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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/5/2026 has been entered.
Claims 1-7, 9-11, 13-19 and 21 remain pending in the present application. Claims 8, 12, and 20 are cancelled. Claims 1 and 13 are currently amended. Claims 1-7, 9-11, 13-19 and 21 are examined on the merits.
Applicant’s amendments have been acknowledged, and overcome each and every 101 rejection previously set forth in the final office action mailed 3/17/2026. All previous 101 rejections have been withdrawn. However, Applicant’s amendments still introduce new 112(a) rejections (see below).
Response to Arguments
Applicant’s arguments, see pages 6-9 of Applicant’s Remarks, filed 6/5/2026, with respect to the rejection under 35 U.S.C. 101 have been fully considered and are persuasive. The 101 rejection of claims 1-11 has been withdrawn.
However, Applicant’s arguments regarding the rejection of claims 13-21 under 35 U.S.C. 112 have been fully considered but they are not persuasive.
Applicant argues Paragraph 75 of the pending application (which appears to refer to the published disclosure) provides support for “dialysis modifications” and “adjusting ultrafiltration rate and/or volume” as evidence for the teaching of modifying a dialysis machine.
In this particular respect, Applicant’s disclosure is ambiguous. However, the cited section begins with a statement that the feedback loop is provided for “ongoing use of the acid-base models”. Given that the rest of Applicant’s disclosure is directed only within the model for providing recommendations, the cited section of Applicant’s specification appears to be discussing adjusting the various treatment parameters, including “ultrafiltration rate and/or volume” only within the context of the acid-base model. Thus, Applicant’s disclosure does not appear to support actively controlling a physical dialysis system.
Further, it is noted that the cited reference, Cherif, discloses the same language regarding a feedback loop in Paragraph 71. Thus, regardless of the interpretation of having support for having direct control of a dialysis machine, Cherif teaches the same subject matter.
Applicant’s arguments with respect to claim(s) 1, 2, 4, 5, and 7-9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Cherif remains as the primary reference in rejecting the present claims, for disclosing a majority of the claimed invention.
Batchinsky is being introduced as a secondary reference in the present rejection for disclosing and/or rendering obvious the newly amended limitations of claim 1.
Lannoy, previously presented, is also now incorporated into the rejection of claim 1.
Habran, Cohen, and Ware remain in the present rejection for disclosing and/or rendering obvious the remaining limitations of the claims.
Applicant argues the rational of combining the ECCO2RD model of Habran to that of Cherif constitutes impermissible hindsight. Examiner disagrees as one of ordinary skill in the art would appreciate that Cherif already teaches modeling some form of CO2 removal and is fundamentally directed to modeling functionality of dialysis processes. The use of ECCO2RD systems is known in the art, as demonstrated by Habran, and thus modeling a particular, known dialysis element is within Cherif's intended function.
Applicant argues an unusual technical effect; however, there does not appear to be evidence that the introduction of the modeling of an ECCO2RD systems does nothing more than allow the model to be applied to that particular system, where the end result (as in determining parameters and providing treatment recommendations) would be highly analogous between Cherif and Applicant’s invention. Applicant’s arguments regarding the dependent claims are moot as claim one remains rejected as set forth below.
Claim Objections
Claims 9-10 objected to because of the following informalities:
Claims 9-10 are dependent on now canceled claim 8. In an effort to promote compact prosecution, claims 9-10 are interpreted as being dependent off of claim 1.
Appropriate correction is suggested
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 1-7, 9-11, 13-19 and 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.
Claims 1 and 13 now recite 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.
The remaining claims are rejected via their respective dependency on claims 1 and 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, 9-11 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), Batchinsky et al. (US 2020/0000999 A1), and Lannoy (US 20110264025 A1).
Regarding claim 1, Cherif teaches 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);
wherein the acid-base homeostasis logic is configured to implement a feedback loop parameter that adjusts the parameters of the dialysis model to modify a dialysis treatment of the patient, within the model, wherein the parameters are adjusted based on the treatment recommendation (¶ 71).
Cherif does not explicitly teach the acid-base model comprising an extracorporeal CO2 removal device (ECCO2RD) model, wherein the acid-base model includes a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, to an ECCO2RD model, and back to the patient; wherein the acid-base homeostasis logic is configured to adjust parameters of a dialysis machine to modify a dialysis treatment of the patient, wherein the parameters are adjusted 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), and would also allow the model of Cherif to be used with physical ECCO2RD systems.
The combination of Cherif and Habran still do not explicitly teach wherein the acid-base model includes a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, to an ECCO2RD model, and back to the patient; wherein the acid-base homeostasis logic is configured to adjust parameters of a dialysis machine to modify a dialysis treatment of the patient, wherein the parameters are adjusted based on the treatment recommendation.
However, Batchinsky teaches a extracorporeal blood treatment device (Figs. 2-6; Abstract), thus being in the same field of endeavor, where the device comprises a blood flow circuit flowing from a patient (¶s 86-87 indicate a patient), where the blood flows through a blood circuit to a dialyzer (shunt line 36 and dialysis membrane 40), and then to a CO2 removal device (lung membrane 32), and back to the patient (this ordering is best seen in Fig. 4).
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 model of Cherif and Habran to comprise a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, to an CO-2 removal model, and back to the patient, to match the physical arrangement of Batchinsky. Doing so would thus comprise the model including a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, to an ECCO2RD model, and back to the patient. Doing so would be advantageous in modeling the physical components of a practical treatment device to provide treatment recommendations, such as to devices like Batchinsky (as Cherif is fundamentally directed to modeling functionality of dialysis processes).
The combination of Cherif, Habran, and Batchinsky still does not explicitly teach wherein the acid-base homeostasis logic is configured to adjust parameters of a dialysis machine to modify a dialysis treatment of the patient, wherein the parameters are adjusted based on the treatment recommendation.
However, Lannoy teaches a blood treatment circuit (Fig. 2; Abstract), thus being in the same field of endeavor, which uses controller logic to adjust parameters of the dialysis machine (¶s 3, 27, and 33).
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 logic of Cherif, Habran, and Batchinsky to adjust the parameters of a dialysis machine based on controller optimization, as taught by Lannoy. Doing so would comprise the acid-base homeostasis logic being configured to adjust parameters of a dialysis machine to modify a dialysis treatment of the patient, wherein the parameters are adjusted based on the treatment recommendation. Doing so would be advantageous in optimizing extracorporeal treatment, as taught by Lannoy (¶ 26).
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 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 ECCO2RD with diffusion 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 10, Cherif does not teach all of the elements and features of claim 10. However, Lannoy teaches further 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 further modified the invention of Cherif, Habran, Batchinsky, and Lannoy 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, Batchinsky, 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 3 and 6 rejected under 35 U.S.C. 103 as being unpatentable over Cherif, Habran, Batchinsky, and Lannoy, 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, Lannoy teaches the device being used for CRRT, but does not appear to provide motivation therein.
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, Batchinsky, and Lannoy 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).
Lannoy teaches the device being used for CRRT, but does not appear to provide motivation therein.
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 13-14, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Cherif, in view of, Habran, Batchinsky, and Cohen et al. (US 2018/0316505 A1).
Regarding claim 13, Cherif teaches 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 wherein the acid-base model includes a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, to an ECCO2RD model, and back to the patient; wherein the acid-base homeostasis logic is configured to adjust parameters of a dialysis machine to modify a dialysis treatment of the patient, wherein the parameters are adjusted based on the treatment recommendation, 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), and would also allow the model of Cherif to be used with physical ECCO2RD systems.
The combination of Cherif and Habran does not explicitly teach wherein the acid-base model includes a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, to an ECCO2RD model, and back to the patient; wherein the acid-base homeostasis logic is configured to adjust parameters of a dialysis machine to modify a dialysis treatment of the patient, wherein the parameters are adjusted based on the treatment recommendation, or setting treatment parameters of a dialysis machine based on the treatment recommendation,
Batchinsky teaches a extracorporeal blood treatment device (Figs. 2-6; Abstract), thus being in the same field of endeavor, where the device comprises a blood flow circuit flowing from a patient (¶s 86-87 indicate a patient), where the blood flows through a blood circuit to a dialyzer (shunt line 36 and dialysis membrane 40), and then to a CO2 removal device (lung membrane 32), and back to the patient (this ordering is best seen in Fig. 4).
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 model of Cherif and Habran to comprise a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, to an CO-2 removal model, and back to the patient, to match the physical arrangement of Batchinsky. Doing so would thus comprise the model including a blood flow circuit flowing from a patient, modeled by the patient model, to a dialyzer, modeled by the dialyzer model, to an ECCO2RD model, and back to the patient. Doing so would be advantageous in modeling the physical components of a practical treatment device to provide treatment recommendations, such as to devices like Batchinsky (as Cherif is fundamentally directed to modeling functionality of dialysis processes).
The combination still 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, Habran, and Batchinsky 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).
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALESSANDRO R DEL PRIORE/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
Prosecution Insights