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 Rejections - 35 USC § 112
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 3, 7, 8 and 10, and Claim 4 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 Claim 3, Claims 3 recites “the sinus rhythm.” There is insufficient antecedent basis for this term.
Further regarding Claim 3, Claim 3 recites “wherein the data processing unit is configured to define a sequence of states of the individual's heart rhythm taken among the arrhythmias and the sinus rhythm from sets of global indicators generated for successive time windows.” It is grammatically unclear in what sense this limitation further limits Claim 1.
It is grammatically unclear which claim element the term “taken among the arrhythmias and the sinus rhythm” is intended to modify (e.g., the “sequence of states” is so-taken, the “individual’s heart rhythm” is so-taken, etc.).
It is grammatically unclear which claim element the term “from sets of global indicators generated for successive time windows” is intended to modify.
For purposes of this Office Action, Claim 3 is being interpreted to mean that the system labels consecutive heartbeats in the manner of Claim 1.
Regarding Claim 7, Claim 7 recites “the set of statistical indicators representative of the time distribution of the R-R intervals.” There is insufficient antecedent basis for this term.
Regarding Claim 8, Claim 7 recites “the set of statistical indicators representative of the time distribution of the R-R intervals.” There is insufficient antecedent basis for this term.
Regarding Claim 10, Claim 10 recites “the acquisition system.” There is insufficient antecedent basis for this term.
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 1-14 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.
Regarding Independent Claim 1, Claim 1 is ineligible.
Eligibility Step 1: Claim 1 is directed to “system” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 1 recites an abstract idea.
“generating a first set of indicators of probability of presence of the arrhythmia in the time window using a first classifier using values of the set of at least one lead …” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation. “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP2106.04(a)(2)(I)(C). Generating indicators using a classifier in the manner claimed is such a mathematical operation.
“generating a second set of indicators of probability of presence of the arrhythmia in the time window using a second classifier using first portions including a portion preceding an R wave, of combinations of second portions of beats of the set of at least one lead” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation for the same reasons as explained above.
“generating a third set of indicators of probability of presence of the arrhythmia in the time window using a third classifier using a set of statistical indicators representative of the R-R interval distribution of the electrocardiogram” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation for the same reasons as explained above.
“… generate a set of global indicators comprising global indicators of probabilities of presence of arrhythmias in the time window, using a global classifier using an input vector generated from the sets of indicators generated for the arrhythmias” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation for the same reasons as explained above.
Eligibility Step 2A, Prong Two: Claim 1 does not recite additional elements that integrate the judicial exception into a practical application.
“A system for characterizing a heart rhythm comprising a data processing unit configured to generate, by computer…” amounts to merely reciting the words “apply it” with the judicial exception, and as such is insufficient to integrate the recited abstract idea into a practical application. See MPEP 2106.04(d)(I).
Eligibility Step 2B: Claim 1 does not amount to significantly more than the abstract ideas recited therein.
“A system for characterizing a heart rhythm comprising a data processing unit configured to generate, by computer…” does not contribute an inventive concept. Such applying is a mere instruction to apply the judicial exception. Mere instructions to apply a judicial exception cannot provide an inventive concept. MPEP 2106.05(f).
Regarding Claim 2, Claim 2 is ineligible.
Eligibility Step 1: Claim 2 is directed to “system” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 2 recites an abstract idea.
“…discriminate a sinus rhythm from the arrythmia…” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation. “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP2106.04(a)(2)(I)(C). Discriminating using a classifier in the manner claimed is such a mathematical operation.
Eligibility Step 2A, Prong Two: Claim 2 does not recite additional elements, and thus does not integrate the judicial exception into a practical application.
Eligibility Step 2B: Claim 2 does not recite additional elements, and thus does not amount to significantly more than the abstract ideas recited therein.
Regarding Claim 3, Claim 3 is ineligible.
Eligibility Step 1: Claim 3 is directed to “system” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 3 recites an abstract idea.
“…define a sequence of states of the individual’s heart rhythm…” recites an abstract idea (specifically, a mental process) when afforded its broadest reasonable interpretation. Such defining is practically performable in the human mind. For example, a human could observe data reflective of heart rhythm and exercise judgment to define such a sequence of states based thereupon.
Eligibility Step 2A, Prong Two: Claim 3 does not recite additional elements, and thus does not integrate the judicial exception into a practical application.
Eligibility Step 2B: Claim 3 does not recite additional elements, and thus does not amount to significantly more than the abstract ideas recited therein.
Regarding Claim 4, Claim 4 is ineligible.
Eligibility Step 1: Claim 4 is directed to “system” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 4 recites an abstract idea.
“…wherein the definition of the sequence of states uses a Viterbi algorithm…” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation. “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP2106.04(a)(2)(I)(C). Using a Viterbi algorithm in the manner claimed is such a mathematical operation.
Eligibility Step 2A, Prong Two: Claim 4 does not recite additional elements, and thus does not integrate the judicial exception into a practical application.
Eligibility Step 2B: Claim 4 does not recite additional elements, and thus does not amount to significantly more than the abstract ideas recited therein.
Regarding Claims 5-6, Claims 5-6 are ineligible. Claims 5-6 fall within one of the four statutory categories. Claims 5-6 further limit the abstract ideas recited in Claim 1. Claims 5-6 do not contain any additional elements, and therefore do not integrate the recited abstract ideas into a practical application and do not contribute an inventive concept.
Regarding Claim 7, Claim 7 is ineligible.
Eligibility Step 1: Claim 7 is directed to “system” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 7 recites an abstract idea.
“…parameterizing a Gaussian mixture model so as to obtain parameters of the Gaussian mixture comprising averages of Gaussians making up the model…” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation. “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP2106.04(a)(2)(I)(C). Parameterizing a Gaussian mixture model in the manner claimed is such a mathematical operation.
“generating first statistical indicators of the set of statistical indicators representative of the distribution of the R-R intervals of the electrocardiogram from the Gaussian averages” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation. “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP2106.04(a)(2)(I)(C). Generating statistical indicators in the manner claimed is such a mathematical operation
Eligibility Step 2A, Prong Two: Claim 7 does not recite additional elements, and thus does not integrate the judicial exception into a practical application.
Eligibility Step 2B: Claim 7 does not recite additional elements, and thus does not amount to significantly more than the abstract ideas recited therein.
Regarding Claim 8, Claim 8 is ineligible.
Eligibility Step 1: Claim 8 is directed to “system” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 8 recites an abstract idea.
“…generating a sequence of relationships between consecutive R- R intervals …” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation. “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP2106.04(a)(2)(I)(C). Generating a sequence of relationships in the manner claimed is such a mathematical operation.
“generating input indicators of probabilities of presence of the arrhythmia from the sequence of relationships using an R-R ratio classifier” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation. “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP2106.04(a)(2)(I)(C). Generating input indicators in the manner claimed is such a mathematical operation
Eligibility Step 2A, Prong Two: Claim 8 does not recite additional elements, and thus does not integrate the judicial exception into a practical application.
Eligibility Step 2B: Claim 8 does not recite additional elements, and thus does not amount to significantly more than the abstract ideas recited therein.
Regarding Claim 9, Claim 9 is ineligible.
Eligibility Step 1: Claim 9 is directed to “system” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 9 depends from and further limits Claim 1, and recites an abstract idea for the same reasons as Claim 1.
Eligibility Step 2A, Prong Two: Claim 9 does not integrate the judicial exception into a practical application.
“an acquisition system comprising electrodes configured to acquire the set of at least one lead of the electrocardiogram of the individual” amounts to necessary data gathering in conjunction with the recited abstract idea, and is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Eligibility Step 2B: Claim 9 does not amount to significantly more than the abstract ideas recited therein.
“an acquisition system comprising electrodes configured to acquire the set of at least one lead of the electrocardiogram of the individual” does not contribute an inventive concept. Such electrodes are well-understood, routine and conventional. See, e.g., US 5772604 A at Col. 7, Ln. 51-61.
Regarding Claim 10, Claim 10 is ineligible. Claim 10 falls within one of the four statutory categories. Claim 10 further limit the abstract ideas recited in Claim 1. Claim 10 does not contain any additional elements, and therefore does not integrate the recited abstract ideas into a practical application and does not contribute an inventive concept.
Regarding Claim 11, Claim 11 is ineligible.
Eligibility Step 1: Claim 11 is directed to “system” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 11 depends from and further limits Claim 1, and recites an abstract idea for the same reasons as Claim 1.
Eligibility Step 2A, Prong Two: Claim 11 does not integrate the judicial exception into a practical application.
“wherein the set of at least one lead comprises several leads” amounts to necessary data gathering in conjunction with the recited abstract idea, and is insignificant extra-solution activity insufficient to integrate the judicial exception into a practical application.
Eligibility Step 2B: Claim 11 does not amount to significantly more than the abstract ideas recited therein.
“wherein the set of at least one lead comprises several leads” does not contribute an inventive concept. Such electrodes are well-understood, routine and conventional. See, e.g., US 5772604 A at Col. 7, Ln. 51-61.
Regarding Independent Claim 12, Claim 12 is ineligible.
Eligibility Step 1: Claim 12 is directed to a “method” (i.e., a process) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 1 recites an abstract idea.
“generating a first set of indicators of probability of presence of the arrhythmia in the time window using a first classifier using values of the set of at least one lead …” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation. “A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number….” MPEP2106.04(a)(2)(I)(C). Generating indicators using a classifier in the manner claimed is such a mathematical operation.
“generating a second set of indicators of probability of presence of the arrhythmia in the time window, using a second classifier from first portions, preceding the R wave, of combinations of second portions of beats of the set of at least one lead” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation for the same reasons as explained above.
“generating a third set of indicators of probability of presence of the arrhythmia in the time window using a third classifier using a set of statistical indicators representative of the R-R interval distribution of the electrocardiogram” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation for the same reasons as explained above.
“generating a set of global indicators comprising global indicators of probabilities of presence of arrhythmias in the time window, using a global classifier using an input vector generated from sets of indicators generated for the arrhythmias” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation for the same reasons as explained above.
Eligibility Step 2A, Prong Two: Claim 12 does not recite additional elements that integrate the judicial exception into a practical application.
“A method for characterizing a heart rhythm comprising the a generation, implemented by computer,…” amounts to merely reciting the words “apply it” with the judicial exception, and as such is insufficient to integrate the recited abstract idea into a practical application. See MPEP 2106.04(d)(I).
Eligibility Step 2B: Claim 12 does not amount to significantly more than the abstract ideas recited therein.
“A method for characterizing a heart rhythm comprising the a generation, implemented by computer,…” does not contribute an inventive concept. Such applying is a mere instruction to apply the judicial exception. Mere instructions to apply a judicial exception cannot provide an inventive concept. MPEP 2106.05(f).
Regarding Claim 13, Claim 13 is ineligible.
Eligibility Step 1: Claim 13 is directed to a “computer program product comprising a non- transitory readable information medium” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 13 depends from and further limits Claim 1, and recites an abstract idea for the same reasons as Claim 12.
Eligibility Step 2A, Prong Two: Claim 13 does not integrate the judicial exception into a practical application.
“A computer program product comprising a non- transitory readable information medium, on which a computer program comprising program instructions is stored, the computer program being loadable on a data processing unit” amounts to merely reciting the words “apply it” with the judicial exception, and as such is insufficient to integrate the recited abstract idea into a practical application. See MPEP 2106.04(d)(I).
Eligibility Step 2B: Claim 13 does not amount to significantly more than the abstract ideas recited therein.
“A computer program product comprising a non- transitory readable information medium, on which a computer program comprising program instructions is stored, the computer program being loadable on a data processing unit” does not contribute an inventive concept. Such applying is a mere instruction to apply the judicial exception. Mere instructions to apply a judicial exception cannot provide an inventive concept. MPEP 2106.05(f)
Regarding Claim 14, Claim 14 is ineligible.
Eligibility Step 1: Claim 14 is directed to a “non-transitory readable information medium” (i.e., an apparatus) and thus falls within one of the four statutory categories.
Eligibility Step 2A, Prong One: Claim 14 depends from and further limits Claim 1, and recites an abstract idea for the same reasons as Claim 12.
Eligibility Step 2A, Prong Two: Claim 14 does not integrate the judicial exception into a practical application.
“A non-transitory readable information medium including program instructions forming a computer program, the computer program being loadable on a data processing unit” amounts to merely reciting the words “apply it” with the judicial exception, and as such is insufficient to integrate the recited abstract idea into a practical application. See MPEP 2106.04(d)(I).
Eligibility Step 2B: Claim 14 does not amount to significantly more than the abstract ideas recited therein.
“A non-transitory readable information medium including program instructions forming a computer program, the computer program being loadable on a data processing unit” does not contribute an inventive concept. Such applying is a mere instruction to apply the judicial exception. Mere instructions to apply a judicial exception cannot provide an inventive concept. MPEP 2106.05(f)
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 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP0333435761 (“Yazdani”).
Regarding Independent Claim 1, Yazdani discloses:
A system for characterizing a heart rhythm comprising a data processing unit configured to generate, by computer, for each arrhythmia of a set of arrhythmias, from descriptors of a set of at least one lead of an electrocardiogram of an individual acquired during a time window, a set of indicators of probability of presence of the arrhythmia in the time window, the generation comprising: (Pg. 1, Right Column, First Full Paragraph);
generating a first set of indicators of probability of presence of the arrhythmia in the time window using a first classifier using values of the set of at least one lead, (Pg. 2, Left Column, Second Paragraph through Pg. 2, Right Column, First Paragraph; Figure 1; See Annotated Figure 1, below);
See Present Specification at Pg. 10, Fourth Paragraph in support of this interpretation (“Advantageously, each set of elementary classifiers associated with an arrhythmia comprises a first classifier, so-called morphological, a second classifier, so-called P wave analyzer, and a third classifier, so-called R-R analyzer.”).
Present Specification at Pg. 9, Sixth Paragraph explains that the “indicators” of Claim 1 are derived via the “classifiers” described at Present Specification at Pg. 10, Fourth Paragraph.
The Present Specification at Pg. 10, Fourth Paragraph describes the “first classifier” from which the “first set of indicators” is derived as “morphological.”
Yazdani’s “Generate First Set of Indicators” as denoted in Annotated Figure 1 entails “QRS-cycle Morphology Analysis.” Such morphology analysis is additionally described at Yazdani’s Pg. 2, Left Column, Second Paragraph through Pg. 2, Right Column, First Paragraph.
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generating a second set of indicators of probability of presence of the arrhythmia in the time window using a second classifier using first portions including a portion preceding an R wave, of combinations of second portions of beats of the set of at least one lead, (Pg. 2, Right Column, Second Paragraph through Pg. 3, Left Column, First Paragraph; Figure 1; See Annotated Figure 1, above);
See Present Specification at Pg. 10, Fourth Paragraph in support of this interpretation (“Advantageously, each set of elementary classifiers associated with an arrhythmia comprises a first classifier, so-called morphological, a second classifier, so-called P wave analyzer, and a third classifier, so-called R-R analyzer.”).
Present Specification at Pg. 9, Sixth Paragraph explains that the “indicators” of Claim 1 are derived via the “classifiers” described at Present Specification at Pg. 10, Fourth Paragraph.
The Present Specification at Pg. 10, Fourth Paragraph describes the “second classifier” from which the “second set of indicators” is derived as a “P wave analyzer.”
Yazdani’s “Generate Second Set of Indicators” as denoted in Annotated Figure 1 entails “P-wave/T-wave Analysis.” Such “P-wave/T-wave Analysis” is additionally described at Yazdani’s Pg. 2, Right Column, Second Paragraph through Pg. 3, Left Column, First Paragraph.
generating a third set of indicators of probability of presence of the arrhythmia in the time window using a third classifier using a set of statistical indicators representative of the R-R interval distribution of the electrocardiogram, (Pg. 3, Left Column, Second Paragraph through Pg. 3, Right Column, First Paragraph; Figure 1; See Annotated Figure 1, above);
See Present Specification at Pg. 10, Fourth Paragraph in support of this interpretation (“Advantageously, each set of elementary classifiers associated with an arrhythmia comprises a first classifier, so-called morphological, a second classifier, so-called P wave analyzer, and a third classifier, so-called R-R analyzer.”).
Present Specification at Pg. 9, Sixth Paragraph explains that the “indicators” of Claim 1 are derived via the “classifiers” described at Present Specification at Pg. 10, Fourth Paragraph.
The Present Specification at Pg. 10, Fourth Paragraph describes the “third classifier” from which the “third set of indicators” is derived as an “R-R analyzer.”
Yazdani’s “Generate Third Set of Indicators” as denoted in Annotated Figure 1 entails analysis of R-R Intervals. Such analysis of R-R Intervals is additionally described at Yazdani’s Pg. 3, Left Column, Second Paragraph through Pg. 3, Right Column, First Paragraph.
the data processing unit being configured to generate a set of global indicators comprising global indicators of probabilities of presence of arrhythmias in the time window, using a global classifier using an input vector generated from the sets of indicators generated for the arrhythmias. (Pg. 3, Right Column, Second and Third Paragraphs; Figure 1; See Annotated Figure 1, above)
Yazdani’s “Classification Result” is such a “set of global classifiers” as claimed. Yazdani’s “Classification Result” uses the output of Yazdani’s three classifiers as its “input vector” to generate a probability of presence of arrhythmias.
See Present Specification at Pg. 28, Third Paragraph in support of this interpretation.
Regarding Independent Claim 12, Yazdani discloses:
A method for characterizing a heart rhythm comprising the a generation, implemented by computer, for each arrhythmia of a set of arrhythmias, from descriptors of the set of at least one lead of an electrocardiogram of an individual acquired during the time window, of a set of indicators of probability of presence of the arrhythmia over the time window, the generation comprising: (Pg. 1, Right Column, First Full Paragraph);
- generating a first set of indicators of probability of presence of the arrhythmia in the time window using a first classifier using values of the set of at least one lead(Pg. 2, Left Column, Second Paragraph through Pg. 2, Right Column, First Paragraph; Figure 1; See Annotated Figure 1, above at Claim 1);
This limitation is being interpreted similarly to Claim 1.
- generating a second set of indicators of probability of presence of the arrhythmia in the time window, using a second classifier from first portions, preceding the R wave, of combinations of second portions of beats of the set of at least one lead, (Pg. 2, Right Column, Second Paragraph through Pg. 3, Left Column, First Paragraph; Figure 1; See Annotated Figure 1, above);
This limitation is being interpreted similarly to Claim 1.
- generating a third set of indicators of probability of presence of the arrhythmia in the time window using a third classifier using a set of statistical indicators representative of the R-R interval distribution of the electrocardiogram, (Pg. 3, Left Column, Second Paragraph through Pg. 3, Right Column, First Paragraph; Figure 1; See Annotated Figure 1, above);
This limitation is being interpreted similarly to Claim 1.
- generating a set of global indicators comprising global indicators of probabilities of presence of arrhythmias in the time window, using a global classifier using an input vector generated from sets of indicators generated for the arrhythmias. (Pg. 3, Right Column, Second and Third Paragraphs; Figure 1; See Annotated Figure 1, above).
This limitation is being interpreted similarly to Claim 1.
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 2, 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP033343576 (“Yazdani”) as applied to Claim 1 above, and further in view of Huang, ML., Wu, YS. Classification of atrial fibrillation and normal sinus rhythm based on convolutional neural network. Biomed. Eng. Lett. 10, 183–193 (2020) (“Huang”).
Regarding Claim 2, Yazdani discloses the entirety of Claim 1 as explained above.
Yazdani does not disclose:
wherein each of the first, second, and third classifiers is configured to discriminate a sinus rhythm from the arrhythmia
Huang describes “Classification of atrial fibrillation and normal sinus rhythm based on convolutional neural network” (Title). Huang is analogous art.
Huang teaches:
wherein each of the first, second, and third classifiers is configured to discriminate a sinus rhythm from the arrhythmia (Abstract, “This study proposes a computer-aided diagnosis (CAD) system for classification of Atrial Fibrillation and Normal Sinus Rhythm based on ECG signals through convolutional neural network.”).
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 Yazdani with the teachings of Huang (i.e., to modify the device of Yazdani such that each of the first, second, and third classifiers is configured to discriminate a sinus rhythm from the arrhythmia) in order to avoid misjudgments due to inaccurate extraction, thereby improving diagnosis accuracy (Huang at Abstract).
Regarding Claim 3, Yazdani discloses the entirety of Claim 1 as explained above.
Yazdani does not disclose:
wherein the data processing unit is configured to define a sequence of states of the individual's heart rhythm taken among the arrhythmias and the sinus rhythm from sets of global indicators generated for successive time windows.
Huang describes “Classification of atrial fibrillation and normal sinus rhythm based on convolutional neural network” (Title). Huang is analogous art.
Huang teaches:
wherein the data processing unit is configured to define a sequence of states of the individual's heart rhythm taken among the arrhythmias and the sinus rhythm from sets of global indicators generated for successive time windows (Pg. 184, Right Column, First Paragraph, “The ECG signal length was 128 samples for analysis….”).
Huang performs Huang’s analysis and labeling on 128 samples of individual heartbeats. This analysis is such a “sequence of states” as claimed.
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 Yazdani with the teachings of Huang (i.e., to define a sequence of states of the individual's heart rhythm taken among the arrhythmias and the sinus rhythm from sets of global indicators generated for successive time windows) in order to avoid misjudgments due to inaccurate extraction, thereby improving diagnosis accuracy (Huang at Abstract).
Regarding Claim 5, Yazdani discloses the entirety of Claim 1 as explained above.
Yazdani does not disclose:
wherein the first classifier comprises a convolution neural network and/or the second classifier comprises a convolution neural network
Huang describes “Classification of atrial fibrillation and normal sinus rhythm based on convolutional neural network” (Title). Huang is analogous art.
Huang teaches:
wherein the first classifier comprises a convolution neural network and/or the second classifier comprises a convolution neural network (Abstract, “This study proposes a computer-aided diagnosis (CAD) system for classification of Atrial Fibrillation and Normal Sinus Rhythm based on ECG signals through convolutional neural network;” Pg. 184, Right Column, Third Paragraph).
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 Yazdani with the teachings of Huang (i.e., to use such a convolution neural network as taught by Huang in the first and/or second classifier of Yazdani) in order to avoid misjudgments due to inaccurate extraction, thereby improving diagnosis accuracy (Huang at Abstract).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP033343576 (“Yazdani”) and Huang, ML., Wu, YS. Classification of atrial fibrillation and normal sinus rhythm based on convolutional neural network. Biomed. Eng. Lett. 10, 183–193 (2020) (“Huang”) as applied to Claim 3 above, and further in view of US 20220175300 A1 to Viswam et al. (“Viswam”).
Regarding Claim 4, the combination of Yazdani and Huang renders obvious the entirety of Claim 3 as explained above.
The combination of Yazdani and Huang does not disclose:
wherein the definition of the sequence of states uses a Viterbi algorithm configured to determine the most probable sequence of states likely to be obtained by a hidden Markov model from the sets of global indicators.
Viswam describes “…systems and methods for atrial fibrillation burden estimation, notification and management …” (Para. [0001]). Viswam is analogous art.
Viswam teaches:
wherein the definition of the sequence of states uses a Viterbi algorithm configured to determine the most probable sequence of states likely to be obtained by a hidden Markov model from the sets of global indicators (Para. [0079], “…in some embodiments, the mobile device 302 can execute a Viterbi algorithm to determine a probable sequence of AF states for the subject 306 over a time period (e.g., over one day);” Para. [0080], “As known in the art, a Viterbi algorithm can be used to find a most probable sequence of states Q, given an input HMM with a transition probability matrix A, an emission probability matrix B, and a sequence of observations O;” Para. [0062], “…the mobile device 302 can use a Hidden Markov Model (HMM) to estimate AF burden when there are gaps in the sensor observations 308;” Para. [0063], “FIG. 4 illustrates an example HMM architecture 400…”).
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 combined Yazdani and Huang with the teachings of Viswam (i.e., to use a Viterbi algorithm configured to determine the most probable sequence of states likely to be obtained by a hidden Markov model from the sets of global indicators for defining the sequence of states) in order to account for gaps in data (Viswam at Para. [0062]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP033343576 (“Yazdani”) as applied to Claim 1 above, and further in view of US 2022/0031223 A1 to Li et al. (“Li”).
Regarding Claim 6, Yazdani discloses the entirety of Claim 1 as explained above.
Yazdani additionally discloses:
wherein the arrhythmias are auricular fibrillation (Pg. 1, Right Column, Second Paragraph);
Yazdani does not disclose:
and auricular flutter
Li describes “Systems and methods … for analyzing electrocardiogram (ECG) data of a patient using a substantial amount of ECG data” (Abstract). Li is analogous art.
Li teaches:
and auricular flutter (Para. [0095], “Abnormalities and conditions may include but are not limited to, sinoatrial block, paralysis or arrest, atrial fibrillation, atrial flutter…”).
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 Yazdani with the teachings of Li (i.e., to modify the device of Yazdani such that the arrhythmias are auricular flutter and auricular fibrillation) for the benefit of identifying additional abnormalities which may be discerned from the ECG (Li at Para. [0095]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP033343576 (“Yazdani”) as applied to Claim 1 above, and further in view of US 2005/0033191 A1 to Povinelli et al. (“Povinelli”).
Regarding Claim 7, Yazdani discloses the entirety of Claim 1 as explained above.
Yazdani does not disclose:
wherein the data processing unit comprises a data processing sub-unit configured to generate the set of statistical indicators representative of the time distribution of the R-R intervals of the set of at least one lead from a sequence of R-R intervals of the electrocardiogram, the generation comprising:- parameterizing a Gaussian mixture model so as to obtain parameters of the Gaussian mixture comprising averages of Gaussians making up the model,- generating first statistical indicators of the set of statistical indicators representative of the distribution of the R-R intervals of the electrocardiogram from the Gaussian averages. (Para. [0058], “For instance, atrial fibrillation can be detected by measuring the time interval between adjacent R waves (the R-R interval). If the R-R interval is chaotic (meaning that the interval varies from interval-to-interval beyond a predetermined variance threshold well known in the art), then it is determined that the patient is experiencing atrial fibrillation;” Para. [0066], “Once the phase space has been produced and combined for all segments of the rhythm, process 204 proceeds to step 222, whereby a Gaussian Mixture Model (GMM) is created for the combined RPS for all sub-banded RPSs of a given rhythm type. GMMs are well known in the art…;” Paras. [0067] through [0072]).
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 Yazdani with the teachings of Povinelli (i.e., to further include a data processing sub-unit configured to generate the set of statistical indicators representative of the time distribution of the R-R intervals of the set of at least one lead from a sequence of R-R intervals of the electrocardiogram, the generation comprising: parameterizing a Gaussian mixture model so as to obtain parameters of the Gaussian mixture comprising averages of Gaussians making up the model, and generating first statistical indicators of the set of statistical indicators representative of the distribution of the R-R intervals of the electrocardiogram from the Gaussian averages in the manner of Povinelli) in order to provide a redundant system for detecting arrhythmias (Povinelli at Para. [0072]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP033343576 (“Yazdani”) as applied to Claim 1 above, and further in view of US 2009/0275849 A1 to Stewart (“Stewart”).
Regarding Claim 8, Yazdani discloses the entirety of Claim 1 as explained above.
Yazdani does not disclose:
wherein the data processing unit comprises a data processing sub-unit configured to generate the set of statistical indicators representative of the time distribution of the R-R intervals of the set of at least one lead from a sequence of R-R intervals of the electrocardiogram, the generation comprising the following second set of steps:- generating a sequence of relationships between consecutive R- R intervals,- generating input indicators of probabilities of presence of the arrhythmia from the sequence of relationships using an R-R ratio classifier
Stewart describes “A method for calculating a variability value that is indicative of AF by obtaining a signal sequence of a plurality of RR intervals by monitoring electrical activity of a patient's heart” (Abstract). Stewart is analogous art.
Stewart teaches:
wherein the data processing unit comprises a data processing sub-unit configured to generate the set of statistical indicators representative of the time distribution of the R-R intervals of the set of at least one lead from a sequence of R-R intervals of the electrocardiogram, the generation comprising the following second set of steps:- generating a sequence of relationships between consecutive R- R intervals,- generating input indicators of probabilities of presence of the arrhythmia from the sequence of relationships using an R-R ratio classifier. (Abstract; Para. [0022])
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 Yazdani with the teachings of Stewart (i.e., to generate a sequence of relationships between consecutive R- R intervals and generate input indicators of probabilities of presence of the arrhythmia from the sequence of relationships using an R-R ratio classifier) in order to avoid variability caused by PVCs, bigeminy and trigeminy (Stewart at Para. [0022]).
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP033343576 (“Yazdani”) as applied to Claim 1 above, and further in view of US 5772604 A to Langberg et al. (“Langberg”).
Regarding Claim 9, Yazdani discloses the entirety of Claim 1 as explained above.
Yazdani does not disclose:
comprising an acquisition system comprising electrodes configured to acquire the set of at least one lead of the electrocardiogram of the individual.
Langberg describes a “Method, system and apparatus for determining prognosis in atrial fibrillation” (Title). Langberg is analogous art.
Langberg teaches:
comprising an acquisition system comprising electrodes configured to acquire the set of at least one lead of the electrocardiogram of the individual (Col. 7, Ln. 51-61, “The diagnostic system 10 includes electrodes and corresponding leads 12 attached to a patient P for detecting the electrical activity of the heart. The electrodes may comprise any single electrode or combination of electrodes conventionally used to generate electrocardiograms (ECGs), such as leads aVF, V1, and V5, or they may comprise other types of skin electrodes. The electrodes 12 produce electrical signals based on the electric fields generated by the heart and these heart signals are passed through a pre-amplifier circuit 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 Yazdani with the teachings of Langberg (i.e., to include such an acquisition system as taught by Langberg in the device of Yazdani) in order to “provide a device for rapidly analyzing the electrical signals from the heart of a patient in atrial fibrillation, with the purpose of assessing the suitability of administering electric shock, or ibutilide, or other treatments” (Langberg at Col. 4, Ln. 46-50).
Regarding Claim 11, Yazdani discloses the entirety of Claim 1 as explained above.
Yazdani does not disclose:
wherein the set of at least one lead comprises several leads
Langberg describes a “Method, system and apparatus for determining prognosis in atrial fibrillation” (Title). Langberg is analogous art.
Langberg teaches:
wherein the set of at least one lead comprises several leads (Col. 8, Ln. 52-57, “The diagnostic system 10 includes electrodes and corresponding leads 12 attached to a patient P for detecting the electrical activity of the heart. The electrodes may comprise any single electrode or combination of electrodes conventionally used to generate electrocardiograms (ECGs), such as leads aVF, V1, and V5, …”).
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 Yazdani with the teachings of Langberg (i.e., to use several leads in the manner of Langberg) in order to “provide a device for rapidly analyzing the electrical signals from the heart of a patient in atrial fibrillation, with the purpose of assessing the suitability of administering electric shock, or ibutilide, or other treatments” (Langberg at Col. 4, Ln. 46-50).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP033343576 (“Yazdani”) and US 2005/0033191 A1 to Povinelli et al. (“Povinelli”) as applied to Claim 7 above, and further in view of US 5772604 A to Langberg et al. (“Langberg”).
Regarding Claim 10, the combination Yazdani and Povinelli renders obvious the entirety of Claim 7 as explained above.
The combination of Yazdani and Povinelli does not disclose:
wherein the acquisition system is capable of forming an acquisition device comprising the processing sub-unit
That is, the combination of Yazdani and Povinelli does not teach an “acquisition system.”
However, as explained above, Povinelli teaches such a “processing sub-unit” as claimed.
Langberg describes a “Method, system and apparatus for determining prognosis in atrial fibrillation” (Title). Langberg is analogous art.
Langberg teaches:
wherein the acquisition system is capable of forming an acquisition device comprising the processing sub-unit (Col. 7, Ln. 51-61, “The diagnostic system 10 includes electrodes and corresponding leads 12 attached to a patient P for detecting the electrical activity of the heart. The electrodes may comprise any single electrode or combination of electrodes conventionally used to generate electrocardiograms (ECGs), such as leads aVF, V1, and V5, or they may comprise other types of skin electrodes. The electrodes 12 produce electrical signals based on the electric fields generated by the heart and these heart signals are passed through a pre-amplifier circuit 14.”).
Langberg’s “acquisition system” is structurally capable of forming an acquisition device comprising the processing sub-unit.
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 combined Yazdani and Povinelli with the teachings of Langberg (i.e., to include such an acquisition system as taught by Langberg in the device of Yazdani) in order to “provide a device for rapidly analyzing the electrical signals from the heart of a patient in atrial fibrillation, with the purpose of assessing the suitability of administering electric shock, or ibutilide, or other treatments” (Langberg at Col. 4, Ln. 46-50).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP033343576 (“Yazdani”) as applied to Claim 1 above, and further in view of US 2017/0119273 A1 to Thakur et al. (“Thakur”).
Regarding Claim 13, Yazdani discloses the entirety of Claim 12 as explained above.
Yazdani does not disclose:
A computer program product comprising a non- transitory readable information medium, on which a computer program comprising program instructions is stored, the computer program being loadable on a data processing unit and adapted to drive the implementation of steps of the method according to claim 12, when the computer program is implemented on the data processing unit.
That is, Yazdani discloses a method according to Claim 12, but does not disclose its computer implementation in the manner claimed.
Thakur describes “SYSTEMS AND METHODS FOR DETECTING ATRIAL TACHYARRHYTHMIA USING HEART SOUNDS” (Title). Thakur is analogous art.
Thakur teaches:
A computer program product comprising a non- transitory readable information medium, on which a computer program comprising program instructions is stored, the computer program being loadable on a data processing unit and adapted to drive the implementation of steps of the method according to claim 12, when the computer program is implemented on the data processing unit. (Para. [0106]).
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 Yazdani with the teachings of Thakur (i.e., to implement Yazdani’s method as a computer program embodied on a non- transitory readable information medium in the manner of Thakur) in order to facilitate machine implementation of the method (Thakur at Para. [0106]).
Regarding Claim 14, Yazdani discloses the entirety of Claim 12 as explained above.
Yazdani does not disclose:
A non-transitory readable information medium including program instructions forming a computer program, the computer program being loadable on a data processing unit and adapted to drive the implementation of steps of the method according to claim 12 when the computer program is implemented on the data processing unit.
That is, Yazdani discloses a method according to Claim 12, but does not disclose its computer implementation in the manner claimed.
Thakur describes “SYSTEMS AND METHODS FOR DETECTING ATRIAL TACHYARRHYTHMIA USING HEART SOUNDS” (Title). Thakur is analogous art.
Thakur teaches:
A non-transitory readable information medium including program instructions forming a computer program, the computer program being loadable on a data processing unit and adapted to drive the implementation of steps of the method according to claim 12 when the computer program is implemented on the data processing unit. (Para. [0106]).
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 Yazdani with the teachings of Thakur (i.e., to implement Yazdani’s method as a computer program embodied on a non- transitory readable information medium in the manner of Thakur) in order to facilitate machine implementation of the method (Thakur at Para. [0106]).
Conclusion
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/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
1 YAZDANI S. et al., “Heart rhythm classification using short-term ECG atrial and ventricular activity analysis,” 2017 COMPUTING IN CARDIOLOGY (CINC), CCAL, September 24 2017, Pg. 1-4, XP033343576 was disclosed by Applicant in the IDS dated 1/6/2025.
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