 210”);
The Examiner notes that Attia measures ejection fraction in percent. See Attia at Para. [0003], “The percentage of blood that actually is ejected from the ventricles during a pumping cycle is referred to as the ejection fraction.”
The term “status” is being interpreted in accordance with its plain meaning to modify the term “ejection fraction percentage” such that it is a current state of the ejection fraction with respect to ECG data.
and provide a report to a user of the assessed ejection fraction percentage for the subject. (Para. [0058], “ The system then stores and/or outputs the estimated ejection-fraction characteristic at stage 216, e.g., for presentation to the patient or his or her healthcare provider;” Fig. 2, “Output EF Prediction 216”).
Regarding Claim 2, Attia discloses the entirety of Claim 1 as explained above.
Attia additionally discloses:
wherein the software, when executed, is configured to accomplish one or more of the following: - resample the LII and LIII electrical signal waveform data captured over an extended period of time to 250Hz; - derive LI waveform with resampled LI and LII waveform data; - utilize the derived LI waveform and resampled LII and LIII waveform data to derive the following other bipolar frontal leads: aVF, aVR and aVL; - estimate a Wilson Central Terminal Reference potential with a spatial vector cardiography transform; e approximate a beat-by-beat maxima for pre-cordial leads V1 thru V6 with the spatial vector cardiography transform; - filter the derived LI waveform data, LII waveform data, LIII waveform data, aVF data, aVR data, aVL data, Wilson Central Terminal Reference potential, and V1 thru V6 data to remove motion (and other) artifacts; - calculate a spectral entropy for each heartbeat over the time period and remove all heartbeats above a pre-set threshold model; - compute PR, QT, ST interval for remaining stable heart-beats; - compute windowed HRV; - measure ventricular activation time (VAT) for derived lead aVR, wherein the VAT is measured from the onset of the QRS complex to the peak of the R wave; - measure P-wave terminal velocity, wherein the P-wave terminal velocity is measured by multiplying the amplitude of the derived V2 in millimeters (mm) and the time duration of the derived V2 negative deflection in milliseconds (ms); - measure Global QRS derivation, wherein measuring the Global QRS derivation comprises looking at the direction and magnitude of the QRS complexes in the derived LI waveform data, LII waveform data, LIII waveform data; - measure a vector of beat and rhythm burdens that includes quantified beat-type and rhythm with ST, PR, QT attributes; - synthesize the measured VAT, the measured P-wave terminal velocity, the measured Global QRS derivation, and the measured vector of beat and rhythm burdens into an Ejection Fraction (EF) biomarker value; - assess the subject's ejection fraction percentage status through comparing the subject's synthesized EF biomarker value with established EF biomarker value norms correlated with specific ejection fraction percentages; and - provide a report to a user of the assessed ejection fraction percentage for the subject. (Para. [0058], “ The system then stores and/or outputs the estimated ejection-fraction characteristic at stage 216, e.g., for presentation to the patient or his or her healthcare provider;” Fig. 2, “Output EF Prediction 216”).
Regarding Claim 3, Attia discloses the entirety of Claim 2 as explained above.
Attia additionally discloses:
wherein the software is configured to implement artificial intelligence (AI) based predictive analysis in assessing the subject's ejection fraction percentage status through comparing the subject's synthesized EF biomarker value with established EF biomarker value norms correlated with specific ejection fraction percentages (Para. [0099]; Para. [0107]; “Primary Outcome—AI Augmented ECG to Identify a Low EF. …;” Para. [0108], “Secondary Outcome—AI Augmented ECG to Predict a Future Low EF.;” Paras. [0112] through [0115]; Para. [0045], “…machine-learning models such as neural networks are configured to process predictive inputs that characterize ECG data and output an indication of the estimated ejection fraction of a mammal.”).
Regarding Claim 4, Attia discloses the entirety of Claim 1 as explained above.
Attia additionally discloses:
wherein the ECG has only two leads: LII and LIII, or wherein the ECG has three leads including at least LII and LIII. (Para. [0073], “Although a number of examples are described herein … us[e] data from a standard 12-lead ECG, in other implementations fewer leads—including even a single-lead—ECG, can be used…. An ejection-fraction prediction model can be trained and implemented based on data from any number of ECG leads, including a single lead, any multi lead configuration and a standard 12-lead ECG.”).
Attia’s “standard 12-lead ECG” includes LII and LIII leads. See Rejection of Claim 1 above, elaborating.
Regarding Claim 17, Attia discloses the entirety of Claim 1 as explained above.
Attia additionally discloses:
wherein the EF is left ventricular ejection fraction (LVEF) (Para. [0003], “Although ejection fraction often relates only to the measurement of the fraction of blood ejected from the left ventricle, for purposes of this specification, ejection fraction can alternatively refer to the fraction of blood ejected from the left ventricle alone, the right ventricle alone, or both ventricles….”).
Regarding Claim 19, Attia discloses the entirety of Claim 1 as explained above.
Attia additionally discloses:
wherein the subject is a human subject experiencing or at risk of experiencing a cardiovascular event (Abstract; Para. [0014], “The mammal can be a human;” Para. [0063], discussing measures that can be taken if “the patient's ejection-fraction … is deemed risky or unsafe,” which measures include “ beta blockers, angiotensin receptor antagonists, statins (in coronary artery disease), implantable defibrillators, cardiac resynchronization devices”).
The Examiner notes that Claim 19 is being interpreted to further limit Claim 1 in that it expands on the “a subject” whose “Ejection Fraction (EF) percentage status” the system is “for characterizing.” That is, Claim 19 is being interpreted to further limit the type of subject upon whom EF percentage may be characterized such that it includes “a human subject experiencing or at risk of experiencing a cardiovascular event.”
Attia’s device is capable of charactering EF percentage in such a subject, as evidenced by Attia at Abstract, Para. [0014] and Para. [0063].
Regarding Claim 20, Attia discloses the entirety of Claim 19 as explained above.
Attia additionally discloses:
wherein the cardiovascular event is one or more cardiovascular events selected from heart failure, congenital heart disease, heart attack, myocarditis, high blood pressure, low blood pressure, ATTR amyloidoisis, cardiotoxicity, ventricular arrhythmia, heart failure risk, cardiomyopathy, arrhythmias, impairment of cardiac pumping, etc. (Para. [0004], describing such low ejection fraction as can be deduced via Attia’s methodology as a pertinent marker for heart failure; Para. [0063], describing various treatments for conditions which Attia’s device can diagnose, which treatments are derived from “2013 ACCF/AHA Guideline for the Management of Heart Failure”).
As noted above with respect to Claim 19, Claim 20 is being interpreted as further limiting Claim 1 in that it expands on the “a subject” whose “Ejection Fraction (EF) percentage status” the system is “for characterizing.” Attia’s device is capable of charactering EF percentage in such a subject with heart failure, as evidenced by Attia at Paras. [0004] and [0063].
Regarding Claim 24, Attia discloses the entirety of Claim 1 as explained above.
Attia additionally discloses:
wherein the ECG device does not include the processor (Paras. [0049] through [0050], describing Attia’s processing being done via “ECG processing system 110” rather than via a processor in Attia’s ECG device itself).
Regarding Claim 25, Attia discloses the entirety of Claim 1 as explained above.
Attia additionally discloses:
A method for characterizing a subject's Ejection Fraction (EF) percentage status, comprising: (Abstract, “Systems, methods, devices, and techniques for estimating an ejection-fraction characteristic…”);
- providing a system recited in claim 1; (see Rejection of Claim 1, above);
- placing the ECG device onto the subject; (Para. [0047], “A set of electrodes 104 are disposed on a surface of the patient 102 to enable recording of signals indicating the cardiac electrical activity…”);
- obtaining LII and LIII electrical signal waveform data captured over an extended period of time; (Para. [0073], “…the electrodes may be provided in a wearable patch for continuous monitoring over a period of time;” Para. [0073], “An ejection-fraction prediction model can be trained and implemented based on data from any number of ECG leads, including a single lead, any multi lead configuration and a standard 12-lead ECG;” Para. [0058], “The ECG data may span a single cardiac cycle of the patient, a portion of a cardiac cycle, or multiple cardiac cycles.”);
Attia’s “traditional 12 lead” electrocardiogram includes LII and LIII, as explained above with respect to Claim 1.
- wirelessly transmitting the obtained LII and LIII electrical signal waveform data captured over an extended period of time to the processor via the ECG device; (Para. [0050], describing transmission of ECG data to “ECG processing system 110” which “may or may not be in the same physical location as the patient 102 and the data recorder;” data transmission to a processing system that is in a different physical location than the patient from whom data is gathered is wireless; see Paras. [0080], [0083], and [0084] detailing various such wireless communication means; Para. [0073]);
- executing the software to: assess the subject's ejection fraction percentage status; (Para. [0073]; Para. [0058], “ At stage 210, the ejection-fraction prediction model processes the predictive inputs that represent the patient's ECG result to generate an estimated (predicted) ejection-fraction characteristic. In some implementations (212), the ejection-fraction characteristic is an absolute estimate of the patient's ejection fraction that identifies a specific value for the ejection fraction;” Fig. 2, “Process Predictive Inputs With EF-Prediction Model to Generate EF Prediction 210”);
and provide a report to a user of the assessed ejection fraction percentage for the subject. (Para. [0058], “ The system then stores and/or outputs the estimated ejection-fraction characteristic at stage 216, e.g., for presentation to the patient or his or her healthcare provider;” Fig. 2, “Output EF Prediction 216”).
Regarding Claim 26, Attia discloses the entirety of Claim 1 as explained above.
Attia additionally discloses:
wherein executing the software comprises one or more of the following:- resampling the LII and LIII electrical signal waveform data captured over an extended period of time to 250Hz;- deriving LI waveform with resampled LI and LII waveform data;- utilizing the derived LI waveform and resampled LII and LIII waveform data to derive the following other bipolar frontal leads: aVF, aVR and aVL;- estimating a Wilson Central Terminal Reference potential with a spatial vector cardiography transform;- approximating a beat-by-beat maxima for pre-cordial leads V1 thru V6 with the spatial vector cardiography transform;- filtering the derived LI waveform data, LII waveform data, LIII waveform data, aVF data, aVR data, aVL data, Wilson Central Terminal Reference potential, and V1 thru V6 data to remove motion (and other) artifacts; - calculating a spectral entropy for each heartbeat over the time period and remove all heartbeats above a pre-set threshold model; - computing PR, QT, ST interval for remaining stable heart-beats; - computing windowed HRV; - measuring ventricular activation time (VAT) for derived lead aVR, wherein the VAT is measured from the onset of the QRS complex to the peak of the R wave; - measuring P-wave terminal velocity, wherein the P-wave terminal velocity is measured by multiplying the amplitude of the derived V2 in millimeters (mm) and the time duration of the derived V2 negative deflection in milliseconds (ms); - measuring Global QRS derivation, wherein measuring the Global QRS derivation comprises looking at the direction and magnitude of the QRS complexes in the derived LI waveform data, LII waveform data, LIII waveform data; - measuring a vector of beat and rhythm burdens that includes quantified beat-type and rhythm with ST, PR, QT attributes; - synthesizing the measured VAT, the measured P-wave terminal velocity, the measured Global QRS derivation, and the measured vector of beat and rhythm burdens into an Ejection Fraction (EF) biomarker value; e assessing the subject's ejection fraction percentage status through comparing the subject's synthesized EF biomarker value with established EF biomarker value norms correlated with specific ejection fraction percentages; and - providing a report to a user of the assessed ejection fraction percentage for the subject. (Para. [0058], “ The system then stores and/or outputs the estimated ejection-fraction characteristic at stage 216, e.g., for presentation to the patient or his or her healthcare provider;” Fig. 2, “Output EF Prediction 216”).
Regarding Claim 29, Claim 29 is similar to Claim 19. Attia discloses the entirety of Claim 29 for the same reasons as explained above with respect to Claim 19.
Regarding Claim 30, Claim 30 is similar to Claim 20. Attia discloses the entirety of Claim 30 for the same reasons as explained above with respect to Claim 20.
Claim 1 is alternatively rejected under 35 U.S.C. 102(a)(1) as being anticipated by BR 102021023399 A22 to Cloves et al. (“Cloves”) as evidenced by American Heart Association, heart.org, "Ejection Fraction Heart Failure Measurement," accessed online on 9/8/2026 via https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement (2026) (“heart.org”).
Regarding Independent Claim 1, Cloves teaches:
A system for characterizing a subject's Ejection Fraction (EF) percentage status, comprising: (Para. [00l]: "the present invention is a new method and system for enhancing the analysis and interpretation of electrocardiograms (ECGs) ... which are tools used to determine the ejection;” Para. [005]: "The method of ejection fraction has the need for additional examination of echocardiography. The current method contemplates various considerations to achieve the final value.”);
providing an electrocardiogram (ECG) device and a processor: (Para. [059], “The system includes one or more electrodes for acquiring ECG signals 10 ( e.g., a traditional ECG electrodes 12 Repeat taps), an interface for the connection of … Electrodes either to the processing system….”);
wherein the ECG device is wearable, wherein the ECG device has LII and LIII leads, wherein the ECG device is configured upon placement onto a subject to capture LII and LIII electrical signal waveform data from the subject via the LII and LIII leads over an extended period of time, (Fig. 2; Para. [035]: "The vectors to be extracted from the chart (Einthoven's triangle), vectors I, II and III, points 1, 2 by means of sensors installed in the patient (Figure 2 and 3)…;” Para. [044], detailing “the default configuration” for electrode placement, which placement corresponds to that claimed);
wherein the ECG device is configured to wirelessly transmit LII and LIII electrical signal waveform data from the subject captured over an extended period of time to a processor, (Paras. [035] through [036], “Those sensors will be linked to a data reading module, located in the patient is connected to the sensors via plug's, composed of analog input, filters, converters, processors and Bluetooth communication, … where it is capable of transferring the data collected from the patient to the analysis module…. The analysis module … is housed within the doctor's office at an average distance of 10 meters from the patient and communicates with the data reading module.”);
and wherein the processor comprises software that, when executed, causes the processor to manually or automatically: (Para. [036]: "The analysis module and detection of heart conditions is housed within the doctor's office at an average distance of 10 meters from the patient and communicates with the data reading module. This module performs reading data via Bluetooth and has shipped in your hardware the mathematical method of Magnetic Map ‘3D.’”);
- receive LII and LIII electrical signal waveform data captured over an extended period of time from a subject wirelessly transmitted from the ECG device; and (Para. [035]: "vectors I, II and III ... via Bluetooth…”);
- utilize the received LII and LIII electrical signal waveform data captured over an extended period of time to: assess the subject's ejection fraction percentage status; (Para. [038]: “Through the method and system of the present invention it is possible to determine the condition of a disease;” Paras. [00l] and [005], discussing “ejection fraction” as a determination made; Para. [005], “The method of ejection fraction has the need for additional examination of echocardiography. The current method contemplates various considerations to achieve the final value….”);
The Examiner notes that ejection fraction is measured in units of percent (see heart.org at Pg. 1 of 4, Third Paragraph from Bottom of Page, “EF [(Ejection Fraction)] is measured as a percentage.”). Thus, despite Cloves’s omission of the term “percentage,” Cloves’s determination of “the final value” of ejection fraction is a percentage.
and provide a report to a user of the assessed ejection fraction percentage for the subject. (FIG. 9, Para. [060] “The system further includes a display device to provide the results of the ECG (including, for example, ECGs, Cardiac Impulse Current, Cardiac Potential Cardiac Geometric Place map, and the map itself extensive cardiologic magnetic vectors and/or various metrics and quantitative indexes);” Paras. [00l] and [005]; reasonably assuming the ejection fraction is one of the results provided as it is one of the measures stated as requiring the instant method).
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 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0397313 A1 to Attia et al. (“Attia”) as applied to Claim 1 above, and further in view of US 2019/0269344 A1 to Shah (“Shah”).
Regarding Claim 22, Attia discloses the entirety of Claim 1 as explained above.
Attia does not disclose:
wherein the ECG device is configured to wirelessly transmit via Bluetooth, WI-FI, SD-card, and/or any type or kind of mobile data network.
Shah describes “An electrocardiogram (“ECG”) system…” (Abstract). Shah is analogous art.
Shah teaches:
wherein the ECG device is configured to wirelessly transmit via Bluetooth, WI-FI, SD-card, and/or any type or kind of mobile data network. (Para. [0061], “…each electrode, bracelet and chest piece can comprise a processor and/or a wireless transceiver (e.g., Bluetooth transceiver, WiFi transceiver, etc.) or transmitter to transmit the ECG data to a transceiver in the ECG device 12 or in the user device 14.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Attia with the teachings of Shah (i.e., to modify the device of Attia such that its ECG device is configured to wirelessly transmit via Bluetooth in the manner of Shah) in order to facilitate implementation of a mobile ECG system, which is beneficial in that its mobility results in reduced costs to both patients and medical providers (Shah at Para. [0021]).
Regarding Claim 23, Attia discloses the entirety of Claim 1 as explained above.
Attia does not disclose:
wherein the ECG device includes the processor. (Para. [0061], “…each electrode, bracelet and chest piece can comprise a processor and/or a wireless transceiver (e.g., Bluetooth transceiver, WiFi transceiver, etc.) or transmitter to transmit the ECG data to a transceiver in the ECG device 12 or in the user device 14.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Attia with the teachings of Shah (i.e., to modify the device of Attia such that its ECG device includes a processor in the manner of Shah) in order to facilitate implementation of a mobile ECG system, which is beneficial in that its mobility results in reduced costs to both patients and medical providers (Shah at Para. [0021]).
Claims 27 and 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0397313 A1 to Attia et al. (“Attia”) as applied to Claim 1 above, and further in view of Hudson S, "What is ‘normal’ left ventricular ejection fraction?" Heart 2020; 106:1445–1446 (“Hudson”).
Regarding Claim 27, Attia discloses the entirety of Claim 25 as explained above.
Attia does not disclose:
wherein a subject's assessed ejection fraction percentage of equal to or greater than 52% for a male and equal to or greater than 54% for a female indicates a normal EF percentage; wherein a subject's assessed ejection fraction percentage of 41% to 51% for a male and 41% to 53% for a female indicates a mildly abnormal EF percentage; wherein a subject's assessed ejection fraction percentage of between 30% to 40% for a male or female indicates a moderately abnormal EF percentage; wherein a subject's assessed ejection fraction percentage of less than 30% for a male or female indicates a severely abnormal EF percentage.
Hudson describes “Categorisation of LVEF” (Pg. 1445, Left Column, Second Paragraph). Hudson is analogous art.
Hudson teaches:
wherein a subject's assessed ejection fraction percentage of equal to or greater than 52% for a male and equal to or greater than 54% for a female indicates a normal EF percentage; wherein a subject's assessed ejection fraction percentage of 41% to 51% for a male and 41% to 53% for a female indicates a mildly abnormal EF percentage; wherein a subject's assessed ejection fraction percentage of between 30% to 40% for a male or female indicates a moderately abnormal EF percentage; wherein a subject's assessed ejection fraction percentage of less than 30% for a male or female indicates a severely abnormal EF percentage; (Pg. 1445, Figure 1, “ASE/EACVI” categories; see Annotated Figure 1, below).
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It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Attia with the teachings of Hudson (i.e., to use such categories of normal, mildly abnormal, moderately abnormal, or severely abnormal and their associated EF percentages as taught by Hudson) because such a categorization system in order to comport with the standards of the American Society of Echocardiography and the European Association of Cardiovascular Imaging (Hudson at Pg. 1445, Left Column, Second Paragraph)
Regarding Claim 44, Attia discloses the entirety of Claim 1 as explained above.
Attia additionally discloses:
A method of treating or preventing reduced ejection fraction (HFrEF) in a subject, comprising: (Para. [0063]);
providing a system recited in claim 1; (see Rejection of Claim 1, above);
- assessing the ejection fraction percentage status for the subject as [very low ejection fraction, low ejection fraction, or normal ejection fraction] (Para. [0058], “In other implementations (214), the ejection-fraction characteristic is a category or range of ejection-fraction values (e.g., very low ejection fraction, low ejection fraction, or normal ejection fraction). For example, the ejection-fraction model may be trained to classify a patient's ejection fraction into one of two, three, or more possible ejection-fraction categories defined by specified threshold ejection-fraction values.”);
Attia’s describes “very low ejection fraction, low ejection fraction, or normal ejection fraction” and additionally describes “more possible ejection-fraction categories defined by specified threshold ejection-fraction values.” However, Attia does not fairly disclose the specific four-category system of “normal, mildly abnormal, moderately abnormal, or severely abnormal.” This deficiency is addressed below.
- administering to the subject a therapeutic agent capable of treating or preventing heart failure with reduced ejection fraction if the subject's assessed ejection fraction percentage status is mildly abnormal, moderately abnormal, or severely abnormal. (Para. [0063], “…if … the patient's ejection-fraction characteristic is a classification into a range of ECG values that is deemed risky or unsafe, therapeutic medicine can be administered to the patient, or treatment can be performed on the patient. Such medicine or treatment may include beta blockers, angiotensin receptor antagonists, statins (in coronary artery disease), implantable defibrillators, cardiac resynchronization devices and other well defined treatments (see 2013 ACCF/AHA Guideline for the Management of Heart Failure. Circulation. 2013; 128:e240-e327; and 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure, Circulation. 2016; 134:e282-e293)” (emphasis added)).
Attia does not disclose:
normal, mildly abnormal, moderately abnormal, or severely abnormal;
Hudson describes “Categorisation of LVEF” (Pg. 1445, Left Column, Second Paragraph). Hudson is analogous art.
Hudson teaches:
normal, mildly abnormal, moderately abnormal, or severely abnormal; (Pg. 1445, Figure 1, “ASE/EACVI” categories; see Annotated Figure 1, above).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Attia with the teachings of Hudson (i.e., to use such categories of normal, mildly abnormal, moderately abnormal, or severely abnormal as taught by Hudson) because such a categorization system in order to comport with the standards of the American Society of Echocardiography and the European Association of Cardiovascular Imaging (Hudson at Pg. 1445, Left Column, Second Paragraph).
Regarding Claim 45, the combination of Attia and Hudson renders obvious the entirety of Claim 44 as explained above.
Hudson additionally teaches:
wherein a subject's assessed ejection fraction percentage of equal to or greater than 52% for a male and equal to or greater than 54% for a female indicates a normal EF percentage; wherein a subject's assessed ejection fraction percentage of 41% to 51% for a male and 41% to 53% for a female indicates a mildly abnormal EF percentage; wherein a subject's assessed ejection fraction percentage of between 30% to 40% for a male or female indicates a moderately abnormal EF percentage; wherein a subject's assessed ejection fraction percentage of less than 30% for a male or female indicates a severely abnormal EF percentage. (Pg. 1445, Figure 1, “ASE/EACVI” categories; see Annotated Figure 1, above).
Regarding Claim 46, the combination of Attia and Hudson renders obvious the entirety of Claim 44 as explained above.
Attia additionally teaches:
wherein the therapeutic agent is selected from an ACE inhibitor, an ARB inhibitor, an ARB/neprilysin inhibitor, a beta blocker, an aldosterone antagonist, isosorbide dintrate/hydralazine, a diueretic, and ivabradine. (Para. [0063], “ Such medicine or treatment may include beta blockers…”).
Regarding Claim 47, the combination of Attia and Hudson renders obvious the entirety of Claim 44 as explained above.
Hudson additionally teaches
wherein the subject is a human subject experiencing or at risk of experiencing heart failure with HFrEF. (Pg. 1445, Figure 1, “ACC/AHA HF Guidelines” and “ESC HF Guidelines” categorize patients with <40% EF as “HF reduced EF =HFrEH”).
Art Made of Record Although Not Relied Upon
The Examiner notes the following prior art which is deemed relevant although not relied upon in any foregoing rejection:
US 2011/0306859 A13 to Saldivar et al. (“Saldivar”) describes an ECG configuration wherein only three leads (LI, LII and LIII) arranged in an Einthoven triangular arrangement are used for sensing (see, e.g., Saldivar at Abstract).
Were Claim 1 to require “only” leads LII and LIII as appears to be the inventive concept, Claim 1 would likely be rejected in view of Saldivar.
Proulx, R. Clifford, S. Sorensen, Dah-Jye Lee and J. Archibald, "Development and Evaluation of a Bluetooth EKG Monitoring Sensor," 19th IEEE Symposium on Computer-Based Medical Systems (CBMS'06), Salt Lake City, UT, USA, 2006, pp. 507-511 (“Proulx”) describes “a 3-lead EKG circuit” which “measures differential voltages on the chest and on the left leg or in an alternate configuration on both arms” (Pg. 509, Heading 3.1) employing an Einthoven’s triangle (Figure 1).
Were Claim 1 to require “only” leads LII and LIII as appears to be the inventive concept, Claim 1 could alternatively be rejected in view of Proulx.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
1 US 2020/0397313 A1 was disclosed by Applicant in the IDS dated 4/1/2026.
2 BR 102021023399 A2 was disclosed by Applicant in the IDS dated 4/1/2026.
3 US 2011/0306859 A1 was disclosed by Applicant in the IDS dated 4/1/2026.
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