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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) received on August 11, 2023 has been considered by examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: “wherein the big data module is configured to obtain a large amount of medical and health data on cardiovascular and cerebrovascular diseases and send the data to the model building module” should be “wherein the big data module is configured to obtain a large amount of medical and health data on cardiovascular and cerebrovascular diseases and send the medical and health data to the model building module.” Appropriate correction is required.
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 limitations are in claim 1:
big data module is configured to obtain
model building module is configured to build
data collection module is configured to collect
electrocardiogram comparison module is configured to compare
physical status monitoring module is configured to monitor
preliminary diagnosis module is configured to make
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recites sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth 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 1-9 are rejected under 35 U.S.C. 101 because the claims are not directed to patent eligible subject matter.
Claims 1-9 do fall within at least one of the four categories of patent eligible subject matter because the claims recite a machine (i.e., system).
Although claims 1-9 fall under at least one of the four statutory categories, it should be determined whether the claim wholly embraces a judicially recognized exception, which includes laws of nature, physical phenomena, and abstract ideas, or is it a particular practical application of a judicial exception (See MPEP 2106 I and II).
Claims 1-9 are directed to a judicial exception (i.e., a law of nature, natural phenomenon, or abstract idea) without significantly more.
Part I: Step 2A, Prong One: Identify the Abstract Idea
Under step 2A, Prong One of the Alice framework, the claims are analyzed to determine if the claims are directed to a judicial exception. MPEP §2106.04(a). The determination consists of a) identifying the specific limitations in the claim that recite an abstract idea; and b) determining whether the identified limitations fall within at least one of the three subject matter groupings of abstract ideas (i.e., mathematical concepts, mental processes, and certain methods of organizing human activity).
The identified limitations of independent claim 1 recite:
a data collection module, a physical status monitoring module, a preliminary diagnosis module, an electrocardiogram comparison module, a model building module, a big data module, and a server, wherein the big data module is configured to obtain a large amount of medical and health data on cardiovascular and cerebrovascular diseases and send the data to the model building module, and the model building module is configured to build a disease diagnosis model with reference to the medical and health data on cardiovascular and cerebrovascular diseases and feedback the disease diagnosis model to the server for storage;
the data collection module is configured to collect electrocardiogram data and physical status data of a person to be diagnosed and send the electrocardiogram data and physical status data to the server, and the server sends the electrocardiogram data to the electrocardiogram comparison module and the physical status data to the physical status monitoring module;
the electrocardiogram comparison module is configured to compare an electrocardiogram of cardiovascular and cerebrovascular systems of the person to be diagnosed to obtain an electrocardiogram deviation level and a corresponding electrocardiogram deviation coefficient and feedback the electrocardiogram deviation level and the electrocardiogram deviation coefficient to the server, and the server sends the electrocardiogram deviation level and the corresponding electrocardiogram deviation coefficient to the preliminary diagnosis module;
the physical status monitoring module is configured to monitor a physical status of the person to be diagnosed to obtain a physical status deviation level and a corresponding physical status deviation coefficient and feedback the physical status deviation level and the physical status deviation coefficient to the server, and the server sends the physical status deviation level and the corresponding physical status deviation coefficient to the preliminary diagnosis module;
the preliminary diagnosis module is configured to make a preliminary diagnosis of cardiovascular and cerebrovascular diseases for the person to be diagnosed to generate a signal indicating a healthy body, a signal indicating reexamination, or a signal indicating a Y006. diagnosis, and feedback the signal to the server;
if the server receives the signal indicating a healthy body, no operation is performed;
if the server receives the signal indicating reexamination, physical conditions of the person to be diagnosed are monitored and diagnosed again; and
if the server receives the signal indicating a disease, a disease query instruction is generated and then loaded into the data collection module; and
the data collection module retakes various physical feature values of the person to be diagnosed that are required for the disease diagnosis model, and sends the physical feature values to the server, and the server inputs the various physical feature values of the person to be diagnosed to the disease diagnosis model to obtain a diagnostic report of the person to be diagnosed by using the disease diagnosis model
The identified limitations, under their broadest reasonable interpretation, cover performance of the limitations in the mind (including observation, evaluation, judgement or opinion) but for the recitation of generic computer components. That is, other than reciting a server, nothing in the claim elements precludes the steps form practically being performed in the mind. For example, the identified limitations encompass a user drafting a diagnostic report for a patient based on collecting, comparing, and monitoring electrocardiogram (ECG) data. The claim limitations fall within the Mental Processes groupings of abstract ideas. Thus, the claimed invention recites a judicial exception.
Part I: Step 2A, prong two: additional elements that integrate the judicial exception into a practical application
Under step 2A, Prong Two of the Alice framework, the claims are analyzed to determine whether the claims recite additional elements that integrate the judicial exception into a practical application. In particular, the claims are evaluated to determine if there are additional elements or a combination of elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claims are more than a drafting effort designed to monopolize the judicial exception.
This judicial exception is not integrated into a practical application. As a whole, the server in the steps is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Dependent claims 2-9, when analyzed as a whole, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed to an abstract idea. For instance, claims 4, 6, and 8 recites a comparing, monitoring, and preliminary diagnosis process using formulas to calculate values. Thus, claims 4, 6, and 8 fall within the Mathematical Concepts grouping. Claims, 2, 3, 5,7, and 9 recite screening value to build a diagnosis model, the type of ECG and physical status data, type of ECH deviation coefficient and level, type of physical status deviation coefficient and level, and the diagnostic ranges. The claims 2, 3, 5,7, and 9 cover performance of the limitations in the mind (including observation, evaluation, judgement or opinion), and fall within the Mental Processes grouping.
Since these claims are directed to an abstract idea, the Office must determine whether the remaining limitations “do significantly more” than describe the abstract idea.
Part II. Determine whether any Element, or Combination, Amounts to“Significantly More” than the Abstract Idea itself
Under Part II, the steps of the claims, when considered individually and as an ordered combination, do not improve another technology or technical field, do not improve the functioning of the computer itself, and are not enough to qualify as "significantly more". For example, the steps require no more than a conventional computer to perform generic computer functions. The server in the steps is recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer component. Therefore, based on the two-part Mayo analysis, there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself. Claims 1-9, when considered individually and as an ordered combination, are rejected as ineligible subject matter under 35 U.S.C. 101.
Dependent claims 2-9 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional claims do no recite significantly more than an abstract idea.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Rhyne et al. (US 2019/0369120 A1), Diagnostic And Prognostic Methods For Cardiovascular Diseases And Events
The prior art reference, Rhyne, discloses diagnosing cardiovascular diseases based on measuring and comparing the level of proteins (e.g., Rhyne paragraph [0106]) as recited in claims 3 and 6, and creating a diagnostic model (e.g., Rhyne Paragraphs [0126], [0145]) as recited in claims 1 and 2. Rhyne does not teach or suggest an deviation coefficients to build the diagnosis model.
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/CHINYERE MPAMUGO/Primary Examiner, Art Unit 3685