Notice of Pre-AIA or AIA Status
This action is made in response to the amendments/remarks filed on March 16, 2026. This action is made NON-FINAL.
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 March 16, 2026 has been entered. Claims 20-37 remain pending in the application. Claims 38-44 have been cancelled. Claims 45-48 have been newly added. Applicant’s amendments to the claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed 12/18/2025.
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 48 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.
Claim 48 recites the limitation "wherein the treatment-relevant patient data…" in line 1. The only previous mention of treatment-relevant patient data is in claim 25, which claim 26 is not dependent on. Therefore, claim 48 should be dependent on claim 25 instead of claim 26. There is insufficient antecedent basis for this limitation in the claim.
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 20-37 and 45-48 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claims
Step 1 analysis:
Claims 20 and 35 are drawn to a system, which are all within the four statutory categories. (Step 1 – Yes, the claim falls into one of the statutory categories).
Step 2A analysis – Prong One:
Claim 20 recites:
A computer system for specifying settings of a blood treatment apparatus, the computer system comprising:
a calculation device; and
a display device configured or programmed to display:
a target renal dose for a treatment of a patient to be delivered using the blood treatment apparatus; and
a first input interface for changing the target renal dose by a user, and a second input interface for entering a correction of an acid-base balance of the patient by the user for the treatment of the patient using the blood treatment apparatus; and
a first output interface for outputting technical parameter values of the blood treatment apparatus,
wherein the calculation device is programmed to:
determine the technical parameter values for the blood treatment apparatus based on the target renal dose entered via the first input interface and the correction of the acid-base balance entered via the second input interface; and
output the determined technical parameter values for an operation of the blood treatment apparatus, via the first output interface.
The series of steps as recited above, excluding the underlined portions, describes managing personal behavior or relationships or interactions between people including following rules or instructions, and therefore fall within the scope of certain methods of organizing human activity. Fundamentally, the claim recites receiving a renal dose and a correction of an acid-base balance from a user and determining technical parameter values of a blood treatment apparatus based on the received data. This describes methods of organizing human activity including interactions between people, for example, interactions between a patient and healthcare provider, and accordingly, the claim recites an abstract idea of managing interactions between people.
The claim also falls within the “mathematical concepts” grouping of abstract ideas. The concept of determining the technical parameter values for the blood treatment apparatus based on the target renal dose and the correction of the acid-base balance recites mathematical calculations because the determination/calculation of the technical parameters utilizes mathematical formulas. Therefore, the claim recites an abstract idea of a mathematical concept.
Claim 35 recites/describes nearly identical steps as claim 20 (and therefore also recite limitations that fall within this subject matter grouping of abstract ideas), and these claims are therefore determined to recite an abstract idea under the same analysis.
Step 2A analysis – Prong 2:
This judicial exception is not integrated into a practical application. Specifically, independent claims 20 and 35 recite the following additional elements beyond the abstract idea: a computer system, a calculation device, a display device, a first and second input interface, a first output interface, and one or more blood treatment apparatuses (claim 35 only). These limitations of a computer system, a calculation device, a display device, a first and second input interface, a first output interface are recited at a high level of generality and amount to no more than mere instructions to apply the exception using generic computer components. The limitation of one or more blood treatment apparatuses amounts to no more than merely invoking computers or machinery as a tool to perform an existing process. The limitations do not impose any meaningful limits on practicing the abstract idea, and therefore do not integrate the abstract idea into a practical application (see MPEP 2106.05(f)).
Specifically, the computer system is a fixed computer terminal, desktop computer, a mobile device, hand-held device, mobile phone, smartphone, tablet, etc., or includes at least one such device (Specification Pg. 14, lines 18-24). The display device may be in the form of a GUI (Graphical User Interface) (Spec. Pg. 2, lines 21-23) and the output interface and the display device may be identical (Spec. Pg. 17, lines 22-24).
The limitation “output the determined technical parameter values for an operation of the blood treatment apparatus, via the first output interface” is mere data outputting recited at a high level of generality, and thus is insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”). In addition, all uses of the recited judicial exceptions require such data gathering and output, and, as such, these limitations do not impose any meaningful limits on the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05.
The additional elements do not show an improvement to the functioning of a computer or to any other technology, rather the additional elements perform general computing functions and do not indicate how the particular combination improves any technology or provides a technical solution to a technical problem. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, Claims 20 and 35 are directed to an abstract idea without practical application. (Step 2A – Prong 2: No, the additional elements are not integrated into a practical application).
Step 2B analysis:
As discussed above in “Step 2A analysis – Prong 2”, the identified additional elements in Independent Claims 20 and 35 are equivalent to adding the words “apply it” on a generic computer, and/or generally link the use of the judicial exception to a particular technological environment or field of use. Therefore, the claims as a whole do not amount to significantly more than the judicial exception itself.
For the role of a computer in a computer implemented invention to be deemed meaningful in the context of this analysis, it must involve more than performance of “well- understood, routine, [and] conventional activities previously known to the industry.” Further, “the mere recitation of a generic computer cannot transform a patent ineligible abstract idea into a patent-eligible invention.”
The applicant’s specification discloses: the computer system is a fixed computer terminal, desktop computer, a mobile device, hand-held device, mobile phone, smartphone, tablet, etc., or includes at least one such device (Specification Pg. 14, lines 18-24). The display device may be in the form of a GUI (Graphical User Interface) (Spec. Pg. 2, lines 21-23) and the output interface and the display device may be identical (Spec. Pg. 17, lines 22-24).
The additional element of “output the determined technical parameter values for an operation of the blood treatment apparatus, via the first output interface” was found to be insignificant extra-solution activity in Step 2A, Prong Two, because they were determined to be insignificant limitations as necessary data gathering and outputting. However, a conclusion that an additional element is insignificant extra -solution activity in Step 2A, Prong Two should be re-evaluated in Step 2B. See MPEP 2106.05, subsection I.A. At Step 2B, the evaluation of the insignificant extra-solution activity consideration takes into account whether or not the extra-solution activity is well understood, routine, and conventional in the field. See MPEP 2106.05(g).
Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. Here, the claim limitations are similar to receiving and sending information over a network (Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OJP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); See MPEP 2106.05(d)(ll)(i)).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the steps amount to no more than using computer related devices to implement the abstract idea.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing. Therefore, the claims are not patent eligible. The Examiner has therefore determined that no additional element, or combination of additional claims elements is/are sufficient to ensure the claims amount to significantly more than the abstract idea identified above (Step 2B: Independent claims - NO).
Dependent Claims
Dependent Claims 21-34, 36-37, and 45-46 are directed towards elements used to describe interfaces and the technical parameters. (claim 21) decreasing or increasing a target value for a renal dose as a target treatment parameter, (claim 22) initiate an acid/base correction as an input treatment specification, (claim 25) displaying treatment-relevant patient data to the user, (claim 26) display a graphic for acid-base correction to the user, (claim 27) the graphic comprises curves with combinations of adjustable settings, (claim 28) adjustable setting comprise selectable combinations of a flow rate for a blood pump and dialysis liquid pump, (claim 30) the system is in an intensive care unit or central monitoring room, (claim 31) the technical parameter values comprise an adjustable setting for a blood pump and dialysis liquid pump, (claim 33) controlling or regulating the blood treatment apparatus based on the calculated adjustable settings and based on a target treatment parameter changed by the user or a treatment specification entered by the user, (claim 34) the calculated or determined adjustable settings comprise a flow rate as technical parameters, (claim 45) the renal dose comprises a quotient of effluent flow or filtrate flow over patient weight, (claim 46) the effluent flow is determined by taking into account at least one of: dialysate flow, dialysis liquid flow, substitute fluid flow, calcium flow, citrate flow, and net ultrafiltration, (claim 47) the output technical parameter comprises an expected bicarbonate concentration at an end of the treatment of the patient, (claim 48) the treatment-relevant patient data comprises a desired citrate-calcium anticoagulation. The limitations recited above describe managing personal behavior or relationships or interactions between people including following rules or instructions, and therefore fall within the same scope of certain methods of organizing human activity as the independent claims.
Additionally, the limitations recited above fall within the same abstract idea of mathematical calculations as the independent claims. The limitations of claims 34 and 45 further limit the mathematical calculations by comprising a flow rate and calculating renal dose using the quotient of effluent flow or filtrate flow over patient weight. Therefore, the dependent claims also fall within the same mathematical concepts grouping of abstract ideas as the independent claims.
This judicial exception is not integrated into a practical application. Specifically, the dependent
claims recite the following additional elements beyond the abstract idea: (claim 21) the first input interface comprises switches, (claim 22) the second input interface, (claim 23) the first output interface is or comprises an optical interface or a graphic interface, (claim 25 and 26) a second and third output interface, (claim 29) the computer system comprises a mobile device, a handheld device, a mobile phone, a smartphone, a tablet, a fixed computer terminal, or a desktop computer, (claim 30) the computer system comprises an application, (claim 32) the computer system comprises or is in signal communication with a control device or a closed-loop control device of the blood treatment apparatus, (claim 36) the blood treatment apparatus includes a hemodialysis apparatus, a hemofiltration apparatus, a hemodiafiltration apparatus, an apparatus for acute, chronic renal replacement therapy, or an apparatus for continuous renal replacement therapy (CRRT), and (claim 37) a digital storage medium. The additional elements in claims 21-23, 25-26, 29-32, and 37 are recited at a high level of generality and amount to no more than mere instructions to apply the exception using generic computer components. The additional elements of claim 36 amount to no more than merely invoking computers or machinery as a tool to perform an existing process. The limitations do not impose any meaningful limits on practicing the abstract idea, and therefore do not integrate the abstract idea into a practical application (see MPEP 2106.05(f)).
The additional elements do not show an improvement to the functioning of a computer or to
any other technology, rather the additional elements perform general computing functions and do not
indicate how the particular combination improves any technology or provides a technical solution to a
technical problem. Accordingly, these additional elements, when considered separately and as an
ordered combination, do not integrate the abstract idea into a practical application because they do not
impose any meaningful limits on practicing the abstract idea. Therefore, the dependent claims are
directed to an abstract idea without practical application. (Step 2A – Prong 2: No, the additional
elements are not integrated into a practical application).
As discussed above, the identified additional elements in Dependent Claims 21-34, 36-37, and 45-48, are equivalent to adding the words “apply it” on a generic computer, and/or generally link the use of the judicial exception to a particular technological environment or field of use. Therefore, the claims as a whole do not amount to significantly more than the judicial exception itself.
For the role of a computer in a computer implemented invention to be deemed meaningful in
the context of this analysis, it must involve more than performance of “well-understood, routine, [and]
conventional activities previously known to the industry.” Further, “the mere recitation of a generic
computer cannot transform a patent ineligible abstract idea into a patent-eligible invention.”
The use of a computer or processor to merely automate or implement the abstract idea cannot
provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the
additional limitations alone or in combination improves the functioning of a computer or any other
technology, improves another technology or technical field, or effects a transformation or reduction of a
particular article to a different state or thing. Therefore, the claims are not patent eligible.
The Examiner has therefore determined that no additional element, or combination of
additional claims elements is/are sufficient to ensure the claims amount to significantly more than the
abstract idea identified above (Step 2B: Dependent claims - NO).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 20, 21, 23-25, 29, 31-37, 45, 46, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Torvin et al. (WO 2018/001989 A1) (hereinafter Torvin) in view of Lyndon et al. Solute clearance in CRRT: prescribed dose versus actual delivered dose (Hereinafter Lyndon).
Regarding Claim 20, Torvin teaches the following:
A computer system for specifying settings of a blood treatment apparatus (Pg. 4, lines 17-19 and Pg. 2, lines 11-13: One exemplary extracorporeal blood treatment system may include extracorporeal blood treatment apparatus for use in performing an extracorporeal blood treatment. The exemplary systems and methods may be described as resulting in a unique and user-friendly way to navigate and adjust a plurality of settings and subsettings.), the computer system comprising:
a calculation device (Pg. 4, line 20: a computing apparatus); and
a display device (Pg. 4, line 19: a display apparatus including a graphical user interface) configured or programmed to display (Pg. 1, lines 10-12: A user may use the graphical user interface to, among other things, configure and setup a treatment, monitor and perform a treatment, and perform various post-treatment processes)
a target [renal] dose for a treatment of a patient to be delivered using the blood treatment apparatus (Pg. 10, lines 9-13, Pg. 15, lines 3-6, and Pg. 39, lines 5-10, 23-27: the selected process feature graphical element may include an alphanumeric name identifying the process feature of the selected process feature graphical element and an alphanumeric value depicting the value of a parameter associated with the process feature of the selected process feature graphical element. The system also displays settings cards which may be defined as being each and every settings card that includes settings and/or parameters related to the present treatment cycle including preparation, treatment, and post-treatment portions of the treatment cycle. A user can set a prescription concentration into the system, and can be graphically identified in the setting cards and mini settings cards as being part of the prescription. The examiner interprets the prescription as a target dose for the treatment.); and
a first input interface for changing the target [renal] dose by a user (Pg. 14, lines 4-7, Fig. 5, Pg. 39, lines 23-27, and Pg. 43, lines 5-6 and 11-14: The graphical interface may allow a user to adjust one or more settings (e.g., parameters, values, modes, etc.) with respect to one or more processes (e.g., one or more processes of an extracorporeal blood treatment system, etc.). A user has changed the "Concentrate" from the prescription set concentrate value to "Conc. X," and as such, the prescription graphical element has been changed to a modified prescription graphical element to indicate that the prescription-set concentrate has been changed or modified from the prescription. Dialysate/dialysis fluid bicarbonate concentration, and dialysate/dialysis fluid temperature, each of which may be adjusted by a user. The switch elements include a bicarbonate (HCO3-) profile switch element to initiate or disable a bicarbonate profile process feature), and a second input interface for entering a correction of an acid-base balance of the patient by the user for the treatment of the patient using the blood treatment apparatus (Pg. 1, lines 25-27, Pg. 17, lines 16-21, Pg. 18, lines 4-8, Pg. 43, lines 2-7, and Fig. 9: the input apparatus may allow an operator to interact with a graphical user interface including an operation region containing, or depicting, graphical elements, graphical regions, and graphical areas associated with and representative of (or corresponding to) one or more features or processes of the extracorporeal blood treatment system when used in conjunction with the display apparatus. The graphical user interface may include multiple graphical regions, graphical areas, and graphical elements related to the extracorporeal blood treatment system and for control of the processes during a treatment cycle. Such graphical regions, areas, and elements may include settings cards configured to allow a user to adjust or configure settings associated with the processes. The four bar-type parameter adjustment elements 325 may correspond to and display values with respect to dialysate/dialysis fluid flow rate, dialysate/dialysis fluid sodium concentration, dialysate/dialysis fluid bicarbonate concentration, and dialysate/dialysis fluid temperature, each of which may be adjusted by a user selecting and moving the handle element 324 along the bar element. Patients may undergo extracorporeal blood treatment to add to or to eliminate matter from their blood, to maintain an acid-base balance, and/or to eliminate excess body fluids); and
a first output interface for outputting technical parameter values of the blood treatment apparatus (Pg. 16, lines 4-11: The computing apparatus transmits output to display apparatus, which includes parameters, metrics, variables, values, etc. in the output.),
wherein the calculation device (Pg. 4, line 20: a computing apparatus) is programmed (Pg. 19, lines 1-5: The processing programs or routines may include programs or routines for performing computational mathematics, touchscreen gesture interpretation algorithms, process performance algorithms, process automation algorithms, matrix mathematics, standardization algorithms, comparison algorithms, or any other processing) to:
determine the technical parameter values for the blood treatment apparatus based on the target [renal] dose entered via the first input interface and the correction of the acid-base balance entered via the second input interface (Pg. 29, lines 25-29, Pg. 39, lines 18-27, Pg. 43, lines 3-5, Fig. 5: When user-interactable settings are modified, or adjusted, by a user in a settings card or mini settings card, the computing apparatus of the exemplary extracorporeal blood treatment system may change (e.g., modify, adjust, set, etc.) the user-modified, or adjusted, setting. After a user modifies a prescription-set user-interactable setting, the prescription graphical element may change to a modified prescription graphical element to indicate that the value of the prescription-set setting has been changed or modified. For example, a user has changed the "Concentrate" from the prescription set concentrate value to "Conc. X," and as such, the prescription graphical element 350 has been changed to a modified prescription graphical element 352 to indicate that the prescription-set concentrate has been changed or modified from the prescription. Display values with respect to dialysate/dialysis fluid flow rate, dialysate/dialysis fluid sodium concentration, dialysate/dialysis fluid bicarbonate concentration); and
output the determined technical parameter values for an operation of the blood treatment apparatus, via the first output interface (Pg. 15, lines 26-29, Pg. 16, lines 4-11: The computing apparatus transmits output to display apparatus, which includes parameters, metrics, variables, values, etc. in the output. The extracorporeal blood treatment system may be used to execute, or perform, the exemplary graphical user interface methods and/or processes described herein and may be a machine for the extracorporeal treatment of blood.).
However, Torvin does not explicitly teach the following that is met by Lyndon:
a target renal dose (Abstract and Pg. 2, para. 6-7: Continuous renal replacement therapy (CRRT) dose is expressed as total effluent volume (TEV) per weight and unit time (mL/kg/h). A prescribed clearance calculated as effluent rate over weight)
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the system, as taught by Torvin, with the renal dose, as taught by Lyndon, because the claimed invention is only a combination of these well-known elements which would have performed the same function in combination as each did separately. Torvin already discloses displaying and changing a target dose (i.e., a concentration of a prescription) for use in a blood treatment apparatus. Including a renal dose as a treatment parameter for use in a blood-treatment system, as taught by Lyndon, performs the same function of a target dose used as a setting in a blood treatment apparatus. Therefore, the results would have been predictable to one of ordinary skill in the art (MPEP 2143).
Regarding Claim 21, the combination of Torvin and Lyndon teaches the computer system of claim 20, and Torvin further teaches:
The computer system of claim 20, wherein the first input interface comprises switches, and wherein when actuated, the switches of the first input interface are programmed to decrease or increase a target value for a renal dose as a target treatment parameter (Fig. 5, Pg. 39, lines 23-27, and Pg. 43, lines 5-6 and 11-14: a user has changed the "Concentrate" from the prescription set concentrate value to "Conc. X," and as such, the prescription graphical element has been changed to a modified prescription graphical element to indicate that the prescription-set concentrate has been changed or modified from the prescription. Dialysate/dialysis fluid bicarbonate concentration, and dialysate/dialysis fluid temperature, each of which may be adjusted by a user. The switch elements include a bicarbonate (HCO3-) profile switch element to initiate or disable a bicarbonate profile process feature, which is a key factor in renal dosage).
Regarding Claim 23, the combination of Torvin and Lyndon teaches the computer system of claim 20, and Torvin further teaches:
The computer system of claim 20, wherein the first output interface is or comprises an optical interface or a graphic interface for the user (Pg. 4, line 19: a display apparatus including a graphical user interface).
Regarding Claim 24, the combination of Torvin and Lyndon teaches the computer system of claim 20, and Torvin further teaches:
The computer system of claim 20, wherein the first output interface is or comprises an interface with a control device or with a closed-loop control device of the blood treatment apparatus (Pg. 27, lines 15-20: Exemplary graphical user interfaces, or portions thereof, for use in displaying information related to extracorporeal blood treatments, providing functionality to an operator for use in preparing and performing extracorporeal blood treatments (e.g., controlling performance and/or one or more processes of treatment), and/or configuring or maintaining an extracorporeal blood treatment system)).
Regarding Claim 25, the combination of Torvin and Lyndon teaches the computer system of claim 20, and Torvin further teaches:
The computer system of claim 20, further comprising a second output interface for displaying treatment-relevant patient data to the user within the second output interface via the display device (See Fig. 5 and 8, Pg. 19, lines 6-16, Pg. 31, lines 21-30, and Pg. 33, lines 10-12: Data may include variables, graphics, graphical user interfaces, alarm data, fluid data, flow rates, fluid volumes, notifications, pressures, pressure limits, blood flow, blood flow limits, blood temperature, heuristics, etc. Further, some settings are dependent on the selected treatment mode, and may display certain data based on the treatment modes. The one or more settings provided, or displayed, by each mini settings card may include, e.g., options, values, limits, ranges, modes, profiles, time periods, time intervals, bolus values, volumes, rates, sensor values, etc.).
Regarding Claim 29, the combination of Torvin and Lyndon teaches the computer system of claim 20, and Torvin further teaches:
The computer system of claim 20, wherein the computer system comprises a mobile device, a handheld device, a mobile phone, a smartphone, a tablet, a fixed computer terminal, or a desktop computer (Pg. 20, lines 11-13: The computing apparatus may be, for example, any fixed or mobile computer system (e.g., a controller, a microcontroller, a personal computer, mini computer, etc.)).
Regarding Claim 31, the combination of Torvin and Lyndon teaches the computer system of claim 20, and Torvin further teaches:
The computer system of claim 20, wherein the technical parameter values determined by the calculation device comprise an adjustable setting for a blood pump and an adjustable setting for a dialysis liquid pump (Pg. 16, lines 4-11 and Pg. 23, lines 5-8 and 19-21: The computing apparatus transmits output to display apparatus, which includes parameters, metrics, variables, values, etc. in the output. The system includes on ore more disposable elements including fluid circuits such as dialysis fluid circuits and blood circuits, which is integrated with pumps. The computing system has adjustable settings for the pumps.).
Regarding Claim 32, the combination of Torvin and Lyndon teaches the computer system of claim 20, and Torvin further teaches:
The computer system of claim 20, wherein the computer system comprises or is in signal communication with a control device or a closed-loop control device of the blood treatment apparatus or a part thereof (Pg. 20, lines 11-16: The computing apparatus may be any fixed or mobile computer system (e.g., a controller, a microcontroller, etc.). The exact configuration of the computing apparatus is not limiting, and essentially any device capable of providing suitable computing capabilities and control capabilities (e.g., graphics processing, control of extracorporeal blood treatment apparatus, etc.) may be used.).
Regarding Claim 33 the combination of Torvin and Lyndon teaches the computer system of claim 32, and Torvin further teaches:
The computer system of claim 32, wherein the control device or the closed-loop control device is programmed to control or regulate the blood treatment apparatus (Pg. 20, lines 11-16: The computing apparatus may be any fixed or mobile computer system (e.g., a controller, a microcontroller, etc.). The exact configuration of the computing apparatus is not limiting, and essentially any device capable of providing suitable computing capabilities and control capabilities (e.g., graphics processing, control of extracorporeal blood treatment apparatus, etc.) may be used.), which comprises a blood pump and a dialysis liquid pump, based on the calculated or determined adjustable settings (Pg. 16, lines 4-11 and Pg. 23, lines 5-8 and 19-21: The computing apparatus transmits output to display apparatus, which includes parameters, metrics, variables, values, etc. in the output. The system includes on ore more disposable elements including fluid circuits such as dialysis fluid circuits and blood circuits, which is integrated with pumps. The computing system has adjustable settings for the pumps.), and based on a target treatment parameter changed by the user or a treatment specification entered by the user (Pg. 15, lines 5-7: The graphical interface may allow a user to adjust one or more settings (e.g., parameters, values, modes, etc.) with respect to one or more processes (e.g., one or more processes of an extracorporeal blood treatment system, etc.)).
Regarding Claim 34, the combination of Torvin and Lyndon teaches the computer system of claim 33, and Torvin further teaches:
The computer system of claim 33, wherein the calculated or determined adjustable settings comprise a flow rate for the blood pump and a flow rate for the dialysis liquid pump as technical parameters (Pg. 33, lines 10-12, Pg. 16, lines 4-11 and Pg. 23, lines 5-8 and 19-21: The one or more settings provided, or displayed, by each mini settings card may include, e.g., options, values, limits, ranges, modes, profiles, time periods, time intervals, bolus values, volumes, rates, sensor values, etc. The computing apparatus transmits output to display apparatus, which includes parameters, metrics, variables, values, etc. in the output. The system includes one or more disposable elements including fluid circuits such as dialysis fluid circuits and blood circuits, which is integrated with pumps.).
Regarding Claim 35, Torvin teaches the following:
A system (Pg. 2, line 11: an extracorporeal blood treatment system) comprising:
one or more blood treatment apparatuses, each designed as dialysis apparatus (Pg. 22, lines 7-10 and lines 23-24: The system may include dialysis systems, which is implemented as an extracorporeal blood treatment system, or apparatus,); and
a computer system for specifying settings of a blood treatment apparatus (Pg. 4, lines 17-19 and Pg. 2, lines 11-13: One exemplary extracorporeal blood treatment system may include extracorporeal blood treatment apparatus for use in performing an extracorporeal blood treatment. The exemplary systems and methods may be described as resulting in a unique and user-friendly way to navigate and adjust a plurality of settings and subsettings.), the computer system comprising:
a calculation device (Pg. 4, line 20: a computing apparatus); and
a display device configured or programmed to display (Pg. 4, line 19: a display apparatus including a graphical user interface)
a target [renal] dose for a treatment of a patient to be delivered using the blood treatment apparatus (Pg. 10, lines 9-13, Pg. 15, lines 3-6, and Pg. 39, lines 5-10, 23-27: the selected process feature graphical element may include an alphanumeric name identifying the process feature of the selected process feature graphical element and an alphanumeric value depicting the value of a parameter associated with the process feature of the selected process feature graphical element. The system also displays settings cards which may be defined as being each and every settings card that includes settings and/or parameters related to the present treatment cycle including preparation, treatment, and post-treatment portions of the treatment cycle. A user can set a prescription concentration into the system, and can be graphically identified in the setting cards and mini settings cards as being part of the prescription. The examiner interprets the prescription as a target dose for the treatment.); and
a first input interface for changing the target [renal] dose by a user (Pg. 14, lines 4-7, Fig. 5, Pg. 39, lines 23-27, and Pg. 43, lines 5-6 and 11-14: The graphical interface may allow a user to adjust one or more settings (e.g., parameters, values, modes, etc.) with respect to one or more processes (e.g., one or more processes of an extracorporeal blood treatment system, etc.). A user has changed the "Concentrate" from the prescription set concentrate value to "Conc. X," and as such, the prescription graphical element has been changed to a modified prescription graphical element to indicate that the prescription-set concentrate has been changed or modified from the prescription. Dialysate/dialysis fluid bicarbonate concentration, and dialysate/dialysis fluid temperature, each of which may be adjusted by a user. The switch elements include a bicarbonate (HCO3-) profile switch element to initiate or disable a bicarbonate profile process feature), and a second input interface for entering a correction of an acid-base balance of the patient by the user for the treatment of the patient using the blood treatment apparatus (Pg. 1, lines 25-27, Pg. 17, lines 16-21, Pg. 18, lines 4-8, Pg. 43, lines 2-7, and Fig. 9: the input apparatus may allow an operator to interact with a graphical user interface including an operation region containing, or depicting, graphical elements, graphical regions, and graphical areas associated with and representative of (or corresponding to) one or more features or processes of the extracorporeal blood treatment system when used in conjunction with the display apparatus. The graphical user interface may include multiple graphical regions, graphical areas, and graphical elements related to the extracorporeal blood treatment system and for control of the processes during a treatment cycle. Such graphical regions, areas, and elements may include settings cards configured to allow a user to adjust or configure settings associated with the processes. The four bar-type parameter adjustment elements 325 may correspond to and display values with respect to dialysate/dialysis fluid flow rate, dialysate/dialysis fluid sodium concentration, dialysate/dialysis fluid bicarbonate concentration, and dialysate/dialysis fluid temperature, each of which may be adjusted by a user selecting and moving the handle element 324 along the bar element. Patients may undergo extracorporeal blood treatment to add to or to eliminate matter from their blood, to maintain an acid-base balance, and/or to eliminate excess body fluids); and
a first output interface for outputting technical parameter values of the blood treatment apparatus (Pg. 16, lines 4-11: The computing apparatus transmits output to display apparatus, which includes parameters, metrics, variables, values, etc. in the output.);
wherein the calculation device (Pg. 4, line 20: a computing apparatus) is programmed (Pg. 19, lines 1-5: The processing programs or routines may include programs or routines for performing computational mathematics, touchscreen gesture interpretation algorithms, process performance algorithms, process automation algorithms, matrix mathematics, standardization algorithms, comparison algorithms, or any other processing) to:
determine the technical parameter values for the blood treatment apparatus based on the target [renal] dose entered via the first input interface and the correction of the acid-base balance entered via the second input interface (Pg. 29, lines 25-29, Pg. 39, lines 18-27, Pg. 43, lines 3-5, Fig. 5: When user-interactable settings are modified, or adjusted, by a user in a settings card or mini settings card, the computing apparatus of the exemplary extracorporeal blood treatment system may change (e.g., modify, adjust, set, etc.) the user-modified, or adjusted, setting. After a user modifies a prescription-set user-interactable setting, the prescription graphical element may change to a modified prescription graphical element to indicate that the value of the prescription-set setting has been changed or modified. For example, a user has changed the "Concentrate" from the prescription set concentrate value to "Conc. X," and as such, the prescription graphical element 350 has been changed to a modified prescription graphical element 352 to indicate that the prescription-set concentrate has been changed or modified from the prescription. Display values with respect to dialysate/dialysis fluid flow rate, dialysate/dialysis fluid sodium concentration, dialysate/dialysis fluid bicarbonate concentration); and
output the determined technical parameter values for an operation of the blood treatment apparatus, via the first output interface (Pg. 15, lines 26-29, Pg. 16, lines 4-11: The computing apparatus transmits output to display apparatus, which includes parameters, metrics, variables, values, etc. in the output. The extracorporeal blood treatment system may be used to execute, or perform, the exemplary graphical user interface methods and/or processes described herein and may be a machine for the extracorporeal treatment of blood.);
wherein the one or more blood treatment apparatuses and the computer system are separate from each other (Pg. 21, lines 14-16 and Pg. 27, lines 10-11: any of the described components may be implemented together or separately as discrete but interoperable logic devices. the treatment apparatus may be operatively coupled, or connected, to the computing apparatus).
However, Torvin does not explicitly teach the following that is met by Lyndon:
a target renal dose (Abstract and Pg. 2, para. 6-7: Continuous renal replacement therapy (CRRT) dose is expressed as total effluent volume (TEV) per weight and unit time (mL/kg/h). A prescribed clearance calculated as effluent rate over weight)
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the system, as taught by Torvin, with the renal dose, as taught by Lyndon, because the claimed invention is only a combination of these well-known elements which would have performed the same function in combination as each did separately. Torvin already discloses displaying and changing a target dose (i.e., a concentration of a prescription) for use in a blood treatment apparatus. Including a renal dose as a treatment parameter for use in a blood-treatment system, as taught by Lyndon, performs the same function of a target dose used as a setting in a blood treatment apparatus. Therefore, the results would have been predictable to one of ordinary skill in the art (MPEP 2143).
Regarding Claim 36, the combination of Torvin and Lyndon teaches the system of claim 35, and Torvin further teaches:
The system of claim 35, wherein the blood treatment apparatus includes a hemodialysis apparatus, a hemofiltration apparatus, a hemodiafiltration apparatus, an apparatus for acute, chronic renal replacement therapy, or an apparatus for continuous renal replacement therapy (CRRT) (Pg. 22, lines 7-22, Pg. 24, lines 4-5, and Fig. 2: The systems/blood treatment units may include dialysis systems such as hemodialysis, hemofiltration, hemodiafiltration, hemoperfusion, liver dialysis, continuous renal replacement therapy (CRRT), etc.).
Regarding Claim 37, the combination of Torvin and Lyndon teaches the system of claim 36, and Torvin further teaches:
The system of claim 36, further comprising a digital storage medium having electronically readable control instructions stored therein that when executed on the computer system, causes programming of the calculation device and the display device (Pg. 20, lines 17-24: a digital file may be any medium (e.g., volatile or nonvolatile memory, a CD-ROM, a punch card, magnetic recordable tape, etc.) containing digital bits (e.g., encoded in binary, trinary, etc.) that may be readable and/or writeable by computing apparatus. Additionally, a file in user-readable format may be any representation of data (e.g., ASCII text, binary numbers, hexadecimal numbers, decimal numbers, graphically, etc.) presentable on any medium (e.g., paper, a display, etc.) readable and/or understandable by an operator.).
Regarding Claim 45, the combination of Torvin and Lyndon teaches the computer system of claim 20, and Lyndon further teaches:
The computer system of claim 20, wherein the renal dose comprises a quotient of effluent flow or filtrate flow over patient weight (Abstract and Pg. 2, para. 6-7: Continuous renal replacement therapy (CRRT) dose is expressed as total effluent volume (TEV) per weight and unit time (mL/kg/h). A prescribed clearance calculated as effluent rate over weight).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the system, as taught by Torvin, with the renal dose formula, as taught by Lyndon, because the claimed invention is only a combination of these well-known elements which would have performed the same function in combination as each did separately. Torvin already discloses displaying and changing a target dose (i.e., a concentration of a prescription) for use in a blood treatment apparatus. Including a renal dose as a treatment parameter for use in a blood-treatment system, as taught by Lyndon, performs the same function of a target dose used as a setting in a blood treatment apparatus. Therefore, the results would have been predictable to one of ordinary skill in the art (MPEP 2143).
Regarding Claim 46, the combination of Torvin and Lyndon teaches the computer system of claim 45, and Lyndon further discloses:
The computer system of claim 45, wherein the effluent flow is determined by taking into account at least one of: dialysate flow, dialysis liquid flow, substitute fluid flow, calcium flow, citrate flow, and net ultrafiltration (Abstract and Pg. 2, para. 6-7: Continuous renal replacement therapy (CRRT) dose is expressed as total effluent volume (TEV) per weight and unit time (mL/kg/h). A prescribed clearance calculated as effluent rate over weight. The prescribed clearance incorporates prefilter replacement fluid flow rate, dialysate flow rate, and fluid removal rate.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the system, as taught by Torvin, with the renal dose including dialysate flow, as taught by Lyndon, because the claimed invention is only a combination of these well-known elements which would have performed the same function in combination as each did separately. Torvin already discloses displaying and changing a target dose (i.e., a concentration of a prescription) for use in a blood treatment apparatus. Including a renal dose as a treatment parameter for use in a blood-treatment system, as taught by Lyndon, performs the same function of a target dose used as a setting in a blood treatment apparatus. Therefore, the results would have been predictable to one of ordinary skill in the art (MPEP 2143).
Regarding Claim 48, the combination of Torvin and Lyndon teaches the computer system of claim 45, and Lyndon further discloses:
The computer system of claim 26, wherein the treatment-relevant patient data comprises a desired citrate-calcium anticoagulation (Pg. 2, para. 3 and Table 1: Table of patient characteristics including citrate anticoagulation. Regional citrate or no anticoagulation was used according to the consulting nephrologist’s clinical decision, with regional citrate anticoagulation employed ~95% of the time and no anticoagulation in the remainder).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the system, as taught by Torvin, with the patient data including a desired citrate-calcium anticoagulation, as taught by Lyndon, because the claimed invention is only a combination of these well-known elements which would have performed the same function in combination as each did separately. Torvin already discloses treatment relevant patient parameters. Including anticoagulation as a treatment parameter for use in a blood-treatment system, as taught by Lyndon, performs the same function of providing treatment-relevant patient data. Therefore, the results would have been predictable to one of ordinary skill in the art (MPEP 2143).
Claims 22, 26-28, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Torvin et al. (WO 2018/001989 A1) (hereinafter Torvin) in view of Lyndon et al. Solute clearance in CRRT: prescribed dose versus actual delivered dose (Hereinafter Lyndon), in further view of Mazak et al. (CN 108404238 A) (Hereinafter Mazak).
Regarding Claim 22, the combination of Torvin and Lyndon teaches the computer system according to claim 20, however, does not teach the following that is met by Mazak:
The computer system of claim 20, wherein the second input interface is programmed to initiate an acid/base correction as an input treatment specification when actuated (Pg. 14, para. 6, Pg. 15, para. 3: Controller, which includes an input interface, can manage patient acid-alkali state to added to the dialysate by controlling alkali concentrate and cation concentrate. Patient parameters used by the system may include any one or more of the following: a patient before dialysis bicarbonate content, urea content, patient before dialysis patient before dialysis patient weight, acid generator and patient bicarbonate consumption rate).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the computer system for blood treatment, as taught by Torvin, with the blood treatment system including acid/base correction functions, as taught by Mazak, because it allows for a more accurate flow rate for controlling the dialysis content within a predetermined target range (See Mazak Pg. 23, para. 4).
Regarding Claim 26, the combination of Torvin and Lyndon teaches the computer system according to claim 20, however, does not teach the following that is met by Mazak:
The computer system of claim 20, further comprising a third output interface, programmed or configured to display to the user a graphic for acid-base correction within the third output interface (Pg. 15, para. 1 and Pg. 17, para. 3-4: the input/output interface may also have an output interface to bicarbonate addition rate or characteristic curve of the output. curve (d) display or delivering bicarbonate concentrate by linear interpolation, so as to change the speed by nonlinear manner of bicarbonate total mass of the target.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the computer system for blood treatment, as taught by Torvin, with the blood treatment system including acid/base correction graphics, as taught by Mazak, because it visualizes the flow rate required for the acid/base correction and allows for monitoring of the flow and time period to better fit the patient (See Mazak Pg. 17, para. 3-5).
Regarding Claim 27, the combination of Torvin, Lyndon, and Mazak teaches the computer system according to claim 26, and Mazak further discloses the following:
The computer system of claim 26, wherein the graphic comprises curves with combinations of adjustable settings (Pg. 15, para. 1 and Pg. 17, para. 3-4: the input/output interface may also have an output interface to bicarbonate addition rate or characteristic curve of the output. curve (d) display or delivering bicarbonate concentrate by linear interpolation, so as to change the speed by nonlinear manner of bicarbonate total mass of the target.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the computer system for blood treatment, as taught by Torvin, with the blood treatment system including acid/base correction graphics, as taught by Mazak, because it visualizes the flow rate required for the acid/base correction and allows for monitoring of the flow and time period to better fit the patient (See Mazak Pg. 17, para. 3-5).
Regarding Claim 28, the combination of Torvin, Lyndon, and Mazak teaches the computer system according to claim 26, and Torvin further discloses the following:
The computer system of claim 27, wherein the adjustable settings comprise selectable combinations of a flow rate for a blood pump and a flow rate for a dialysis liquid pump (Torvin Pg. 40, lines 23-24, Pg. 43, lines 3-4: Further, portions of the blood flow process feature graphical element may be used to adjust the blood flow rate of a treatment. The parameter adjustment elements also may correspond with dialysate/dialysis fluid flow rate.)
Regarding Claim 47, the combination of Torvin and Lyndon teaches the computer system of claim 20, however, the combination does not teach the following that is met by Mazak:
The computer system of claim 20, wherein the output technical parameter comprises an expected bicarbonate concentration at an end of the treatment of the patient (Pg. 3, para. 8, Pg. 6, para. 13: the processor can be iterative algorithm based on user-specified patient after dialysis bicarbonate content to set dialysate bicarbonate prescription or a characteristic curve. The algorithm is used to produce output).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the computer system for blood treatment, as taught by Torvin, with the blood treatment system including expected bicarbonate concentration, as taught by Mazak, because it allows for a more accurate flow rate for controlling the dialysis content within a predetermined target range (See Mazak Pg. 23, para. 4).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Torvin et al. (WO 2018/001989 A1) (hereinafter Torvin) in view of Lyndon et al. Solute clearance in CRRT: prescribed dose versus actual delivered dose (Hereinafter Lyndon), in further view of Mazak et al. (CN 108404238 A) (Hereinafter Mazak), in further view of O’Mahony et al. (WO 2016/089741 A1) (Hereinafter O’Mahony).
Regarding Claim 30, the combination of Torvin and Lyndon teaches the computer system according to claim 29, however, Torvin and Lyndon do not teach the following that is met by O’Mahony:
The computer system of claim 29, wherein the computer system is in an intensive care unit and/or a central monitoring room, or comprises an application suitable for an intensive care unit and/or central monitoring purpose (Pg. 10, lines 20-23: The systems and/or methods may provide graphical user interfaces for an extracorporeal blood treatment system or for any other medical treatment system (e.g., intensive care unit systems).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the teachings of Torvin and Mazak with the blood treatment device including use in an intensive care unit as taught by O’Mahony because it will provide efficiency, cost benefits, and simplicity in the intensive care unit, or any other unit that may benefit from the device (See Pg. 8, lines 24-25).
Response to Arguments
Applicant’s arguments, see Pg. 7 of applicant’s remarks, filed 03/16/2026, with respect to the rejection(s) of claim(s) 20, 21, 23-25, 29, and 31-43 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art Lyndon et al. (Hereinafter Lyndon). Applicant argues Torvin fails to describe or render obvious “a display device configured or programmed to display a target renal dose for a treatment of a patient to be delivered using the blood treatment apparatus,” “a first input interface for changing the target renal dose by a user, and a second input interface for entering a correction of an acid-base balance of the patient by the user for the treatment of the patient using the blood treatment apparatus," and "a first output interface for outputting technical parameter values of the blood treatment apparatus," and a calculation device programmed to "determine the technical parameter values for the blood treatment apparatus based on the target renal dose entered via the first input interface and the correction of the acid-base balance entered via the second input interface." The Examiner agrees Torvin does not explicitly teach a target renal dose, however, Lyndon does disclose a renal dose as calculated using a quotient of effluent flow over patient weight in a similar treatment process to the claimed invention (See Lyndon Abstract and Pg. 2, para. 6-7). However, examiner disagrees that Torvin does not disclose each and every other limitation as listed above in the independent claims. Torvin does disclose: “a display device configured or programmed to display a target [renal] dose for a treatment of a patient to be delivered using the blood treatment apparatus,” (See Torvin Pg. 10, lines 9-13, Pg 15, lines 3-6, and Pg. 39, lines 5-10 and 23-27); “a first input interface for changing the target [renal] dose by a user, and a second input interface for entering a correction of an acid-base balance of the patient by the user for the treatment of the patient using the blood treatment apparatus," (See Torvin Pg. 14, lines 4-7, Fig. 5, Pg. 39, lines 23-27, and Pg. 43, lines 5-6 and 11-14) and (See Torvin Pg. 1, lines 25-27, Pg. 17, lines 16-21, Pg. 18, lines 4-8, Pg. 43, lines 2-7, and Fig. 9); and "a first output interface for outputting technical parameter values of the blood treatment apparatus," (See Torvin Pg. 16, lines 4-11); and a calculation device programmed to "determine the technical parameter values for the blood treatment apparatus based on the target [renal] dose entered via the first input interface and the correction of the acid-base balance entered via the second input interface." (See Torvin Pg. 29, lines 25-29, Pg. 39, lines 18-27, Pg. 43, lines 3-5, Fig. 5).
Regarding Claims 22 and 26-28, applicant argues Torvin fails to describe or render obvious all features of independent claims 25 and 35, however, as discussed above, Torvin in view of the newly found prior art Lyndon does disclose the limitations of the independent claims, and Mazak and O’Mahony cures the deficiencies of Torvin and Lyndon.
Conclusion
The relevant art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Moll et al. (EP 1936524 B1) discloses a blood treatment device which comprises a control device for controlling functional processes and a user interface having a screen and input means.
Bluemler et al. (US 20090037216) discloses a medical treatment system, specifically for dialysis, which provides input to the medical treatment device for controlling the related processes of the device (feed rates of the blood and dialyzing fluid pump, ultrafiltration rate, etc.).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXIS K VAN DUZER whose telephone number is (571)270-5832. The examiner can normally be reached Monday thru Thursday 8-5 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.K.V./Examiner, Art Unit 3682
/EVANGELINE BARR/Primary Examiner, Art Unit 3682
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