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 .
Response to Amendment
In response to amendments, see Remarks, filed November 24, 2025, claims 1 and 10 have been amended. Claim 8 has been cancelled. No claims have been added. Claims 1, 5-6, and 9-10 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/24/2025 has been entered.
Response to Arguments
Applicant’s arguments and amendments, see Remarks, filed November 24, 2025, with respect to the rejections under 35 U.S.C. 103 rejections of claims 1, 5-6, and 9-10 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to the prior art claims have been considered but are moot because the new ground of rejection does not rely on the same reference combination applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. A new ground(s) of rejection is made in view of the combinations of Akbari (US 20220032074 A1)/Valkirs (US 20030119064 A1)/Li (CN 104055524 A)/Howard (US 20200060566 A1). Any arguments still relevant based on the new grounds of rejection are addressed below.
In response to applicant’s argument that the combination of Akbari (US 20220032074 A1)/Valkirs (US 20030119064 A1)/Li (CN 104055524 A) fails to disclose “the information about a prognosis value derived from a prediction model which has a positive correlation with a result of the phase coherence analysis and has a negative correlation with the concentration of the neuron-specific enolase,” Examiner respectfully disagrees. 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).
Akbar provides near-infrared spectroscopy (NIRS) based devices, or optical measurement devices that can measure CBF, tissue oxygenation, and/or tissue scattering through intact human skull ([0013]) and in [0098] specifies measuring concentrations of oxy- and deoxy-hemoglobin (ctHbO2, ctHb) and the tissue oxygenation (StO2). Li further provides calculated biological information to evaluate neurological outcome based on “the left and right brain prefrontal hemoglobin signal acquisition is passed to signal wavelet coherent, wavelet phase coherent processing module by using the small wave coherent method” (Li Pg 2 [6]). Regarding combining the calculated biological information with an NSE biomarker to provide a prognosis, Valkirs has per [0021], “members of a marker ‘panel’ comprising a plurality of markers that are measured in a sample, and used for determining a diagnosis or prognosis related to stroke” and specifies neuron-specific enolase as one of the markers in [0026]. In combining Akbari/Valkirs/Li, the biological information from Akbari and Li may being incorporated with the biomarker information from Valkirs via the Valkirs [0134] “combined result of a variety of panels [biological information per Akbari and Li as well as biomarker information of Valkirs] could be interpreted as a probability, expressed either as a numerical score or a percentage,” thereby utilizing both calculated biological information and a biomarker relating to the prognosis after cardiac arrest to provide information about the prognosis after cardiac arrest. Combining results to express probability is a prediction model. The expression of the probability via the numerical score or percentage is the prognosis value.
The positive correlation of WPCO is disclosed via Li’s figures 5a and 5b, with Fig. 5a showing higher values in interval 2, the myogenic activity range, which are described as “good,” while the comparatively lower values in 5b’s interval 2 is described as “poor.” The positive correlation between WPCO analysis values and good brain function may be combined with other markers of cerebral injury to result in the prognosis value expressed as a numerical score or percentage per Valkirs. The prediction model’s negative correlation with NSE is described via Valkirs [0070] “Elevations in the serum concentration of NSE correlate with the severity of damage and the neurological outcome of the individual.”
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are in claim 10:
“a biological information management unit configured to calculate biological information” and “a prognosis information provision unit configured to provide the information about the prognosis” – Specification pg 8, lines 1-3, “biological information management unit210, the prognosis information provision unit220 … program modules, while they may be physically stored in a variety of known storage devices.”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 and 10 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.
Claims 1 and 10 recite the limitation “the sum of sensitivity and specificity.” There is insufficient antecedent basis for this limitation in the claim.
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, 5-6, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Akbari (US 20220032074 A1) in view of Valkirs (US 20030119064 A1), Li (CN 104055524 A), and Howard (US 20200060566 A1).
Regarding claim 1, Akbari teaches a method of providing information about prognosis after cardiac arrest ([0015] a method of improving neurological outcome in a subject during cardiac arrest), the method comprising steps of:
calculating biological information based on a signal relating to a hemoglobin concentration measured from a cerebral region of a subject to be measured ([0013] near-infrared spectroscopy [NIRS] based devices, or optical measurement devices that can measure CBF, tissue oxygenation, and/or tissue scattering through intact human skull. [0098] concentrations of oxy- and deoxy-hemoglobin [ctHbO2, ctHb] and the tissue oxygenation [StO2]);
and providing the information about the prognosis after cardiac arrest of the subject with reference to the calculated biological information ([0012] comparing the … tissue oxygenation measurements to the plurality of metrics to determine an estimated neurological outcome score, and identifying a neurological condition of the brain based on the neurological outcome score).
However, Akbari fails to disclose information about prognosis incorporating an additional biomarker from the blood, two sections of the cerebral region, and phase coherence analysis.
Valkirs teaches a method and kit for determining a diagnosis or prognosis related to stroke. Valkirs discloses: and a biomarker relating to the prognosis after cardiac arrest measured from a blood of the subject ([0010] cardiac cause of stroke; [0021] markers may be used individually, or as members of a marker "panel" comprising a plurality of markers that are measured in a sample, and used for determining a diagnosis or prognosis related to stroke; [0025] test samples include blood… specific markers of cerebral injury include … neuron-specific enolase… [0027] other non-specific markers include… hemoglobin α2 chain; [0134] combined result of a variety of panels could be interpreted as a probability, expressed either as a numerical score or a percentage).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Akbari to include a plurality of markers, including from a blood sample, for determining a prognosis related to stroke as disclosed in Valkirs to provide a global probability that an individual has had a stroke, is at risk for a stroke, and/or the type of stroke (ischemic or hemorrhagic) which the individual has had or is at risk for (Valkirs [0023]).
However, the combination of Akbari/Valkirs fails to disclose two sections of the cerebral region and phase coherence analysis. Li (CN 104055524 A) teaches a brain function based on near infrared spectrum joint detection method and system. Li discloses:
wherein the signal relating to the hemoglobin concentration is measured for each of at least two sections included in the cerebral region of the subject based on a near-infrared ray sensed from each of the at least two sections using a near-infrared spectroscopy (NIRS) (Pg 2 [4] oximeter by near infrared spectrum signal collecting module collects 15 minutes left and right brain prefrontal hemoglobin pulse signal; Fig. 1),
wherein the biological information is calculated based on a phase coherence analysis performed on a pair of two signals selected from measured signals relating to the hemoglobin concentration (Pg 2 [6] the left and right brain prefrontal hemoglobin signal acquisition is passed to signal wavelet coherent, wavelet phase coherent processing module by using the small wave coherent method).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Akbari/Valkirs to include collecting hemoglobin related signals from left and right prefrontal cortexes and using wavelet phase coherence analysis as disclosed in Li to analyze the left and right forehead blood oxygen signal coherence with a characteristic frequency that allows for non-invasive and robust evaluation of myogenic activity (Li Pg 3 [5-8, 16-18]).
The combination of Akbari/Valkirs/Li further discloses:
wherein the biomarker comprises a concentration of a neuron-specific enolase (NSE) (Valkirs: [0025] test samples include blood… specific markers of cerebral injury include … neuron-specific enolase; [0070] concentration of NSE),
and wherein in the step of providing the information about the prognosis after cardiac arrest of the subject (Li: Pg 5 [6] automatically calculate brain function connected with the detecting result, result is displayed on the liquid crystal display screen, and recording the test date and time, a data storage device in the memory, and it can print and output the data transmitted to the computer) is determined based on a prognosis value derived from a prediction model (Li: Pg 3 [4] brain function connected with the detection module, using the small wave of different characteristic frequency space coherent coefficient and wavelet function connection of detected phase coherent coefficient as index, establishing the partial least square correction model, the brain function connection is detected; Valkirs: [0010] cardiac cause of stroke; [0021] markers may be used individually, or as members of a marker "panel" comprising a plurality of markers that are measured in a sample, and used for determining a diagnosis or prognosis related to stroke; [0025] test samples include blood… specific markers of cerebral injury include … neuron-specific enolase… [0027] other non-specific markers include… hemoglobin α2 chain; [0134] combined result of a variety of panels could be interpreted as a probability, expressed either as a numerical score or a percentage) which has a positive correlation with a result of the phase coherence analysis (Li: Pg 3, [16-18] FIG. 5a wavelet phase coherent method (WPCO) analysis, brain function with good people right forehead spontaneous rhythm pulse phase coherence diagram; FIG. 5b wavelet phase coherent method (WPCO) analysis, brain function connected with the poor people right forehead spontaneous rhythm pulse phase coherence diagram; wherein the 1-neurological activity, 2-a muscle activity, 3-respiratory activity, 4-heart activity. [Fig. 5a shows higher values in interval 2, the myogenic activity range, which are described as “good,” while the comparatively lower values in 5b’s interval 2 is described as “poor.” The positive correlation between WPCO analysis values and good brain function may be combined with other markers of cerebral injury to result in the prognosis value expressed as a numerical score or percentage per Valkirs]) and has a negative correlation with the concentration of the neuron-specific enolase (Valkirs: [0073] Elevations in the serum concentration of NSE correlate with the severity of damage and the neurological outcome of the individual),
wherein in the step of providing the information about the prognosis after cardiac arrest of the subject (Li: Pg 5 [6] automatically calculate brain function connected with the detecting result, result is displayed on the liquid crystal display screen, and recording the test date and time, a data storage device in the memory, and it can print and output the data transmitted to the computer), the information about the prognosis after cardiac arrest of the subject is determined as good when the prognosis value derived from the prediction model is no less than a preset reference value (Valkirs: [0133] “Individual results obtained from several markers may be combined in various combinations for further information on diagnosis and/or prognosis of an individual. For example, using ROC curves, threshold values for each of a set of markers may be determined, and values from a sample compared to these threshold values.” [0134] “combined result of a variety of panels could be interpreted as a probability, expressed either as a numerical score or a percentage… ROC curves are prepared by plotting ROC curves for the sensitivity of a particular panel of markers versus 1-(specificity) for the panel at various cutoffs. The results provide an empirical description of the decision threshold effect. "ROC area" refers to the area under the ROC curve. The area under the ROC curve is a measure of the probability that the perceived measurement will allow correct identification of a condition. The greater the area under the curve (AUC), the greater the discriminatory ability. A test with no discriminatory ability has an AUC of 0.5. A test with perfect discriminatory ability has an AUC of 1.0. In such a way, combined information can be used to improve the value of individual marker assays.”).
However, the combination of Akbari/Valkirs/Li fails to disclose the present reference value as the maximal sum of sensitivity and specificity on a receiver operating characteristic curve. Howard (US 20200060566 A1) teaches a method for detection of pain using electroencephalogram signals. Howard discloses and the present reference value is a prognosis value with the sum of sensitivity and specificity being maximal in a receiver operating characteristic (ROC) curve ([0920] “The optimal threshold and its combination of sensitivity and specificity was chosen to be the data point with the least distance from the optimal classification point (0, 1) in the cartesian ROC space.”).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Akbari/Valkirs/Li to include the present reference value as the maximal sum of sensitivity and specificity on a receiver operating characteristic curve as disclosed in Howard to establish a discrimination threshold that is as close to a perfect solution with 100% sensitivity and specificity as possible (Howard [0920]).
Regarding claim 5, the combination of Akbari/Valkirs/Li/Howard discloses the method of Claim 1 (Akbari [0015] a method of improving neurological outcome in a subject during cardiac arrest), wherein the measured signals relating to the hemoglobin concentrations comprise a frequency range relating to a myogenic activity (Li: Pg 2 [5] using wavelet phase coherent method [WPCO] left and right forehead hemoglobin phase analyzing the pulse signal in a low frequency range, the frequency is in 0.021-2 HZ; Pg 3 [8] muscle activity; Figs. 5a and 5b, section 2).
Regarding claim 6, the combination of Akbari/Valkirs/Li/Howard discloses the method of Claim 1 (Akbari: [0015] a method of improving neurological outcome in a subject during cardiac arrest), wherein the phase coherence analysis comprises a wavelet phase coherence (WPCO) analysis (Li: Pg 2 [5] using wavelet phase coherent method [WPCO] left and right forehead hemoglobin phase analyzing the pulse signal in a low frequency range, the frequency is in 0.021-2HZ).
Regarding claim 9, the combination of Akbari/Valkirs/Li/Howard discloses a non-transitory computer-readable recording medium having stored thereon a computer program for executing the method of Claim 1 (Akbari: [0059] memory, a non-transient storage device, stores one or more metrics for determining a neurological outcome score, and computer-readable instructions that, when executed by the processor, causes the processor to perform operations).
Regarding claim 10, Akbari teaches a system for providing information about prognosis after cardiac arrest ([0011] system for monitoring and determining neurological outcome of a brain post cardiac arrest [CA]), comprising:
a biological information management unit configured to calculate biological information based on a signal relating to a hemoglobin concentration measured from a cerebral region of a subject to be measured ([0012] processor to perform operations. These operations include … receiving measurements of CBF, tissue oxygenation, and/or tissue scattering from the one or more optical measurement devices; [0013] optical measurement devices that can measure CBF, tissue oxygenation, and/or tissue scattering through intact human skull; [0098] concentrations of oxy- and deoxy-hemoglobin [ctHbO2, ctHb] and the tissue oxygenation [StO2]);
and a prognosis information provision unit configured to provide the information about the prognosis after cardiac arrest of the subject with reference to the calculated biological information ([0012] comparing the … tissue oxygenation measurements to the plurality of metrics to determine an estimated neurological outcome score, and identifying a neurological condition of the brain based on the neurological outcome score).
However, Akbari fails to disclose information about prognosis incorporating an additional biomarker from the blood, two sections of the cerebral region, and phase coherence analysis. Valkirs teaches a method and kit for determining a diagnosis or prognosis related to stroke. Valkirs discloses:
and a biomarker relating to the prognosis after cardiac arrest measured from a blood of the subject ([0010] cardiac cause of stroke; [0021] markers may be used individually, or as members of a marker "panel" comprising a plurality of markers that are measured in a sample, and used for determining a diagnosis or prognosis related to stroke; [0025] test samples include blood… specific markers of cerebral injury include … neuron-specific enolase… [0027] other non-specific markers include… hemoglobin α2 chain; [0134] combined result of a variety of panels could be interpreted as a probability, expressed either as a numerical score or a percentage).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Akbari to include a plurality of markers, including from a blood sample, for determining a prognosis related to stroke as disclosed in Valkirs to provide a global probability that an individual has had a stroke, is at risk for a stroke, and/or the type of stroke (ischemic or hemorrhagic) which the individual has had or is at risk for (Valkirs [0023]).
However, the combination of Akbari/Valkirs fails to disclose two sections of the cerebral region and phase coherence analysis. Li discloses:
wherein the signal relating to the hemoglobin concentration is measured for each of at least two sections included in the cerebral region of the subject based on a near-infrared ray sensed from each of the at least two sections using a near-infrared spectroscopy (NIRS) (Pg 2, [4] oximeter by near infrared spectrum signal collecting module collects 15 minutes left and right brain prefrontal hemoglobin pulse signal; Fig. 1),
wherein the biological information management unit is configured to calculate the biological information based on a phase coherence analysis performed on a pair of two signals selected from measured signals relating to the hemoglobin concentration (Pg 2 [6] the left and right brain prefrontal hemoglobin signal acquisition is passed to signal wavelet coherent, wavelet phase coherent processing module by using the small wave coherent method).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Akbari/Valkirs to include collecting hemoglobin related signals from left and right prefrontal cortexes and using wavelet phase coherence analysis as disclosed in Li to analyze the left and right forehead blood oxygen signal coherence with a characteristic frequency (for specifically evaluating myogenic activity) and strong interference immunity to establish a joint (left and right) region of the brain function detection method (Li Pg 3 [5-8]).
The combination of Akbari/Valkirs/Li further discloses:
wherein the biomarker comprises a concentration of a neuron-specific enolase (NSE) (Valkirs: [0025] test samples include blood… specific markers of cerebral injury include … neuron-specific enolase; [0070] concentration of NSE),
and wherein the prognosis information provision unit is configured to determine the information about the prognosis after cardiac arrest of the subject based on a prognosis value derived from a prediction model (Li: Pg 3 [4] brain function connected with the detection module, using the small wave of different characteristic frequency space coherent coefficient and wavelet function connection of detected phase coherent coefficient as index, establishing the partial least square correction model, the brain function connection is detected; Valkirs: [0010] cardiac cause of stroke; [0021] markers may be used individually, or as members of a marker "panel" comprising a plurality of markers that are measured in a sample, and used for determining a diagnosis or prognosis related to stroke; [0025] test samples include blood… specific markers of cerebral injury include … neuron-specific enolase… [0027] other non-specific markers include… hemoglobin α2 chain; [0134] combined result of a variety of panels could be interpreted as a probability, expressed either as a numerical score or a percentage) which has a positive correlation with a result of the phase coherence analysis (Li: Pg 3, [16-18] FIG. 5a wavelet phase coherent method (WPCO) analysis, brain function with good people right forehead spontaneous rhythm pulse phase coherence diagram; FIG. 5b wavelet phase coherent method (WPCO) analysis, brain function connected with the poor people right forehead spontaneous rhythm pulse phase coherence diagram; wherein the 1-neurological activity, 2-a muscle activity, 3-respiratory activity, 4-heart activity. [Fig. 5a shows higher values in interval 2, the myogenic activity range, which are described as “good,” while the comparatively lower values in 5b’s interval 2 is described as “poor.” The positive correlation between WPCO analysis values and good brain function may be combined with other markers of cerebral injury to result in the prognosis value expressed as a numerical score or percentage per Valkirs]) and has a negative correlation with the concentration of the neuron-specific enolase (Valkirs: [0073] Elevations in the serum concentration of NSE correlate with the severity of damage and the neurological outcome of the individual)
and wherein the prognosis information provision unit is configured to determine the information about the prognosis after cardiac arrest of the subject as good when the prognosis value derived from the prediction model is no less than a preset reference value (Valkirs: [0133] “Individual results obtained from several markers may be combined in various combinations for further information on diagnosis and/or prognosis of an individual. For example, using ROC curves, threshold values for each of a set of markers may be determined, and values from a sample compared to these threshold values.” [0134] “combined result of a variety of panels could be interpreted as a probability, expressed either as a numerical score or a percentage… ROC curves are prepared by plotting ROC curves for the sensitivity of a particular panel of markers versus 1-(specificity) for the panel at various cutoffs. The results provide an empirical description of the decision threshold effect. "ROC area" refers to the area under the ROC curve. The area under the ROC curve is a measure of the probability that the perceived measurement will allow correct identification of a condition. The greater the area under the curve (AUC), the greater the discriminatory ability. A test with no discriminatory ability has an AUC of 0.5. A test with perfect discriminatory ability has an AUC of 1.0. In such a way, combined information can be used to improve the value of individual marker assays.”).
However, the combination of Akbari/Valkirs/Li fails to disclose the present reference value as the maximal sum of sensitivity and specificity on a receiver operating characteristic curve. Howard discloses, and the present reference value is a prognosis value with the sum of sensitivity and specificity being maximal in a receiver operating characteristic (ROC) curve ([0920] “The optimal threshold and its combination of sensitivity and specificity was chosen to be the data point with the least distance from the optimal classification point (0, 1) in the cartesian ROC space.”).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Akbari/Valkirs/Li to include the present reference value as the maximal sum of sensitivity and specificity on a receiver operating characteristic curve as disclosed in Howard to establish a discrimination threshold that is as close to a perfect solution with 100% sensitivity and specificity as possible (Howard [0920]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLY HALPRIN whose telephone number is (703)756-1520. The examiner can normally be reached 12PM-8PM ET.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791