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 1-11 and 21-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process without significantly more. The claim(s) recite(s) :
1. (ORIGINAL) A system, comprising:
at least one processor coupled to a memory and configured to:
“receive, from an imaging system including an imager configured to image a patient, for a procedure for the patient, imager protocol data associated with an imager protocol according to which the imaging system is configured to control imaging of the patient with the imager, wherein the imaging system is in communication with an injection system including an injector configured to deliver fluid and/or imaging agent to the patient; “, which is a step of mere data gathering. See MPEP 2106.05(g)
“receive, via at least one user interface, for the procedure for the patient, at least one of a selection, a programming, a modification, or any combination thereof of an injector protocol according to which the injection system is configured to control delivery of at least one fluid and/or imaging agent to the patient with the injector; and “ , which is a step of mere data gathering. See MPEP 2106.05(g)
“associate, in at least one database, the imager protocol with the injector protocol”, which is directed to the mental process. For example a person could mentally associate or with a pen/paper write a pair of imager protocol data and injector protocol which are visually seen by the person.
This judicial exception is not integrated into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the processor, memory, database ad user interface are recited at a high level of generality and merely apply the exception on a computer. See MPEP 2106.05(f)(h).
Claims 11 and 21 are rejected under similar grounds as claim 1.
Claims 2-10 and 22-30 recite either additional element without significantly more than the judicial exception or are directed to the mental process (2,3,5,6,8, 22, 23, 25, 26, 28)
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 6 and 26 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 6 and 26 recites “calculating, based on the at least one value of at least one procedure specific imager parameter, at least one smart injector protocol parameter of the following smart injector protocol parameters: a flow rate of at least one fluid and/or imaging agent to be delivered to a patient in at least one phase of an injection, a volume of the at least one fluid and/or imaging agent to be delivered to the patient in the at least one phase of the injection, a contrast or imaging agent dose amount, a contrast or imaging agent dose rate, a weight-based parameter, a patient identifier, a patient body surface area, a patient height, a patient body mass index (BMI), a patient sex, a patient cardiac output, a patient anatomy to be imaged, or any combination thereof”. It is unclear how to calculate a patient identifier or a patient sex. In general those are constant values that are assigned/fixed, not calculated.
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) 1-11 and 20-30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gonzalez (2008/0119715).
Gonzalez discloses 1. (ORIGINAL) A system, comprising:
at least one processor coupled to a memory and configured to: (Gonzalez, Fig. 1,)
receive, from an imaging system including an imager configured to image a patient, for a procedure for the patient, imager protocol data associated with an imager protocol according to which the imaging system is configured to control imaging of the patient with the imager, wherein the imaging system is in communication with an injection system including an injector configured to deliver fluid and/or imaging agent to the patient; (Gonzalez, paragraph 20, “[0020] Referring to FIG. 1, a block diagram of a diagnostic imaging system 10 is shown. Diagnostic imaging system 10 includes scanner hardware 12, controlled by a system control 14 to acquire images of a scan subject. System control 14 therefore includes a scanner control module 24 which operates to provide scanner hardware 12 with scan details, such as scan locations, scan durations, x-ray intensities, RF pulse sequences, ultrasound intensities, and the like. System control 14 also contains a data acquisition module 22 to receive scan data resulting from a scan, and a data processing module 28 to process the scan data for future scan localization, image reconstruction, etc.”;)
receive, via at least one user interface, for the procedure for the patient, at least one of a selection, a programming, a modification, or any combination thereof of an injector protocol according to which the injection system is configured to control delivery of at least one fluid and/or imaging agent to the patient with the injector; and (Gonzalez, ” [0022] Interface 20 is used to allow operators to enter scan subject or patient information, select scan parameters, control contrast agent administration, and control scout, bolus, and image scans. As will be described below, static scan subject information and scan parameters entered on user interface 20, in combination with dynamic data from scan subject monitoring equipment 16, are used by a protocol module 26 of system control 14 to determine a scan/injection protocol which coordinates image data acquisition with peak contrast enhancement time.”;)”)
associate, in at least one database, the imager protocol with the injector protocol.(Gonzalez, “[0035] Scan information is displayed in another scan section 68 of the interface. The scan information displayed in scan section 68 may be auto-populated upon selection of a scan type 62, though a user may also manually edit the settings in scan section 68. Similarly, a scan and injection protocol section 74 shows a variety of factors influencing the timing of the injection and subsequent scan, including the scan delay time 88. As shown, the delay time 88 calculated for the present scan is 12s. The interface also allows a user to select whether the contrast agent will be manually or automatically administered in contrast delivery section 72. When a user alters the selected form of delivery 72, the interface may automatically re-calculate a scan delay time 88 if necessary. In the alternative, a user may simply select an auto-scan feature 76, in which case the scan sequence will automatically commence according to a real-time bolus tracking, as set forth above. Injection-related parameters are summarized in the injection data section 78 of the interface. The injection-related parameters 78, as well as the protocol data 74 (including the scan delay time 88) are automatically updated in response to significant changes in the dynamic scan subject parameters from the monitoring equipment, as described above.”, where when the scan type is selected the scan and injection protocols which )
Gonzalez discloses 2. (ORIGINAL) The system of claim 1, wherein the at least one processor is further configured to: determine, from the at least one database, based on the imager protocol data associated with the imager protocol, at least one proposed injector protocol proposed to be used with the imager protocol in the procedure for the patient; and provide, via the at least one user interface, an option to select, program, or modify the at least one proposed injector protocol proposed for use with the imager protocol in the procedure for the patient.(Gonzalez, paragraph 36-37, “[0036] An "Auto-Injector" button 70 causes the system to prescribe the injection protocol for the current scan subject. In accordance with the technique set forth above, static and dynamic patient-specific parameters are combined with injection parameters and scan parameters to coordinate the timing of the injection and the commencement of the scan into a particular protocol to efficiently utilize the contrast enhancement of the contrast agent administered to the scan subject. This may also include automatic adapting of the scan and injection parameters in real time to ensure image acquisition of a ROI coincides with a desired (or maximum) contrast enhancement in the ROI. A user may confirm the resulting protocol by clicking button 86 or may manually edit the resulting protocol or the settings according to which the system determines protocols by clicking button 84. [0037] When the "Auto-Injector" button 70 is selected, the pop-up window of FIG. 5 is shown. Auto Inject Optimizer window 109 shows a number of details relating to the contrast injection. In certain embodiments, some or all of the details of window 109 may be pre-populated based upon the data already entered into control interface 60 (FIG. 4), such as scan type, contrast delivery type, scan delay, etc. Regardless, an operator is given the opportunity via optimizer window 109 to edit injection parameters such as the number of phases of contrast injection 112, the type of contrast agent 114 for each phase, the desired average rate of flow 116 for each contrast agent, the volume 118 to be used for each phase, the duration 120 of each phase, the saline ratio 122 of each administration, and the length of an injection delay 124, if used. Once an operator is satisfied with the parameters of the Auto Inject Optimizer window, the parameters will be summarized in the injection data section 78 of the system control interface 60 of FIG. 4. Alternatively, if a user has checked the auto-inject box 110 of FIG. 5, the parameters will be sent directly from an injector or contrast pump for automated delivery to the scan subject.”)
Gonzalez discloses 3. (ORIGINAL) The system of claim 2, wherein the at least one proposed injector protocol is further determined, from the at least one database, based on a number of previous procedures for which the at least one proposed injector protocol was used with the imager protocol. (Gonzalez, paragraph 33, “Alternatively, protocol number box 106 may be used to recall the settings and data of a previous scan”)
Gonzalez discloses 4. (ORIGINAL) The system of claim 2, wherein the imager protocol data associated with the imager protocol includes at least one procedure specific imager parameter of the following procedure specific imager parameters: a patient name, a patient weight, a tube current level, a tube voltage level, an image acquisition sequence, an identifier of the imager protocol, or any combination thereof. (Gonzalez, paragraph 33, “including a scan subject's gender 96, age 98, weight 100, and height 104. Other relevant medical history data may be entered in box 104. An operator may give the impending scan a protocol number 106, to save the settings and data for later use. Alternatively, protocol number box 106 may be used to recall the settings and data of a previous scan. Start page 90 also allows a user to select the scan type and anatomy of interest 94 for the impending scan.”)
Gonzalez discloses 5. (ORIGINAL) The system of claim 4, wherein the at least one processor is further configured to: automatically determine, based on at least one value of the at least one procedure specific imager parameter, at least one value of at least one procedure specific injector parameter associated with the at least one proposed injector protocol.(Gonzalez, paragraph 37, “[0037] When the "Auto-Injector" button 70 is selected, the pop-up window of FIG. 5 is shown. Auto Inject Optimizer window 109 shows a number of details relating to the contrast injection. In certain embodiments, some or all of the details of window 109 may be pre-populated based upon the data already entered into control interface 60 (FIG. 4), such as scan type, contrast delivery type, scan delay, etc. Regardless, an operator is given the opportunity via optimizer window 109 to edit injection parameters such as the number of phases of contrast injection 112, the type of contrast agent 114 for each phase, the desired average rate of flow 116 for each contrast agent, the volume 118 to be used for each phase, the duration 120 of each phase, the saline ratio 122 of each administration, and the length of an injection delay 124, if used. Once an operator is satisfied with the parameters of the Auto Inject Optimizer window, the parameters will be summarized in the injection data section 78 of the system control interface 60 of FIG. 4. Alternatively, if a user has checked the auto-inject box 110 of FIG. 5, the parameters will be sent directly from an injector or contrast pump for automated delivery to the scan subject)
Gonzalez discloses 6. (ORIGINAL) The system of claim 5, wherein the at least one proposed injector protocol includes a smart injector protocol, and wherein automatically determining the at least one value of the at least one procedure specific injector parameter associated with the at least one proposed injector protocol includes calculating, based on the at least one value of at least one procedure specific imager parameter, at least one smart injector protocol parameter of the following smart injector protocol parameters: a flow rate of at least one fluid and/or imaging agent to be delivered to a patient in at least one phase of an injection, a volume of the at least one fluid and/or imaging agent to be delivered to the patient in the at least one phase of the injection, a contrast or imaging agent dose amount, a contrast or imaging agent dose rate, a weight-based parameter, a patient identifier, a patient body surface area, a patient height, a patient body mass index (BMI), a patient sex, a patient cardiac output, a patient anatomy to be imaged, or any combination thereof. (Gonzalez, paragraph 33, “including a scan subject's gender 96, age 98, weight 100, and height 104. Other relevant medical history data may be entered in box 104. An operator may give the impending scan a protocol number 106, to save the settings and data for later use. Alternatively, protocol number box 106 may be used to recall the settings and data of a previous scan. Start page 90 also allows a user to select the scan type and anatomy of interest 94 for the impending scan.”)
Gonzalez discloses 7. (ORIGINAL) The system of claim 5, wherein automatically determining the at least one value of the at least one procedure specific injector parameter associated with the at least one proposed injector protocol includes automatically populating a prompt for the at least one procedure specific injector parameter in the at least one user interface with the determined at least one value of the at least one procedure specific injector parameter.(Gonzalez, “[0037] When the "Auto-Injector" button 70 is selected, the pop-up window of FIG. 5 is shown. Auto Inject Optimizer window 109 shows a number of details relating to the contrast injection. In certain embodiments, some or all of the details of window 109 may be pre-populated based upon the data already entered into control interface 60 (FIG. 4), such as scan type, contrast delivery type, scan delay, etc. “)
Gonzalez discloses 8. (ORIGINAL) The system of claim 5, wherein the at least one processor is further configured to: receive, via the at least one user interface, one or more values of one or more procedure specific injector parameters associated with the at least one proposed injector protocol; and automatically determine, based on the one or more values of the one or more procedure specific injector parameters, one or more values of one or more procedure specific imager parameters associated with the imager protocol.(Gonzalez, “[0035] Scan information is displayed in another scan section 68 of the interface. The scan information displayed in scan section 68 may be auto-populated upon selection of a scan type 62, though a user may also manually edit the settings in scan section 68. Similarly, a scan and injection protocol section 74 shows a variety of factors influencing the timing of the injection and subsequent scan, including the scan delay time 88. As shown, the delay time 88 calculated for the present scan is 12s. The interface also allows a user to select whether the contrast agent will be manually or automatically administered in contrast delivery section 72. When a user alters the selected form of delivery 72, the interface may automatically re-calculate a scan delay time 88 if necessary. In the alternative, a user may simply select an auto-scan feature 76, in which case the scan sequence will automatically commence according to a real-time bolus tracking, as set forth above. Injection-related parameters are summarized in the injection data section 78 of the interface. The injection-related parameters 78, as well as the protocol data 74 (including the scan delay time 88) are automatically updated in response to significant changes in the dynamic scan subject parameters from the monitoring equipment, as described above.”)
Gonzalez discloses 9. (ORIGINAL) The system of claim 8, wherein automatically determining the one or more values of the one or more procedure specific imager parameters associated with the imager protocol includes automatically populating a prompt for the one or more procedure specific imager parameters in the at least one user interface with the determined one or more values of the one or more procedure specific imager parameters. .(Gonzalez, “[0035] Scan information is displayed in another scan section 68 of the interface. The scan information displayed in scan section 68 may be auto-populated upon selection of a scan type 62, though a user may also manually edit the settings in scan section 68. Similarly, a scan and injection protocol section 74 shows a variety of factors influencing the timing of the injection and subsequent scan, including the scan delay time 88. As shown, the delay time 88 calculated for the present scan is 12s. The interface also allows a user to select whether the contrast agent will be manually or automatically administered in contrast delivery section 72. When a user alters the selected form of delivery 72, the interface may automatically re-calculate a scan delay time 88 if necessary. In the alternative, a user may simply select an auto-scan feature 76, in which case the scan sequence will automatically commence according to a real-time bolus tracking, as set forth above. Injection-related parameters are summarized in the injection data section 78 of the interface. The injection-related parameters 78, as well as the protocol data 74 (including the scan delay time 88) are automatically updated in response to significant changes in the dynamic scan subject parameters from the monitoring equipment, as described above.”)
Gonzalez discloses 10. (ORIGINAL) The system of claim 5, wherein the at least one user interface provides, in a same display, a plurality of prompts for a plurality of procedure specific imager parameters associated with the imager protocol and a plurality of prompts for a plurality of procedure specific injector parameters associated with the at least one proposed injector protocol. (Gonzalez, Fig. 4)
Claims 11 and 21 are rejected under similar grounds as claim 1.
Claims 22-30 are rejected under similar grounds as claims 2-10, respectively.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANDHI THIRUGNANAM whose telephone number is (571)270-3261. The examiner can normally be reached M-F 8:30-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sumati Lefkowitz can be reached at 571-272-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GANDHI THIRUGNANAM/ Primary Examiner, Art Unit 2672
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