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
Claims 1-15 were previously pending and subject to a non-final Office Action having a notification date of January 5, 2026 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on April 2, 2026 (the “Amendment”), amending claims 1-9 and 11-15; canceling claim 10; and adding new claim 16.
The present Final Office Action addresses pending claims 1-9 and 11-16 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Interpretation Under 35 USC §112(f)
These interpretations are withdrawn in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112
While these rejections are withdrawn in view of the Amendment, new rejections are presented herein in view of the Amendment.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §101
The rejection of claim 15 under 35 USC 101 as not falling within at least one of the four categories of patent eligible subject matter is withdrawn in view of the Amendment.
At page 12 of the Amendment, Applicant takes the position that the present claims are "directed to a method of treatment." The Examiner disagrees because the present claims do not require administration of a treatment but instead only classify a treatment priority of a patient based on objective symptom information.
At page 14 of the Amendment, Applicant takes the position that independent claims 1 and 14 categorize vitals to triage the patient and then display a "complete picture" of the vitals. However, the claims do not recite these features.
At page 15 of the Amendment, Applicant asserts that the present claims present more than a drafting effort to monopolize the abstract idea and do not pre-empt practice of the abstract idea. However, while preemption is the concern underlying the judicial exceptions, it is not a standalone test for determining eligibility. Rapid Litig. Mgmt. v. CellzDirect, Inc., 827 F.3d 1042, 1052, 119 USPQ2d 1370, 1376 (Fed. Cir. 2016). It is necessary to evaluate eligibility using the Alice/Mayo test, because while a preemptive claim may be ineligible, the absence of complete preemption does not demonstrate that a claim is eligible. Diamond v. Diehr, 450 U.S. 175, 191-92 n.14, 209 USPQ 1, 10-11 n.14 (1981) ("We rejected in Flook the argument that because all possible uses of the mathematical formula were not pre-empted, the claim should be eligible for patent protection"). See also Synopsys v. Mentor Graphics, 839 F.3d at 1150, 120 USPQ2d at 1483; FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1098, 120 USPQ2d 1293, 1299 (Fed. Cir. 2016); Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1320-21, 120 USPQ2d 1353, 1362 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015). MPEP 2106.04(I). In the present case, the Alice/Mayo test has been conducted in detail in the rejection below and a determination made that the present claims are ineligible.
Finally, the Examiner disagrees with Applicant's assertion that categorizing and displaying a patient's symptoms for a clinician provides an improvement in the functioning of a computer or other technology or technological field because such limitations are part of the abstract idea(s) rather than amounting to "additional limitations."
The 35 USC 101 rejection is maintained.
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §103
At the bottom of page 18 of the Amendment, Applicant takes the position that Hettig does not disclose classifying severity grades individual for each vital and then presenting the final grade together with the per-item grades and the causative items on a display. The Examiner disagrees and refers Applicant's attention to at least the top of Figure 9 of Hettig which illustrates per-item scores/grades 284, 286, etc. which collectively result in a final grade 230.
In relation to selecting the grade/score with the highest treatment priority as the final grade, Hann teaches ([0043]) that it was known in the healthcare informatics art to select a highest risk score among a plurality of differing risk scores as an overall/final risk level for a patient which advantageously avoids diminishing the importance of a highly dangerous one of the different risk scores that might otherwise occur in the case of averaging of the various risk scores or the like, thereby allowing dangerous patient situations to be addressed and patient health outcomes to be improved.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for a highest risk value among multiple risk values to be selected as a final grade if the classification grades corresponding to each of the multiple items are different in the system of the Hettig/Lee combination similar to as taught by Hann to advantageously avoid diminishing the importance of a highly dangerous one of the different risk scores that might otherwise occur in the case of averaging of the various risk scores or the like, thereby allowing dangerous patient situations to be addressed and patient health outcomes to be improved. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Objections
Claims 5 and 16 are objected to because of the following informalities:
All occurrences of "SPB" should be changed to --SBP--.
Appropriate correction is required.
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 1-9 and 11-16 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.
Claim 1 recites the limitation "the basic information unit" in lines 13-14. There is insufficient antecedent basis for this limitation in the claim.
Claims 1 and 14 recite the limitation "each input item" in the second to last line. There is insufficient antecedent basis for this limitation in the claims. The Examiner will assume "each input item" is referring to respective pieces of the "objective hospital visitation information."
Claims 1 and 14 recite "wherein the severity classification unit presents, on the display, the final grade together with classification grades classified for each input item and one or more items contributing to the final grade classification to provide a direction for treatment" in the last three lines. However, the difference between "classification grades classified for each input item" and "one or more items contributing to the final grade classification" is not understood as it appears they are both referring to the classification grades of the various objective information. Therefore, the Examiner will assume they are both referring to the classification grades of the various objective information.
Claim 5 now recites "grade 2 if (pulse rate (PR) > a first predetermined pulse rate or a second predetermined pulse rate and outside a predetermined systolic blood pressure (SPB) range" which is nonsensical because it appears that PR is being compared to SBP (i.e. if PR is outside a predetermined SBP range). For purposes of examination, the Examiner will assume Applicant intended --grade 2 if (pulse rate (PR) > a first predetermined pulse rate or a second predetermined pulse rate) and systolic blood pressure (SPB) is outside of a predetermined range--.
Claim 16 recites the limitations "the systolic blood pressure (SPB) and pulse rate (PR)" and "the respiratory rate (RR)." There is insufficient antecedent basis for these limitations in the claim.
The remaining claims are rejected based on their dependency from claims 1 or 14.
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 and 11-16 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more:
Subject Matter Eligibility Criteria - Step 1:
Claims 1-9, 11-13, and 16 are directed to a system (i.e., a machine), claim 14 is directed to a method (i.e., a process), and claim 15 is directed to a non-transitory computer-readable recording medium (i.e., a manufacture). Accordingly, claims 1-9 and 11-16 are all within at least one of the four statutory categories. 35 USC §101.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test (which collectively includes the guidance in the January 7, 2019 Federal Register notice and the October 2019 and July 2024 updates issued by the USPTO as incorporated into the MPEP, as supported by relevant case law), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
An objective severity classification system for emergency patients, comprising:
a processor and a display coupled to the processor;
a hospital visitation information unit, implemented by the processor, that acquires data related to objective hospital visitation information measured about a patient, excluding subjective information;
a symptom unit, implemented by the processor, that distinguishes subjective information and objective information according to predetermined criteria regarding a main symptom of the patient and obtains data regarding the objective information; and
a severity classification unit, implemented by the processor, that automatically classifies severity of the patient's condition by symptom based on at least the data obtained from the hospital visitation information unit among the data obtained from the basic information unit, the hospital visitation information unit and the symptom unit,
wherein when the severity classification unit classifies the severity based on multiple items for each symptom among the data acquired from the hospital visitation information unit, if classification grades corresponding to each of the multiple items are different, a classification grade with a highest treatment priority among the multiple classification grades is selected as a final grade, and wherein the severity classification unit presents, on the display, the final grade together with classification grades classified for each input item and one or more items contributing to the final grade classification to provide a direction for treatment.
The Examiner submits that the foregoing underlined limitations constitute "mental processes" because they are observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind (e.g., with pen and paper). For instance, a medical professional could readily acquire (e.g., via looking at) and review objective hospital visitation information about the patient (e.g., one or more vital signs, tachycardia, facial distortion, etc.), distinguishes subjective information (e.g., pain level, etc.) and objective information (e.g., tachycardia, facial distortion, vital signs, etc.) according to predetermined criteria regarding a main symptom of the patient (e.g., KTAS evaluators) and obtain data regarding the objective information (e.g., presence of tachycardia, facial distortion, etc.), classify (e.g., based on their experience/knowledge/guidelines/an algorithm/rules) an emergency severity of the patient based on the objective information and the distinguishment between the objective and subjective information. For instance, when the severity is classified based on multiple items for each symptom among the acquired data, a medical professional could select a classification grade with a highest treatment priority among the multiple classification grades as a final grade, and then present the final grade together with classification grades classified for each input item and one or more items contributing to the final grade classification to provide a direction for treatment. These recitations, under their broadest reasonable interpretation, are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis found to be "mental processes" in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQe2d 1739 (Fed. Cir. 2016)). MPEP 2106.04(a)(2)(III).
Claims "directed to collection of information, comprehending the meaning of that collected information, and indication of the results, all on a generic computer network operating in its normal, expected manner," fail step one of the Alice framework. In re Killian, 45 F.4th 1373, 1380 (Fed. Cir. 2022). Claims directed to "collecting, analyzing, manipulating, and displaying data" are abstract. Univ. of Fla. Research Found., Inc. v. General Elec. Co., 916 F.3d 1363, 1368 (Fed. Cir. 2019). Claims directed to organizing, storing, and transmitting information determined to be directed to an abstract idea. Cyberfone Sys., L.L.C. v. CNN Interactive Grp., Inc., 558 F. App’x 988, 992 (Fed. Cir. 2014).
Furthermore, the Examiner submits that the foregoing underlined limitations constitute "certain methods of organizing human activity" because they relates to managing personal behavior or relationships or interactions between people (e.g., social activities, teaching, and following rules or instructions) and are similar to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). MPEP 2106.04(a)(2)(II)(C).
Accordingly, the claim recites at least one abstract idea.
Furthermore, dependent claims 2-13 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below:
-Claim 2 recites how basic information including at least one of the patient's gender and date of birth which just further defines the abstract ideas discussed above.
-Claim 3 recites how the hospital visitation information is at least one measurement value of the patient's systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate (PR), respiratory rate (RR), body temperature (BT), oxygen saturation (SpO2), and Glasgow Coma Scale (GCS) which just further defines the abstract ideas discussed above.
-Claim 4 recites how the level of severity is based on the Korean emergency triage tool (KTAS), classified according to a plurality of grades which just further defines the abstract ideas discussed above.
-Claim 5 recites how the patient severity is based on various different combinations of pulse rate and SBP which just further defines the abstract ideas discussed above.
-Claim 6 recites how the patient severity is based on various different combinations of RR breaths per minutes which just further defines the abstract ideas discussed above.
-Claim 7 recites how the patient severity is based on various different ranges of SpO2 which just further defines the abstract ideas discussed above.
-Claim 8 recites how the patient severity is based on various different levels of GCS which just further defines the abstract ideas discussed above.
-Claim 9 recites how the patient severity is based on various different combinations of PR, RR, and BT for classifying SIRS which just further defines the abstract ideas discussed above.
-Claim 11 recites how classifications results appropriate for the patient's age based on the patient's date of birth among the data obtained from the basic information unit is presented which just further defines the abstract ideas discussed above.
-Claim 12 recites how the severity classification grade of the patient is raised by one grade if the patient is an elderly patient according to preset standards which just further defines the abstract ideas discussed above.
-Claim 13 recites how a final classification is made through logistic regression, which reflects the patient's age as a continuous variable which just further defines the abstract ideas discussed above and also relates to mathematical calculations ("mathematical concepts").
-Claim 16 recites how the patient severity is based on different combinations of the Korean emergency triage tool (KTAS), classified according to a plurality of grades, different combinations of pulse rate and SBP, different combinations of RR breaths per minutes, various different ranges of SpO2, and various different levels of GCS, all of which just further defines the abstract ideas discussed above.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2A - Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP §2106.04(II)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements such as merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
In the present case, the additional limitations beyond the above-noted at least one abstract idea recited in the claim are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
An objective severity classification system for emergency patients, comprising:
a processor and a display coupled to the processor;
a hospital visitation information unit, implemented by the processor, that acquires data related to objective hospital visitation information measured about a patient, excluding subjective information;
a symptom unit, implemented by the processor, that distinguishes subjective information and objective information according to predetermined criteria regarding a main symptom of the patient and obtains data regarding the objective information; and
a severity classification unit, implemented by the processor, that automatically classifies severity of the patient's condition by symptom based on at least the data obtained from the hospital visitation information unit among the data obtained from the basic information unit, the hospital visitation information unit and the symptom unit,
wherein when the severity classification unit classifies the severity based on multiple items for each symptom among the data acquired from the hospital visitation information unit, if classification grades corresponding to each of the multiple items are different, a classification grade with a highest treatment priority among the multiple classification grades is selected as a final grade, and wherein the severity classification unit presents, on the display, the final grade together with classification grades classified for each input item and one or more items contributing to the final grade classification to provide a direction for treatment.
For the following reasons, the Examiner submits that the above-identified additional limitations, when considered as a whole with the limitations reciting the at least one abstract idea, do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the system including the processor, display, and various "units," the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application. Furthermore, looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. MPEP §2106.05(I)(A) and §2106.04(II)(A)(2).
For these reasons, representative independent claim 1 and analogous independent claim 14 do not recite additional elements that integrate the judicial exception into a practical application. Accordingly, representative independent claim 1 and analogous independent claim 14 are directed to at least one abstract idea.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claim 15 calls for a non-transitory computer-readable recording medium that is readable by a computer and stores program instructions operable by the computer, wherein when the program instructions are executed by a processor of the computer, the processor determines the objective severity of an emergency patient according to claim 14. This claim just amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
When the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria - Alice/Mayo Test: Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations of the system including the processor, display, and various "units," the Examiner submits that these limitations amount to merely using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
The dependent claims also do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Claim 15 calls for a non-transitory computer-readable recording medium that is readable by a computer and stores program instructions operable by the computer, wherein when the program instructions are executed by a processor of the computer, the processor determines the objective severity of an emergency patient according to claim 14. This claim just amounts to using a computer or other machinery as tools performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f)).
Therefore, claims 1-9 and 11-16 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5, 6, 8, 9, 11, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2020/0066415 to Hettig et al. ("Hettig") in view of NPL "Over-triage occurs when considering the patient's pain in Korean Triage and Acuity Scale (KTAS)" to Lee et al. ("Lee") and U.S. Patent App. Pub. No. 2013/0249695 to Hann ("Hann"):
Regarding claim 1, Hettig discloses an objective severity classification system for emergency patients (Figures 1-3, [0099], and [0105] illustrate/disclose a system for determining a risk of a patient developing sepsis/pressure injury/falling which can occur e.g., at the ED per Figure 4A (severity classification system for emergency patients); furthermore, [0103]-[0104] disclose how the assessment is based on various types of objective data), comprising:
a processor (([0172] of Hettig discloses how the analytics engine 20 can be implemented as a computer executing various algorithms/functions and thus would necessarily include a processor) and a display coupled to the processor ([0006] and Figures 7-35 discloses/illustrate screenshots of a display coupled to the analytics engine that present patient scores for caregivers);
a hospital visitation information unit, implemented by the processor, that acquires data related to objective hospital visitation information measured about a patient, excluding subjective information ([0103] and Figures 1-3 disclose/illustrate how vital signs monitors 18 ("hospital visitation information units") obtain heart rate, pulse oximetry data, BP, respiration rate, etc. ("data related to objective hospital visitation information measured about the patient, excluding subjective information"); [0011], [0166] discloses how physiological monitor ("hospital visitation information unit") obtains SBP, pulse oximetry data, SpO2, RR, body temperature etc.; also note how bed 14 is a "hospital" bed 14 per [0131]);
a symptom unit, implemented by the processor, that distinguishes subjective information and objective information …regarding a main symptom of the patient and obtains data regarding the objective information ([0046] discloses receiving patient symptoms such as anxiety, chest pain, lethargy, etc. while [0172] discloses how the analytics engine receives subjective complaints of the patient ("subjective information"); [0104] discloses receiving pressure injury detail such as location, whether it was present at admission, etc., [0167] discloses receiving tachycardia symptoms, and [0168] discloses how the analytics engine 20 receives clinical examination data such as abdominal respirations, abnormal ECG, etc. ("objective information") all for use in calculating the one or more risk scores; furthermore, as the above subjective/objective information would be received by the analytics engine 20 from some computing device, there is necessarily some code/algorithm/script ("symptom unit") that "distinguishes" the above subjective/objective information (i.e., because they are differently inputted pieces of information) and obtains the objective information; still further, as Figure 12 and [0225] illustrates/discloses primary diagnosis 428 ("patient's main symptom"), then the above subjective/objective information would be regarding such main symptom); and
a severity classification unit, implemented by the processor, that automatically classifies severity of the patient's condition by symptom based on at least the data obtained from the hospital visitation information unit among the data obtained from the basic information unit, the hospital visitation information unit and the symptom unit (Figures 1-3 and [0105] illustrate/disclose how the analytics engine 20 ("severity classification unit") classifies a sepsis/pressure/fall risk ("severity of emergency patient") based on processing the data from the input sources 12 (which includes, inter alia, the vital signs data (the data obtained from the "hospital visitation information unit"); as another example, [0182]-[0184] and Figure 8 discuss/illustrate how a severity score is assigned to various pieces of symptom information such as SBP, BPM, RPM, etc.),
wherein when the severity classification unit classifies the severity based on multiple items among the data acquired from the hospital visitation information unit ([0105], [0166]-[0167] of Hettig disclose using various types of vital/laboratory data to determine the risk/severity score; for instance, note how MEWS score in Figures 8-9 is determined from temperature, SpO2, HR, RR, etc.), … and wherein the severity classification unit presents, on the display, the final grade (MEWS score 230 in Figure 9) together with classification grades classified for each input item and one or more items contributing to the final grade classification (see scores 284-292 for various input items which contribute to the final MEWS score 230) to provide a direction for treatment ([0122]-[0123] discusses how the scores can facilitate determining treatment directions for a caregiver).
While Hettig discloses distinguishing between subjective and objection information regarding the patient's main symptom and obtaining data regarding the objective information as noted above, Hettig might be silent specifically regarding the distinguishing between the subjective and objective information being according to predetermined criteria regarding a main symptom of the patient.
Nevertheless, Lee teaches (bottom of page 2) that it was known in the healthcare informatics art for a triage and acuity scale to start with the patient's main complaint (main symptom) and to identify certain objective information (e.g., tachycardia and facial distortions) relating to a patient's degree of pain (subjective information), where the relationship between the subjective information (e.g., degree of pain) and the objective information (e.g., tachycardia and facial distortions) is a "predetermined criteria regarding the patient's main symptom" (e.g., based on the particular subjective information, there is particular objective information to be obtained). This arrangement advantageously takes into account objective observations which better reflect the patient's degree of pain rather than the patient's subjective experience when determining a final grade, thereby improving accuracy of the final grade to prevent over-triage (bottom of page 2 and bottom of page 10).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the distinguishing between the subjective and objective information in the system of Hettig to be according to predetermined criteria regarding the a main symptom of the patient similar to as taught by Lee to advantageously take into account objective observations which better reflect the patient's degree of pain rather than the patient's subjective experience when determining a final grade, thereby improving accuracy of the final grade to prevent over-triage. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Furthermore, the Hettig/Lee combination appears to be silent regarding if the classification grades corresponding to each of the multiple items are different, the highest grade in the patient's treatment priority with smallest number among the multiple grades is selected as the final grade.
Nevertheless, Hann teaches ([0043]) that it was known in the healthcare informatics art to select a highest risk score among a plurality of differing risk scores as an overall/final risk level for a patient which advantageously avoids diminishing the importance of a highly dangerous one of the different risk scores that might otherwise occur in the case of averaging of the various risk scores or the like, thereby allowing dangerous patient situations to be addressed and patient health outcomes to be improved.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for a highest risk value among multiple risk values to be selected as a final grade if the classification grades corresponding to each of the multiple items are different in the system of the Hettig/Lee combination similar to as taught by Hann to advantageously avoid diminishing the importance of a highly dangerous one of the different risk scores that might otherwise occur in the case of averaging of the various risk scores or the like, thereby allowing dangerous patient situations to be addressed and patient health outcomes to be improved. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
While [0184] of Hettig discloses how increasing score corresponds to higher likelihood of death and thus higher patient treatment priority, Hettig might be silent regarding the patient's treatment priority increasing as the classified grade/score is smaller, such that the smallest number among the multiple grades is selected as the final grade.
Nevertheless, Lee teaches (pages 2-3) that it was known in the healthcare informatics art for a triage and acuity scale to correspond to increasing patient treatment priority with a lower triage level/grade.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the patient's treatment priority in Hettig to increase as the classified grade is smaller similar to as taught by Lee (i.e., opposite from Hettig), such that the smallest number (as opposed to the largest number) among the multiple grades is selected as the final grade because it would have been routine optimization to arrive at the claimed invention and a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). MPEP 2144.05. Furthermore, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Still further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 2, the Hettig/Lee/Hann combination discloses the system according to claim 1, further including
a basic information unit that acquires data related to a patient's basic information ([0104] and Figure 1 of Hettig discloses/illustrates how IPUP survey 22 includes sex/weight of the patient (patient's basic information) and is obtained via input by a caregiver using a PC/tablet computing device; there is therefore some code/algorithm/script ("basic information unit") that acquires the patient's basic information upon input);
wherein the data obtained from the basic information unit comprises at least one of the patient's gender and date of birth ([0104] and Figure 1 of Hettig discloses/illustrates how IPUP survey 22 includes sex/gender of the patient (patient's basic information) while [0267] discloses gender/birth data).
Regarding claim 3, the Hettig/Lee/Hann combination discloses the system according to claim 1, further including wherein the data obtained from the hospital visitation information unit is at least one measurement value of the patient's systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate (PR), respiratory rate (RR), body temperature (BT), oxygen saturation (SpO2), and Glasgow Coma Scale (GCS) ([0011], [0103], [0166] of Hettig disclose SBP/RR/body temperature/pulse data and [0163] discloses GCS data).
Regarding claim 5, the Hettig/Lee/Hann combination discloses the system according to claim 3, further including wherein based on the systolic blood pressure (SBP) and pulse rate (PR) among the data obtained from the hospital visitation information unit, the severity classification unit classifies the severity of the patient as follows:
-grade 1 if systolic blood pressure (SPB) < a predetermined low level (Table 2 and [0184] of Hettig discloses the integers in the columns are added together based on the various readings for the person; accordingly, an SBP <70 (predetermined low level) corresponds to a score of "3");
-grade 2 if (pulse rate (PR) > a first predetermined pulse rate or a second predetermined pulse rate) and [systolic blood pressure (SPB) is outside of a predetermined range] (BPM >100 (first or second predetermined pulse rate) 1is score of 1 and 80<SBP<100mmHG (which is outside of a predetermined range of less than 80mmHG or greater than 100mmHG) is score of 1, the combination of which is a score of "2"); and
-grade 3 if the pulse rate exceeds a second predetermined range and systolic blood pressure (SPB) exceeds a predetermined elevated level (BPM >100 (second predetermined range) is score of 1 and SBP>100mmHG (predetermined elevated level) is score of 0, the combination of which is a score of "1"); and…
While [0184] of Hettig discloses how increasing score corresponds to higher likelihood of death and thus higher patient treatment priority, Hettig might be silent regarding the smaller the classified grade number, the higher the patient's treatment priority.
Nevertheless, Lee teaches (pages 2-3) that it was known in the healthcare informatics art for a triage and acuity scale to correspond to increasing patient treatment priority with a lower triage level/grade.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the patient's treatment priority in Hettig to increase as the classified grade is smaller similar to as taught by Lee (i.e., opposite from Hettig) because it would have been routine optimization to arrive at the claimed invention and a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). MPEP 2144.05. Furthermore, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Still further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 6, the Hettig/Lee/Hann combination discloses the system according to claim 3, further including wherein based on the respiratory rate (RR) among the data obtained from the hospital visitation information unit, the severity classification unit classifies the severity of the patient as follows:
-grade 2 if respiratory rate (RR) ≥ a first predetermined rate of breaths/min or respiratory rate (RR) < a second predetermined rate of breaths/min (Table 2 and [0184] of Hettig discloses a score of 3 if RR is greater than 30 (first predetermined rate)); and
-grade 3 if respiratory rate exceeds a third predetermined rate and is less than a fourth predetermined rate (Table 2 and [0184] of Hettig discloses a score of 2 if RR is equal to 25 (which exceeds a third predetermined rate of 21 but is less than a fourth predetermined rate of 29); and …
While [0184] of Hettig discloses how increasing score corresponds to higher likelihood of death and thus higher patient treatment priority, Hettig might be silent regarding the smaller the classified grade number, the higher the patient's treatment priority.
Nevertheless, Lee teaches (pages 2-3) that it was known in the healthcare informatics art for a triage and acuity scale to correspond to increasing patient treatment priority with a lower triage level/grade.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the patient's treatment priority in Hettig to increase as the classified grade is smaller similar to as taught by Lee (i.e., opposite from Hettig) because it would have been routine optimization to arrive at the claimed invention and a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). MPEP 2144.05. Furthermore, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Still further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 8, the Hettig/Lee/Hann combination discloses the system according to claim 3, further including wherein based on the Glasgow Coma Scale (GCS) among the data obtained from the hospital visitation information unit, the severity classification unit classifies the severity of the patient (the bottom of [0162] and the top left of Table 1 on page 19 of Hettig discloses how GCS can be used to determine the risk score) as follows:
-grade 2 if Glasgow Coma Scale (GCS) < a first number of points (Table 6 on page 28 of Hettig discloses how a GCS of 6 or less (first number of points) corresponds to a score of 3 or 4 (increasing severity); and
-grade 3 if the Glasgow Coma Scale (GCS) falls between the first number of points and a second number of points (Table 6 on page 28 of Hettig discloses how a GCS of 10-12 (which is between the first and a second number of points) corresponds to a score of 2 (less severity than the above); and …
While [0184] of Hettig discloses how increasing score corresponds to higher likelihood of death and thus higher patient treatment priority, Hettig might be silent regarding the smaller the classified grade number, the higher the patient's treatment priority.
Nevertheless, Lee teaches (pages 2-3) that it was known in the healthcare informatics art for a triage and acuity scale to correspond to increasing patient treatment priority with a lower triage level/grade.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the patient's treatment priority in Hettig to increase as the classified grade is smaller similar to as taught by Lee (i.e., opposite from Hettig) because it would have been routine optimization to arrive at the claimed invention and a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). MPEP 2144.05. Furthermore, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Still further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 9, the Hettig/Lee/Hann combination discloses the system according to claim 3, further including wherein the severity classification unit classifies the severity of the patient based on systemic inflammatory response syndrome (SIRS) response criteria based on pulse rate (PR), respiratory rate (RR), and body temperature (BT) among the data obtained from the hospital visitation information unit (Table 3 and [0192]-[0193] of Hettig discloses assessing SIRS of the patient based on HR/PR, RR, and BT; also see HR/PR, RR, and BT for determining SIRS score in Figures 10, 12, 14, etc.),
wherein the systemic inflammatory response syndrome (SIRS) criteria comprise i) pulse rate (PR) > 90 beats/min, ii) respiratory rate (RR) > 20 breaths/min, iii) body temperature (BT) > 38°C or body temperature (BT) <36°C (see Table 3 and [0192]-[0193] of Hettig),
wherein the severity level is classified as follows:
-grade 2 if all three SIRS response criteria are met;
-grade 3 if two of the above SIRS response criteria are met; and
-grade 4 if only body temperature (BT) > 38°C or body temperature (BT) <36°C is satisfied among the SIRS response criteria ([0193] discloses how various numbers of the HR/PR, RR, BT range conditions (e.g., 2, 3, 4 of the conditions) and/or other conditions (e.g., including those in Table 1) need to be met before a patient is considered positive for SIRS; in this regard, in the case where all of the above range conditions are required, then the risk score for SIRS for the patient would become less severe as fewer of the range conditions are met (e.g., only two being met is less severe than when all three are met, and only one being met is less severe than when only two are met; also see [0231] and Figures 12, 14, 16); and…
While [0184] of Hettig discloses how increasing score corresponds to higher likelihood of death and thus higher patient treatment priority, Hettig might be silent regarding the smaller the classified grade number, the higher the patient's treatment priority.
Nevertheless, Lee teaches (pages 2-3) that it was known in the healthcare informatics art for a triage and acuity scale to correspond to increasing patient treatment priority with a lower triage level/grade.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the patient's treatment priority in Hettig to increase as the classified grade is smaller similar to as taught by Lee (i.e., opposite from Hettig) because it would have been routine optimization to arrive at the claimed invention and a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). MPEP 2144.05. Furthermore, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Still further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 11, the Hettig/Lee/Hann combination discloses the system according to claim 2, further including wherein the severity classification unit presents classification results appropriate for the patient's age based on the patient's date of birth among the data obtained from the basic information unit ([0221] and Figures 12-18 disclose/illustrate date of birth (which would be obtained from the "basic information unit" via the caregiver inputting the same per [0104] and Figure 1; also [0051], [0164], [0191] disclose how a patient's risk score can be based on the patient's age which is necessarily based on their date of birth).
Regarding claim 14, Hettig discloses an emergency patient objective severity classification method performed by a processor (Figures 1-3, [0099], and [0105] illustrate/disclose a system/method for determining a risk of a patient developing sepsis/pressure injury/falling which can occur e.g., at the ED per Figure 4A (severity classification system for emergency patients); furthermore, [0103]-[0104] disclose how the assessment is based on various types of objective data; still further, [0105] discloses how the analytics engine 20 processes the data received from sources such that it necessarily includes a "processor"; also see [0172]) in communication with a display ([0006] and Figures 7-35 discloses/illustrate screenshots of a display coupled to the analytics engine that present patient scores for caregivers).
The remaining limitations of claim 14 are disclosed by the Hettig/Lee/Hann combination as discussed above in relation to claim 1.
Regarding claim 15, the Hettig/Lee/Hann combination discloses a non-transitory computer-readable recording medium that is readable by a computer and stores program instructions operable by the computer, wherein when the program instructions are executed by a processor of the computer, the processor determines the objective severity of an emergency patient according to claim 14 ([0172] of Hettig discloses how the analytics engine 20 can be implemented as a computer executing various algorithms/functions which would necessarily be as a recording medium readable by a computer and storing program instructions operable by the computer that determine the objective severity of the emergency patient when the program instructions are executed by a processor of the computer).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2020/0066415 to Hettig et al. ("Hettig") in view of NPL "Over-triage occurs when considering the patient's pain in Korean Triage and Acuity Scale (KTAS)" to Lee et al. ("Lee") and U.S. Patent App. Pub. No. 2013/0249695 to Hann ("Hann"), and further in view of NPL "Triage accuracy and causes of mistriage using the Korean Triage and Acuity Scale" to Moon et al. ("Moon"):
Regarding claim 4, the Hettig/Lee/Hann combination discloses the system according to claim 1, further including wherein the level of severity is … classified according to grade ([0112] and [0183]-[0188] of Hettig disclose sepsis risk scoring from 1-5, where higher score/grade corresponds to increasing severity and thus higher treatment priority)…
However, the Hettig/Lee/Hann combination, as specifically combined in relation to claim 1 above, appears to be silent regarding the level of severity specifically being based on the Korean emergency triage tool (KTAS), where the lower the grade number, the higher the treatment priority, and the grade is classified as follows:
Emergency grade 1 for patients who are life-threatening and require immediate medical attention;
Emergency grade 2 for patients whose lives may be at risk and who require medical attention within a first predetermined time period;
Emergency grade 3 for patients whose lives are not currently in danger but who need to be treated within a second predetermined time period later than the first predetermined time period because a serious condition may occur;
Emergency grade 4 for patients who are not in critical condition and whose condition is unlikely to worsen even if treated within a third predetermined time period, which is later than the second predetermined time period; and
Emergency grade 5 for non-emergency patients who need to be treated within a fourth predetermined time period, which is later than the third predetermined time period.
Nevertheless, Lee already teaches (pages 2-3) that it was known in the healthcare informatics art that the KTAS is a reliable tool for screening an emergency status of patients with potentially life-threatening conditions such as cardiac arrest/shock into five grades, where the lower the grade number the higher the treatment priority, and where grade 1 corresponds to resuscitation (patients who are life-threatening and require immediate medical attention), grade 2 to corresponds to emergency (patients whose lives may be at risk and who require medical attention), grade 3 corresponds to urgent (patients whose lives are not currently in danger but who need to be treated because a serious condition may occur), grade 4 corresponds to less-urgent (patients who are not in critical condition and whose condition is unlikely to worsen even if treated), and grade 5 corresponds to non-urgent (non-emergency patients who still need to be treated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the level of severity in the Hettig/Lee/Hann combination to be based on the Korean emergency triage tool (KTAS), where the lower the grade number, the higher the treatment priority, and the grade is classified as follows:
Emergency grade 1 for patients who are life-threatening and require immediate medical attention;
Emergency grade 2 for patients whose lives may be at risk and who require medical attention;
Emergency grade 3 for patients whose lives are not currently in danger but who need to be treated because a serious condition may occur;
Emergency grade 4 for patients who are not in critical condition and whose condition is unlikely to worsen even if treated; and
Emergency grade 5 for non-emergency patients who need to be treated, all as taught by Lee as the KTAS is a reliable tool for screening an emergency status of patients with potentially life-threatening conditions such as cardiac arrest/shock. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
While the Hettig/Lee/Hann combination appears to be silent regarding grade 2 patients requiring medical attention within a first predetermined time period, grade 3 patients requiring medical attention in a second predetermined time period later than the first predetermined time period, grade 4 patients condition unlikely to worsen if treated within third predetermined time period after second predetermined time period, and grade 5 patients needing treatment within fourth predetermined time period after third predetermined time period, Moon teaches (page 4) that it was known in the healthcare informatics art for KTAS level/grade 2 patients to receive medical care within 10 minutes (within a first predetermined time period), for KTAS level/grade 3 patients to receive medical care within 30 minutes (second predetermined time period later than the first predetermined time period), for KTAS level/grade 4 patients to receive medical care within 60 minutes (within third predetermined time period after second predetermined time period), and for KTAS level/grade 5 patients to receive medical care within 120 minutes (within fourth predetermined time period after third predetermined time period) which advantageously focuses medical resources on patients most in need of medical care thereby improving patient outcomes in view of what may be limited medical resources.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for KTAS grade/level 2 patients to require medical attention within a first predetermined time period, grade 3 patients to requires medical attention in a second predetermined time period later than the first predetermined time period, grade 4 patients condition unlikely to worsen if treated within a third predetermined time period after the second predetermined time period, and grade 5 patients to need treatment within a fourth predetermined time period after the third predetermined time period in the system of the Hettig/Lee/Hann combination similar to as taught by Moon to advantageously focus medical resources on patients most in need of medical care thereby improving patient outcomes in view of what may be limited medical resources.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2020/0066415 to Hettig et al. ("Hettig") in view of NPL "Over-triage occurs when considering the patient's pain in Korean Triage and Acuity Scale (KTAS)" to Lee et al. ("Lee") and U.S. Patent App. Pub. No. 2013/0249695 to Hann ("Hann"), and further in view of NPL "What MFine’s SpO2 Tracker Can Do For You" ("MFine"):
Regarding claim 7, the Hettig/Lee/Hann combination discloses the system according to claim 3, further including wherein based on oxygen saturation (SpO2) among the data obtained from the hospital visitation information unit, the severity classification unit classifies the severity of the patient ([0052] of Hettig discloses how SpO2 is used to determine the risk level)…
However, the Hettig/Lee/Hann combination might be silent specifically regarding wherein:
grade 1 if oxygen saturation (SpO2) < a first predetermined reduced level;
grade 2 if oxygen saturation (SpO2) falls between the first predetermined reduced level and a second predetermined reduced level; and
grade 3 if oxygen saturation falls between the second predetermined reduced level and a third predetermined level; and
the smaller the number of classified grades, the higher the patient's treatment priority.
Nevertheless, MFine teaches (page 2) that it was known in the healthcare informatics art that SpO2 levels below 90% are worrisome/critical, SpO2 levels between 90-92% are closer to worrisome than normal, and SpO2 levels between 92-94% are closer to normal than worrisome. Monitoring these ranges can advantageously provide advance warning of important health conditions that can be addressed to improve patient health outcomes.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for an SpO2 level below a first predetermined reduced level to correspond to a worrisome/critical situation, for an SpO2 level between the first predetermined reduced level and a second predetermined reduced level to be closer to worrisome than normal (but not as serious as a level below the first predetermined reduced level), and SpO2 levels between the second predetermined reduced level and a third predetermined level to be closer to normal than worrisome (but not as series as a level between first and second levels) in the system of the Hettig/Lee/Hann combination similar to as taught by MFine to advantageously provide advance warning of important health conditions that can be addressed to improve patient health outcomes.
While [0184] of Hettig discloses how increasing score corresponds to higher likelihood of death and thus higher patient treatment priority, Hettig might be silent regarding the smaller the classified grade number, the higher the patient's treatment priority.
Nevertheless, Lee teaches (pages 2-3) that it was known in the healthcare informatics art for a triage and acuity scale to correspond to increasing patient treatment priority with a lower triage level/grade.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the patient's treatment priority in Hettig to increase as the classified grade is smaller similar to as taught by Lee (i.e., opposite from Hettig) because it would have been routine optimization to arrive at the claimed invention and a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). MPEP 2144.05. Furthermore, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Still further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2020/0066415 to Hettig et al. ("Hettig") in view of NPL "Over-triage occurs when considering the patient's pain in Korean Triage and Acuity Scale (KTAS)" to Lee et al. ("Lee") and U.S. Patent App. Pub. No. 2013/0249695 to Hann ("Hann"), and further in view of U.S. Patent App. Pub. No. 2013/0197942 to Chiu et al. ("Chiu")
Regarding claim 12, the Hettig/Lee/Hann combination discloses the system according to claim 11, but appears to be silent regarding wherein if the patient is an elderly patient according to preset standards, the severity classification unit raises the severity classification grade of the patient by one grade.
Nevertheless, Chiu teaches ([0032]-[0039]) that it was known in the healthcare informatics art to calculate a health risk score for a patient based on various types of patient data and to increase the risk score by 1 when the patient is 65 years of age or older (elderly according to preset standards)([0039]) to advantageously increase the accuracy of the generated risk scores by taking into account that elderly patients are typically at higher risk of medical complications due to their age (as compared to younger patients) and facilitate allocation of healthcare resources according to patient most in need.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the severity classification unit of the Hettig/Lee/Hann combination to raise the severity classification grade/score of the patient by one grade/score when the patient is an "elderly" patient according to preset standards similar to as taught by Chiu to advantageously increase the accuracy of the generated risk scores by taking into account that elderly patients are typically at higher risk of medical complications due to their age (as compared to younger patients) and facilitate allocation of healthcare resources according to patient most in need. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2020/0066415 to Hettig et al. ("Hettig") in view of NPL "Over-triage occurs when considering the patient's pain in Korean Triage and Acuity Scale (KTAS)" to Lee et al. ("Lee") and U.S. Patent App. Pub. No. 2013/0249695 to Hann ("Hann"), and further in view of JP Patent No. 2022074260 to Shirakawa et al. ("Shirakawa"):
Regarding claim 13, the Hettig/Lee/Hann combination discloses the system according to claim 11, further including wherein the severity classification unit make a final classification through AI and ML ([0176] of Hettig)).
However, the Hettig/Lee/Hann combination appears to be silent regarding wherein the severity classification unit make a final classification through logistic regression, which reflects the patient's age as a continuous variable.
Nevertheless, Shirakawa teaches (top of page 8, top of page 10, and Figure 8) that it was known in the healthcare informatics and machine learning art to utilize logistic regression to calculate a risk score/probability of a disease using a patient's age as one of a plurality of inputs. Specifically, the top of page 8 and Figure 8 discuss/illustrate how the contribution of each factor (thus including age) is calculated in the positive and negative directions and displayed (Figure 8) such that the patient's age is reflected as a continuous variable. For instance, in the case of aortic dissection in the example at the top of page 8 which is typically associated with older people, the contribution of age to the overall risk/likelihood/probability of aortic dissection would increase as the patients' age increases and decrease as the patient's age decreases as determined by the logistic regression. This arrangement advantageously allows for more fine-grained calculations thereby increasing the accuracy of generated risk probabilities.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the severity classification unit to make a final classification through logistic regression which reflects the patient's age as a continuous variable in the system of the Hettig/Lee/Hann combination as taught by Shirakawa to advantageously allows for more fine-grained calculations thereby increasing the accuracy of generated risk probabilities, because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention, and because there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2020/0066415 to Hettig et al. ("Hettig") in view of NPL "Over-triage occurs when considering the patient's pain in Korean Triage and Acuity Scale (KTAS)" to Lee et al. ("Lee"), U.S. Patent App. Pub. No. 2013/0249695 to Hann ("Hann"), NPL "Triage accuracy and causes of mistriage using the Korean Triage and Acuity Scale" to Moon et al. ("Moon"), and NPL "What MFine’s SpO2 Tracker Can Do For You" ("MFine"):
Regarding claim 16, the Hettig/Lee/Hann combination discloses the system according to claim 1, further including wherein the level of severity is … classified according to grade ([0112] and [0183]-[0188] of Hettig disclose sepsis risk scoring from 1-5, where higher score/grade corresponds to increasing severity and thus higher treatment priority)…
wherein based on the systolic blood pressure (SBP) and pulse rate (PR) among the data obtained from the hospital visitation information unit, the severity classification unit classifies the severity of the patient as follows:
grade 1 if systolic blood pressure (SPB) < 80 mmHg (Table 2 and [0184] of Hettig discloses the integers in the columns are added together based on the various readings for the person; accordingly, as SBP <80 (e.g., <70) corresponds to a score of "3");
grade 2 if (pulse rate (PR) > 100 beats/min or pulse rate (PR) < 60 beats/min) and 80 ≤ systolic blood pressure (SPB) < 100 mmHg (BPM >100 is score of 1 and 80<SBP<100mmHG is score of 1, the combination of which is a score of "2"); and
grade 3 if (pulse rate (PR) > 100 beats/min or pulse rate (PR) < 60 beats/min) and systolic blood pressure (SPB) ≥ 100 mmHg (BPM >100 is score of 1 and SBP>100mmHG is score of 0, the combination of which is a score of "1"); and…
wherein based on the respiratory rate (RR) among the data obtained from the hospital visitation information unit, the severity classification unit classifies the severity of the patient as follows:
grade 2 if respiratory rate (RR) ≥ 28 breaths/min or respiratory rate (RR) < 14 breaths/min (Table 2 and [0184] of Hettig discloses a score of 2 or 3 if RR is greater than 28); and
grade 3 if 20 breaths/min ≤ respiratory rate (RR) < 27 breaths/min (Table 2 and [0184] of Hettig discloses a score of 1 if RR is equal to 20); and …
wherein based on oxygen saturation (SpO2) among the data obtained from the hospital visitation information unit, the severity classification unit classifies the severity of the patient ([0052] of Hettig discloses how SpO2 is used to determine the risk level)…
wherein based on the Glasgow Coma Scale (GCS) among the data obtained from the above information unit, the severity classification unit classifies the severity of the patient (the bottom of [0162] and the top left of Table 1 on page 19 of Hettig discloses how GCS can be used to determine the risk score) as follows:
grade 2 if Glasgow Coma Scale (GCS) < 7 points (Table 6 on page 28 of Hettig discloses how a GCS of 6 or less corresponds to a score of 3 or 4 (increasing severity); and
grade 3 if 7 points < Glasgow Coma Scale (GCS) < 13 points (Table 6 on page 28 of Hettig discloses how a GCS of 10-12 (which is between 7 and 13) corresponds to a score of 2 (less severity than the above); and …
However, the Hettig/Lee/Hann combination, as specifically combined in relation to claim 1 above, appears to be silent regarding the level of severity specifically being based on the Korean emergency triage tool (KTAS), where the lower the grade number, the higher the treatment priority, and the grade is classified as follows:
Emergency grade 1 for patients who are life-threatening and require immediate medical attention;
Emergency grade 2 for patients whose lives may be at risk and who require medical attention within a first hour;
Emergency grade 3 for patients whose lives are not currently in danger but who need to be treated within a second hour later than the first hour because a serious condition may occur;
Emergency grade 4 for patients who are not in critical condition and whose condition is unlikely to worsen even if treated within a third hour, which is later than the second hour; and
Emergency grade 5 for non-emergency patients who need to be treated within a fourth hour, which is later than the third hour.
Nevertheless, Lee already teaches (pages 2-3) that it was known in the healthcare informatics art that the KTAS is a reliable tool for screening an emergency status of patients with potentially life-threatening conditions such as cardiac arrest/shock into five grades, where the lower the grade number the higher the treatment priority, and where grade 1 corresponds to resuscitation (patients who are life-threatening and require immediate medical attention), grade 2 to corresponds to emergency (patients whose lives may be at risk and who require medical attention), grade 3 corresponds to urgent (patients whose lives are not currently in danger but who need to be treated because a serious condition may occur), grade 4 corresponds to less-urgent (patients who are not in critical condition and whose condition is unlikely to worsen even if treated), and grade 5 corresponds to non-urgent (non-emergency patients who still need to be treated).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the level of severity in the Hettig/Lee/Hann combination to be based on the Korean emergency triage tool (KTAS), where the lower the grade number, the higher the treatment priority, and the grade is classified as follows:
Emergency grade 1 for patients who are life-threatening and require immediate medical attention;
Emergency grade 2 for patients whose lives may be at risk and who require medical attention;
Emergency grade 3 for patients whose lives are not currently in danger but who need to be treated because a serious condition may occur;
Emergency grade 4 for patients who are not in critical condition and whose condition is unlikely to worsen even if treated; and
Emergency grade 5 for non-emergency patients who need to be treated, all as taught by Lee as the KTAS is a reliable tool for screening an emergency status of patients with potentially life-threatening conditions such as cardiac arrest/shock. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
While the Hettig/Lee/Hann combination appears to be silent regarding grade 2 patients requiring medical attention within a first predetermined time period, grade 3 patients requiring medical attention in a second predetermined time period later than the first predetermined time period, grade 4 patients condition unlikely to worsen if treated within third predetermined time period after second predetermined time period, and grade 5 patients needing treatment within fourth predetermined time period after third predetermined time period, Moon teaches (page 4) that it was known in the healthcare informatics art for KTAS level/grade 2 patients to receive medical care within 10 minutes (within a first predetermined time period), for KTAS level/grade 3 patients to receive medical care within 30 minutes (second predetermined time period later than the first predetermined time period), for KTAS level/grade 4 patients to receive medical care within 60 minutes (within third predetermined time period after second predetermined time period), and for KTAS level/grade 5 patients to receive medical care within 120 minutes (within fourth predetermined time period after third predetermined time period) which advantageously focuses medical resources on patients most in need of medical care thereby improving patient outcomes in view of what may be limited medical resources.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for KTAS grade/level 2 patients to require medical attention within a first predetermined time period, grade 3 patients to requires medical attention in a second predetermined time period later than the first predetermined time period, grade 4 patients condition unlikely to worsen if treated within a third predetermined time period after the second predetermined time period, and grade 5 patients to need treatment within a fourth predetermined time period after the third predetermined time period in the system of the Hettig/Lee/Hann combination similar to as taught by Moon to advantageously focus medical resources on patients most in need of medical care thereby improving patient outcomes in view of what may be limited medical resources.
Furthermore, while the Hettig/Lee/Hann/Moon combination appears to be silent regarding the second time period specifically being a second hour after the first hour, the third time period specifically being a third hour later than the second hour, and the fourth time period specifically being a fourth hour later than the third hour, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the second time period to specifically be a second hour after the first hour, the third time period to specifically be a third hour later than the second hour, and the fourth time period to specifically be a fourth hour later than the third hour because it would have been routine optimization to arrive at the claimed invention and a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). MPEP 2144.05. Furthermore, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Still further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
However, the Hettig/Lee/Hann combination might be silent specifically regarding wherein:
grade 1 if oxygen saturation (SpO2) < a first predetermined reduced level;
grade 2 if oxygen saturation (SpO2) falls between the first predetermined reduced level and a second predetermined reduced level; and
grade 3 if oxygen saturation falls between the second predetermined reduced level and a third predetermined level; and
the smaller the number of classified grades, the higher the patient's treatment priority.
Nevertheless, MFine teaches (page 2) that it was known in the healthcare informatics art that SpO2 levels below 90% are worrisome/critical, SpO2 levels between 90-92% are closer to worrisome than normal, and SpO2 levels between 92-94% are closer to normal than worrisome. Monitoring these ranges can advantageously provide advance warning of important health conditions that can be addressed to improve patient health outcomes.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for an SpO2 level below a first predetermined reduced level to correspond to a worrisome/critical situation, for an SpO2 level between the first predetermined reduced level and a second predetermined reduced level to be closer to worrisome than normal (but not as serious as a level below the first predetermined reduced level), and SpO2 levels between the second predetermined reduced level and a third predetermined level to be closer to normal than worrisome (but not as series as a level between first and second levels) in the system of the Hettig/Lee/Hann combination similar to as taught by MFine to advantageously provide advance warning of important health conditions that can be addressed to improve patient health outcomes.
While [0184] of Hettig discloses how increasing score corresponds to higher likelihood of death and thus higher patient treatment priority, Hettig might be silent regarding the smaller the classified grade number, the higher the patient's treatment priority.
Nevertheless, Lee teaches (pages 2-3) that it was known in the healthcare informatics art for a triage and acuity scale to correspond to increasing patient treatment priority with a lower triage level/grade.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the patient's treatment priority in Hettig to increase as the classified grade is smaller similar to as taught by Lee (i.e., opposite from Hettig) because it would have been routine optimization to arrive at the claimed invention and a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). MPEP 2144.05. Furthermore, a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Still further, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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