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 .
Status of Claims
This action is in response to the application filed 5/24/2024.
Claims 1-20 are currently pending and have been examined.
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.
Claims 1-20 are drawn to a method and a non-transitory computer readable medium which are statutory categories of invention (Step 1: YES).
Independent claims 1 and 20 recite: prevent a failure to rescue event, the method comprising: providing a user with a first query; receiving a first user input in response to the first query; providing the user with a second query, wherein the second query is at least partially based on the first user input; receiving a second user input in response to the second query; analyzing at least one of the first user input and the second user input to provide a failure to rescue analysis; and outputting the failure to rescue analysis.
Independent claim 13 recites: failure to rescue prevention, the method comprising: receiving an electronic medical record; performing a failure to rescue analysis by comparing the electronic medical record; and outputting the failure to rescue analysis.
The 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 systems and methods described herein can be used both directly by staff (e.g., nurses) to assess patients systematically for clinical warning signs, and/or by computer systems (e.g., a patient management system) to automatically detect patient decline based on medical records and monitoring. Additionally, implementations of the present disclosure can provide guidance to clinical staff in performing diagnosis and treatment based on the detected stages of clinical decline that can improve education and training. Accordingly, implementations of the present disclosure include improved systems and methods for preventing failure to rescue events and generally improving diagnosis, treatment, and other clinical practices” (see: specification paragraph 55). 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 they address “FIG. SD illustrates an example user interface 540 for outputting a failure to rescue analysis to a user, according to implementations of the present disclosure. As shown in FIG. SB, the user interface 520 can optionally include a score referring to one or more of the clinical warning curves described herein. Alternatively or additionally, as shown in FIG. SD, an user interface 540 can include outputting instructions 542 to the user to direct diagnosis and/or treatment of a subject.” (see: specification paragraph 66 and Figure 5D). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
The judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “computer”, “non-transitory computer readable medium”, “branching logic database”, and “processor”, are recited at a high level of generality (e.g., that the analyzing and outputting is performed using generic computer components with instructions are executed to perform the claimed limitations). Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
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 into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic component cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, 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. The originally filed specification supports this conclusion at Figure 1A, Figure 3 and
Paragraph 136, where “Referring to FIG. 3, an example computing device 300 upon which the methods described herein may be implemented is illustrated. It should be understood that the example computing device 300 is only one example of a suitable computing environment upon which the methods described herein may be implemented. Optionally, the computing device 300 can be a well-known computing system including, but not limited to, personal computers, servers, handheld or laptop devices, multiprocessor systems, microprocessor-based systems, network personal computers (PCs), minicomputers, mainframe computers, embedded systems, and/or distributed computing environments including a plurality of any of the above systems or devices. Distributed computing environments enable remote computing devices, which are connected to a communication network or other data transmission medium, to perform various tasks. In the distributed computing environment, the program modules, applications, and other data may be stored on local and/or remote computer storage media.”
Paragraph 141, where “It should be understood that the various techniques described herein may be implemented in connection with hardware or software or, where appropriate, with a combination thereof. Thus, the methods and apparatuses of the presently disclosed subject matter, or certain aspects or portions thereof, may take the form of program code (i.e., instructions) embodied in tangible media, such as floppy diskettes, CD-ROMs, hard drives, or any other machine-readable storage medium wherein, when the program code is loaded into and executed by a machine, such as a computing device, the machine becomes an apparatus for practicing the presently disclosed subject matter. In the case of program code execution on programmable computers, the computing device generally includes a processor, a storage medium readable by the processor (including volatile and non-volatile memory and/or storage elements), at least one input device, and at least one output device. One or more programs may implement or utilize the processes described in connection with the presently disclosed subject matter, e.g., through the use of an application programming interface (API), reusable controls, or the like. Such programs may be implemented in a high-level procedural or objectoriented programming language to communicate with a computer system. However, the program(s) can be implemented in assembly or machine language, if desired. In any case, the language may be a compiled or interpreted language and it may be combined with hardware implementations.”
Paragraph 60, where “Optionally, the second query can be determined by comparing the first query to a branching logic database. In some implementations, the branching logic database can include a database of medical reference value that the user input in response to the first and/or second query can be compared to.”
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 with route, 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 (Step 2B: NO).
Dependent claims 2-12, 14-19 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 limitations fail to establish that the claims are directed to an abstract idea without significantly more. Claim 2-12 and 14-10 recite comparing, analyzing, and displaying of clinical data on the generically recited computing device as shown in the parent claims above.
Claims 2 and 8 further recite “branching logic database” which is recited at a high level of generality (e.g., that the associating and correlating are performed using generic computer components with instructions are executed to perform the claimed limitations) as shown in the specification paragraph 60. Such that they amount to no more than mere instructions to apply the exception using generic computer components. See: MPEP 2106.05(f).
These claims fail to remedy the deficiencies of their parent claims above, and therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
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) 1-11, 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverman (US 2020/0381127 A1) in view of Lafountain (WO 2008/057606 A2).
CLAIM 1-
Silverman teaches:
A computer-implemented method to prevent a failure to rescue event, the method comprising: providing a user with a first query; (Silverman teaches a computer system that uses questionnaires (i.e., queries) to a user to determine severity of the condition that is a threat to life (i.e., failure to rescue) (para [0323, 0497, 0598, 0157, Table 4]))
receiving a first user input in response to the first query; (Silverman teaches that the user uses an input source for the questionnaire (para [0513-0518]))
providing the user with a second query,; (Silverman teaches that the questions are sequenced in an order through obtained feature categories that the user can select (para [0159, 0395]))
receiving a second user input in response to the second query; (Silverman teaches that multiple questions are asked sequentially with multiple queries responded to (para [0159, 0395]))
analyzing at least one of the first user input and the second user input to provide a failure to rescue analysis; (Silverman teaches a computer system that uses questionnaires (i.e., queries) to a user to determine severity of the condition that is a threat to life (i.e., failure to rescue) (para [0323, 0497, 0598, 0157, Table 4]))
and outputting the failure to rescue analysis (Silverman teaches that there is an output of the patient morbidities based on the patient questionnaire (claim 21))
Silverman teaches sequential ordering, however Silverman does not explicitly teach but Lafountain teaches:
wherein the second query is at least partially based on the first user input (Lafountain teaches new questions based on the previous question answers and their correlation (para [0012]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the questionnaire risk stratification computing system of Silverman to integrate the application of specific questions correlating with each other of Lafountain with the motivation of improving patient outcomes by improving patient adherence and medical treatment to avoid risk to the patient (see: Lafountain, paragraph 7).
CLAIM 2-
Silverman in view of Lafountain teach the limitations of claim 1. Regarding claim 2, Silverman further teaches:
wherein analyzing at least one of the first user input and the second user input comprises performing a comparison of the first user input and the second user input to a branching logic database, and wherein outputting the failure to rescue analysis is based on the comparison (Silverman teaches using branched-chain logic in a system with a database when branching the risk indicators through the questionnaire using the user input and outputting the patient morbidity risk (para [0063-0064, 0287-0292, 0314, 0105, 0071]))
CLAIM 3-
Silverman in view of Lafountain teach the limitations of claim 1. Regarding claim 3, Lafountain further teaches:
wherein the failure to rescue analysis comprises a three-point scale (Lafountain teaches using the medical questionnaire using three factors for the questionnaire based on whether the patient will continue with treatment (i.e., risk of failure of treatment) (para [0053]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the questionnaire risk stratification computing system of Silverman to integrate the application of specific questions correlating with each other of Lafountain with the motivation of improving patient outcomes by improving patient adherence and medical treatment to avoid risk to the patient (see: Lafountain, paragraph 7).
CLAIM 4-
Silverman in view of Lafountain teach the limitations of claim 1. Regarding claim 4, Lafountain further teaches:
wherein the failure to rescue analysis comprises a four-point scale (Lafountain teaches using the medical questionnaire using four points to determine measure adherence of the patient based on their psychological factors (i.e., risk of failure of treatment) (para [0037]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the questionnaire risk stratification computing system of Silverman to integrate the application of specific questions correlating with each other of Lafountain with the motivation of improving patient outcomes by improving patient adherence and medical treatment to avoid risk to the patient (see: Lafountain, paragraph 7).
CLAIM 5-
Silverman in view of Lafountain teach the limitations of claim 1. Regarding claim 5, Silverman further teaches:
wherein the failure to rescue analysis comprises a treatment recommendation (Silverman teaches that with the patient morbidity (i.e., failure to rescue) data, treatments and procedures are recommended (para [0799, 0227]))
CLAIM 6-
Silverman in view of Lafountain teach the limitations of claim 1. Regarding claim 6, Silverman further teaches:
wherein the failure to rescue analysis comprises a predicted diagnosis or a predicted prognosis (Silverman teaches that with the patient morbidity (i.e., failure to rescue) data, a diagnostic algorithm is performed (para [0799, 0227]))
CLAIM 7-
Silverman in view of Lafountain teach the limitations of claim 1. Regarding claim 7, Silverman further teaches:
wherein the failure to rescue analysis comprises an analysis of at least one of: sepsis (Silverman teaches that sepsis is one of the coded diagnostic conditions in the analysis (Table 35))
CLAIM 8-
Silverman in view of Lafountain teach the limitations of claim 1. Regarding claim 8, Lafountain further teaches:
wherein the second query is at least partially based on comparing the first query to a branching logic database (Lafountain teaches using the hierarcheracal clustering of branches in their electronic device and teaches new questions based on the previous question answers and their correlation (para [0012, 0046, 0065]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the questionnaire risk stratification computing system of Silverman to integrate the application of specific questions correlating with each other of Lafountain with the motivation of improving patient outcomes by improving patient adherence and medical treatment to avoid risk to the patient (see: Lafountain, paragraph 7).
CLAIM 9-
Silverman in view of Lafountain teach the limitations of claim 8. Regarding claim 9, Lafountain further teaches:
wherein the second query is at least partially based on the first query (Lafountain teaches new questions based on the previous question answers and their correlation (para [0012]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the questionnaire risk stratification computing system of Silverman to integrate the application of specific questions correlating with each other of Lafountain with the motivation of improving patient outcomes by improving patient adherence and medical treatment to avoid risk to the patient (see: Lafountain, paragraph 7).
CLAIM 10-
Silverman in view of Lafountain teach the limitations of claim 8. Regarding claim 10, Lafountain further teaches:
wherein the second query is determined by comparing the first user input to a database of medical reference values (Lafountain teaches predictive factor values that show the relationship between the user inputted factor data based on the questionnaires on the electronic device (para [0049, 0065, claim 40]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the questionnaire risk stratification computing system of Silverman to integrate the application of specific questions correlating with each other of Lafountain with the motivation of improving patient outcomes by improving patient adherence and medical treatment to avoid risk to the patient (see: Lafountain, paragraph 7).
CLAIM 11-
Silverman in view of Lafountain teach the limitations of claim 8. Regarding claim 9, Silverman further teaches:
further comprising generating graphical display data associated with the failure to rescue analysis (Silverman teaches the display of the data in a table and based on life-threatening data (para [0708, Table 28, Figure 26.34]))
CLAIM 13-
Claim 13 is significantly similar to claims 1 and 2 and is rejected upon the same prior art as claims 1 and 2.
CLAIMS 14-18-
Claims 14-18 are significantly similar to claims 3-7 and are rejected upon the same prior art as claims 3-7.
CLAIM 19-
Silverman in view of Lafountain teach the limitations of claim 13. Regarding claim 19, Silverman further teaches:
wherein the branching logic database comprises a database of medical reference values (Silverman teaches multiple databases including an institutional database that has scores of clinical information (i.e., medical reference values) connected to the branching logic model of the system on the database (para [0068-0069, 0092, 0348]))
CLAIM 20-
Claim 20 is significantly similar to claim 1 and is rejected upon the same prior art as claim 1.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverman (US 2020/0381127 A1) in view of Lafountain (WO 2008/057606 A2) and further in view of Rothman (US 2010/0100392 A1).
CLAIM 12-
Silverman in view of Lafountain teach the limitations of claim 11. Regarding claim 12, Silverman in view of Lafountain do not explicitly teach, however Rothman teaches:
wherein the graphical display data comprises color-coded patient statuses plotted on a clinical warning curve ( teaches that color coding of the slope of the lines that denote the patient’s determination if the patient is getting worse (i.e., clinical warning) (para [0107], Figure 5]))
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the specific questionnaire risk stratification and correlation computing system of Silverman in view of Lafountain to integrate the application of color coordinated risk charts associated with patients with the motivation of improving patient outcomes by monitoring patient’s risk in a sensitive method (see: Rothman, paragraphs 3 and 7).
Conclusion
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/KIMBERLY A. SASS/Examiner, Art Unit 3686