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
The amendment filed 12/18/2025 has been entered: Claims 1-11 and 13-21 remain pending in the present application. Claim 12 is cancelled. Claims 1-4, 8-11, and 13-20 are currently amended. Claim 21 is new. Claims 1-11 and 13-21 are examined on the merits.
Applicant’s amendments have been acknowledged, and overcome each and every objection, 112(b) rejection, and the 101 rejections with respect to claims 13-20 previously set forth in the non-final office action mailed 10/1/2025. All previous objections, 112(b) rejections, and certain 101 rejections have been withdrawn.
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
Applicant argues the amendments to claim 1 sufficiently integrate the judicial exception into a practical application in that it is applied to effect a particular treatment.
However, in the context of claim 1, the invention (i.e. the apparatus comprising processor and memory) does not actually effect treatment as the produced recommended parameters are the end result of the invention. An independent user (which would fall outside the scope of the claimed apparatus) is subsequently required to actually implement the judicial exception while the recommendation itself does not effect treatment.
Merely “providing” information, such as the treatment recommendation as claimed, is generally considered as extra-solution activity. See MPEP 2106.05(d)(II) which includes examples where presenting information is considered extra-solution activity.
However, such limitations aren’t recited as a method step in claim 13, and thus the act of controlling the dialysis machine is within the scope of the claim. As such, the 101 rejection of claim 13, and its dependents have been withdrawn. Although, the limitations appeared to recite new matter, as stated in the 112(a) rejection below.
Applicant further argues the combination of Cherif and Habran is improper as such a combination would render the prior art invention being modified to be unsatisfactory for its intended purpose, defining said purpose as modeling a physiological acid-based model to determine operating parameters for an CO2, and HCO3 buffer system.
However, a mere statement of a function of the invention (as in ¶ 50 of Cherif) does not constitute the sole and unalterable purpose of the invention. Further, Cherif is directed to a computer model. The modification with Habran is not set forth as replacing the HCO3/ CO2 buffer model of Cherif, nor would it be required to do so. Rather, one of ordinary skill in the art would appreciate how additional computer functionalities can be incorporated into an existing program (or model), thus expanding the total capabilities and flexibility of the original computer function without overwriting the original functions.
Thus, a user would be able to utilize the original modeling of Cherif, as well as the ECCOR2D model as incorporated from Habran, to suit the needs of the user/patient.
Further, the use of an ECCOR2D model is still compatible with the overall function of Cherif in determining acid-based homeostasis, and thus would be within the principle of operation.
Applicant’s arguments regarding the dependent claims are moot as claim one remains rejected as set forth below.
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 1-11 are rejected under 35 U.S.C. 101 as directed to non-statutory subject
matter.
Claim 1 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites accessing an acid-base model, and determining predicted patient information, including a treatment recommendation for an acid-base disorder of the patient, using the acid-base model. This judicial exception is not integrated into a practical application because the steps required by the claim can be performed in the mind and that a person would be capable of observing an acid-base model (i.e. accessing the table of Fig. 4) and can use said model to predict patient information including a treatment recommendation for an acid-based disorder of the patient. Additionally, the claims require no other structure besides a processor and memory.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites only additional elements in the form of general-purpose computing structures (the at least one processor and memory comprising instructions). These computing structures are cited in a high-level of generality such that it amounts to no more than mere instructions to apply the exception using generic computer components. Additionally, the steps of accessing the acid-base model and providing a treatment recommendation to set treatment parameters of a dialysis machine also comprise insignificant extra-solution activity. Accessing the acid-base model comprises insignificant extra-solution activity in the form of mere data gathering and display while the step of providing the previously determined treatment recommendation merely conveys the judicial exception to a user (See MPEP 2106.05). The claim is not patent eligible.
Claim 2 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only that the patient information determined in claim 1 includes at least one of blood flow rate (Q), a serum pH level, a pCO2 level, or an HCO3 level. This judicial exception is not integrated into a practical application because the steps required by the claim can be performed in the mind and that a person would be capable of observing an acid-base model (i.e. accessing) and can use said model to predict patient information where the blood flow rate (Q), a serum pH level, a pCO2 level, or an HCO3 level merely reflect the result of the determining step of claim 1.
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 3 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only the additional step of determining continuous renal replacement therapy (CRRT) parameters for the dialysis machine to control acid-base status based on the predicted patient information. This judicial exception is not integrated into a practical application because the steps required by the claim can be performed in the mind and that a person would be capable of using the acid-base model and predicted patient information to determine CRRT parameters for a dialysis machine (¶ 4 of Applicant’s specification sets forth that these parameters are intended to guide physicians and do not actively operate any systems).
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 4 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only the additional element of the acid-base model being configured to model regulation of H+, CO2, and HCO3-. This judicial exception is not integrated into a practical application because the contents of the acid-base model would not change a user being able to observe the model. Additionally, the step of accessing the acid-base model may also comprise insignificant extra-solution activity in the form of mere data gathering (See MPEP 2106.05), in which case the contents of the model merely represent the data being used. The claim is not patent eligible.
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 5 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only the additional element of the patient model configured to model patient physiology having input of blood flow and output of hydrogen ion concentration, carbon dioxide concentration, and bicarbonate concentration. This judicial exception is not integrated into a practical application because the contents of the patient model would not change a user being able to observe the model. Additionally, the step of accessing the patient model may also comprise insignificant extra-solution activity in the form of mere data gathering (See MPEP 2106.05), in which case the contents of the model merely represent the data being used. The claim is not patent eligible.
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 6 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only the additional element of the dialyzer model configured to model CRRT. This judicial exception is not integrated into a practical application because the contents of the dialyzer model would not change a user being able to observe the model. Additionally, the step of accessing the dialyzer model may also comprise insignificant extra-solution activity in the form of mere data gathering (See MPEP 2106.05), in which case the contents of the model merely represent the data being used. The claim is not patent eligible.
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 7 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only the additional element of the ECCO2RD model configured to model a one-dimensional (1D) diffusion device between blood and air. This judicial exception is not integrated into a practical application because the contents of the dialyzer model would not change a user being able to observe the model. Additionally, the step of accessing the ECCO2RD model may also comprise insignificant extra-solution activity in the form of mere data gathering (See MPEP 2106.05), in which case the contents of the model merely represent the data being used. The claim is not patent eligible.
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 8 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only the additional element of the acid-base model comprising a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, to an ECCO2RD, modeled by the ECCO2RD mode, and back to the patient. This judicial exception is not integrated into a practical application because the contents of the various model would not change a user being able to observe the models. Additionally, the step of accessing the models may also comprise insignificant extra-solution activity in the form of mere data gathering (See MPEP 2106.05), in which case the contents of the model merely represent the data being used. The claim is not patent eligible.
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 9 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only the additional element of the blood circuit comprising diffusion at any point. This judicial exception is not integrated into a practical application because the blood flow circuit is merely a part of the acid-base model. Additionally, the step of accessing the model appears to comprise insignificant extra-solution activity in the form of mere data gathering (See MPEP 2106.05), in which case the contents of the model merely represent the data being used. The claim is not patent eligible.
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 10 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only the additional elements of the blood flow circuit comprising a dilution model inserted between the patient model and the dialyzer model, between the dialyzer model and the ECCO2RD model, or between the ECCO2RD model and the patient model. This judicial exception is not integrated into a practical application because the dilution model is merely a part of the acid-based model and does not contribute to integration into a practical application. Additionally, the step of accessing the model appears to comprise insignificant extra-solution activity in the form of mere data gathering (See MPEP 2106.05), in which case the contents of the model merely represent the data being used. The claim is not patent eligible.
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim 11 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to an abstract idea without significantly more. The claim recites only dilution model being configured to model an increase in blood flow rate, as well as a corresponding decrease in concentration, between the patient model and the dialyzer model, between the dialyzer model and the ECCO2RD model, or between the ECCO2RD model and the patient model. This judicial exception is not integrated into a practical application because the contents of the various model would not change a user being able to observe the models. Additionally, the step of accessing the model appears to comprise insignificant extra-solution activity in the form of mere data gathering (See MPEP 2106.05), in which case the contents of the model merely represent the data being used. The claim is not patent eligible.
The claim does not include any additional elements, and thus is not sufficient to amount to significantly more than the judicial exception. The claim is not patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 13 now recites the step of setting treatment parameters of a dialysis machine based on the treatment recommendation. However, Applicant’s invention is directed only to the provision of recommendations (¶ 4 of Applicant’s specification sets forth that these parameters are intended to guide physicians and do not actively operate any systems). Actively setting the treatment parameters of a dialysis machine appears to be outside the scope of Applicant’s invention and disclosure.
Claims 14-21 are rejected via their dependency on claim 13.
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.
Claims 1-2, 4-5, 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cherif et al. (US 2020/0294676 A1), in view of Habran et al. (Mathematical modeling of extracorporeal CO2 removal therapy).
Regarding claim 1, Cherif teaches an apparatus comprising an apparatus (Fig. 1; Abstract), comprising:
at least one processor (computing device 194; ¶ 14); and
a memory coupled to the at least one processor (memory unit 140; ¶ 61), the memory comprising instructions that, when executed by the at least one processor, cause the at least one processor to:
access an acid-base model configured to model acid-base homeostasis of a patient (¶s 49-56, 59, and 65-68 all describe the use of an acid-base for patient homeostasis), the acid-base model comprising a patient model (¶s 14, 19-20, 59-68, and ¶s 115-116), a dialyzer model (¶s 14, 19-20, 59-68, and ¶s 115-116),
determine, using the acid-based model, predicted patient information using the acid-based model (¶s 8-9, 14-15, 51, 64, and 67), including a treatment recommendation for an acid-based disorder of the patient (¶s 2, 5, 13, and 22-25 describe treatment recommendations); and
provide the treatment recommendation to set treatment parameters of a dialysis machine (Abstract, ¶s 5, and 8-9 describe determining operating parameters for a dialysis buffer system).
Cherif does not explicitly teach the acid-base model comprising an extracorporeal CO2 removal device (ECCO2RD) model.
However, Habran teaches a mathematical model for CO2 removal and ECCO2RD (Abstract), thus being in the same field of endeavor, which predicts patient information (Page 424, right column under “2.4 Statistics” describes how the mathematical model is used to predict pCO2 for different blood flows) and to optimize device settings (Page 428, section under “4.4 Application of the model of the ICU”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif to comprise the ECCO2RD model of Habran. Doing so would be advantageous in determining the best settings for CO2 removal with rapid decision making to improve care (Page 428, section under “4.4 Application of the model of the ICU”; also see page 429, under “5 Conclusion and future works).
Regarding claim 2, Cherif further teaches the patient information comprising serum pH level (¶ 9).
Regarding claim 4, Cherif further teaches the acid-base model being configured to model regulation of H+, CO2, and HCO3- (¶s 20, 50, 54, and 75 describes the use of H+, CO2, and HCO3- ; the formulas from ¶s 10-18 also utilize H+, CO2, and HCO3- ).
Regarding claim 5, Cherif further teaches the patient model configured to model patient physiology having input of blood flow and output of hydrogen ion concentration, carbon dioxide concentration, and bicarbontate concentration (¶s 116-118; and equations 7-14 between ¶s 118 and 121).
Regarding claim 7, Cherif does not teach all of the elements of claim 7. However, Habran further teaches the ECCO2RD model being configured to model a one-dimensional (1D) diffusion device between blood and air (Page 430, under “A.3 ECCO2RD” describes how the modeled device is reduced to one dimension; Page 427, under “4.1 Modeling of lung gas exchange” indicates the model uses air flux).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif to comprise the ECCO2RD model of Habran. Doing so would thus comprise the ECCO2RD model configured to model a 1D diffusion device between blood and air. Doing so would be advantageous in determining the best settings for CO2 removal with rapid decision making to improve care (Page 428, section under “4.4 Application of the model of the ICU”; also see page 429, under “5 Conclusion and future works).
Regarding claim 8, Cherif further teaches the acid-base model comprising a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, and back to the patient (¶s 14, 19-20, 59-68, and 115-116 describe how the devices intended to simulate a patient undergoing hemodialysis using a dialyzer system, which would require blood flowing from a patient to a dialyzer).
Further, as previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif to comprise the ECCO2RD model of Habran. Doing so would thus comprise the ECCO2RD in the model circuit of Cherif. Doing so would be advantageous in determining the best settings for CO2 removal with rapid decision making to improve care (Page 428, section under “4.4 Application of the model of the ICU”; also see page 429, under “5 Conclusion and future works).
Regarding claim 9, Cherif does not teach all of the elements and features of claim 9. However, Habran further teaches the ECCO2RD model comprises diffusion (Page 427, under “4.1 Modeling of lung gas exchange” indicates the model uses air flux; page 423, under “2.2 Experimental data” and 425, left column, discusses atmospheric air flow rate; Page 429, under “A.1 Pulmonary gas exchange” and Page 430, under “A.3 ECCO2RD” describes how the model includes gas diffusion from said air flux VL). Further, as previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif to comprise the ECCO2RD model of Habran. Doing so would thus comprise the ECCO2RD in the model circuit of Cherif. Doing so would be advantageous in determining the best settings for CO2 removal with rapid decision making to improve care (Page 428, section under “4.4 Application of the model of the ICU”; also see page 429, under “5 Conclusion and future works).
Claims 3 and 6 rejected under 35 U.S.C. 103 as being unpatentable over Cherif and Habran as applied to claim 1 above, and further in view of Ware et al. (US 2005/0085760 A1).
Regarding claim 3, Cherif further teaches instructions, when executed by the at least one processor, to cause the at least one processor to determine fluid removal parameters for the dialysis machine to control the acid-base status based on the predicted patient information (¶s 66,74, 102, 118, and 127).
The combination does not explicitly teach the parameters being for continuous renal replacement therapy (CRRT).
However, Ware teaches a medical fluid therapy and balancing system (Fig. 1; Abstract), thus being in the same field of endeavor, which teaches utilizing CRRT to balance pH and fluid removal during blood treatment (¶s 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif and Habran to utilize CRRT for acid-base balancing, as taught by Ware. Doing so would thus comprise the processor configured to determine CRRT parameters to control acid-base status based on the predicted patient information. Doing so would be advantageous in allowing for CRRT use which would avoid cardiovascular instability (¶s 7-8 of Ware).
Regarding claim 6, Cherif further teaches a dialyzer model for modeling the regulation of chemical components (¶s 20, 50, 66,74, 102, and 118).
The combination does not explicitly teach the dialyzer model being configured to model CRRT.
However, Ware teaches a medical fluid therapy and balancing system (Fig. 1; Abstract), thus being in the same field of endeavor, which teaches utilizing CRRT to balance pH and fluid removal during blood treatment (¶s 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif and Habran to utilize CRRT for the dialyzer acid-base balancing, as taught by Ware. Doing so would thus comprise the dialyzer model configured to model CRRT. Doing so would be advantageous in allowing for CRRT use which would avoid cardiovascular instability (¶s 7-8 of Ware).
Claims 10-11 rejected under 35 U.S.C. 103 as being unpatentable over Cherif and Habran as applied to claim 1 above, and further in view of Lannoy (US 2011/0264025 A1).
Regarding claim 10, Cherif does not explicitly teach the blood flow circuit further comprises a dilution model inserted between the patient model and the dialyzer model, between the dialyzer model and the ECCO2RD model, or between the ECCO2RD model and the patient model.
However, Lannoy teaches a blood circuit for CRRT (Fig. 2; Abstract), thus being in the same field of endeavor, comprising a dilution system (citrate solution 17; ¶ 36) between the patient and the dialyzer (citrate solution 17 is in between patient access 29 and haemofilter 39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Cherif and Habran such that the blood flow circuit further comprises a dilution model inserted between the patient model and the dialyzer model. Doing so would be advantageous in adding the computer functionality for modeling and accounting for the delivery rate of additives that dilute the blood, such as anticoagulants in the form of citrate (¶s 11-15 of Lannoy).
Regarding claim 11, Cherif does not teach all of the elements and features of claim 11. However, Lannoy further teaches monitoring blood flow rate and concentration with respect to dilution (¶s 3, 11-15, and 27-30 describes the optimization of flow rate and concentration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the device of Cherif, Habran, and Lannoy such that the model is configured to model an increase in a blood flow rate, as well as a corresponding decrease in concentration, between the patient model and the dialyzer model. Doing so would be advantageous in adding the computer functionality for modeling and accounting for the delivery rate of additives that dilute the blood, such as anticoagulants in the form of citrate (¶s 11-15 of Lannoy).
Claims 13-14, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Cherif, in view of Habran, and Cohen et al. (US 2018/0316505 A1).
Regarding claim 13, Cherif a computer-implemented method of acid-based homeostasis analysis (Fig. 1; Abstract), the method comprising, via a processor of a computing device (computing device 194; ¶ 14 and memory unit 140; ¶ 61):
providing an acid-base model configured to model acid-base homeostasis of a patient (¶s 49-56, 59, and 65-68 all describe the use of an acid-base for patient homeostasis), the acid-base model comprising a patient model (¶s 14, 19-20, 59-68, and ¶s 115-116), a dialyzer model (¶s 14, 19-20, 59-68, and ¶s 115-116), and
executing the acid-based model to determine predicted patient information (¶s 8-9, 14-15, 51, 64, and 67) including a treatment recommendation for an acid-based disorder of the patient (¶s 2, 5, 13, and 22-25 describe treatment recommendations);
Cherif does not explicitly teach the acid-base model comprising an extracorporeal CO2 removal device (ECCO2RD) model or setting treatment parameters of a dialysis machine based on the treatment recommendation.
However,Habran teaches a mathematical model for CO2 removal and ECCO2RD (Abstract), thus being in the same field of endeavor, which predicts patient information (Page 424, right column under “2.4 Statistics” describes how the mathematical model is used to predict pCO2 for different blood flows) and to optimize device settings (Page 428, section under “4.4 Application of the model of the ICU”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif to comprise the ECCO2RD model of Habran. Doing so would be advantageous in determining the best settings for CO2 removal with rapid decision making to improve care (Page 428, section under “4.4 Application of the model of the ICU”; also see page 429, under “5 Conclusion and future works).
The combination of Cherif and Habran does not explicitly teach setting treatment parameters of a dialysis machine based on the treatment recommendation.
However,Cohen teaches a digitally controlled dialysis machine (Fig. 4; Abstract), thus being in the same field of endeavor, where digital treatment parameters are applied to a dialysis machine (Abstract and ¶ 47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Cherif and Habran to comprise setting treatment parameters of a dialysis machine based off a digital treatment regimen (i.e. the treatment recommendation of Cherif), as taught by Cohen. Doing so would be advantageous in providing more secure control over the dialysis machine (¶ 47 of Cohen), and would also reduce human error in providing additional automation in the treatment process.
Regarding claim 14, Cherif further teaches the patient information comprising serum pH level (¶ 9).
Regarding claim 16, Cherif further teaches the acid-base model being configured to model the regulation of H+, CO2, and HCO3- (¶s 20, 50, 54, and 75 describes the use of H+, CO2, and HCO3- ; the formulas from ¶s 10-18 also utilize H+, CO2, and HCO3- ).
Regarding claim 17, Cherif further teaches the patient model configured to model patient physiology having input of blood flow and output of hydrogen ion concentration, carbon dioxide concentration, and bicarbontate concentration (¶s 116-118; and equations 7-14 between ¶s 118 and 121).
Regarding claim 19, Habran further teaches the ECCO2RD model being configured to model a one-dimensional (1D) diffusion device between blood and air (Page 430, under “A.3 ECCO2RD” describes how the modeled device is reduced to one dimension; Page 427, under “4.1 Modeling of lung gas exchange” indicates the model uses air flux).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif to comprise the ECCO2RD model of Habran. Doing so would thus comprise the ECCO2RD model configured to model a 1D diffusion device between blood and air. Doing so would be advantageous in determining the best settings for CO2 removal with rapid decision making to improve care (Page 428, section under “4.4 Application of the model of the ICU”; also see page 429, under “5 Conclusion and future works).
Regarding claim 20, Cherif further teaches the acid-base model comprising a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, and back to the patient (¶s 14, 19-20, 59-68, and 115-116 describe how the devices intended to simulate a patient undergoing hemodialysis using a dialyzer system, which would require blood flowing from a patient to a dialyzer).
Further, as previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif to comprise the ECCO2RD model of Habran. Doing so would thus comprise the ECCO2RD in the model circuit of Cherif. Doing so would be advantageous in determining the best settings for CO2 removal with rapid decision making to improve care (Page 428, section under “4.4 Application of the model of the ICU”; also see page 429, under “5 Conclusion and future works).
Claims 15 and 18 rejected under 35 U.S.C. 103 as being unpatentable over Cherif, Habran, and Cohen, as applied to claim 1 above, and further in view of Ware et al. (US 2005/0085760 A1).
Regarding claim 15, Cherif further teaches instructions, prescribing fluid removal parameters to control the acid-base status based on the predicted patient information (¶s 66,74, 102, and 118).
The combination does not explicitly teach the parameters being for continuous renal replacement therapy (CRRT).
However,Ware teaches a medical fluid therapy and balancing system (Fig. 1; Abstract), thus being in the same field of endeavor, which teaches utilizing CRRT to balance pH and fluid removal during blood treatment (¶s 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif, Habran, and Cohen to utilize CRRT for acid-base balancing, as taught by Ware. Doing so would thus comprise prescribing CRRT parameters to control acid-base status based on the predicted patient information. Doing so would be advantageous in allowing for CRRT use which would avoid cardiovascular instability (¶s 7-8 of Ware).
Regarding claim 18, Cherif further teaches a dialyzer model for modeling the regulation of chemical components (¶s 20, 50, 66,74, 102, and 118).
The combination does not explicitly teach the dialyzer model being configured to model CRRT.
However, Ware teaches a medical fluid therapy and balancing system (Fig. 1; Abstract), thus being in the same field of endeavor, which teaches utilizing CRRT to balance pH and fluid removal during blood treatment (¶s 6-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Cherif, Habran, and Cohen to utilize CRRT for the dialyzer acid-base balancing, as taught by Ware. Doing so would thus comprise the dialyzer model configured to model CRRT. Doing so would be advantageous in allowing for CRRT use which would avoid cardiovascular instability (¶s 7-8 of Ware).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Cherif, Habran, and Cohen as applied to claim 13 above, and further in view of Lannoy.
Regarding claim 21, the combination of Cherif, Habran, and Cohen does not explicitly teach the blood flow circuit further comprises a dilution model inserted between the patient model and the dialyzer model, between the dialyzer model and the ECCO2RD model, or between the ECCO2RD model and the patient model, and
wherein the dilution model is configured to model an increase of a blood flow rate, as well as a corresponding decrees in concentration between the patient model and the dialyzer model, between the dialyzer model and the ECCO2RD model, or between the ECCO2RD model and the patient model.
However, Lannoy teaches a blood circuit for CRRT (Fig. 2; Abstract), thus being in the same field of endeavor, comprising a dilution system (citrate solution 17; ¶ 36) between the patient and the dialyzer (citrate solution 17 is in between patient access 29 and haemofilter 39), and monitoring blood flow rate and concentration with respect to dilution (¶s 3, 11-15, and 27-30 describes the optimization of flow rate and concentration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Cherif and Habran such that the blood flow circuit further comprises a dilution model inserted between the patient model and the dialyzer model, such that the model is configured to model an increase in a blood flow rate, as well as a corresponding decrease in concentration, between the patient model and the dialyzer model. Doing so would be advantageous in adding the computer functionality for modeling and accounting for the delivery rate of additives that dilute the blood, such as anticoagulants in the form of citrate (¶s 11-15 of Lannoy).
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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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781