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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20 and 35 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the limitation "a pre-set target treatment parameter" in line 5, and “changing the pre-set value of the target treatment parameter” in lines 7-8. It is unclear whether the pre-set value in line 7 is the same as “a pre-set target treatment parameter” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation "a pre-set target treatment parameter" in line 7, and “changing the pre-set value of the target treatment parameter” in lines 9-10. It is unclear whether the pre-set value in line 9 is the same as “a pre-set target treatment parameter” in line 7. 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 38-44 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:
Claim 38 is drawn to a method (i.e., process), which is within the four statutory categories. (Step 1 – Yes, the claim falls into one of the statutory categories).
Step 2A analysis – Prong One:
Claim 38 recites:
A method for preparing a treatment session of a patient, which is to be carried out using a medical treatment apparatus, the method comprising:
receiving a changing of a pre-set value of a target treatment parameter of the treatment session by actuating, by a user, a first input interface of a display device, and/or an inputting of a treatment specification for the treatment session by actuating a second input interface; and
displaying or outputting adjustable settings for a blood pump and a dialysis liquid pump calculated or determined by a calculation device based on a change in the pre-set value of the target treatment parameter or based on the inputting of the treatment specification, and/or outputting a treatment-relevant patient parameter.
The series of steps as recited above 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 method is that of a person gathering treatment parameter information to treat a patient, which encompasses a person interacting with another individual including following rules or instructions. Accordingly, the claim recites an abstract idea of managing interactions between people.
Step 2A analysis – Prong 2:
This judicial exception is not integrated into a practical application. Specifically, independent claim 38 recites the following additional elements beyond the abstract idea: a medical treatment apparatus, a first input interface, a display device, a second input interface, a blood pump, a dialysis liquid pump, and a calculation device. These limitations 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 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 first and/or the second input interface can each be or encompass a correspondingly designed touch screen, a rotary switch, a slider, a keyboard or the like (See Applicant’s specification Pg. 9, lines 15-20).
The limitations “receiving a changing of a pre-set value of a target treatment parameter”, “outputting adjustable settings” and “outputting a treatment-relevant patient parameter” are mere data gathering and output recited at a high level of generality, and thus are 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, Claim 38 is 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 claim 38 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.
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 for preparing a treatment session amount to no more than using computer related devices to implement the abstract idea.
Additional elements of “receiving a changing of a pre-set value of a target treatment parameter”, “outputting adjustable settings”, and “outputting a treatment-relevant patient parameter” were 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,
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 39-44 are directed towards elements used to describe the inputting and outputting steps, as well as the control functions of the method. These elements describe 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.
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.
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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 20-21, 23-25, 29, and 31-43 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Torvin et al. (WO 2018/001989 A1) (hereinafter Torvin).
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
a pre-set target treatment parameter for a treatment of a patient to be delivered using the blood treatment apparatus (Pg. 10, lines 9-13 and Pg. 15, lines 3-6: 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.), and
a first input interface for changing the pre-set value of the target treatment parameter by a user, and/or a second input interface for entering a treatment specification by the user for the treatment of the patient using the blood treatment apparatus (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.)), 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 technical parameter values for the blood treatment apparatus based on the changed target treatment parameter value entered via the first input interface and/or the treatment specification entered via the second input interface (Pg. 29, lines 25-29: 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.), and
output the determined technical parameter values for an operation of the blood treatment apparatus, via the first output interface (Pg. 16, lines 4-11: The computing apparatus transmits output to display apparatus, which includes parameters, metrics, variables, values, etc. in the output.).
Regarding Claim 21, Torvin teaches the computer system of claim 20, and further teaches:
The computer system according to 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, Torvin teaches the computer system of claim 20, and further teaches:
The computer system according to 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, Torvin teaches the computer system of claim 20, and further teaches:
The computer system according to 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, Torvin teaches the computer system of claim 20, and further teaches:
The computer system according to 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, Torvin teaches the computer system of claim 20, and further teaches:
The computer system according to 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, Torvin teaches the computer system of claim 20, and further teaches:
The computer system according to 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, Torvin teaches the computer system of claim 20, and further teaches:
The computer system according to 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, Torvin teaches the computer system of claim 32, and further teaches:
The computer system according to 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, Torvin teaches the computer system of claim 32, and further teaches:
The computer system according to 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 pre-set target treatment parameter for a treatment of a patient to be delivered using the blood treatment apparatus (Pg. 10, lines 9-13 and Pg. 15, lines 3-6: 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.), and
a first input interface for changing the pre-set value of the target treatment parameter by a user, and/or a second input interface for entering a treatment specification by the user for the treatment of the patient using the blood treatment apparatus (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.)), 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 technical parameter values for the blood treatment apparatus based on the changed target treatment parameter value entered via the first input interface and/or the treatment specification entered via the second input interface (Pg. 29, lines 25-29: 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.), and
output the determined technical parameter values for an operation of the blood treatment apparatus, via the first output interface (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 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).
Regarding Claim 36, Torvin teaches the system of claim 35, and further teaches:
The system according to 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, Torvin teaches the system of claim 36, and 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 38, Torvin teaches the following:
A method for preparing a treatment session of a patient, which is to be carried out using a medical treatment apparatus (Pg. 27, lines 16-20: 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), the method comprising:
receiving a changing of a pre-set value of a target treatment parameter of the treatment session by actuating, by a user, a first input interface of a display device, and/or an inputting of a treatment specification for the treatment session by actuating a second input interface (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.)); and
displaying or outputting adjustable settings for a blood pump and a dialysis liquid pump calculated or determined by a calculation device based on a change in the pre-set value of the target treatment parameter or based on the inputting of the treatment specification, and/or outputting a treatment-relevant patient parameter (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 39, Torvin teaches the method of claim 38, and further teaches:
The method of claim 38, wherein displaying or outputting the adjustable settings comprises displaying or outputting the adjustable settings via the first output interface of the display device (Pg. 16, lines 4-11 and Pg. 29, lines 15-16: The computing apparatus transmits output to display apparatus, which includes parameters, metrics, variables, values, etc. in the output. The settings cards and the plurality of mini settings cards may be displayed).
Regarding Claim 40, Torvin teaches the method of claim 38, and further teaches:
The method of claim 38, wherein outputting the treatment-relevant patient parameter comprises outputting the treatment-relevant patient parameter via a second output interface or a third output interface (See Fig. 5 and Fig. 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 41, Torvin teaches the method of claim 38, and further teaches:
The method of claim 38, further comprising receiving an input from the user indicating pressing of buttons on the display device to confirm or reject the displayed changes (Pg. 37, lines 12-18 and Pg. 38, lines 10-15: a user may select one of the user-interactable settings to change the selected setting, the settings including elements such as an on/off switch for confirmation of the displayed settings).
Regarding Claim 42, Torvin teaches the method of claim 38, and further teaches:
The method of claim 38, further comprising transmitting to a control device or closed-loop control device of the blood treatment apparatus the calculated or determined adjustable setting for the blood pump and the calculated or determined adjustable setting for the dialysis liquid pump of a confirmed change (Pg. 16, lines 4-11, Pg. 23, lines 5-8 and 19-21, and Pg. 27, lines 15-20: 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. 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 43, Torvin teaches the method of claim 38, and further teaches:
The method of claim 38, further comprising controlling or regulating the blood treatment apparatus via a control device or closed-loop control device (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.) using the calculated or determined adjustable setting for the blood pump or for the 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.) based on a value change of the target treatment parameter initiated by the user or by the entering of a treatment specification (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.)).
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 22 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Torvin et al. (WO 2018/001989 A1) (hereinafter Torvin) in view of Mazak et al. (CN 108404238 A) (Hereinafter Mazak).
Regarding Claim 22, Torvin teaches the computer system according to claim 20, however, Torvin does not teach the following that is met by Mazak:
The computer system according to 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 and 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, Torvin teaches the computer system according to claim 20, however, Torvin does not teach the following that is met by Mazak:
The computer system according to 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 and Mazak teaches the computer system according to claim 26, and Mazak further discloses the following:
The computer system according to 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 and Mazak teaches the computer system according to claim 26, and Torvin further discloses the following:
The computer system according to 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.)
Claims 30 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Torvin et al. (WO 2018/001989 A1) (hereinafter Torvin) in 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, Torvin teaches the computer system according to claim 29, however, Torvin and Mazak do not teach the following that is met by O’Mahony:
The computer system according to 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).
Regarding Claim 44, Torvin teaches the method of claim 43, however, Torvin and Mazak do not teach the following that is met by O’Mahony:
The method of claim 43, wherein controlling or regulating the blood treatment apparatus is performed automatically (Pg. 24, lines 24-26: The system may automatically determine the configuration process and the changing of the configuration of the apparatus).
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 automatically regulating the apparatus 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).
Relevant Prior Art of Record Not Currently Being Applied
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.).
Conclusion
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/A.K.V./Examiner, Art Unit 3681
/MARC Q JIMENEZ/Supervisory Patent Examiner, Art Unit 3681
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