DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-25 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claim 24 is directed to a method (i.e., a process), claims 1-23 are directed to a system (i.e., a machine), and claim 25 is directed to a computer program product comprising at least one non-transitory computer-readable medium (i.e., a machine). Accordingly, claims 1-25 are all within at least one of the four statutory categories.
Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts.
Representative independent claim 24 includes limitations that recite at least one abstract idea. Specifically, independent claim 24 recites:
24. A method comprising: providing, with at least one processor, a user interface; receiving, with the at least one processor, from at least one of an injection system including an injector configured to deliver fluid to a patient and an imaging system including a scanner configured to scan the patient, procedure data associated with a procedure for the patient, wherein at least one of the injection system and the imaging system includes at least one further user interface different than the user interface, and wherein the injection system is in communication with the imaging system; providing, with the at least one processor, via the user interface, a display, wherein the display is generated based on the procedure data; receiving, with the at least one processor, via the user interface, user input; and controlling, with the at least one processor, based on the user input, an operation of at least one of the injection system and the imaging system.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity” because to deliver fluid to a patient and to scan the patient; receiving procedure data associated with a procedure for the patient; receiving user input; and controlling, based on the user input, an operation of at least one of the injection system and the imaging system amount to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions), at the currently claimed high level of generality.
Accordingly, the claim recites at least one abstract idea.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 24, and 25, as drafted, is a process that, under its broadest reasonable interpretation, covers certain methods of organizing human activity but for the recitation of generic computer components. That is, other than reciting at least one processor, a user interface, at least one further user interface, a display, and a computer program product comprising at least one non-transitory computer-readable medium to perform the limitations, nothing in the claim elements precludes the steps from practically being certain methods of organizing human activity. If a claim limitation, under its broadest reasonable interpretation, covers certain methods of organizing human activity but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the at least one processor, user interface, at least one further user interface, display, and computer program product comprising at least one non-transitory computer-readable medium are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of providing data, receiving data, displaying data, and controlling operation) such that it amounts no more than mere instructions to apply the exception using generic computer components. The claims recite the additional limitations of receiving data from at least one of an injection system including an injector configured to deliver fluid to a patient and an imaging system including a scanner configured to scan the patient. Such steps would be routinely used by those of ordinary skill in the art and are well-understood, routine and conventional activities specified at a high level of generality. It is mere data gathering in conjunction with the abstract idea and therefore adds insignificant extrasolution activity to the judicial exception. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05). Their collective functions merely provide conventional computer implementation.
Claims 2-23 are ultimately dependent from Claim(s) 1 and include all the limitations of Claim(s) 1. Therefore, claim(s) 2-23 recite the same abstract idea. Claims 2-23 describe further limitations regarding types of procedure data, types of images, types of information received, types of sensors and sensor data, generating an alert, retrieving information, types of user input, including a prompt to confirm the operation, types of operations, at least one of modifying and aborting the operation, processing the one or more images to select a subset of the one or more images, wherein the display is generated based on the selected subset of the one or more images, types of scanners, locations, types of user input, types of alerts, receiving authentication data, restricting one or more operations, and determining/selecting authorization level. These are all just further describing the abstract idea recited in claim 1, without adding significantly more.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, independent claims 1, 24, and 25 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations directed to the at least one processor receiving data from at least one of an injection system and an imaging system and the injection system is in communication with the imaging system, all of which the Examiner submits merely add insignificant extra-solution activity to the abstract idea or are claimed in a merely generic manner (e.g., at a high level of generality), the Examiner further submits that such steps are not unconventional as they merely consist of receiving and transmitting data over a network. See MPEP 2106.05(d)(II).
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-25 are ineligible under 35 USC §101.
Claim Objections
Claim 5 is objected to because of the following informalities: change “a patient” to “the patient” in the last step of the claim. Appropriate correction is required.
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.
Claim(s) 1-7, 11-20, 24, and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams, JR. et al. (US 2007/0083152 A1).
(A) Referring to claim 1, Williams discloses A system, comprising (para. 12 of Williams; the invention may comprise a fluid injection system that may include a fluid injection device, a computer that may be operably connected to the fluid injection device.):
a user interface (para. 12 of Williams; the computer may have a computer readable code thereon for enabling a processor to control the fluid injector device and to permit a user to graphically input fluid injection parameters for one or more fluids into the computer using a graphical user interface.); and
at least one processor programmed and/or configured to (para. 12 of Williams; the computer may have a computer readable code thereon for enabling a processor to control the fluid injector device and to permit a user to graphically input fluid injection parameters for one or more fluids into the computer using a graphical user interface.):
receive, from at least one of an injection system including an injector configured to deliver fluid to a patient and an imaging system including a scanner configured to scan the patient, procedure data associated with a procedure for the patient, wherein at least one of the injection system and the imaging system includes at least one further user interface different than the user interface, and wherein the injection system is in communication with the imaging system (para. 53 & 80 of Williams; the graphical visualization tool may be used in conjunction with an injection system for administering a fluid to a subject. In one embodiment, the fluid injection system may include a fluid injection device that can be used to administer an effective dosage of a fluid, such as contrast medium, and a control interface that is operatively connected to the fluid injection device. The injection system may have one or more control interfaces. The control interface may send and receive data to and from the fluid injection device. In one alternative embodiment, a graphical user interface according to the present invention may be running on a control interface that may be operably connected to a fluid injection device. The injection system may be used in conjunction with an imaging system. The imaging system may be comprised of an imaging control console, an imaging device or equipment that can be used to monitor and display the contrast medium within a patient or subject, acquire internal images of a patient or subject, and to provide other diagnostic data to a control console or storage media. The imaging system may have an imaging interface that may be operatively connected to the imaging equipment. The graphical visualization tool may use the input provided by the external device to generate an injection function and/or injection protocol. The external device 1200 may include one or more input sensors or monitoring devices that may collect sensor information from one or more medical devices (e.g., a patient monitor, CT scanner, blood analyzer or bio-impedance device). Data from the external device may be communicated via connection 1210 to the control console for the fluid injection device.);
provide, via the user interface, a display, wherein the display is generated based on the procedure data (para. 53, 80, and 81 of Williams; the injection system may be used in conjunction with an imaging system. The imaging system may be comprised of an imaging control console, an imaging device or equipment that can be used to monitor and display the contrast medium within a patient or subject, acquire internal images of a patient or subject, and to provide other diagnostic data to a control console or storage media. The graphical visualization tool may create and display fluid injection control graphic 1230 (injection function) based on the data provided by the external device.);
receive, via the user interface, user input (para. 86 of Williams; With reference to FIG. 15, an exemplary graphical user interface 1500 for a fluid injection device is illustrated. As shown, graphical user interface 1500 may includes a graphical visualization tool 1502 for graphically inputting injection parameters into the fluid injection device. The graphical visualization tool 1502 that may permit a user to use a graphical user interface to input injection parameters into a fluid injection device to control the injection behavior of the fluid injection device. The graphical visualization tool may include a display means for displaying a graph and an input device for inputting one or more desired injection parameters into the graph.); and
control, based on the user input, an operation of at least one of the injection system and the imaging system (para. 86 of Williams; The graphical visualization tool 1502 that may permit a user to use a graphical user interface to input injection parameters into a fluid injection device to control the injection behavior of the fluid injection device.).
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other element is also disclosed.
(B) Referring to claim 2, Williams discloses wherein the procedure data includes at least one of the following (para. 53 of Williams):
at least one image captured by a camera associated with at least one of the injection system and the imaging system;
information received via the at least one further user interface (para. 53 of Williams);
sensor data captured by at least one sensor associated with at least one of the injection system and the imaging system;
or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(C) Referring to claim 3, Williams discloses wherein the procedure data includes the at least one image, and wherein the at least one image includes at least one of the following (para. 53 of Williams):
one or more images of the patient (para. 53 of Williams);
one or more images of an operator of at least one of the injection system and the imaging system;
one or more images of an IV access location on the patient;
one or more images of the injector;
one or more images of the scanner;
or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(D) Referring to claim 4, Williams discloses wherein the procedure data includes the information received via the at least one further user interface, and wherein the information received via the at least one further user interface includes at least one of the following (para. 53 of Williams):
an imaging prescription; a pre-procedure checklist; an indication of patient consent; an adverse reaction checklist; at least one of a selection, a programming, and a modification of an injection protocol (para. 85 of Williams); at least one of a selection, a programming, and a modification of an imaging protocol; a request to initiate the operation; a request to end the procedure; information captured at an end of the procedure; information for a secondary capture; information for a billing procedure; or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(E) Referring to claim 5, Williams discloses wherein the procedure data includes the sensor data captured by the at least one sensor associated with the at least one of the injection system and the imaging system, and wherein the at least one sensor includes at least one of the following sensors (para. 80 of Williams): a flow sensor; a temperature sensor; an accelerometer; a vibration sensor; a strain gauge; a motor current sensor; an optical sensor; the scanner (para. 80 of Williams); or any combination thereof, and
wherein the procedure data includes at least one of the following parameters determined based on the sensor data (para. 53 & 80 of Williams): a movement associated with the patient; a sound associated with the patient; a communication state between the scanner and the injector; one or more images of the patient captured by the scanner (para. 53 & 80 of Williams); an amount of noise associated with the one or more image of the patient captured by scanner; an enhancement or saturation level associated with the one or more images of the patient captured by scanner; a flow rate during one or more fluid injections by the injector; a duration of the one or more fluid injections by the injector; a volume pumped and/or delivered during the one or more injections by the injector; an achieved pressure of the one or more injections by the injector; an imaging signal from a region of interest at a time or over a length of time; an ECG gating sequence; a pulse of a patient; or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(F) Referring to claim 6, Williams discloses wherein the sensor data is captured by the at least one sensor during at least one of the following (para. 53 & 80 of Williams): a setup of at least one of the injector and the scanner; an arming of the injector; a period of time when the injector is armed; a keep vein open (KVO) operation by the injector; a delivery of a test bolus and/or a tracking bolus to the patient by the injector; a delivery of a contrast media to the patient by the injector (para. 3, 53, and 54 of Williams); a period of time after delivery of the contrast media to the patient; a delivery of a saline flush to the patient by the injector; a period of time after delivery of the saline flush to the patient; a scanning of the patient by the scanner; or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(G) Referring to claim 7, Williams discloses wherein the display includes an alert, and wherein at least one of the injection system and the imaging system generates the alert based on at least one of the following: the sensor data; the user input (Fig. 15 and para. 86 of Williams); patient data associated with the patient; or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(H) Referring to claim 11, Williams discloses wherein the user input includes at least one of a selection, a programming, and a modification of at least one of an injection protocol and an imaging protocol (para. 85 of Williams).
(I) Referring to claim 12, Williams discloses wherein the display includes a prompt to confirm the operation of the at least one of the injection system and the imaging system, and wherein the at least one processor is programmed and/or configured to control the operation of the at least one of the injection system and the imaging system by: controlling the at least one of the injection system and the imaging system such that the at least one of the injection system and the imaging system is prevented from performing the operation until a response to the prompt is received via the user interface (para. 33, 4, and 55-57 of Williams).
(J) Referring to claim 13, Williams discloses wherein the operation includes at least one of the following operations: changing a display of the at least one further user interface; receiving further user input via the at least one further user interface, setting an injection protocol at the injector (para. 53 & 55-57 of Williams); setting an imaging protocol at the scanner; initiating a loading process with the injector; initiating a data capture with the injector; arming the injector; initiating a keep vein open (KVO) procedure with the injector; initiating a saline test injection with the injector; initiating a drug injection with the injector; initiating a contrast media test injection with the injector; initiating a contrast media injection with the injector; initiating a scan with the scanner; aborting the saline test injection with the injector; aborting the contrast media test injection with the injector; aborting the contrast media injection with the injector; initiating a saline flush injection with the injector; aborting the saline flush injection with the injector; aborting the scan with the scanner; ending the procedure for the patient; or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(K) Referring to claim 14, Williams discloses wherein the operation includes at least one of delivering fluid to the patient with the injector and scanning the patient with the scanner, and wherein the at least one processor is programmed and/or configured to control the operation of the at least one of the injection system and the imaging system by: controlling the at least one of the injection system and the imaging system such that the at least one of the injection system and the imaging system at least one of modifies and aborts the operation (para. 5, 36, and 65 of Williams).
(L) Referring to claim 15, Williams discloses wherein the procedure data includes one or more images of the patient captured by the scanner, and wherein the at least one processor is programmed and/or configured to process the one or more images to select a subset of the one or more images, and wherein the display is generated based on the selected subset of the one or more images (para. 53 & 54 of Williams).
(M) Referring to claim 16, Williams discloses wherein the scanner includes at least one of the following: a magnetic resonance (MR) scanner; a computed tomography (CT) scanner (para. 54 & 80 of Williams); a positron emission tomography/computed tomography (PET/CT) scanner; a positron emission tomography/magnetic resonance (PET/MR) scanner; a single- photon emission computerized tomography (SPECT) scanner; an ultrasound system, an infrared imaging system, a photo-acoustic imaging system, or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(N) Referring to claim 17, Williams discloses wherein the injection system, the imaging system, and the at least one further user interface are located at a procedure location, and wherein the user interface is located at a support location different than the procedure location (para. 85 of Williams).
(O) Referring to claim 18, Williams discloses wherein the procedure location includes at least one of the following locations: a hospital, an imaging center (Fig. 14 and para. 85 of Williams), a mobile imaging trailer, a vehicle, or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(P) Referring to claim 19, Williams discloses wherein the user input includes at least one of the following: a response to a prompt to confirm the operation of the at least one of the injection system and the imaging system; an instruction to the at least one of the injection system and the imaging system to initiate, modify, and/or perform the operation of the at least one of the injection system and the imaging system (para. 59 & 86 of Williams); or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(Q) Referring to claim 20, Williams discloses wherein the display includes at least one alert, and wherein the at least one alert includes at least one of the following: an indication that the procedure is complete; an indication of whether the procedure executed correctly; an indication that an operator appears hesitant during programming; a real-time display of measured parameters associated with a fluid injection (Fig. 15, para. 38, 66, 83, 84, and 86 of Williams); an indication of a detected adverse event; an indication of a quality of one or more images of the patient captured by the scanner; or any combination thereof.
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(R) Referring to claim 24, Williams discloses A method comprising (para. 14 & 15 of Williams):
providing, with at least one processor, a user interface (para. 12 of Williams; the computer may have a computer readable code thereon for enabling a processor to control the fluid injector device and to permit a user to graphically input fluid injection parameters for one or more fluids into the computer using a graphical user interface.);
receiving, with the at least one processor, from at least one of an injection system including an injector configured to deliver fluid to a patient and an imaging system including a scanner configured to scan the patient, procedure data associated with a procedure for the patient, wherein at least one of the injection system and the imaging system includes at least one further user interface different than the user interface, and wherein the injection system is in communication with the imaging system (para. 53 & 80 of Williams; the graphical visualization tool may be used in conjunction with an injection system for administering a fluid to a subject. In one embodiment, the fluid injection system may include a fluid injection device that can be used to administer an effective dosage of a fluid, such as contrast medium, and a control interface that is operatively connected to the fluid injection device. The injection system may have one or more control interfaces. The control interface may send and receive data to and from the fluid injection device. In one alternative embodiment, a graphical user interface according to the present invention may be running on a control interface that may be operably connected to a fluid injection device. The injection system may be used in conjunction with an imaging system. The imaging system may be comprised of an imaging control console, an imaging device or equipment that can be used to monitor and display the contrast medium within a patient or subject, acquire internal images of a patient or subject, and to provide other diagnostic data to a control console or storage media. The imaging system may have an imaging interface that may be operatively connected to the imaging equipment. The graphical visualization tool may use the input provided by the external device to generate an injection function and/or injection protocol. The external device 1200 may include one or more input sensors or monitoring devices that may collect sensor information from one or more medical devices (e.g., a patient monitor, CT scanner, blood analyzer or bio-impedance device). Data from the external device may be communicated via connection 1210 to the control console for the fluid injection device.);
providing, with the at least one processor, via the user interface, a display, wherein the display is generated based on the procedure data (para. 53, 80, and 81 of Williams; the injection system may be used in conjunction with an imaging system. The imaging system may be comprised of an imaging control console, an imaging device or equipment that can be used to monitor and display the contrast medium within a patient or subject, acquire internal images of a patient or subject, and to provide other diagnostic data to a control console or storage media. The graphical visualization tool may create and display fluid injection control graphic 1230 (injection function) based on the data provided by the external device.);
receiving, with the at least one processor, via the user interface, user input (para. 86 of Williams; With reference to FIG. 15, an exemplary graphical user interface 1500 for a fluid injection device is illustrated. As shown, graphical user interface 1500 may includes a graphical visualization tool 1502 for graphically inputting injection parameters into the fluid injection device. The graphical visualization tool 1502 that may permit a user to use a graphical user interface to input injection parameters into a fluid injection device to control the injection behavior of the fluid injection device. The graphical visualization tool may include a display means for displaying a graph and an input device for inputting one or more desired injection parameters into the graph.); and
controlling, with the at least one processor, based on the user input, an operation of at least one of the injection system and the imaging system (para. 86 of Williams; The graphical visualization tool 1502 that may permit a user to use a graphical user interface to input injection parameters into a fluid injection device to control the injection behavior of the fluid injection device.).
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other element is also disclosed.
(S) Referring to claim 25, Williams discloses A computer program product comprising at least one non-transitory computer-readable medium including program instructions that, when executed by at least one processor, cause the at least one processor to (para. 13 & 81 of Williams; the invention may comprise a computer program product that may include a computer usable medium having computer readable program code embodied therein that may be configured to control a fluid injection device. In some embodiments, the computer program product may include computer readable code configured to cause a computer to display a graphical user interface that may be used to graphically plot an injection function.):
provide a user interface (para. 12 of Williams; the computer may have a computer readable code thereon for enabling a processor to control the fluid injector device and to permit a user to graphically input fluid injection parameters for one or more fluids into the computer using a graphical user interface.);
receive, from at least one of an injection system including an injector configured to deliver fluid to a patient and an imaging system including a scanner configured to scan the patient, procedure data associated with a procedure for the patient, wherein at least one of the injection system and the imaging system includes at least one further user interface different than the user interface, and wherein the injection system is in communication with the imaging system (para. 53 & 80 of Williams; the graphical visualization tool may be used in conjunction with an injection system for administering a fluid to a subject. In one embodiment, the fluid injection system may include a fluid injection device that can be used to administer an effective dosage of a fluid, such as contrast medium, and a control interface that is operatively connected to the fluid injection device. The injection system may have one or more control interfaces. The control interface may send and receive data to and from the fluid injection device. In one alternative embodiment, a graphical user interface according to the present invention may be running on a control interface that may be operably connected to a fluid injection device. The injection system may be used in conjunction with an imaging system. The imaging system may be comprised of an imaging control console, an imaging device or equipment that can be used to monitor and display the contrast medium within a patient or subject, acquire internal images of a patient or subject, and to provide other diagnostic data to a control console or storage media. The imaging system may have an imaging interface that may be operatively connected to the imaging equipment. The graphical visualization tool may use the input provided by the external device to generate an injection function and/or injection protocol. The external device 1200 may include one or more input sensors or monitoring devices that may collect sensor information from one or more medical devices (e.g., a patient monitor, CT scanner, blood analyzer or bio-impedance device). Data from the external device may be communicated via connection 1210 to the control console for the fluid injection device.);
provide, via the user interface, a display, wherein the display is generated based on the procedure data (para. 53, 80, and 81 of Williams; the injection system may be used in conjunction with an imaging system. The imaging system may be comprised of an imaging control console, an imaging device or equipment that can be used to monitor and display the contrast medium within a patient or subject, acquire internal images of a patient or subject, and to provide other diagnostic data to a control console or storage media. The graphical visualization tool may create and display fluid injection control graphic 1230 (injection function) based on the data provided by the external device.);
receive, via the user interface, user input (para. 86 of Williams; With reference to FIG. 15, an exemplary graphical user interface 1500 for a fluid injection device is illustrated. As shown, graphical user interface 1500 may includes a graphical visualization tool 1502 for graphically inputting injection parameters into the fluid injection device. The graphical visualization tool 1502 that may permit a user to use a graphical user interface to input injection parameters into a fluid injection device to control the injection behavior of the fluid injection device. The graphical visualization tool may include a display means for displaying a graph and an input device for inputting one or more desired injection parameters into the graph.); and
control, based on the user input, an operation of at least one of the injection system and the imaging system (para. 86 of Williams; The graphical visualization tool 1502 that may permit a user to use a graphical user interface to input injection parameters into a fluid injection device to control the injection behavior of the fluid injection device.).
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other element is also disclosed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams, JR. et al. (US 2007/0083152 A1) in view of Iddon et al. (US 2018/0169327 A1).
(A) Referring to claim 8, Williams does not disclose wherein the procedure data includes patient data including at least one of the following parameters associated with the patient: an age; a weight; a height; a body mass index; a cardiac output; a risk or probability of an adverse event; an adverse event; an estimated glomerular filtration rate (eGFR); a prior injection history including one or more allergic reactions to contrast media; a location of a patient IV access point; a quality of the patient IV access point; or any combination thereof.
Iddon discloses wherein the procedure data includes patient data including at least one of the following parameters associated with the patient: an age; a weight (para. 69 of Iddon); a height; a body mass index; a cardiac output; a risk or probability of an adverse event; an adverse event; an estimated glomerular filtration rate (eGFR); a prior injection history including one or more allergic reactions to contrast media; a location of a patient IV access point; a quality of the patient IV access point; or any combination thereof.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the procedure data in Williams to include the aforementioned parameters of Iddon. The motivation for doing so would have been to control patient specific information (para. 69 of Iddon).
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(B) Referring to claim 9, Williams does not expressly disclose wherein the display includes an alert, and wherein at least one of the injection system and the imaging system generates the alert based on the patient data before arming the injector for the procedure.
Iddon discloses wherein the display includes an alert, and wherein at least one of the injection system and the imaging system generates the alert based on the patient data before arming the injector for the procedure (para. 69, 70, and 92 of Iddon).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Iddon within Williams. The motivation for doing so would have been to allow a user to acknowledge the alert or warning (para. 92 of Iddon).
(C) Referring to claim 10, Williams does not disclose wherein the at least one processor is further programmed and/or configured to retrieve information associated with at least one of the procedure and the patient from at least one of the following: an electronic medical record (EMR) system; a radiology information system (RIS); a picture archiving and communication system (PACS);a hospital information system (HIS); a hospital enterprise information system; a cross location network; or any combination thereof.
Iddon discloses wherein the at least one processor is further programmed and/or configured to retrieve information associated with at least one of the procedure and the patient from at least one of the following: an electronic medical record (EMR) system; a radiology information system (RIS); a picture archiving and communication system (PACS); a hospital information system (HIS) (para. 76 & 8 of Iddon); a hospital enterprise information system; a cross location network; or any combination thereof.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned feature of Iddon within Williams. The motivation for doing so would have been to display pertinent information (para. 8 of Iddon).
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
Claim(s) 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams, JR. et al. (US 2007/0083152 A1) in view of Blomquist (US 2008/0033402 A1).
(A) Referring to claim 21, Williams does not disclose wherein the at least one processor is programmed and/or configured to: receive, from the at least one of the injection system and the imaging system via the at least one further user interface, authentication data associated with a user account; restrict, based on an authorization level associated with the user account, one or more operations of at least one of the injection system and the imaging system from being initiated and/or modified via the at least one further user interface by the user account, wherein the authorization level associated with the user account is determined based on the authentication data.
Blomquist discloses wherein the at least one processor is programmed and/or configured to: receive, from the at least one of the injection system and the imaging system via the at least one further user interface, authentication data associated with a user account (para. 124 & 126 of Blomquist); restrict, based on an authorization level associated with the user account, one or more operations of at least one of the injection system and the imaging system from being initiated and/or modified via the at least one further user interface by the user account, wherein the authorization level associated with the user account is determined based on the authentication data (para. 105, 106, and 124 of Blomquist).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Blomquist within Williams. The motivation for doing so would have been to give appropriate users a right to edit, create, and download protocols and/or programs (para. 106 of Blomquist).
(B) Referring to claim 22, Williams does not disclose wherein the authorization level is further determined based on at least one of the following: a number of procedures associated with the user account; a quality, experience, and/or other rating associated with the user account; a type and/or an aspect of the procedure; a type of the patient; or any combination thereof.
Blomquist discloses wherein the authorization level is further determined based on at least one of the following: a number of procedures associated with the user account; a quality, experience, and/or other rating associated with the user account (para. 105, 106, and 124 of Blomquist); a type and/or an aspect of the procedure; a type of the patient; or any combination thereof.
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Blomquist within Williams. The motivation for doing so would have been to give appropriate users a right to edit, create, and download protocols and/or programs (para. 106 of Blomquist).
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
(C) Referring to claim 23, Williams does not disclose wherein the authorization level associated with the user account is selected from one of the following authorization levels: a first authorization level at which the user account is restricted from modifying at least one of an injection protocol and a scanning protocol; a second authorization level at which the user account is restricted from modifying a first subset of parameters of the at least one of the injection protocol and the scanning protocol and enabled to modify a second subset of parameters of the at least one of the injection protocol and the scanning protocol; a third authorization level at which the user account is enabled to modify each parameter of the at least one of the injection protocol and the scanning protocol.
Blomquist discloses wherein the authorization level associated with the user account is selected from one of the following authorization levels: a first authorization level at which the user account is restricted from modifying at least one of an injection protocol and a scanning protocol; a second authorization level at which the user account is restricted from modifying a first subset of parameters of the at least one of the injection protocol and the scanning protocol and enabled to modify a second subset of parameters of the at least one of the injection protocol and the scanning protocol; a third authorization level at which the user account is enabled to modify each parameter of the at least one of the injection protocol and the scanning protocol (para. 105, 106, and 124 of Blomquist).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Blomquist within Williams. The motivation for doing so would have been to give appropriate users a right to edit, create, and download protocols and/or programs (para. 106 of Blomquist).
Insofar as the claim recites “at least one of,” it is immaterial whether or not the other elements are also disclosed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches system and method for assuring patient medication and fluid delivery at the clinical point of use (US 2015/0209510 A1); integrated medical imaging systems (US 2009/0177050 A1); and patient-based parameter generation systems for medical injection procedures (US 2010/0113887 A1).
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687