DETAILED ACTION
Applicant’s response, filed 05/20/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Status
Claims 1, 4-7, 9, and 12-15 are pending.
Claims 2, 3, 8, 10, 11, and 16 are canceled.
Claims 1, 4-7, 9, and 12-15 are rejected.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to App. No. TAIWAN 110123616, filed 06/28/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The Drawings submitted 09/13/2021 are accepted.
Claim Rejections- 35 USC § 112
The outstanding rejections to the claims are withdrawn in view of the amendments submitted herein as the limitation was removed from the claims.
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.
For the following rejections, underlined text indicates newly recited portions necessitated by claim amendment.
Claims 1, 4-7, 9, and 12-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more. Any newly recited portions are necessitated by claim amendment.
MPEP 2106 organizes judicial exception analysis into Steps 1, 2A (Prongs One and Two) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1
With respect to Step 1: yes, the claims are directed to method and system, i.e., a process, machine, or manufacture within the above 101 categories [Step 1: YES; See MPEP § 2106.03].
Step 2A, Prong One
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas are as follows:
Independent claims 1 and 9:
read a sepsis database and at least one database to be tested of a storing unit, wherein the sepsis database comprises a plurality of sepsis data, and the at least one database to be tested comprises a plurality of data to be tested;
to create a sepsis data table according to the sepsis data and create a data table to be tested according to the data to be tested;
to train a sepsis diagnosis model with the sepsis data table according to a K-fold cross-validation and a machine learning algorithm;
performing a data integrating step to drive the processing unit to collect the maximum value, the minimum value, the latest value, the patient basic data and the patient blood test data to generate the sepsis data table; wherein the machine learning algorithm is an eXtreme Gradient Boosting (XGBoost), and a variable K of the K-fold cross-validation is 5
to calculate a sepsis prediction result; wherein the sepsis data are a patient basic data, a patient vital sign data and a patient blood test data;
Dependent claims 7 and 15:
to cut the sepsis data table into K data sets according to the K-fold cross-validation, wherein the K data sets comprise K-1 training sets and a validation set,
trains the K-1 training sets according to a plurality of initial hyperparameters and the machine learning algorithm to generate a plurality of initial models corresponding to each of the initial hyperparameters;
to calculate the initial models through the validation set to generate a plurality of mean area under curves corresponding to the initial models,
compare the mean area under curves to select a target hyperparameter from the initial hyperparameters;
to retrain the sepsis data table according to the target hyperparameter and the machine learning algorithm to generate the sepsis diagnosis model.
Dependent claims 4-6, 12-14 and 16 recite further steps that limit the judicial exceptions in independent claim 1 and, as such, also are directed to those abstract ideas. For example, claims 4 and 12 further limits the patient basic data of claim 2, claims 5 and 13 further limits the patient vital sign data of claims 2 and 9, claims 6 and 14 further limits the patient blood test data of claims 2 and 9,
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation. Without further detail as to the methodology involved in “read a sepsis database”, “to create a sepsis data table”, “ to calculate a sepsis prediction “, “to extract a maximum value, a minimum value “, “to integrate the maximum value, the minimum value, the latest value, the patient basic data and the patient blood test data“, “to cut the sepsis data table“, “to calculate the initial models “, “compare the mean area under curves “, and “to retrain the sepsis data table “under the BRI, are mathematical concepts.
Therefore, claims 1 and 9 and those claims dependent therefrom recite an abstract idea [Step 2A, Prong 1: YES; See MPEP § 2106.04].
Step 2A, Prong Two
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two, provides that the claims must be examined further to determine whether they integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d).III).
Additional elements, Step 2A, Prong Two
With respect to the instant recitations, the claims recite the following additional elements:
Independent claim 1:
A sepsis database
A storing unit
to input the data table to be tested into the sepsis diagnosis model to calculate a sepsis prediction result.
a wearable device
to extract a maximum value, a minimum value and a latest value of the patient vital sign data within the feature window, wherein an inspection frequency of each of the sepsis patients within the feature window is not the same, such that a number of inspections of the patient vital sign data within the feature window differs for each of the sepsis patients; and
providing a real-time monitoring for the sepsis by outputting a clinical alert to a wearable device or an electronic equipment of an intensive care unit (ICU) according to the sepsis prediction result; wherein the sepsis data are a patient basic data, a patient vital sign data and a patient blood test data and collected from a plurality of sepsis patients after a feature window, and the feature window refers to a 12-hour period before a clinical recognition
Independent claim 9:
a storing unit
a sepsis database
input the data table to be tested into the sepsis diagnosis model to calculate a sepsis prediction result.
The claims also include non-abstract computing elements. For example, independent claim 1 includes “a processing unit” and claim 9 includes “an artificial intelligence assisted medical diagnosis system”.
Considerations under Step 2A, Prong Two
With respect to Step 2A, Prong Two, the additional elements of the claims do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to data gathering, such as “inputting”, “collect”, and “extract”, and to data outputting, such as “outputting” and “storing”, perform functions of collecting the data needed to carry out the judicial exceptions. Data gathering and outputting do not impose any meaningful limitation on the judicial exceptions, or on how the judicial exceptions are performed. Data gathering and outputting steps are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
Further steps directed to additional non-abstract elements of “a system and a processor” do not describe any specific computational steps by which the “computer parts” perform or carry out the judicial exceptions, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions using a computer, and therefore the claim does not integrate that judicial exceptions into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc.… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer (MPEP 2106.05(f)).
With respect, the additional elements of a database and storing unit, do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to using a storing unit and a database do not impose any meaningful limitations on the abstract idea, or on how the abstract idea is performed. These steps are insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)(2)).
With respect, the additional element of a wearable device o not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to using a storing unit and a database do not impose any meaningful limitations on the abstract idea, or on how the abstract idea is performed. These steps are insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)(2)).
Thus, none of the claims recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to one or more judicial exceptions [Step 2A, Prong 2: NO; See MPEP § 2106.04(d)].
Step 2B (MPEP 2106.05.A i-vi)
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(II)(i)).
As such, the claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to claims 1 and 9 and those claims dependent therefrom, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions using a computer, which the courts have found to not provide significantly more when recited in a claim with a judicial exception (see MPEP 2106.06(A)). The specification also notes that computer processors and systems, as example, are commercially available or widely used at [0038]. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than the judicial exceptions (see MPEP 2106.05(b)I-III).
With respect to claims 1 and 9 and those claims dependent therefrom, the additional elements of a storing unit and database are well-understood, routine, and conventional in the art as the specification discloses a storing unit can be a Hospital Information System (HIS) or a cloud server [0037].
With respect to the additional element of a wearable device it is well-understood, routine, and conventional in the art as the specification discloses the processing unit 320 can be a wearable device, or a Micro Processing Unit (MPU), a Central Processing Unit (CPU), an image processor or other electronic processors of an Intensive Care Unit (ICU) electronic equipment, but the present disclosure is not limited thereto [0037]. The use of wearable devices and electronic equipment of an intensive care unit (ICU) are well-understood, routine, and conventional in the art as disclosed by Joshi et al. (Joshi, Meera, et al. "Digital alerting and outcomes in patients with sepsis: systematic review and meta-analysis." Journal of medical Internet research 21.12 (2019), newly cited). Joshi discloses digital alerting and outcomes in patients with sepsis: systematic review and meta-analysis [title]. Joshi further discloses digital technology holds significant promise in enabling early sepsis recognition [p. 2. Col. 1, par. 3]. Joshi also discloses coupled with the rapid expansion of electronic health records (EHRs) worldwide, it is now possible to provide health care staff with real-time information on laboratory tests, imaging, and physiological vital signs at the bedside which is particularly relevant in sepsis because of the traditional reliance on risk scoring systems used to define sepsis [p. 2. Col. 1, par. 3].
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself [Step 2B: NO; See MPEP § 2106.05].
Therefore, the instant claims are not drawn to eligible subject matter as they are directed to one or more judicial exceptions without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
Response to Applicant Arguments
1. Applicant submits integrate the sepsis prediction result into a practical clinical application by using the sepsis prediction result to actively control and operate external medical-related devices, including wearable devices and ICU electronic equipment, through generation of real-time clinical alerts [p. 12, par. 1].
It is respectfully found not persuasive. The claims are directed to sending an output to a wearable device or electronic equipment of an intensive care unit (ICU), but the output does not direct the additional element to perform any task, therefore it doesn’t not integrate the judicial exception into a practical application.
2. Applicant submits claims 1 and 9 are not well-understood, routine, or conventional activities performed in a generic manner. Instead, amended Claims 1 and 9 recite a specific arrangement in which sepsis prediction results are used to automatically provide real-time clinical alerts to designated medical devices within an ICU monitoring framework. These additional elements amount to significantly more than any alleged judicial exception and provide an inventive concept under Step 2B of the Alice framework [p. 12, par. 4].
It is respectfully found not persuasive. As the applicant stated in the “patent-eligible subject matter found eligible in cases where collected and analyzed data is further used to automatically initiate or control particular technological operations, rather than merely displaying information” [p. 13, par. 2]. The claims are directed to sending an output to a wearable device or electronic equipment of an intensive care unit (ICU), but the output does not direct the additional element to perform any task, therefore it doesn’t not integrate the judicial exception into a practical application.
Claim Rejections - 35 USC § 103
The outstanding rejections to the claims are withdrawn in view of the amendments submitted herein. The prior art of Yuan , George-Gay, or Kam do not disclose wherein the sepsis data are a patient basic data, a patient vital sign data and a patient blood test data; ... " into " ... wherein the sepsis data are a patient basic data, a patient vital sign data and a patient blood test data and collected from a plurality of sepsis patients after a feature window, and the feature window refers to a 12-hour period before a clinical recognition and ... performing a value extracting step (to drive the processing unit) to extract a maximum value, a minimum value and a latest value of the patient vital sign data within the feature window, wherein an inspection frequency of each of the sepsis patients within the feature window is not the same, such that a number of inspections of the patient vital sign data within the feature window differs for each of the sepsis patients”.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
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/D.M.B./Examiner, Art Unit 1685 /Soren Harward/Primary Examiner, TC 1600
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