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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 2-16, drawn to a method and system of operating an autoregulation monitoring system using an algorithm for AKI threshold delta, classified in A61B 5/7267.
II. Claims 17-21, drawn to a method of operating an autoregulation monitoring system determining AKI threshold value during the medical procedure, classified in A61B 5/201.
The inventions are independent or distinct, each from the other because:
Inventions I and II are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed require two different processes of determining AKI threshold value that are mutually exclusive in time and technique, Group I requires an algorithm for determining AKI threshold delta and Group II requires AKI threshold delta to be determined during a medical procedure. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Each of the above disclosed groups requires divergent search and consideration of a distinct issue of patentability, including searching for the specific divergent classifications listed, and additional text searches pertaining to the narrow field of each group. Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Tiffany Parcher on 07/22/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 2-16. Affirmation of this election must be made by applicant in replying to this Office action. Claims 17-21 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
Claim 7-8 and 14-15 is 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.
Regarding claim 7, it is unclear if the “AKI threshold value” of line 17 is the same “AKI threshold value” of claim 2, or the “updated AKI threshold value” of claim 7 line 15.
Regarding claim 8, it is unclear if the “blood pressure zone” of lines 3-4 is the same “blood pressure zone” of claim 2, or the “updated blood pressure zone” of claim 7 line 17.
Regarding claim 14, it is unclear how the one or more laboratory values can be both urine flow and urine oxygenation level, when claim 2 only requires one laboratory value.
Regarding claim 15, it is unclear if the “AKI threshold value” of line 10 is the same “AKI threshold value” of claim 12, or the “updated AKI threshold value” of claim 7 line 7.
Regarding claim 15, it is unclear if the “blood pressure zone” of line 13 is the same “blood pressure zone” of claim 12, or the “updated blood pressure zone” of claim 7 line 11.
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 2-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 12 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 2 is directed to a method and thus meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 2 and 12, the following step is an abstract idea:
“determining, by the processing circuitry, an AKI threshold value based on the AKI threshold delta value and the cerebral autoregulation status value;
determining, by the processing circuitry, a blood pressure zone based on the AKI threshold value and indicative of a risk of the patient developing AKI”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could determine an AKI threshold value based on AKI threshold delta value and cerebral autoregulation value used to determine a blood pressure zone.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 2 and 12, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “display device”, “a memory”, and “a processing circuitry” are recited at a high level of generality and are generic computer components amounting to insignificant extra-solution activity in that they are merely objects on which the functional limitations operate [MPEP 2106.05(b)].
It is noted that the one or more algorithms are by definition automating the human thinking process with a computer.
- “one or more sensors” of claim 3 are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “one or more algorithms” is merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
- “non-cerebral autoregulation status value”, “cerebral autoregulation status value”, “laboratory values”, “kidney function”, “AKI threshold delta value”, “AKI threshold value”, “blood pressure zone”, “risk”, and “blood pressure signal” are data that is necessary to implement the abstract idea on a computer [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “display device”, “a memory”, and “a processing circuitry” are recited at a high level of generality and are generic computer components amounting to insignificant extra-solution activity in that they are merely objects on which the functional limitations operate [MPEP 2106.05(b)].
It is noted that the one or more algorithms are by definition automating the human thinking process with a computer.
- “one or more sensors” of claim 3 are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “one or more algorithms” is merely reciting the words “apply it” (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
- “non-cerebral autoregulation status value”, “cerebral autoregulation status value”, “laboratory values”, “kidney function”, “AKI threshold delta value”, “AKI threshold value”, “blood pressure zone”, “risk”, and “blood pressure signal” are data that is necessary to implement the abstract idea on a computer [MPEP 2106.05(g)].
The additional elements of claims 2, and 12, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the display device, processing circuitry, and memory, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The additional elements are insignificant extra-solution activity and do not amount to more than what is well- understood, routine, and conventional.
Dependent claims 3-11, and 13-16 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to generic gathering structure (claim 3), “apply it” instructions to implement abstract idea (claims 4, 10-11, and 13) and the extra-solution activity (claims 5-9 and 14-16), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 2-16 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Claim Interpretation
Regarding claims 2, and 12, the AKI threshold delta value and adjustment value are mentioned as almost equal across the entire instant specification including [0088] of US 20220400960 that recites that AKI threshold delta value and adjustment value may be determined “based on the actual sensed patient parameters during a medical procedure.” Additionally, [0070] of US 20220400960 mentions that the minimum adjustment value can be set by the AKI threshold delta value. Therefore, Examiner will interpret the “adjustment value” and “AKI threshold delta value” as interchangeable terms when recited in the prior art.
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.
Claims 2, 6, 9-13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. (US 20200121193) (Hereinafter Addison1) in view of Baek et al. (“Optimal systolic blood pressure in noncritically ill patients with acute kidney injury: A retrospective cohort study” Kidney Res Clin Pract. 2019 Sep; 38(3): 356–364. Published online 2019 Sep 30. doi: 10.23876/j.krcp.19.030)(IDS)(Hereinafter Baek).
Regarding claims 2 and 12, Addison1 teaches A method/ system r comprising instructions that, when executed, cause processing circuitry to: (Claim 1 “A method” Claim 15 “system” Claim 29 “non-transitory computer readable storable medium”) comprising:
memory ([0026] “memory 120”); and
receiving, by processing circuitry, a cerebral autoregulation status value for a patient (Claim 1 “a cerebral autoregulation status value based on the blood pressure signal and the oxygen saturation signal” The blood pressure signal and oxygen saturation signal is based on a patient.);
receiving, by the processing circuitry, one or more laboratory values indicative of kidney function of the patient ([0051] “The one or more non-cerebral autoregulation status values may be determined based on a non-cerebral organ blood pressure signal and non-cerebral organ oxygen saturation signal…a second oxygen saturation signal indicative of an oxygen saturation at the non-cerebral organ…to determine one or more cerebral autoregulation status value based on a first correlation index and/or first physiological parameters and one or more non-cerebral autoregulation status values based on a second correlation index and/or second physiological parameters. The predetermined association may include one or more predetermined adjustment values determined based on cerebral autoregulation status values and non-cerebral autoregulation status values previously determined for patient 101 based on patient-specific data.” [0071] “determine a correlation index (e.g., COx, HVx) based on the determined adjustment value and the measured oxygen saturation value, or additional or alternative physiological parameters, and then determine an estimate of an LLA based on the lowest blood pressure value [laboratory values] at which the expected value of COx is less than a threshold value and/or a ULA based on the highest blood pressure value [laboratory values] at which the expected value of COx is greater than a threshold value.” [0016] “LLA of the kidneys (“LLAK”) [indicative of kidney function]”);
inputting, by the processing circuitry and into one or more algorithms, the one or more laboratory values to generate an acute kidney injury (AKI) threshold delta value for the patient ([0076] “determining the adjustment value [AKI threshold delta value] using a neural network algorithm based on patient-specific data and/or population based data.” And [0075] “a population-based model based on a predetermined association between a first set blood pressures and a second set blood pressures.” The adjustment value can be based on patient specific data which individualizes the data based on the patient. [0076] “processing circuitry 110 may input inputting training data, such as patient-specific data or population-based data, into the neural network algorithm to tune the node parameters.”);
determining, by the processing circuitry, an AKI threshold value based on the AKI threshold delta value and the cerebral autoregulation status value ([0068] “a non-cerebral autoregulation status value may include a range of non-cerebral autoregulation status values [blood pressure zone], e.g., determined based on a cerebral autoregulation status value and a range of adjustment values [AKI threshold delta value]… LLA.sub.K band 212 [blood pressure zone] may define a range of non-cerebral autoregulation status values above and below LLA.sub.K 206.”); and
determining, by the processing circuitry, a blood pressure zone based on the AKI threshold value and indicative of a risk of the patient developing AKI ([0068] “a non-cerebral autoregulation status value may include a range of non-cerebral autoregulation status values [blood pressure zone], e.g., determined based on a cerebral autoregulation status value and a range of adjustment values [AKI threshold delta value]… LLA.sub.K band 212 [blood pressure zone] may define a range of non-cerebral autoregulation status values above and below LLA.sub.K 206.”);
outputting, by the processing circuitry for display by a display device, an indication of the blood pressure zone and a blood pressure signal of the patient overlaid onto the blood pressure zone (Fig. 2B where 205 blood pressure signal is overlaid onto the blood pressure zone 212. Abstract: “The processing circuitry provide to an output device a signal indicative of the non-cerebral autoregulation status value” [0067] “to maintain autoregulation of selected organs or organ systems, compared to autoregulation monitoring systems that do not determine and/or display non-cerebral autoregulation status values.” [0073] “Processing circuitry 110 may be further configured to present an indication of one or more limits of autoregulation, blood pressure(s), oxygen saturation(s), or the like, on the graphical user interface.”).
However, Addison1 does not explicitly teach a blood pressure zone being indicative of a risk of AKI in a patient. Baek, in the same field of endeavor, teaches analyzing blood pressure for AKI (Abstract), and further teaches a blood pressure zone indicative of a risk of the patient developing AKI (Pg. 361 right col. lines 29-32 “relative decreases in SBP and DBP and MAP were associated with the development of AKI and a decrease in SBP is a significant independent predictor of the development of severe AKI in noncritically ill patients” Pg. 358 left col. lines 15-18 “The risk of mortality or severe AKI was then evaluated as a function of BP. BP values were categorized into 10-mmHg increments [blood pressure zones] to determine the association with mortality or severe AKI.”) to observe the development of AKI at different blood pressure values (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date to modify the non-cerebral autoregulation status value of Addison1, with the blood pressure zone being indicative of a risk of AKI in a patient of Baek, because such a modification would allow to observe the development of AKI at different blood pressure values.
Regarding claims 6, Addison1 teaches further comprising inputting, by the processing circuitry, demographic data of the patient into the one or more algorithms to generate the AKI threshold delta value ([0055] “The demographic data (e.g., demographic indicators) may include, for example, age, sex, body weight, body mass index, and existing medical conditions.”).
Regarding claims 9 and 16, Addison1 teaches comprising:
outputting, by the processing circuitry for display by the display device, a first additional indication of the AKI threshold value and a second additional indication of the cerebral autoregulation status value (Fig. 2B and [0067] “configured to provide an alert, such as a visual or audible alarm, when the autoregulation of patient 101 is impaired. For example, when blood pressure signal 202 drops below a threshold for intact non-cerebral organ autoregulation (e.g., a threshold for non-cerebral organ dysfunction), such as, one or more of LLA.sub.C 204, LLA.sub.K 206, and LLA.sub.G 208, processing circuitry 110 may cause user interface 130 to provide an alert to a user, such as a clinician. In some examples, the alert may be similar or different for each autoregulation impairment scenario corresponding to when blood pressure signal 202 drops below each of LLA.sub.C 204, LLA.sub.K 206, and LLA.sub.G 208. By including LLA.sub.C 204, LLA.sub.K 206, and LLA.sub.G 208 and, in some examples, alerts for each associated impaired autoregulation scenario, autoregulation monitoring system 100 may enable a clinician to make a more informed decision to correct a blood pressure of patient 101,”); and
providing, by the processing circuitry via a speaker, a first audible alert in response to the blood pressure signal reaching or crossing the AKI threshold value and a second audible alert in response to the blood pressure signal reaching or crossing the cerebral autoregulation status value ([0067] “configured to provide an alert, such as a visual or audible alarm, when the autoregulation of patient 101 is impaired. For example, when blood pressure signal 202 drops below a threshold for intact non-cerebral organ autoregulation (e.g., a threshold for non-cerebral organ dysfunction), such as, one or more of LLA.sub.C 204, LLA.sub.K 206, and LLA.sub.G 208, processing circuitry 110 may cause user interface 130 to provide an alert to a user, such as a clinician. In some examples, the alert may be similar or different for each autoregulation impairment scenario corresponding to when blood pressure signal 202 drops below each of LLA.sub.C 204, LLA.sub.K 206, and LLA.sub.G 208. By including LLA.sub.C 204, LLA.sub.K 206, and LLA.sub.G 208 and, in some examples, alerts for each associated impaired autoregulation scenario, autoregulation monitoring system 100 may enable a clinician to make a more informed decision to correct a blood pressure of patient 101,”).
Regarding claim 10, Addison1 teaches comprising:
receiving, by the processing circuitry, the blood pressure signal of the patient ([0034] “The sensed physiological signals may include signals indicative of physiological parameters from a patient, such as, but not limited to, blood pressure, regional oxygen saturation, blood volume, heart rate, and respiration.”);
receiving, by the processing circuitry, a regional oxygen saturation signal of the patient ([0034] “The sensed physiological signals may include signals indicative of physiological parameters from a patient, such as, but not limited to, blood pressure, regional oxygen saturation, blood volume, heart rate, and respiration.”); and
determining, by the processing circuitry, the cerebral autoregulation status value for the patient based on the blood pressure signal and the regional oxygen saturation signal ([0017] “determine an autoregulation status value based on various physiological parameters of the patient, such as a blood pressure signal indicative of a blood pressure of a patient and an oxygen saturation signal indicative of blood oxygen saturation (e.g., regional oxygen saturation) of a patient.”).
Regarding claim 11, Addison1 teaches wherein the one or more algorithms comprise one or more neural network algorithms trained via machine learning ([0076] “determining the adjustment value (304) may include using a neural network algorithm… a relationship between the cerebral autoregulation status value and the non-cerebral autoregulation status value using a neural network algorithm including a plurality of nodes, at least some of the nodes having node parameters.”).
Regarding claim 13, Addison1 teaches wherein the instructions, when executed by the processing circuitry, cause the processing circuitry to:
input, into the one or more algorithms during a medical procedure for the patient, the cerebral autoregulation status value measured during the medical procedure and the one or more laboratory values measured for the body fluid of the patient during the medical procedure to generate the AKI threshold delta value for the patient ([0076] “determining the adjustment value [AKI threshold delta value] using a neural network algorithm based on patient-specific data and/or population based data. The technique illustrated in FIG. 6 includes, inputting, by processing circuitry 110, at least the cerebral autoregulation status value of patient 101 into the neural network algorithm (602), as described above.” And [0075] “a population-based model based on a predetermined association between a first set blood pressures and a second set blood pressures.” The adjustment value can be based on patient specific data which individualizes the data based on the patient. [0076] “processing circuitry 110 may input inputting training data, such as patient-specific data or population-based data, into the neural network algorithm to tune the node parameters.” [0015] “A clinician may monitor the autoregulation status of a patient, e.g., during a medical procedure, and take one or more actions to keep the patient in or bring the patient to an intact autoregulation status, such as by increasing or decreasing the patient's blood pressure.”).
Claims 3, 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. (US 20200121193) (Hereinafter Addison1) in view of Baek et al. (“Optimal systolic blood pressure in noncritically ill patients with acute kidney injury: A retrospective cohort study” Kidney Res Clin Pract. 2019 Sep; 38(3): 356–364. Published online 2019 Sep 30. doi: 10.23876/j.krcp.19.030) (Hereinafter Baek) and Kuck et al. (US 11395616)(Hereinafter Kuck).
Regarding claim 3, claim 2 is obvious over Addison1 and Baek. However, Addison1 in view of Baek does not teach measuring the one or more laboratory values on a body fluid of the patient using one or more sensors, wherein the one or more sensors are communicatively coupled to the processing circuitry and fluidically coupled to a flow of the body fluid from or through a catheter coupled to the patient. Kuck, in the same field of endeavor, teaches determining AKI using blood flow and oxygen (Abstract and Col. 16 lines 1-3), and further teaches comprising measuring the one or more laboratory values on a body fluid of the patient using one or more sensors, wherein the one or more sensors are communicatively coupled to the processing circuitry and fluidically coupled to a flow of the body fluid from or through a catheter coupled to the patient (Col. 15 lines 15-25 “may determine oxygen level within the fluid flowing through the flow pathway 130 of the oxygen-sensing assembly 104 and/or the fluid flowing through the lumen 112 of the urinary catheter 102 of the catheter assembly 100 in real-time based on measurements taken with the oxygen sensor 120 and/or the additional oxygen sensor 140. In additional embodiments, the control system 106 may further determine additional markers such as, for example, pH, CO.sub.2, bladder pressure, abdominal pressure, etc., utilizing the oxygen sensor 120, the additional oxygen sensor 140, the temperature sensor 124, and/or the flowrate sensor 122.”) to determine marker relating to the development of AKI (Col. 1 lines 52-57). It would have been obvious to one skilled in the art, prior to the effective filing date to modify the non-cerebral autoregulation status value of Addison1 in view of Baek, with the measuring the one or more laboratory values on a body fluid of the patient using one or more sensors, wherein the one or more sensors are communicatively coupled to the processing circuitry and fluidically coupled to a flow of the body fluid from or through a catheter coupled to the patient of Kuck, because such a modification would allow to determine marker relating to the development of AKI.
Regarding claims 5 and 14, claim 2 is obvious over Addison1 and Baek. However, Addison1 in view of Baek does not teach one or more laboratory values comprise a serum creatinine level, a urine flow rate of the patient, a urine oxygenation level of the patient, a urine pH, a urine calcium level, or any combination thereof…wherein the one or more laboratory values comprise a urine flow rate of the patient and a urine oxygenation level of the patient. Kuck, in the same field of endeavor, teaches determining AKI using blood flow and oxygen (Abstract and Col. 16 lines 1-3), and further teaches wherein the one or more laboratory values comprise a serum creatinine level, a urine flow rate of the patient, a urine oxygenation level of the patient, a urine pH, a urine calcium level, or any combination thereof…wherein the one or more laboratory values comprise a urine flow rate of the patient and a urine oxygenation level of the patient (Col. 16 lines 14-17 “the control system 106 may cause an indication of an instantaneous/real-time urine flow through the catheter assembly 100 to be displayed on the user interface 154 of the control system 106.” Col. 15 lines 56-67 “the method 300 may include determining oxygen tension of the fluid flowing through the flow pathway 130 of the oxygen-sensing assembly 104 and/or the fluid flowing through the lumen 112 of the urinary catheter 102 of the catheter assembly 100, as shown in act 318 of FIG. 3. In some embodiments, the method 300 may include measuring the oxygen tension (pO2) (mmHg) (e.g., partial pressure) directly with the oxygen sensor 120. Additionally, the method 300 may include determining urinary oxygen tension (pO2) (mmHg) and/or mean medullary oxygen tension (mmHg) based on the oxygen levels determined in act 316 of FIG. 3.”) to determine marker relating to the development of AKI (Col. 1 lines 52-57). It would have been obvious to one skilled in the art, prior to the effective filing date to modify the non-cerebral autoregulation status value of Addison1 in view of Baek, with the one or more laboratory values comprise a serum creatinine level, a urine flow rate of the patient, a urine oxygenation level of the patient, a urine pH, a urine calcium level, or any combination thereof…wherein the one or more laboratory values comprise a urine flow rate of the patient and a urine oxygenation level of the patient of Kuck, because such a modification would allow to determine marker relating to the development of AKI.
Claims 4 are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. (US 20200121193) (Hereinafter Addison1) in view of Baek et al. (“Optimal systolic blood pressure in noncritically ill patients with acute kidney injury: A retrospective cohort study” Kidney Res Clin Pract. 2019 Sep; 38(3): 356–364. Published online 2019 Sep 30. doi: 10.23876/j.krcp.19.030) (Hereinafter Baek) and Tomasev et al. (“A clinically applicable approach to continuous prediction of future acute kidney injury” Nature volume 572, pages116–119 (2019))(Hereinafter Tomasev).
Regarding claim 4, claim 2 is obvious over Addison1 and Baek. However, Addison1 in view of Baek does not teach automatically measuring the one or more laboratory values on the body fluid of the patient repeatedly during a medical procedure for the patient to generate a plurality of updated one or more laboratory values and inputting, by the processing circuitry and into the one or more algorithms, the plurality of updated one or more laboratory values to update the acute kidney injury (AKI) threshold delta value for the patient during the medical procedure. Tomasev, in the same field of endeavor, teaches predicting AKI for an individual through predictors (Abstract), and further teaches comprising:
automatically measuring the one or more laboratory values on the body fluid of the patient repeatedly during a medical procedure for the patient to generate a plurality of updated one or more laboratory values (Page 120 right col. lines 67-71 “The AKI stages were computed at times at which there was a serum creatinine measurement present in the sequence, and then copied forward in time until the next creatinine measurement, at which time the ground-truth AKI state was updated accordingly.”); and
inputting, by the processing circuitry and into the one or more algorithms, the plurality of updated one or more laboratory values to update the acute kidney injury (AKI) threshold delta value for the patient during the medical procedure (Page 120 left col. lines 55-57 “The available data within these six-hour windows, along with additional summary statistics and augmentations, formed a feature set that was used as input to our predictive models.” Page 121 left col. lines 18-19 “At each time point, input features (as described in ‘Feature representation’) were provided to a statistical model, the output of which is a probability of any-severity stage of AKI occurring in the next 48 h.”) to accurately predict AKI (Abstract). It would have been obvious to one skilled in the art, prior to the effective filing date to modify the non-cerebral autoregulation status value of Addison1 in view of Baek, with the automatically measuring the one or more laboratory values on the body fluid of the patient repeatedly during a medical procedure for the patient to generate a plurality of updated one or more laboratory values and inputting, by the processing circuitry and into the one or more algorithms, the plurality of updated one or more laboratory values to update the acute kidney injury (AKI) threshold delta value for the patient during the medical procedure of Tomasev, because such a modification would allow to accurately predict AKI.
Conclusion
Claims 7-8 and 15 overcome the prior art but are still rejected under 35 U.S.C. 101 and 35 U.S.C. 112(b).
The following is a statement of reasons for the indication of the claims overcoming the prior art:
The receiving, by the processing circuitry during a medical procedure, a plurality of updated cerebral autoregulation status values for the patient measured during the medical procedure, receiving, by the processing circuitry during the medical procedure, a plurality of updated one or more laboratory values for the patient measured during the medical procedure, inputting, by the processing circuitry and into the one or more algorithms during the medical procedure, the plurality of updated cerebral autoregulation status values and the plurality of updated one or more laboratory values to generate a plurality of AKI threshold delta values for the patient, updating, by the processing circuitry during the medical procedure, the AKI threshold value based on the plurality of AKI threshold delta values and the plurality of updated cerebral autoregulation status values, updating, by the processing circuitry during the medical procedure, the blood pressure zone based on by the AKI threshold value, and output, for display by the display device during the medical procedure, the indication of the blood pressure zone as a graph of the blood pressure zone over time to visually present changes to the blood pressure zone during the medical procedure are not conventionally relied upon in AKI risk and are therefore allowable over the prior art.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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