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 § 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1:
Claims 1-20 are drawn to an apparatus and a method, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One:
Independent claim 1 recites input the voltage-time data into a classification model, wherein the classification model is configured to: receive the voltage-time data; and apply a multi-dimensional convolution operation to the voltage-time data across all leads of the plurality of leads of the 12-lead electrocardiograph; generate a disease indication in a subject as a function of at least the classification model; and display the disease indication.
Independent claim 11 recites inputting the voltage-time data into a classification model, wherein the classification model is configured to: receive the voltage-time data; and apply a multi-dimensional convolution operation to the voltage-time data across all leads of the plurality of leads of the 12-lead electrocardiograph; generating a disease indication in a subject as a function of at least the classification model; and displaying the disease indication.
The respective dependent claims 2-10 and 12-20, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
The above recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that the invention is directed to “detecting a level of cardiovascular disease” (see: specification paragraph 2) and “can be used to detect levels of myocarditis without invasive testing…can be used in the detection of cardiovascular diseases and conditions” (see: specification paragraph 9). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because the invention “may be used to hone different diagnosis and risk stratify patients” (see: specification paragraph 9), “enabl[e] accurate diagnosis, risk assessment, and treatment planning in clinical practice” (see: specification paragraph 19), and otherwise “facilitate[e] applications in healthcare monitoring, diagnosis and treatment” (see: specification paragraph 46). With the invention “healthcare professionals may gain insights into a patient's overall electrical activity and health, identify abnormalities, and make diagnostic or prognostic assessments” (see: specification paragraph 41) and “ensure prompt intervention in case of critical cardiac events and facilitates collaborative decision-making regarding subject care” (see: specification paragraph 74). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
Step 2A Prong Two:
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including an “at least a processor; and a memory communicatively connected to the at least a processor, wherein the memory contains instructions configuring the at least a processor to:…using a convolutional neural network (CNN)…” (claim 1) and “by at least a processor…by the at least a processor…using a convolutional neural network (CNN)…by the at least a processor…by the at least a processor…” (claim 11), which are additional elements that are recited at a high level of generality (e.g., the “at least a processor” performs the functions of the apparatus through no more than a statement than that “instructions configuring” said at least a processor do so; the “memory” communicatively connected to said processor is configured through no more than a statement than that it “contains” said instructions; the “convolutional neural network (CNN)” is configured to perform functions through no more than a statement than that “using” said CNN does so) such that they amount to no more than mere instruction to apply the exception using generic computer elements. See: MPEP 2106.05(f).
The claims recite the additional elements of “a 12-lead electrocardiograph comprising a plurality of leads; receive voltage-time data of a subject from the 12-lead electrocardiograph;” (claim 1) and “receiving a voltage-time data of a subject from a 12-lead electrocardiograph, wherein the 12-lead electrocardiograph comprises a plurality of leads;” (claim 11), which are nominal or tangential addition to the abstract idea(s) and amount to extra-solution activity concerning mere data gathering. The addition of an insignificant extra-solution activity limitation does not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, these claimed additional elements are incidental to the performance of the recited abstract idea(s) as outlined in the recitations above. See: MPEP 2106.05(g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer elements and additional elements. Accordingly, even in combination, these additional elements do not integrate the abstract idea(s) into a practical application because they do not impose any meaningful limits on practicing the abstract idea(s). Accordingly, the claims are directed to an abstract idea(s) (Step 2A Prong Two: NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea(s) into a practical application, using the additional elements to perform the abstract idea(s) amounts to no more than mere instructions to apply the exception using generic elements. Mere instructions to apply an exception using generic elements cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements directed toward extra-solution activity, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea(s). The originally filed specification supports this conclusion at Fig. 6, ele. 602, and:
Paragraph 125, where “Electrocardiogram (ECG) data may be received directly from an electrocardiography device 602. In an exemplary 12-lead ECG, ten electrodes are placed on the patient's limbs and on the surface of the chest…”
Paragraph 197, where “As provided herein, a deep-learning neural network can detect myocarditis using only a single 12-lead ECG with high diagnostic performance...”
Stating that the 12-lead ECG is “exemplary” and that detection “using only a single 12-lead ECG” indicate that the 12-lead ECG was used for data gathering purposes and was well-understood, routine, and conventional. The claims recite the additional elements directed to pre-solution activity, as recited and indicated above, each of which amount to extra-solution activity. The specification (e.g., as excerpted above) does not indicate that the additional element(s) provide anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are presently).
Further, the claimed “voltage-time data” of a subject produced by a “12-lead electro-cardiograph” that has “a plurality of leads” represents a clinical test on said subject for the purpose of gathering data to be analyzed, and the concept of performing clinical tests on individuals to obtain input for an equation, for example, has been identified by the courts as insignificant extra-solution activity. See: MPEP 2106.05(g). Further, the concepts related to the claimed function to “receive”, or “receiving”, the test data “from the 12-lead electrocardiograph”, or transmitting data over a network, such as using the Internet to gather data, and storing and retrieving such information in memory, have been identified by the courts as well-understood, routine, and conventional activities. See: MPEP 2106.05(d)(II). Hence, the additional element(s) concern extra-solution activity that the courts consider well‐understood, routine, and conventional when claimed in a merely generic manner (as they are presently).
Further, the claimed the claimed “voltage-time data” of a subject produced by a “12-lead electro-cardiograph” that has “a plurality of leads” represents a clinical test on said subject for the purpose of gathering data to be analyzed is show by U.S. Patent Application Publication 2003/0028119 to Xue to be well‐understood, routine, and conventional in paragraphs 2-3 of the Background by stating for instance that: “The electrocardiograph has a long history of being an important tool in diagnosing heart disease. While more and more new diagnostic tools are invented in cardiology (e.g., imaging technology), the electrocardiograph still remains an indispensable diagnostic tool. However, the presentation of the conventional twelve-lead ECG has remained relatively the same over the past half century.”
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea(s) with routine, conventional activity specified at a high level of generality in a particular technological environment. Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea(s) (Step 2B: NO).
Dependent claim(s) 2-10 and 12-20, when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea(s) without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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 1-20 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 pre-AIA the applicant regards as the invention.
As per claim 1, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “a plurality of leads”, and the claim also recites “12-lead”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 11 is rejected for similar reasons.
Claims 2-10 and 12-20 depend from and incorporate the specifically rejected claims above while failing to remedy the limitations shown as indefinite; therefore, they are rejected here for similar reasons.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2022/0384044 to Ulloa-Cerna in view of U.S. Patent Application Publication 2003/0028119 to Xue.
As per claim 1, Ulloa-Cerna teaches an apparatus for detecting a level of cardiovascular disease, the apparatus comprising:
at least a processor (see: Ulloa-Cerna, Fig. 9-10, and paragraph 117, 120-121, and 124, is met by processor); and
a memory communicatively connected to the at least a processor, wherein the memory contains instructions configuring the at least a processor to (see: Ulloa-Cerna, Fig. 9-10, and paragraph 117, 120-121, and 124, is met by memory and program, instructions and values):
input the voltage-time data into a classification model, wherein the classification model is configured to (see: Ulloa-Cerna, paragraph 24, 35, 95-96, 104-105, 109, and 115, is met by model may use data such as 12-lead electrocardiograms (ECGs)):
receive the voltage-time data (see: Ulloa-Cerna, Fig. 5, and paragraph 93, 96, 99-100, 104, is met by voltage-time data for each lead); and
apply, using a convolutional neural network (CNN) (see: Ulloa-Cerna, paragraph 92-97, is met by a neural network that can be a convolutional neural network), a multi-dimensional convolution operation to the voltage-time data across all leads of the plurality of leads of the 12-lead electrocardiograph (see: Ulloa-Cerna, paragraph 92-103, especially: paragraph 93, which describes a branch structure combining multiple lead dimensions at matching time points: “a first branch 704 including leads I, II, V1, and V5, acquired from time (t) = 0…to t=5 seconds…the leads may be aligned to demonstrate to the neural network model which data was collected at the same time”; paragraph 94, which describes the convolutional block structure where each lead is a channel and the convolutional operation’s kernel spans each channel lead axis at every time-step - the channel leads are each along a 1D time axis thereby representing multi-dimensional convolution: “each inception block 700B may include three 1D convolutional blocks concatenated across the channel axis”; paragraph 96, which describes that lead-derived and demographic data are combined before generating the score: data “can be fed into a 64-unit hidden layer and concatenated with the other branches”; paragraph 100, which describes all leads being fed into one convolutional pathway simultaneously and confirms that the input tensor itself is multi-dimensional (time x leads): “can include five thousand data points collected over a period of 10 seconds and 8 leads…”; and paragraphs 92-103, the operations the CNN are many, including: convolution (paragraph 94, 101), activation (paragraph 94), batch normalization (paragraph 94), concatenation across channel/lead axis (paragraph 93, 103), max pooling (paragraph 94, 103), global average pooling (paragraph 103), dense layers with sigmoid (paragraph 94));
generate a disease indication in a subject as a function of at least the classification model (see: Ulloa-Cerna, Fig. 2B, and paragraph 51-52, is met by vector is the input to a classification pipeline; and paragraph 6, 23-25, 28, and 110, is met by evaluate the data with respect to each disease of a set of cardiology diseases, automatically generate the cardiac disease state risk score); and
display the disease indication (see: Ulloa-Cerna, paragraph 6, 110, and 113, is met by outputting the composite risk score to a display).
Ulloa-Cerna teaches 12-lead electrocardiogram data, but Ulloa-Cerna fails to specifically teach a 12-lead electrocardiograph comprising a plurality of leads so as to receive voltage-time data of a subject from the 12-lead electrocardiograph; however, Xue teaches a physiological-signal-analysis device that is an electrocardiograph that acquires a twelve-lead ECG (see: Xue, paragraph 29-30).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system including 12-lead electrocardiogram data as taught by Ulloa-Cerna to include a physiological-signal-analysis device that is an electrocardiograph that acquires a twelve-lead ECG as taught by Xue with the motivation of generating a refined representation of the physiological signal in order to generate an optimal lead-set for further analysis (see: Xue, paragraph 4).
As per claim 2, Ulloa-Cerna and Xue teach the invention as claimed, see discussion of claim 1, and further teach:
wherein generating the disease indication in a subject as a function of at least the classification model comprises receiving a probability value associated with the disease indication from the classification model (see: Ulloa-Cerna, paragraph 6-8, 74, 87, 97, and 103, is met by a composite risk score reflecting a likelihood of the patient being diagnosed with one or more of the cardiology diseases of the set of cardiology diseases).
As per claim 3, Ulloa-Cerna and Xue teach the invention as claimed, see discussion of claim 2, and further teach:
wherein generating the disease indication in a subject as a function of at least the classification model comprises classifying the probability value to the disease indication (see: Ulloa-Cerna, paragraph 94 and 97, is met by the dense layer component can including four dense layers of 256, 64, 8 and 1 unit(s) with a sigmoid function as the final layer, indicating the final layer has 1 unit and a sigmoid function on a single output unit squashes the result to a value between 0 and 1, which paragraph 97 confirms by stating that the risk score “can be indicative of a likelihood the patient will suffer from one or more conditions”).
As per claim 4, Ulloa-Cerna and Xue teach the invention as claimed, see discussion of claim 3, and further teach:
wherein classifying the probability value to the disease indication comprises classifying the probability value to the disease indication using a sigmoid function for binary classification (see: Ulloa-Cerna, paragraph 94 and 97, is met by the dense layer component can including four dense layers of 256, 64, 8 and 1 unit(s) with a sigmoid function as the final layer, indicating the final layer has 1 unit and a sigmoid function on a single output unit squashes the result to a value between 0 and 1, which paragraph 97 confirms by stating that the risk score “can be indicative of a likelihood the patient will suffer from one or more conditions”).
As per claim 5, Ulloa-Cerna and Xue teach the invention as claimed, see discussion of claim 1, and further teach:
wherein the disease indication comprises the cardiovascular disease (see: Ulloa-Cerna, paragraph 6, 23-25, 28, and 110, is met by evaluate the data with respect to each disease of a set of cardiology diseases).
As per claim 6, Ulloa-Cerna and Xue teach the invention as claimed, see discussion of claim 1, and further teach:
wherein the disease indication comprises the level of the cardiovascular disease (see: Ulloa-Cerna, Fig. 4A, and paragraph 13, 25, 28, 55, 75, and 88, is met by identify patients likely to experience cardiac disease states, and the trained composite model may be selected based at least in part on a severity of cardiology diseases the generated risk score represents, and the severity of cardiology diseases may include labels for one or more of normal, mild, moderate, and severe).
As per claim 7, Ulloa-Cerna and Xue teach the invention as claimed, see discussion of claim 1, and further teach:
wherein receiving the voltage-time data comprises generating at least a feature vector from the voltage-time data using at least a feature model (see: Ulloa-Cerna, Fig. 2B, and paragraph 51-52, 93, and 103, is met by forming a feature vector from the output of each neural network as applied to the input data, and the “single downstream array” is a feature vector summarizing learned features across all leads, and is fed into the dense layers).
As per claim 8, Ulloa-Cerna and Xue teach the invention as claimed, see discussion of claim 1, and further teach:
wherein receiving the voltage-time data comprises receiving the voltage-time data from an electronic medical record (see: Ulloa-Cerna, paragraph 36, 51, and 96, is met by ECG trace and other EHR data, “these EHR features can be extracted directly from the standard 12-lead ECG report”).
As per claim 9, Ulloa-Cerna and Xue teach the invention as claimed, see discussion of claim 1, and further teach:
wherein the voltage-time data comprises electrocardiogram (ECG) data (see: Ulloa-Cerna, Fig. 5, and paragraph 93, 96, 99-100, 104, is met by voltage-time data from 12-lead ECG).
As per claim 10, Ulloa-Cerna teaches the invention as claimed, see discussion of claim 1, and further teach:
wherein the voltage-time data comprises a 12 row matrix (see: Xue, Fig. 3; and paragraph 34, is met by, for stored twelve-lead ECG samples, voltages or data for all of the leads may be stored in a matrix (V), where each row of the table includes a lead having sampled voltages and each column is a sample point).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system including 12-lead electrocardiogram data as taught by Ulloa-Cerna to include voltages or data for all of the leads in a stored in a matrix (V), where each row of the table includes a lead having sampled voltages and each column is a sample point, as taught by Xue with the motivation of generating a refined representation of the physiological signal in order to generate an optimal lead-set for further analysis (see: Xue, paragraph 4).
Claims 11-20 repeat the subject matter of claims 1-10, which have been shown to be fully disclosed by the cited prior art in the rejections above; as such, claims 11-20 are rejected here for the same reasons given in the above rejections of claims 1-10, which are incorporated herein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A SOREY whose telephone number is (571)270-3606. The examiner can normally be reached Monday through Friday, 8am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A SOREY/ Primary Examiner, Art Unit 3682
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