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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is 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.
Claim 10 claims the following: “wherein the feature screening method comprises a wrapper method, an intrinsic method, an implicit method and a filter method.” Applicant has provided one example, of a wrapper method in ¶[0070] of the Specification filed 6/18/2024. However, there appears to be no additional disclosure of feature screening methods and therefore, the application lacks adequate written description. From MPEP § 2161: “In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.” As the instant application appears to be directed to computer based tools, additional disclosure of algorithmic steps, pseudocode, a flowchart is required.
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 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see
this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is
established:
Claim 1 is directed to a device for processing ECG signals for classifying the ECG signals into a first or second type.
Step 1 of the analysis is the question: “Is the claim to a process, machine,
manufacture, or composition of matter?” and the answer is determined to be yes, as the
claims as a whole are directed to a manufacture.
For Step 2, the preliminary question is whether the eligibility of the claim is self-
evident. The answer is determined to be no, as the claim is not immediately self-evident
as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural
phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim.
While the terms “set forth” and “describe” are thus both equated with “recite”, their
different language is intended to indicate that there are different ways in which an
exception can be recited in a claim. For instance, the claims in Diehr set forth a
mathematical equation in the repetitively calculating step, the claims in Mayo set forth
laws of nature in the wherein clause, meaning that the claims in those cases contained
discrete claim language that was identifiable as a judicial exception. The claims in Alice
Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 1 (and equivalently in claim 11) recites the following limitations:
classify the electrocardiography signal using a first classification model
classify the electrocardiography signal into a first type or a second type
classify the electrocardiography signal of the first type using a second classification model
classify the electrocardiography signal of the first type into the first type or the second type
The above identified elements comprise an explicit claim recitation of an abstract idea. Therefore, rather than merely involve a judicial exception, the claims are directed to the identified judicial exception.
This claim language is identified as an abstract idea, because in MPEP §
2106.04(a)(2) III B. this language is similar to concepts relating to organizing or
analyzing information in a way that can be performed mentally or are analogous to
human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d
1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods
of logic circuit design, comprising converting a functional description of a level sensitive
latch into a hardware component description of the latch. 839 F.3d at 1140; 120 USPQ2d at 1475. Although the patentee argued that the claims were intended to be
used in conjunction with computer-based design tools, the claims did not include any
limitations requiring computer implementation of the methods and thus do not involve
the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The
court therefore concluded that the claims “read on an individual performing the claimed
steps mentally or with pencil and paper,” and were directed to a mental process of
“translating a functional description of a logic circuit into a hardware component
description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea is similar to Synopsys because the
language reads on an individual performing the classification of ECG signals mentally or with a pencil and paper. They do not require any computer implementation that relies specifically upon computer technology and therefore are directed to a mental process of determining areas of a signal that comprise a first or second type of signal through observation of sensor signal and analytical decision-making. Further, they appear to be directed to explicit recitations of mathematics or mathematical concepts as the classifications appear to be based entirely on mathematically derived algorithmic steps.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified: measurement unit, processing unit, receiving signal.
The measurement unit, is only nominally tied to the abstract idea and the data acquisition is all performed as pre-solution activity to the abstract idea claimed. Therefore the claimed sensor amounts to mere data gathering and considered an insignificant extra-solution activity.
The processing unit and receiving signals appear together to comprise an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The additional elements were identified in the above section under Step 2A Prong Two.
The processing unit and receiving signals appear together to comprise an addition of a general purpose computer post-hoc to an abstract idea and is therefore not considered to transform the abstract idea into patent eligible subject matter.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
The remaining features in the claims are directed to further specifying the intended use but do not impose further limits to the recited system because they are generally linking the use of the judicial exception to a particular field of use or technological environment.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zubair et al. (U.S. Patent Application Publication No. 2023/0200742) hereinafter referred to as Zubair.
Regarding claim 1, Zubair teaches an electrocardiography processing device (Abstract), comprising:
a measurement unit, configured to measure an object to generate an electrocardiography signal (¶[0043] data acquisition unit acquires electrocardiogram signal); and
a processing unit (¶[0038]), configured to
receive the electrocardiography signal (¶[0053] input unit receives an electrocardiogram signal);
classify the electrocardiography signal using a first classification model to classify the electrocardiography signal into a first type or a second type (¶[0040] classifier 140, tagged with labels), and
classify the electrocardiography signal of the first type using a second classification model to classify the electrocardiography signal of the first type into the first type or the second type (¶¶[0040-0041], ¶[0060]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zubair as applied to claim 1 above, and further in view of Sirendi et al. (U.S. Patent Application Publication No. 2021/0353166) hereinafter referred to as Sirendi, and Fathieh et al. (U.S. Patent Application Publication No. 2021/0212582) hereinafter referred to as Fathieh.
Regarding claim 2, Zubair teaches the electrocardiography processing device as claimed in claim 1.
Zubair further teaches wherein the processing unit obtains a training data set (¶[0040]);
Zubair does not teach the following:
the processing unit uses a predetermined time length to divide the training data set into a plurality of first signal segments and a plurality of second signal segments;
the processing unit performs an R-wave interval detection on each of the plurality of first signal segments to obtain a plurality of R-wave interval segments of each of the plurality of first signal segments;
the processing unit performs an R-wave interval average value calculation on the plurality of R-wave interval segments of each of the plurality of first signal segments to obtain an R-wave interval average value of each of the plurality of first signal segments;
the processing unit sets a plurality of interval templates, and distributes the plurality of first signal segments to the plurality of interval templates according to the R-wave interval average values of the plurality of first signal segments;
the processing unit performs an R-wave interval difference value calculation on each of the plurality of first signal segments to obtain a plurality of R-wave interval difference values of each of the plurality of first signal segments;
the processing unit distributes the plurality of R-wave interval difference values of the plurality of first signal segments to the plurality of interval templates corresponding to the plurality of first signal segments to generate the first classification model.
Attention is brought to the Sirendi reference, which teaches a processing unit divides the training data set into a plurality of first signal segments and a plurality of second signal segments (¶[0170]);
the processing unit performs an R-wave interval detection on each of the plurality of first signal segments to obtain a plurality of R-wave interval segments of each of the plurality of first signal segments (¶[0080] extracted from ECG or pulsometers, ¶[0213], ¶[0273]);
the processing unit performs an R-wave interval average value calculation on the plurality of R-wave interval segments of each of the plurality of first signal segments to obtain an R-wave interval average value of each of the plurality of first signal segments (Fig. 5a-b, ¶¶[0123-0127], ¶¶[0274-0283]);
the processing unit performs an R-wave interval difference value calculation on each of the plurality of first signal segments to obtain a plurality of R-wave interval difference values of each of the plurality of first signal segments (¶¶[0123-0127] successive differences, ¶¶[0274-0283]);
the processing unit distributes the plurality of R-wave interval difference values of the plurality of first signal segments to the plurality of interval templates corresponding to the plurality of first signal segments to generate the first classification model (¶¶[0274-0283], step 5).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the arrhythmia detection of Zubair to include RR interval statistical properties for the classifier, as taught by Sirendi, because statistical compatibility tests allow for selecting evidence based optimally discriminating training data values (Sirendi, ¶¶[0155-156]).
Zubair as modified does not teach using a predetermined time length to divide the training data set into a plurality of first signal segments and a plurality of second signal segments or the processing unit sets a plurality of interval templates, and distributing the plurality of first signal segments to the plurality of interval templates according to the R-wave interval average values of the plurality of first signal segments.
Attention is drawn to the Fatieh reference, which teaches using a predetermined time length to divide the training data set into a plurality of first signal segments and a plurality of second signal segments (¶[0228], ¶[0248]) or the processing unit sets a plurality of interval templates, and distributing the plurality of first signal segments to the plurality of interval templates according to the R-wave interval average values of the plurality of first signal segments (¶¶[0175-0176] and mean can be used in place of median).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the arrhythmia detection of Zubair as modified to include a predetermined time length to segment training data, and templates, to improve system operational capacity (Fatieh ¶[0134]) and detection and treatment of heart disease (Fatieh ¶[0024]).
Regarding claim 3, Zubair as modified teaches the electrocardiography processing device as claimed in claim 2.
Sirendi further teaches wherein the processing unit performs the R-wave interval average value calculation on the electrocardiography signal to obtain the R-wave interval average value of the electrocardiography signal (¶¶[0124-0127]); and the processing unit performs the R-wave interval difference value calculation on the electrocardiography signal to obtain a plurality of R-wave interval difference values of the electrocardiography signal (¶¶[0124-0127] successive differences).
Fatieh further teaches the processing unit selects a first interval template of the plurality of interval templates in the first classification model according to the R-wave interval average value of the electrocardiography signal (¶¶[0175-0176] and mean can be used in place of median).
Regarding claim 4, Zubair as modified teaches the electrocardiography processing device as claimed in claim 3.
Zubair does not teach wherein the processing unit performs a cumulative distribution function calculation on the R-wave interval difference values of the first interval template and the plurality of R-wave interval difference values of the electrocardiography signal to obtain a first cumulative distribution function and a second cumulative distribution function; the processing unit verifies the cumulative distribution function and the second cumulative distribution function using a testing method to obtain a verification value; and the processing unit classifies the electrocardiography signal into the first type or the second type according to the verification value and a threshold value.
Attention is drawn to the Sirendi reference, which teaches a cumulative distribution function (¶[0031], ¶¶[0160-0165]) calculation on the R-wave interval difference values of the first interval template and the plurality of R-wave interval difference values of the electrocardiography signal to obtain a first cumulative distribution function and a second cumulative distribution function (¶[0031], ¶¶[0160-0165], this is apparently performed for each proposed discriminating feature); the processing unit verifies the cumulative distribution function and the second cumulative distribution function using a testing method to obtain a verification value; and the processing unit classifies the electrocardiography signal into the first type or the second type according to the verification value and a threshold value (¶¶[0301-0302]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the arrhythmia detection of Zubair to include a discriminative feature test for the classifier, as taught by Sirendi, because statistical compatibility tests allow for selecting evidence based optimally discriminating training data values (Sirendi, ¶¶[0155-156]).
Regarding claim 5, Zubair as modified teaches the electrocardiography processing device as claimed in claim 4.
Sirendi further teaches wherein the testing method is a Kolmogorov-Smirnov test method (¶[0301]).
Claim(s) 6-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zubair as applied to claim 1 above, and further in view of Sirendi et al. (U.S. Patent Application Publication No. 2021/0353166) hereinafter referred to as Sirendi
Regarding claim 6, Zubair teaches the electrocardiography processing device as claimed in claim 1.
Zubair further teaches wherein the processing unit obtains a training data set (¶[0040]);
the processing unit performs an R-wave interval detection on each of the plurality of first signal segments and the plurality of second signal segments to calculate a plurality of R-wave interval segments of each of the plurality of first signal segments and the plurality of second signal segments (¶[0050]);
Zubair does not teach the processing unit uses a predetermined time length to divide the training data set into a plurality of first signal segments and a plurality of second signal segments.
Attention is brought to the Sirendi reference, which teaches a processing unit divides the training data set into a plurality of first signal segments and a plurality of second signal segments (¶[0170]);
the processing unit performs an R-wave interval detection on each of the plurality of first signal segments to obtain a plurality of R-wave interval segments of each of the plurality of first signal segments (¶[0080] extracted from ECG or pulsometers, ¶[0213], ¶[0273]);
the processing unit obtains a sample entropy, a plurality of Shannon entropies and a plurality of spectral energies according to the plurality of R-wave interval segments of each of the plurality of first signal segments and the plurality of second signal segments (¶¶[0132-0139]);
the processing unit performs a feature screening on the sample entropy, the plurality of Shannon entropies and the plurality of spectral energies corresponding to each of the plurality of first signal segments and the plurality of second signal segments using a feature screening method to obtain a plurality of training features corresponding to each of the plurality of first signal segments and the plurality of second signal segments (¶[0141]);
the processing unit generates the second classification model according to the plurality of training features and the training data set; and the processing unit classifies the electrocardiography signal of the first type into the first type or the second type according to the second classification model (¶¶[0142-0145]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the arrhythmia detection of Zubair to include RR interval entropies for the classifier, as taught by Sirendi, because statistical compatibility tests allow for selecting evidence based optimally discriminating training data values (Sirendi, ¶¶[0155-156]).
Regarding claim 7, Zubair as modified teaches the electrocardiography processing device as claimed in claim 6.
Sirendi further teaches wherein the processing unit rearranges the plurality of R-wave interval segments of each of the plurality of first signal segments and the plurality of second signal segments to generate a plurality of sub R-wave interval segment sequences, and calculates the plurality of sub R-wave interval segment sequences to obtain the sample entropy (¶¶[0132-0139]);
Regarding claim 10, Zubair as modified teaches the electrocardiography processing device as claimed in claim 6.
Sirendi further teaches wherein the feature screening method comprises a wrapper method, an intrinsic method, an implicit method and a filter method (¶¶[0141-0145] this appears to be directed to any type of feature screening).
Allowable Subject Matter
Claims 8-9 are dependent upon a rejected base claim, and rejected on their own merits under 35 U.S.C. § 101 but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and further overcome the rejections for being directed to a judicial exception.
The prior art of record does not fairly anticipate or make obvious the combination of features claimed including second-order decomposition on the Poincaré plot with discrete wavelet transforms to obtain wavelet transformation diagrams, further combined with the subject matter in claims 1 and 6. Additional close prior art is made of record: U.S. Patent Application Publication No. 2021/0251552 to Demazumder et al. teaches wavelet transforms to obtain wavelet transformation diagrams but is silent as to a second-order decomposition performed on the Poincaré plot in combination, or calculating the Shannon entropies and spectral energies according to the wavelet transformation diagrams.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2021/0282692 to Yaniv et al. teaches classifying heart data using Shannon entropy distribution, cumulative distribution functions, and a Kolmogorov-Smirnov statistic.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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