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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/09/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 11-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. US PG-Pub(US 20230069601 A1) in view of Uber et al. US PG-Pub(US 20070282198 A1).
Regarding Claim 1, McDermott teaches a computer-implemented method for providing a contrast agent alert([0002] discloses “The present disclosure relates generally to a system and method for calibrating a fluid injector, such as a medical fluid injector” and ¶[0083] discloses providing an alert to a user to provide the desired volume.), comprising: determining a reference volume of contrast agent based on the medical imaging data(¶[0070]-¶[0073] disclose having a desired/programed volume to be administered to the patient during the procedure.); and providing an alert if the volume of contrast agent administered fulfills a condition, wherein the condition is based on the reference volume of contrast agent ¶[0083] discloses if the processor determines that there is sufficient fluid volume for delivery of the desired volume, then the processor may instruct the injector to proceed with the injection. However, if the processor determines that there is not sufficient volume to provide the desired volume, when accounting for the system volume compliance, the processor may provide an alert to the user to warn that the reservoir does not contain sufficient fluid. Alternatively, the processor may instruct the injector in draw in additional fluid into the fluid reservoir so that sufficient volume is present to accurately provide the desired volume”, the user is presented with an alert if the volume of the contrast agent is not sufficient and additional fluid is needed.)
McDermott does not explicitly teach receiving medical imaging data related to a medical imaging procedure, wherein a contrast agent was administered to a patient during the medical imaging procedure;
Uber teaches receiving medical imaging data related to a medical imaging procedure, wherein a contrast agent was administered to a patient during the medical imaging procedure ([0063] “Operational and state parameters are preferably provided between components of system 10 via interface 90 (for example, between injector controller 120 and imaging unit 100) at an update rate sufficient to allow effective real-time control of the imaging procedure (for example, to allow imaging unit 100 to produce a clear image of the injection process).”, discloses receiving real-time image data during the administration process of the contrast agent.); determining a volume of contrast agent administered to the patient based on the medical imaging data(¶[0086] discloses “The discussion below provides a list of example capabilities possible with interface 90c between the subsystems of the present invention. Many of these have also been discussed above. Injector subsystem 15a can send information about its state or its programs to imaging subsystem 15b such as, but not restricted to:” and ¶[0101] “Actual Volume Delivered Total Injected Volume” [0102] “Volume Remaining” discloses determining the actual volume delivered and remaining.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott with Uber in order to receive real-time image during the administration of the contrast agent. One skilled in the art would have been motivated to modify McDermott in this manner in order to provide a visual display of an internal view of the patient based upon a signal resulting from the energy applied to the region of the patient. (Uber, Abstract)
Regarding Claim 11, the combination of McDermott and Uber teach the method of claim 1, where Uber further teaches furthermore comprising: determining a body region being subject of the medical imaging procedure, wherein the condition is furthermore based on the body region. (¶[0014], “The system also includes an imaging energy source adapted to apply imaging energy to a region of the patient and an imaging unit providing a visual display (preferably in real-time) of an internal view of the patient based upon a signal resulting from the imaging energy applied to the region of the patient. The system further includes a control unit adapted to control delivery of the active substance by adjusting the condition of the contrast agent in the patient.”, discloses determining a region of interest and adjusting the condition of the contrast agent.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott with Uber in order to determine a region of interest during the administration of the contrast agent. One skilled in the art would have been motivated to modify McDermott in this manner in order to provide a visual display of an internal view of the patient based upon a signal resulting from the energy applied to the region of the patient. (Uber, Abstract)
Regarding Claim 12, the combination of McDermott and Uber teach the method of claim 1, where McDermott further teaches wherein the condition is based on at least one of an accumulated volume of contrast agent administered or maximal volume of contrast agent administered. (¶[0009] discloses determining a volume for administering the contrast agent.)
Regarding Claim 14, claim 14 is considered an apparatus claim substantially corresponding to claim 1. Please see the discussion of claim 1 above for a discussion of similar limitations. Furthermore, McDermott teaches a system for providing a contrast agent alert(Fig. 1), comprising: at least one processor configured to cause the system to(See, ¶[0011]),
Regarding Claim 15, the combination of McDermott and Uber teach the limitations of claim 1 where McDermott further teaches a non-transitory computer-readable storage medium comprising instructions which, when executed by a system, cause the system to perform the method of claim 1. ([0013] The controller in various embodiments comprises computer readable memory containing instructions that, when executed by the controller,)
Claims 2-3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. US PG-Pub(US 20230069601 A1) in view of Uber et al. US PG-Pub(US 20070282198 A1) in view of Ullaskrishnan et al. US PG-Pub(US 20230343121 A1).
Regarding Claim 2, while the combination of McDermott and Uber teach the method of claim 1, they do not explicitly teach wherein the medical imaging data comprises a secondary capture image, wherein the determining the volume of contrast agent administered comprises: performing an optical character recognition within the secondary capture image, and determining the volume of contrast agent administered based on recognized characters within the secondary capture image.
Ullaskrishnan teaches wherein the medical imaging data comprises a secondary capture image(¶[0046]-¶[0047] disclose obtaining a secondary photo), wherein the determining the volume of contrast agent administered comprises: performing an optical character recognition within the secondary capture image(¶[0050], “At block 2030, characters associated with clinical data are extracted from the at least one DICOM SC image based on the configuration information.[0051] The characters associated with the clinical data may be extracted using OCR.”, discloses performing OCR to extract clinical data.), and determining the volume of contrast agent administered based on recognized characters within the secondary capture image(¶[0036] “For example, the configuration information associated with the SC image depicted in FIG. 5 may include a keyword—Volume, and/or pre-defined variables—EDV, ESV, and SV.”, discloses the volume maybe be determined from the OCR extraction.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott and Uber with Ullaskrishnan in order to perform OCR on the medical image. One skilled in the art would have been motivated to modify McDermott and Uber in this manner in order to facilitating processing of Digital Imaging and Communications in Medicine (DICOM) Secondary Capture (SC) images to automatically extract relevant clinical data. (Ullaskrishnan, ¶[0002])
Regarding Claim 3, the combination of McDermott, Uber and Ullaskrishnan teach the method of claim 2, where McDermott further teaches further comprising: determining a planned volume of contrast agent based on recognized characters within the secondary capture image, wherein at least one of the condition or the reference volume of contrast agent is based on the planned volume of contrast agent. (¶[0070]-¶[0073] disclose having a desired/programed volume to be administered to the patient during the procedure.);
Regarding Claim 16, the combination of McDermott, Uber and Ullaskrishnan teach the limitations of claim 2, where McDermott further teaches a non-transitory computer-readable storage medium comprising instructions which, when executed by a system, cause the system to perform the method of claim 2. ([0013] The controller in various embodiments comprises computer readable memory containing instructions that, when executed by the controller,)
Claims 4-6, 9-10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. US PG-Pub(US 20230069601 A1) in view of Uber et al. US PG-Pub(US 20070282198 A1) in view of Ortenzi et al. US PG-Pub(US 20150127376 A1).
Regarding Claim 4, while the combination of McDermott and Uber the method of claim 1, they do not explicitly teach wherein the medical imaging data comprises a structured report document and the structured report document comprises a first data element related to the volume of contrast agent administered.
Ortenzi teaches wherein the medical imaging data comprises a structured report document and the structured report document comprises a first data element related to the volume of contrast agent administered. (¶[0070] discloses “Contrast media data may include at least one of prescribed contrast media data and dispensed contrast media data, for instance at least one of a prescribed contrast media volume”, media data includes contrast volume amount.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott and Uber with Ortenzi in order to generate a report with contrast agent volume included. One skilled in the art would have been motivated to modify McDermott and Uber in this manner in order to manage contrast media injection/administration data. (Ortenzi, ¶[0002])
Regarding Claim 5, the combination of McDermott, Uber and Ortenzi teach the method of claim 4, where Ortenzi further teaches wherein the structured report document comprises a second data element related to a planned volume of contrast agent, wherein at least one of the condition or the reference volume of contrast agent is based on the planned volume of contrast agent.(¶[0354] discloses “an administered contrast media volume field 826 (e.g., a number that identifies the volume of contrast media that was administered (injected) by the contrast media injector system 602 for the corresponding imaging operation); an administered contrast media concentration field 828 (e.g., a number that identifies the concentration of contrast media that was administered (injected) by the contrast media injector system 602 during the corresponding imaging operation);”, the data record pertains to the amount that was administered and the planned amount.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott and Uber with Ortenzi in order to generate a report with contrast agent volume included. One skilled in the art would have been motivated to modify McDermott and Uber in this manner in order to manage contrast media injection/administration data. (Ortenzi, ¶[0002])
Regarding Claim 6, the combination of McDermott, Uber and Ortenzi teach the method of claim 4, where Ortenzi further teaches wherein the structured report document further comprises a second data element related to at least one of injection details, syringe pump details, flow rate details, or pressure data details, and at least one of the volume of contrast agent administered or the reference volume of contrast agent is determined based on the second data element. (¶[0354] discloses the data report includes the volume administered and ¶[0191] discloses the syringe pump details.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott and Uber with Ortenzi in order to generate a report with contrast agent volume included. One skilled in the art would have been motivated to modify McDermott and Uber in this manner in order to manage contrast media injection/administration data. (Ortenzi, ¶[0002])
Regarding Claim 9, while the combination of McDermott and Uber teach the method of claim 1, they do not explicitly teach wherein the determining the reference volume of contrast agent comprises: determining imaging metadata based on the medical imaging data, and querying a database comprising a plurality of reference volumes of contrast agent based on the imaging metadata.
Ortenzi teaches wherein the determining the reference volume of contrast agent comprises: determining imaging metadata based on the medical imaging data, and querying a database comprising a plurality of reference volumes of contrast agent based on the imaging metadata. ([0116] The DMS console for each contrast media injector system may be configured to transmit DMS patient records (from storage on the DMS console) to the DMS server over the network. The DMS server may be configured with a DMS patient records database, where a plurality of DMS patient records from each DMS console are stored, ¶[0116] discloses patient records are stored in a data base and ¶[0074] discloses injection histories may be accessed.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott and Uber with Ortenzi in order to store data related to the contrast agent in a database. One skilled in the art would have been motivated to modify McDermott and Uber in this manner in order to manage contrast media injection/administration data. (Ortenzi, ¶[0002])
Regarding Claim 10, the combination of McDermott, Uber and Ortenzi teach the method of claim 9, where McDermott further teaches wherein the imaging metadata corresponds to a procedure description of the medical imaging procedure. (¶[0072]-¶[0073] discloses calibrating the volume of fluid for a medical procedure.)
Regarding Claim 17, the combination of McDermott, Uber and Ortenzi teach the method of claim 5, where Ortenzi further teaches wherein the structured report document further comprises a second data element related to at least one of injection details, syringe pump details, flow rate details, or pressure data details, and at least one of the volume of contrast agent administered or the reference volume of contrast agent is determined based on the second data element. (¶[0354] discloses the data report includes the volume administered and ¶[0191] discloses the syringe pump details.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott and Uber with Ortenzi in order to generate a report with contrast agent volume included. One skilled in the art would have been motivated to modify McDermott and Uber in this manner in order to manage contrast media injection/administration data. (Ortenzi, ¶[0002])
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. US PG-Pub(US 20230069601 A1) in view of Uber et al. US PG-Pub(US 20070282198 A1) in view of Deshpande et al. US PG-Pub(US 20260215747 A1).
Regarding Claim 7, the combination of McDermott and Uber teach the method of claim 1, where McDermott further teaches the method further comprising: determining at least one of the volume of contrast agent administered or the reference volume of contrast agent based on the medical image. (¶[0070]-¶[0073] disclose having a desired/programed volume to be administered to the patient during the procedure.);
However, McDermott and Uber do not explicitly teach wherein the medical imaging data comprises an axial image
Deshpande teaches wherein the medical imaging data comprises an axial image(¶[0032]-¶[0033] discloses axial imagery and tracking an ROI in the axial slice.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott and Uber with Deshpande in order to have axial image of a ROI of the patient. One skilled in the art would have been motivated to modify McDermott and Uber in this manner in order to monitor for presence of contrast agent in relation to the target anatomical feature.(Deshpande, Abstract)
Regarding Claim 8, while the combination of McDermott and Uber teach the method of claim 1, they do not explicitly teach wherein the medical imaging data comprises at least two axial images, the method further comprising: selecting one of the at least two axial images based on a contrast bolus time; and determining at least one of the volume of contrast agent administered and the reference volume of contrast agent based on the selected one of the at least two axial images.
Deshpande teaches wherein the medical imaging data comprises at least two axial images, the method further comprising: selecting one of the at least two axial images based on a contrast bolus time; and determining at least one of the volume of contrast agent administered and the reference volume of contrast agent based on the selected one of the at least two axial images. ([0004] “It is common practice in CT imaging to perform a 2D surview scan covering the entire area of interest including an expected “bolus” tracking location. Bolus is a volume of administered contrast agent material such as Iodine. Contrast agent may be used in order to boost image contrast of weakly radiation absorbing anatomical structures of interest, such as cardiac vessels in cardiac imaging. The user then manually selects the z-position on such 2D surview(s), and the corresponding axial image, also known as a “locator”, is acquired and reconstructed for definition (“placement”) of a region of interest (“ROI”) for bolus tracking or monitoring for bolus arrival. Bolus travels with blood flow and accumulates, for a time, at the anatomy of interest. It is an object to trigger imaging at the right moment to capture imagery at high contrast before bolus wash-out.”, ¶[0004] discloses a user can select an axial image and determine the contrast agent volume such that the image can be captured at high contrast.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott and Uber with Deshpande in order to select an axial image of a ROI of the patient and determine the contrast agent volume. One skilled in the art would have been motivated to modify McDermott and Uber in this manner in order to monitor for presence of contrast agent in relation to the target anatomical feature. (Deshpande, Abstract)
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. US PG-Pub(US 20230069601 A1) in view of Uber et al. US PG-Pub(US 20070282198 A1) in view of Schmidtlein et al. US PG-Pub(US 20240394408 A1).
Regarding Claim 13, while the combination of McDermott and Uber teach the method of claim 1, they do not explicitly teach furthermore comprising: anonymizing or pseudonymizing the medical imaging data.
Schmidtlein teaches anonymizing or pseudonymizing the medical imaging data. ([0070], “Referring now to operation (356), and in some embodiments, the computing system may select and/or identify a modification technique to apply to the medical image(s). In one example, the computing system may select one or more modification techniques to apply to the medical image(s) (e.g., for anonymizing the medical image(s)). In certain embodiments, a selected modification technique may include or correspond to adjusting, modifying, and/or altering one or more intensities of pixels in an image segment (e.g., image segment outside of the identified ROIs”, ¶[0070] discloses anonymizing medical image data by adjusting pixels.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott and Uber with Schmidtlein in order to anonymize medical images. One skilled in the art would have been motivated to modify McDermott and Uber in this manner in order to apply the modification technique to the medical image to render the distinguishing feature indistinguishable. (Schmidtlein, Abstract)
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. US PG-Pub(US 20230069601 A1) in view of Uber et al. US PG-Pub(US 20070282198 A1) in view of Ullaskrishnan et al. US PG-Pub(US 20230343121 A1) in view Deshpande et al. US PG-Pub(US 20260215747 A1).
Regarding Claim 18, the combination of McDermott, Uber and Ullaskrishnan teach the method of claim 2, where McDermott further teaches the method further comprising: determining at least one of the volume of contrast agent administered or the reference volume of contrast agent based on the medical image. (¶[0070]-¶[0073] disclose having a desired/programed volume to be administered to the patient during the procedure.);
However, McDermott, Uber and Ullaskrishnan do not explicitly teach wherein the medical imaging data comprises an axial image
Deshpande teaches wherein the medical imaging data comprises an axial image(¶[0032]-¶[0033] discloses axial imagery and tracking an ROI in the axial slice.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott, Uber and Ullaskrishnan with Deshpande in order to have axial image of a ROI of the patient. One skilled in the art would have been motivated to modify McDermott, Uber and Ullaskrishnan in this manner in order to monitor for presence of contrast agent in relation to the target anatomical feature. (Deshpande, Abstract)
Regarding Claim 19, while the combination of McDermott, Uber and Ullaskrishnan teach the method of claim 2, they do not explicitly teach wherein the medical imaging data comprises at least two axial images, the method further comprising: selecting one of the at least two axial images based on a contrast bolus time; and determining at least one of the volume of contrast agent administered and the reference volume of contrast agent based on the selected one of the at least two axial images.
Deshpande teaches wherein the medical imaging data comprises at least two axial images, the method further comprising: selecting one of the at least two axial images based on a contrast bolus time; and determining at least one of the volume of contrast agent administered and the reference volume of contrast agent based on the selected one of the at least two axial images. ([0004] “It is common practice in CT imaging to perform a 2D surview scan covering the entire area of interest including an expected “bolus” tracking location. Bolus is a volume of administered contrast agent material such as Iodine. Contrast agent may be used in order to boost image contrast of weakly radiation absorbing anatomical structures of interest, such as cardiac vessels in cardiac imaging. The user then manually selects the z-position on such 2D surview(s), and the corresponding axial image, also known as a “locator”, is acquired and reconstructed for definition (“placement”) of a region of interest (“ROI”) for bolus tracking or monitoring for bolus arrival. Bolus travels with blood flow and accumulates, for a time, at the anatomy of interest. It is an object to trigger imaging at the right moment to capture imagery at high contrast before bolus wash-out.”, ¶[0004] discloses a user can select an axial image and determine the contrast agent volume such that the image can be captured at high contrast.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott, Uber and Ullaskrishnan with Deshpande in order to select an axial image of a ROI of the patient and determine the contrast agent volume. One skilled in the art would have been motivated to modify McDermott, Uber and Ullaskrishnan in this manner in order to monitor for presence of contrast agent in relation to the target anatomical feature. (Deshpande, Abstract)
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McDermott et al. US PG-Pub(US 20230069601 A1) in view of Uber et al. US PG-Pub(US 20070282198 A1) in view of Ullaskrishnan et al. US PG-Pub(US 20230343121 A1) in view Ortenzi et al. US PG-Pub(US 20150127376 A1).
Regarding Claim 20, while the combination of McDermott, Uber and Ullaskrishnan teach the method of claim 2, they do not explicitly teach wherein the determining the reference volume of contrast agent comprises: determining imaging metadata based on the medical imaging data, and querying a database comprising a plurality of reference volumes of contrast agent based on the imaging metadata.
Ortenzi teaches wherein the determining the reference volume of contrast agent comprises: determining imaging metadata based on the medical imaging data, and querying a database comprising a plurality of reference volumes of contrast agent based on the imaging metadata. ([0116] The DMS console for each contrast media injector system may be configured to transmit DMS patient records (from storage on the DMS console) to the DMS server over the network. The DMS server may be configured with a DMS patient records database, where a plurality of DMS patient records from each DMS console are stored, ¶[0116] discloses patient records are stored in a data base and ¶[0074] discloses injection histories may be accessed.)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the claimed invention as taught by McDermott, Uber and Ullaskrishnan with Ortenzi in order to store data related to the contrast agent in a database. One skilled in the art would have been motivated to modify McDermott, Uber and Ullaskrishnan in this manner in order to manage contrast media injection/administration data. (Ortenzi, ¶[0002])
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAN D HOANG whose telephone number is (571)272-4344. The examiner can normally be reached Monday-Friday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOHN M VILLECCO can be reached at 571-272-7319. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HAN HOANG/Primary Examiner, Art Unit 2661
Prosecution Insights