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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 1, “an ECG wave acquisition unit;”
Claim 1, “a classification unit;”
Claim 1, “a noise selection unit;”
Claim 1, “a noise removing unit;”
Claim 5, “a learning unit;” and
Claim 11, “an abnormal state detection unit.”
As explained below, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function of the above-identified limitation. Accordingly, some interpretation is necessary.
The Present Specification suggests at Paras. [0034] through [0036] that the above units are software modules implemented in a computer. Accordingly, each of the above identified units is being interpreted as software capable of performing the respective operations.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1, 2 and 11, and Claims 3-10 by dependency, 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 Independent Claim 1, Claim 1 recites “applies segmentation to the ECG wave to check a feature for each section of the ECG wave.” However, the Present Specification provides not detail regarding what the term “check” entails. That is, the Present Specification does not describe what particularly is done when a feature is “checked” in such a manner as to reasonably convey to one skilled in the relevant art that the inventor had possession of the invention at the time the application was filed.
Regarding Claim 2, Claim 2 recites “the classification unit checks features….” The Present Specification does not describe what particularly is done when a feature is “checked” in such a manner as to reasonably convey to one skilled in the relevant art that the inventor had possession of the invention at the time the application was filed.
Regarding Claim 11, Claim 1 recites “an abnormal state detection unit that checks the classification values….” Similarly to as above with respect to Claim 1, the Present Specification does not describe what particularly is done when a value is “checked” in such a manner as to reasonably convey to one skilled in the relevant art that the inventor had possession of the invention at the time the application was filed.
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 1-11 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 ECG wave acquisition unit that acquires an ECG wave for each of a plurality of persons,” and subsequently recites a variety operations performed upon “the ECG wave.” It is unclear whether multiple ECG waves or a single ECG wave is/are contemplated by Claim 1.
For purposes of this Office Action, the term “for each of a plurality of persons” is not being interpreted to require multiple ECG waves be acquired simultaneously, but is being interpreted rather for the device to be capable of taking multiple ECG readings.
Further regarding Independent Claim 1, the limitations “an ECG wave acquisition unit,” “a classification unit,” “a noise selection unit,” and “a noise removing unit” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Regarding Claim 2, Claim 2 recites “the classification unit checks features…” Claim 2 thus recites both an apparatus and the method steps of using the apparatus, and is accordingly indefinite. See MPEP 2173.05(P)(II).
This issue could be remedied by amended Claim 2 to recite “the classification unit is configured to check….”
Regarding Claims 3, 4, and 6-11, Claims 3, 4, and 6-11 recite similar limitations, and are indefinite for the same reasons. These issues could be remedied similarly as explained above with respect to Claim 2.
Regarding Claim 3, Claim 3 recites “wherein the classification unit calculates a noise probability value on the basis of the feature for each section of the ECG wave, sets the noise probability value to a maximum value of 1, discriminates, in a case where the noise probability value is equal to or higher than a threshold, that the section corresponds to the noise and gives a value of 1, and discriminates, in a case where the probability value is lower than the threshold, that the section is not the noise and gives a value of 0.” Claim 3 recites both calculating and setting the same “noise probability value,” and subsequently recited performing actions based on the ”noise probability value.” It is unclear whether the noise probability value is calculated, set or both; whether there is more than one noise probability value; and which – the calculated or the set noise probability value, or both – are used in the subsequent operations.
Regarding Claim 5, the limitation “a learning unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Regarding Claim 6, Claim 6 recites “wherein the classification unit labels, in a case where a specific section of the ECG wave is classified as a baseline on the basis of the feature, the specific section as 0, labels, in a case where a specific section of the ECG wave is classified as the P wave on the basis of the feature, the specific section as 1, labels, in a case where a specific section of the ECG wave is classified as the peak of the R wave on the basis of the feature, the specific section as 5, labels, in a case where a specific section of the ECG wave is classified as the T wave on the basis of the feature, the specific section as 6, and labels, in a case where a specific section of the ECG wave is classified as the noise wave on the basis of the feature, the specific section as 7.” It is grammatically unclear in what sense the terms “in a case where a specific section of the ECG wave is classified as … on the basis of the feature” limit the claim.
The term “the specific section” is used several times, as is the term “a specific section.” It is unclear whether the several “specific sections” are the same or different. It is accordingly unclear what specifically is the claim entails.
There is insufficient antecedent basis for the terms “the P wave,” “the R wave,” and “the T wave.”
Regarding Claim 7, Claim 7 recites “wherein the classification unit labels, in a case where a specific section of the ECG wave is classified as a normal beat (N) of a QRS complex on the basis of the feature, the specific section as 2, labels, in a case where a specific section of the ECG wave is classified as a supraventricular beat (S) of the QRS complex on the basis of the feature, the specific section as 3, and labels, in a case where a specific section of the ECG wave is classified as a ventricular beat (V) of the QRS complex on the basis of the feature, the specific section as 4.” It is grammatically unclear in what sense the term “a specific section of the ECG wave is classified as a normal beat (N) of a QRS complex on the basis of the feature” limits the claim. Similarly, it is grammatically unclear in what sense the term “in a case where a specific section of the ECG wave is classified as a supraventricular beat (S) of the QRS complex on the basis of the feature” and the term “in a case where a specific section of the ECG wave is classified as a ventricular beat (V) of the QRS complex on the basis of the feature” limit the claim.
The term “the specific section” is used several times, as is the term “a specific section.” It is unclear whether the several “specific sections” are the same or different. It is accordingly unclear what specifically is the claim entails
Regarding Claim 9, Claim 9 recites “the ECG waves of the plurality of persons into one-dimensional data.” There is insufficient antecedent basis for this limitation.
Regarding Claim 10, Claim 10 recites “wherein the classification unit records values for the P wave, the QRS wave (the normal beat (N) , the supraventricular beat (S) , and the ventricular beat (V)) , and the T wave in the ECG wave as multiple beats.” There is insufficient antecedent basis for the limitations “the P wave,” “the QRS wave,” “the normal beat (N),” “the supraventricular beat (S),” “the ventricular beat (V),” and “the T wave.”
Regarding Claim 11, the limitation “an abnormal state detection unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
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 1-11 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 1-11 each fall within one of the four categories of statutory subject matter. Claims 1-11 are drawn to an “apparatus” (i.e., a machine), and thus fall within one of the four statutory categories.
Eligibility Step 2A, Prong One
Claims 1-11 recite abstract ideas:
Regarding Independent Claim 1:
“a classification unit that applies segmentation to the ECG wave to check a feature for each section of the ECG wave, and labels classification values for each section on the basis of the feature” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. Such applying segmentation and labeling are practically performable in the human mind, as the former is an evaluation and the latter a judgment. See MPEP 2106.04(a)(III).
“a noise selection unit that selects only a noise wave labeled as noise on the basis of the classification values for each section” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. Such selecting is practically performable in the human mind, as it is an evaluation. See MPEP 2106.04(a)(III). For example, a human could evaluate the data to determine which portion is labeled as noise.
Regarding Claim 2:
“wherein the classification unit checks features of respective sections of a P wave, a Q wave, an R wave, an S wave, a T wave, and the noise wave included in the ECG wave” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. Such checking features is practically performable in the human mind, as it is an observation. See MPEP 2106.04(a)(III).
Regarding Claim 3:
“wherein the classification unit calculates a noise probability value on the basis of the feature for each section of the ECG wave, sets the noise probability value to a maximum value of 1” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation in light of the Specification. See MPEP 2106.04(a)(2)(I)(C).
“discriminates, in a case where the noise probability value is equal to or higher than a threshold, that the section corresponds to the noise and gives a value of 1, and discriminates, in a case where the probability value is lower than the threshold, that the section is not the noise and gives a value of 0” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation. Such discriminating as claimed is practically performable in the human mind, as it is a judgment. See MPEP 2106.04(a)(III).
Regarding Claim 4:
“wherein the classification unit labels the section having the value of 1 as the noise” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation for the same reasons as explained above with respect to the similar limitation of Claim 1.
Regarding Claim 5:
“a learning unit that generates an ECG learning result by performing learning using only the noise wave as input” recites an abstract idea (specifically, a mathematical calculation) when afforded its broadest reasonable interpretation in light of the Specification. See MPEP 2106.04(a)(2)(I)(C).
Regarding Claim 6:
“wherein the classification unit labels…” (i.e., each of the labeling recitations) recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation for the same reasons as explained above with respect to the similar limitation of Claim 1.
Regarding Claim 7:
“wherein the classification unit labels…” (i.e., each of the labeling recitations) recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation for the same reasons as explained above with respect to the similar limitation of Claim 1.
Regarding Claims 8-10, Claims 8-10 depend from and further limit Claim 1, and recite abstract ideas for the same reasons as does Claim 1.
Regarding Claim 11:
“an abnormal state detection unit that checks the classification values…” recites an abstract idea (i.e., a mental process) when afforded its broadest reasonable interpretation for the same reasons as explained above with respect to the similar limitation of Claim 2.
Eligibility Step 2A, Prong Two
Claims 1-11 do not recite additional elements that integrate the judicial exception into a practical application.
Regarding Independent Claim 1:
“an ECG wave acquisition unit that acquires an ECG wave for each of a plurality of persons” amounts to necessary data gathering in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
“and a noise removing unit that removes only the noise wave labeled as the noise” amounts to necessary data outputting in conjunction with the recited mental process, and is insignificant extra-solution activity insufficient to integrate the recited abstract ideas into a practical application. See MPEP 2106.05(g).
The terms “an ECG wave acquisition unit,” “a classification unit,” “a noise selection unit,” and “a noise removing unit” are generic computer structures for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
Regarding Claims 2-4, Claims 2-4 do not recite any additional elements.
Regarding Claim 5:
“a learning unit” is a generic computer structure for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
Regarding Claims 6-10, Claims 6-10 do not recite any additional elements.
Regarding Claim 11:
“an abnormal state detection unit” is a generic computer structure for performing a generic computer functions, and thus simply amounts to using a computer as a tool to implement the abstract idea. See MPEP 2106.05(f).
Eligibility Step 2B
Claims 1-11 do not amount to significantly more than the abstract ideas recited therein:
Regarding Independent Claim 1:
“an ECG wave acquisition unit that acquires an ECG wave for each of a plurality of persons” does not contribute an inventive concept. Such ECG acquisition is well-understood, routine and conventional in the art. See, e.g., US 6171256 B1 at Col. 5, Ln. 56-61.
“and a noise removing unit that removes only the noise wave labeled as the noise” does not contribute an inventive concept. Such noise removal is well-understood, routine and conventional in the art. See, e.g., US 20160228640 A1 at Para. [0031].
The terms “an ECG wave acquisition unit,” “a classification unit,” “a noise selection unit,” and “a noise removing unit” do not contribute an inventive concept. The claimed units are generic computer components for performing a generic computer function, and are recited at a high level of generality. Contextually, the inclusion of such units amounts to mere instructions to implement an abstract an abstract idea on a computer, which “the courts have found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception.” See MPEP 2106.05(I(A), citing Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984.
Regarding Claims 2-4, Claims 2-4 do not recite any additional elements.
Regarding Claim 5:
“a learning unit” does not contribute an inventive concept for the same reasons as explained above with respect to the “units” of Claim 1.
Regarding Claims 6-10, Claims 6-10 do not recite any additional elements.
Regarding Claim 11:
“an abnormal state detection unit” does not contribute an inventive concept for the same reasons as explained above with respect to the “units” of Claim 1.
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, 2, 7 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0089047 A1 to Jonnada et al. (“Jonnada”).
Regarding Independent Claim 1, Jonnada teaches:
An electrocardiogram (ECG) noise discriminating apparatus comprising: (Abstract,” Technology for processing an electrocardiograph (ECG) signal is disclosed. The ECG signal can be identified, wherein the ECG signal is affected by baseline wander noise. Signal processing can be performed on the ECG signal affected by baseline wander noise in order to determine a start time and an end time for individual waveforms in the ECG signal affected by baseline wander noise. Features for the individual waveforms in the ECG signal can be extracted, wherein the features indicate one or more cardiac function metrics.”);
an ECG wave acquisition unit that acquires an ECG wave for each of a plurality of persons; (Para. [0030], “ The ECG signal can be measured via a sensor on the wearable device connected to the user.”);
Jonnada’s “sensor on a wearable device” “acquires an ECG wave for each of a plurality of persons” as claimed, in that it acquires an ECG for each user who wears it.
As explained above, the term “for each of a plurality of persons” is not being interpreted to require multiple ECG waves be acquired simultaneously, but is being interpreted rather for the device to be capable of taking multiple ECG readings
a classification unit that applies segmentation to the ECG wave to check a feature for each section of the ECG wave, and labels classification values for each section on the basis of the feature; (Para. [0042] through [0043]);
Jonnada’s Paras. [0042] through [0043] describes feature extraction, wherein R peak locations are identified and denoted based on time of occurrence. Jonnada’s time denotations are such “classification values” as claimed.
Jonnada states at Para. [0043] that “…other wave intervals in the noisy ECG signal (e.g., P waves, T waves) can be determined for each individual waveform based on the R peak locations.” The determination of “other wave intervals” described at Para. [0043] is such “appl[ying] segmentation to the ECG wave to check a feature for each section of the ECG wave.”
It is noted that the term “each section of the ECG wave” is quite broad. Jonnada’s individual R waves constitute such sections as claimed when the term is afforded its broadest reasonable interpretation.
a noise selection unit that selects only a noise wave labeled as noise on the basis of the classification values for each section; (Para. [0044]);
Jonnada’s Para. [0044] details isolating baseline wander, which Jonnada describes at Para. [0020] as interchangeable with the term noise. Jonnada describes isolating baseline wander based on the above-noted times at which R peak locations occur at Para. [0044].
and a noise removing unit that removes only the noise wave labeled as the noise. (Para. [0048], “FIG. 4B illustrates an exemplary electrocardiograph (ECG) signal after noise correction. After performing baseline wander correction (i.e., DC offset correction or removal), previously undetected R peaks in the noisy ECG signal can now indicate comparable values to other R peaks in the ECG waveform. In other words, detected R peaks can be revealed in the corrected ECG waveform;” Figs. 4A and 4B).
Jonnada’s “noise correction” is such “remov[ing] only the noise wave labeled as the noise” as claimed.
Regarding Claim 2, Jonnada discloses the entirety of Claim 1 as explained above.
Jonnada additionally discloses:
wherein the classification unit checks features of respective sections of a P wave, a Q wave, an R wave, an S wave, a T wave, and the noise wave included in the ECG wave. (Para. [0053], “In other words, the feature extraction module 606 can assign amplitudes for each of the P wave, the R wave, the T wave, etc. with respect to the local reference point. The feature extraction module 606 can extract features from the individual waveform in the noisy ECG signal using the peak locations with respect to the local reference point;” Para. [0065] (quotation omitted for brevity)).
Regarding Claim 7, Jonnada discloses the entirety of Claim 1 as explained above.
Jonnada additionally discloses:
wherein the classification unit labels, in a case where a specific section of the ECG wave is classified as a normal beat (N) of a QRS complex on the basis of the feature, the specific section as 2, labels, in a case where a specific section of the ECG wave is classified as a supraventricular beat (S) of the QRS complex on the basis of the feature, the specific section as 3, and labels, in a case where a specific section of the ECG wave is classified as a ventricular beat (V) of the QRS complex on the basis of the feature, the specific section as 4. (Paras. [0034] through [0035]).
Jonnada discusses identifying characteristics of the QRS complex, what such characteristics are representative of, and estimating time-domain features based thereupon at Paras. [0034] through [0035].
Jonnada does not label “the specific section as 1,” and does not label the other identified sections with numerals 1-4. However, the particular numerical labels recited by Claim 7 are being interpreted as printed matter which bears no functional relationship with the underlying apparatus. Accordingly, the particular numerical labels 1-4 are not afforded patentable weight. See MPEP 2111.05(I)(A) (“To be given patentable weight, the printed matter and associated product must be in a functional relationship.”); MPEP 2111.05(I)(B), (“Where a product merely serves as a support for printed matter, no functional relationship exists.”); See also Ex parte Gwinn, 112 USPQ 439, 446-47 (Bd. Pat. App. & Int. 1955) (Court held that claims directed to a set of dice which differed from the prior art solely by the printed matter in the dice were properly rejected on prior art because there was no new feature of physical structure and no new relation of printed matter to physical structure.).
Regarding Claim 11, Jonnada discloses the entirety of Claim 1 as explained above.
Jonnada additionally discloses:
further comprising: an abnormal state detection unit that checks the classification values for each section in time series in a state where the value labeled as the noise is removed to determine an abnormal state. (Para. [0043], “In one configuration, slope changes in the individual waveform in the ECG signal can be sought in accordance with known approximate time ranges. For example, Q peaks can occur approximately 200 ms after the P peak, the R peak can occur approximately 800 ms after the Q peak, etc. If a slope change is not detected, that individual waveform in the noisy ECG signal can be classified as being abnormal.”).
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 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0089047 A1 to Jonnada et al. (“Jonnada”) as applied to Claim 1 above, and further in view of US 2017/0340288 A1 to Bae et al. (“Bae”).
Regarding Claim 3, Jonnada discloses the entirety of Claim 1 as explained above.
Jonnada does not disclose:
wherein the classification unit calculates a noise probability value on the basis of the feature for each section of the ECG wave, sets the noise probability value to a maximum value of 1, discriminates, in a case where the noise probability value is equal to or higher than a threshold, that the section corresponds to the noise and gives a value of 1, and discriminates, in a case where the probability value is lower than the threshold, that the section is not the noise and gives a value of 0.
Bae describes “A method and an apparatus to remove a noise from an electrocardiography (ECG) sensor signal…” (Abstract). Bae is analogous art.
Bae teaches:
wherein the classification unit calculates a noise probability value on the basis of the feature for each section of the ECG wave, sets the noise probability value to a maximum value of 1, discriminates, in a case where the noise probability value is equal to or higher than a threshold, that the section corresponds to the noise and gives a value of 1, and discriminates, in a case where the probability value is lower than the threshold, that the section is not the noise and gives a value of 0. (Para. [0062], “ In operation 820, the noise removing apparatus extracts an ECG estimation signal from the sensor signal based on a peak value of the sensor signal. In operation 830, the noise removing apparatus determines a first comparison value between the ECG estimation signal and a first reference signal indicating an average form of ECG signals. … Each of the first threshold value and the first comparison value corresponding to the cosine distance between the ECG estimation signal and the first reference signal may have a value between zero and one. In a case in which first threshold value is determined to be a value greater than an appropriate value, a probability of removing a noise from the sensor signal increases, but an individual characteristic of the ECG signal may also be removed, thereby making it more difficult to classify users based on the ECG signal. … The first threshold value of 0.357 is an optimal value…”);
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 Jonnada with the teachings of Bae (i.e., to determine noise probabilistically via comparison to a threshold in the manner of Bae) in order to increase reliability (Bae at Para. [0003]).
Regarding Claim 4, the combination of Jonnada and Bae renders obvious the entirety of Claim 3 as explained above.
Bae additionally teaches:
wherein the classification unit labels the section having the value of 1 as the noise (Para. [0062], “Each of the first threshold value and the first comparison value corresponding to the cosine distance between the ECG estimation signal and the first reference signal may have a value between zero and one. In a case in which first threshold value is determined to be a value greater than an appropriate value, a probability of removing a noise from the sensor signal increases…”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0089047 A1 to Jonnada et al. (“Jonnada”) as applied to Claim 1 above, and further in view of US 2019/0357794 A1 to Bardy et al. (“Bardy”) and Galeotti L, Scully CG. A method to extract realistic artifacts from electrocardiogram recordings for robust algorithm testing. J Electrocardiol. 2018 Nov-Dec;51(6S):S56-S60. doi: 10.1016/j.jelectrocard.2018.08.023. Epub 2018 Aug 18 (“Galeotti”).
Regarding Claim 5, Jonnada discloses the entirety of Claim 1 as explained above.
Jonnada does not disclose:
further comprising: a learning unit that generates an ECG learning result by performing learning using only the noise wave as input.
Bardy describes “A system for facilitating a cardiac rhythm disorder diagnosis with the aid of a digital computer…” (Abstract). Bardy is analogous art.
Bardy teaches:
further comprising: a learning unit that generates an ECG learning result by performing learning using … the noise wave as input (Para. [0093], “The noise can be identified by a reviewer or automatically via a classifier or artificial intelligence, such as by machine learning or based on one or more thresholds.”).
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 Jonnada with the teachings of Bardy (i.e., to incorporate such a learning unit as taught by Bardy in the device of Jonnada) in order to increase accuracy of ECG-based diagnoses (Bardy at Para. [0093]).
The combination of Jonnada and Bardy does not teach:
only the noise wave as input
Galeotti describes “A method to extract realistic artifacts from electrocardiogram recordings for robust algorithm testing” (Title). Galeotti is analogous art.
Galeotti teaches:
only the noise wave as input (Abstract, “Recordings of signal noise and artifacts can be added to clean electrocardiogram (ECG) records to assess the performance of ECG and arrhythmia analysis algorithms in the presence of noise. We present a method to estimate device-specific signal noise and artifacts from ECG records. … Estimating noise from ECG records is a viable approach to generate noise and artifacts-only signals.”).
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 Jonnada and Bardy with the teachings of Galeotti (i.e., to train the learning model of combined Jonnada and Bardy using only noise as an input in the manner taught by Galeotti) in order to facilitate device-specific ECG recording (Galeotti at Abstract, “Objective” section).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0089047 A1 to Jonnada et al. (“Jonnada”) as applied to Claim 1 above, and further in view of Aziz, S., Ahmed, S. & Alouini, MS. ECG-based machine-learning algorithms for heartbeat classification. Sci Rep 11, 18738 (2021). https://doi.org/10.1038/s41598-021-97118-5 (“Aziz”).
Regarding Claim 6, Jonnada discloses the entirety of Claim 1 as explained above.
Jonnada does not disclose:
wherein the classification unit labels, in a case where a specific section of the ECG wave is classified as a baseline on the basis of the feature, the specific section as 0, labels, in a case where a specific section of the ECG wave is classified as the P wave on the basis of the feature, the specific section as 1, labels, in a case where a specific section of the ECG wave is classified as the peak of the R wave on the basis of the feature, the specific section as 5, labels, in a case where a specific section of the ECG wave is classified as the T wave on the basis of the feature, the specific section as 6, and labels, in a case where a specific section of the ECG wave is classified as the noise wave on the basis of the feature, the specific section as 7.
Aziz describes “ECG-based machine-learning algorithms for heartbeat classification” (Title). Aziz is analogous art.
Aziz teaches:
wherein the classification unit labels, in a case where a specific section of the ECG wave is classified as a baseline on the basis of the feature, the specific section as 0, labels, in a case where a specific section of the ECG wave is classified as the P wave on the basis of the feature, the specific section as 1, labels, in a case where a specific section of the ECG wave is classified as the peak of the R wave on the basis of the feature, the specific section as 5, labels, in a case where a specific section of the ECG wave is classified as the T wave on the basis of the feature, the specific section as 6, and labels, in a case where a specific section of the ECG wave is classified as the noise wave on the basis of the feature, the specific section as 7 (Pg. 2, “Figure 1. Morphology of a normal ECG”).
Aziz’s Figure 1 depicts a “normal ECG” wave which is labeled at the claimed sections.
Aziz does not label “the specific section as 1” with respect to the P wave, and does not label the other identified sections with numerals 1-7. However, the particular numerical labels recited by Claim 6 are being interpreted as printed matter which bears no functional relationship with the underlying apparatus. Accordingly, the particular numerical labels 1-7 are not afforded patentable weight. See MPEP 2111.05(I)(A) (“To be given patentable weight, the printed matter and associated product must be in a functional relationship.”); MPEP 2111.05(I)(B), (“Where a product merely serves as a support for printed matter, no functional relationship exists.”); See also Ex parte Gwinn, 112 USPQ 439, 446-47 (Bd. Pat. App. & Int. 1955) (Court held that claims directed to a set of dice which differed from the prior art solely by the printed matter in the dice were properly rejected on prior art because there was no new feature of physical structure and no new relation of printed matter to physical structure.).
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 Jonnada with the teachings of Aziz (i.e., to label the ECG of Jonnada in the manner of Aziz) in order to facilitate peak detection (Aziz at Pg. 2, First Paragraph).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0089047 A1 to Jonnada et al. (“Jonnada”) as applied to Claim 1 above, and further in view of US 5730142 A to Sun et al. (“Sun”).
Regarding Claim 8, Jonnada discloses the entirety of Claim 1 as explained above.
Jonnada does not disclose:
wherein the ECG wave acquisition unit acquires 256 samples of the ECG waves per second for each of the plurality of persons.
Sun describes “A method and apparatus for detecting tachycardia in a patient…” (Abstract). Sun is analogous art.
Sun teaches:
wherein the ECG wave acquisition unit acquires 256 samples of the ECG waves per second for each of the plurality of persons. (Col. 3, Ln. 12-14, “FIG. 1 is representative of the technique of applying HMM to arryhythmia detection as described in the above-referenced Coast et al. articles. The ECG is sampled at a sample frequency, e.g. 256 Hz. or about every 4 ms…”)
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 Jonnada with eth teachings of Sun (i.e., to record ECG at a sampling rate of 256 Hz in the manner of Sun) in order to “retain morphological information.” (Sun at Col. 3, Ln. 28-30).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0089047 A1 to Jonnada et al. (“Jonnada”) as applied to Claim 1 above, and further in view of US 2020/0237246 A1 to Hu et al. (“Hu”)
Regarding Claim 9, Jonnada discloses the entirety of Claim 1 as explained above.
Jonnada does not disclose:
wherein the ECG wave acquisition unit converts the ECG waves of the plurality of persons into one-dimensional data
Hu describes “An automatic recognition and classification method for electrocardiogram heartbeat based on artificial intelligence…” (Abstract). Hu is analogous art.
Hu teaches:
wherein the ECG wave acquisition unit converts the ECG waves of the plurality of persons into one-dimensional data (Para. [0034], “…data combination is performed on the lead heart beat analysis data to obtain the one-dimensional heart beat analysis array…”).
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 Jonnada with the teachings of Hu (i.e., to convert ECG data to one-dimensional data in the manner of Hu) in order to enhance the accuracy of heart beat classification (Hu at Para. [0034]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0089047 A1 to Jonnada et al. (“Jonnada”) as applied to Claim 1 above, and further in view of US 2014/0276160 A1 to Zhang et al. (“Zhang”).
Jonnada does not disclose:
wherein the classification unit records values for the P wave, the QRS wave (the normal beat (N) , the supraventricular beat (S) , and the ventricular beat (V)) , and the T wave in the ECG wave as multiple beats
Zhang describes “…an apparatus and method for avoiding ventricular fibrillation undersensing” (Para. [0001]). Zhang is analogous art.
Zhang teaches:
wherein the classification unit records values for the P wave, the QRS wave (the normal beat (N) , the supraventricular beat (S) , and the ventricular beat (V)) , and the T wave in the ECG wave as multiple beats (Para. [0043], “ The beat may be classified as a normal supraventricular beat, an abnormal ventricular beat, or an unidentified beat based on comparisons of a morphology match metric and/or one or more beat features to a classification threshold. Beats are classified as ventricular beats, for example, when a beat morphology metric has a weak correlation to an analogous metric of a normal supraventricular beat and thus has a relatively stronger correlation to an analogous metric of an abnormal, ventricular beat. Threshold ranges may be defined to classify a beat as supraventricular, ventricular or unidentified, which could be noise.”).
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 Jonnada with the teachings of Zhang (i.e., to classify beats in the manner of Zhang) in order to prevent undersensing of ventricular signals (Zhang at Para. [0003]).
Conclusion
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/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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