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 .
Status of Claims
This action is in reply to the claims filed on 10 February 2026. Claims 1, 13, and 14 were amended. Claims 19-21 were canceled. Claims 4-9, 15, 18, and 22 were previously canceled. Claims 1-3, 10-14, 16-17, and 23-29 are currently pending and have been examined.
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.
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 1-3, 10, 13-14, 16-17, and 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Paysan et al. (U.S. 2016/0220844), hereinafter “Paysan,” in view of Darrow et al. (U.S. 2014/0364720), hereinafter “Darrow,” and further in view of Gerken et al. (U.S. 2015/0057526), hereinafter “Gerken.”
Regarding Claim 1, Paysan discloses a computer-implemented method executed on at least one processor of at least one computer for automatically adjusting a setting of at least one imaging parameter of an imaging device according to an optimization process to configure the imaging device for acquiring an image with the imaging device, the method comprising:
acquiring, at the at least one processor, patient data, the patient data describing information relating to the patient and having an impact on the setting of at least one imaging parameter of the imaging device (See Paysan [0032] gathered patient information can be used for determining image parameter optimization. See also [0046]. [0039] the system can use information about the patient’s disease and anatomical region of interest to be imaged for determining imaging parameters (such as imaging category).), wherein the at least one imaging parameter of the imaging device comprises one or more of:
a position of an isocenter of the imaging device with respect to a patient's anatomy; a position, size and/or shape of an imaging region with respect to the patient's anatomy, with respect to objects coupled the patient's anatomy and/or with respect to the imaging device; a position of a scan trajectory with respect to the patient's anatomy and/or with respect to objects coupled the patient's anatomy; a position of the imaging device with respect to the patient's anatomy and/or with respect to objects coupled the patient's anatomy; a position, size and/or shape of a collimator opening of the imaging device; a scan voltage and/or scan current of an x-ray tube; a dose modulation; a selection of a reconstruction kernel and algorithm; a metal artefact reduction modality; a subtraction angiography modality; a dual-energy imaging modality; a number of x-ray pulses per second; a number of acquired projections; and/or a modality and/or setting for post-processing at least one image obtained with the imaging device (See Paysan [0033] These parameters may include modifying the intensity (source voltage and/or source current) or geometry (angle or trajectory) of the photon beam, or position of the area detector. See also [0034] and [0052].);
acquiring, at the at least one processor, current position data describing a current position of the imaging device with respect to the patient's anatomy (See Paysan [0005] this paragraph describes the use of imaging a patient beforehand to confirm current patient positioning. [0030] the system also generates parameters based on imaging that is performed for patient positioning prior to treatment. Therefore, the system can determine the current patient position with respect to the imaging device.);
determining, by the at least one processor, imaging parameter data based on the patient data, the imaging parameter data describing a patient-specific setting of the at least one imaging parameter of the imaging device (See Paysan [0033] certain radiography imaging parameters of the device may be automatically calibrated (or alternatively, suggested) to produce or emphasize certain qualities of generated images. [0035] the system uses all of the patient data from pre-treatment steps in order to optimize radiography imaging parameters for a patient positioning image capture. [0039] imaging category is also used based on the patient’s anatomical region of interest. This imaging category is understood to be at least one imaging parameter that is based on the patient data.), the determining the imaging parameter data comprising:
determining, by the at least one processor and based on a first subset of information relating to the patient, an initial value of the patient-specific setting of the at least one imaging parameter (See Paysan [0037]-[0038] the system can use patient data to determine preset imaging parameters using expert models and physical models. [0037] database of different cases with unique parameters to use as presets (i.e., “initial value”).), wherein the first subset of information relating to the patient comprises at least one of: a type of disease of the patient; and/or a type of treatment procedure associated with the disease of the patient (See Paysan [0039] the system can use the disease of the patient or treatment/therapy plan for the patient as part of the selecting the initial parameters, using the expert and physical models described in [0037]-[0038].); and
determining, by the at least one processor, target position data based on the current position data and the imaging parameter data, the target position data describing a target position of the imaging device with respect to the patient's anatomy for acquiring image data of the patient with the determined patient-specific setting of the at least one imaging parameter (See Paysan [0039] the target anatomical region can be part of the imaging parameters. This is understood to include target position data. Further, [0033] discusses that the image parameter data can include the position of the couch on which the patient is imaged. This is also understood to include target position data.); and
issuing, by the at least one processor, a control signal to the imaging device… (See Paysan [0053] the values for the imaging parameters may be automatically applied to the imaging system.).
Paysan does not disclose:
optimizing the initial value of the patient-specific setting of the at least one imaging parameter by determining, by the at least one processor based on the determined initial value and based on a second subset of information relating to the patient, an optimized value of the patient-specific setting of one or more of the at least one imaging parameter, the optimized value replacing the initial value, wherein the second subset of information relating to the patient comprises at least one of: a position, size and/or shape of anatomical structures of interest; and/or a position, size and/or shape of at least one predefined object coupled to the patient's anatomy;
the issued control signal controlling repositioning of the imaging device by controlling, based on the current position data and the target position data, locomotion of a motorized carrier of the imaging device to transport the imaging device to the target position to acquire an image at the target position, thereby applying the optimized value of the patient-specific setting of the at least one imaging parameter of the imaging device.
Darrow teaches:
optimizing the initial value of the patient-specific setting of the at least one imaging parameter by determining, by the at least one processor based on the determined initial value and based on a second subset of information relating to the patient, an optimized value of the patient-specific setting of one or more of the at least one imaging parameter, the optimized value replacing the initial value (See Darrow [0056] the system can perform an initial scan to identify the position of anatomy of interest. [0057] the system can use the information from the initial scan to optimize implementation of the desired imaging task by selectively configuring one or more imaging parameters using the processed imaging data. Updating the imaging protocol may include selectively configuring spatial resolution, temporal resolution, and/or image contrast as desired for one or more subsequent scans. Updating the imaging protocol may include determining a suitable scan sequence, image reconstruction technique and/or a type, frequency and/or timing of audio-visual output such as display rendering and color highlighting based on the feedback sought from the navigation subsystem during the medical procedure. See also [0058].),
wherein the second subset of information relating to the patient comprises at least one of: a position, size and/or shape of anatomical structures of interest; and/or a position, size and/or shape of at least one predefined object coupled to the patient's anatomy (See Darrow [0056] the system can perform an initial scan to identify the position of anatomy of interest. [0057] the system can use the information from the initial scan to optimize implementation of the desired imaging task by selectively configuring one or more imaging parameters using the processed imaging data.).
The system of Darrow is applicable to the disclosure of Paysan as they both share characteristics and capabilities, namely, they are directed to automating imaging parameters of imaging devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paysan to include an parameter optimization stage as taught by Darrow. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Paysan in order to optimize implementation of the desired imaging task based on the determined anatomical labeling information (see Darrow [0007]).
Gerken teaches:
the issued control signal controlling repositioning of the imaging device by controlling, based on the current position data and the target position data, locomotion of a motorized carrier of the imaging device to transport the imaging device to the target position to acquire an image at the target position, thereby applying the optimized value of the patient-specific setting of the at least one imaging parameter of the imaging device (See Gerken [0002] the system includes automatic control of imaging device [0021] the operating parameter can be gantry tilt (moving the imaging device). [0044] the gantry is controlled by signals issued by the computer. Therefore, the system includes some type of motor for moving the imaging device to a target position. [0025] the system includes a navigation device for detecting the position of at least one of the medical imaging device, an anatomical body part and an instrument.).
The system of Gerken is applicable to the disclosure of Paysan in view of Darrow as they both share characteristics and capabilities, namely, they are directed to automating imaging parameters of imaging devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paysan in view of Darrow to include apply the parameters to capture an image, including a motorized carrier as taught by Gerken. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Paysan in order to provide automatic control of a medical imaging device so that complicated manual operation of the medical imaging device under sterile conditions can be avoided and costly surgical time can be reduced (see Gerken [0002]).
Regarding claim 2, Paysan in view of Darrow and Gerken discloses the method of claim 1 as discussed above. Paysan does not further disclose a method, comprising:
the acquiring patient data comprises acquiring the patient data from a medical navigation system operably coupled to the imaging device.
Gerken teaches:
the acquiring patient data comprises acquiring the patient data from a medical navigation system operably coupled to the imaging device (See Gerken [0025] the system includes a navigation device for detecting the position of at least one of the medical imaging device, an anatomical body part and an instrument. [0043] the imaging is controlled by the using a navigation system.).
The system of Gerken is applicable to the disclosure of Paysan in view of Darrow as they both share characteristics and capabilities, namely, they are directed to automating imaging parameters of imaging devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paysan in view of Darrow to include apply the parameters to capture an image, including a motorized carrier as taught by Gerken. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Paysan in order to provide automatic control of a medical imaging device so that complicated manual operation of the medical imaging device under sterile conditions can be avoided and costly surgical time can be reduced (see Gerken [0002]).
Regarding claim 3, Paysan in view of Darrow and Gerken discloses the method of claim 2 as discussed above. Paysan further discloses a method, comprising:
the acquiring patient data involves selecting a dataset of the patient (See Paysan [0056] the system can select a full patient dataset or a subset of the patient data.) .
Regarding claim 10, Paysan in view of Darrow and Gerken discloses the method of claim 1 as discussed above. Paysan further discloses a method, comprising:
the imaging device is a x-ray-imaging-device (See Paysan [0024] the system may use an x-ray imaging device. See also [0031].).
Paysan does not disclose:
the method further comprising: spatially tracking the x-ray-imaging-device by a medical tracking system operably coupled to a medical navigation system.
Gerken teaches:
the method further comprising: spatially tracking the x-ray-imaging-device by a medical tracking system operably coupled to a medical navigation system (See Gerken [0025] the system includes a navigation device for detecting the position of at least one of the medical imaging device, an anatomical body part and an instrument. Therefore, the imaging device is “spatially tracked.”).
The system of Gerken is applicable to the disclosure of Paysan in view of Darrow as they both share characteristics and capabilities, namely, they are directed to automating imaging parameters of imaging devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paysan in view of Darrow to include apply the parameters to capture an image, including a motorized carrier as taught by Gerken. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Paysan in order to provide automatic control of a medical imaging device so that complicated manual operation of the medical imaging device under sterile conditions can be avoided and costly surgical time can be reduced (see Gerken [0002]).
Regarding claim 13, Paysan discloses a computer-implemented method executed on at least one processor of at least one computer for automatically adjusting a setting of at least one imaging parameter of an imaging device according to an optimization process to configure the imaging device for acquiring an image with the imaging device, the method comprising:
acquiring, at the at least one processor, patient data, the patient data describing information relating to the patient and having an impact on the setting of at least one imaging parameter of the imaging device (See Paysan [0032] gathered patient information can be used for determining image parameter optimization. See also [0046]. [0039] the system can use information about the patient’s disease and anatomical region of interest to be imaged for determining imaging parameters (such as imaging category).), wherein the at least one imaging parameter of the imaging device comprises one or more of:
a position of an isocenter of the imaging device with respect to a patient's anatomy; a position, size and/or shape of an imaging region with respect to the patient's anatomy, with respect to objects coupled the patient's anatomy and/or with respect to the imaging device; a position of a scan trajectory with respect to the patient's anatomy and/or with respect to objects coupled the patient's anatomy; a position of the imaging device with respect to the patient's anatomy and/or with respect to objects coupled the patient's anatomy; a position, size and/or shape of a collimator opening of the imaging device; a scan voltage and/or scan current of an x-ray tube; a dose modulation; a selection of a reconstruction kernel and algorithm; a metal artefact reduction modality; a subtraction angiography modality; a dual-energy imaging modality; a number of x-ray pulses per second; a number of acquired projections; and/or a modality and/or setting for post-processing at least one image obtained with the imaging device (See Paysan [0033] These parameters may include modifying the intensity (source voltage and/or source current) or geometry (angle or trajectory) of the photon beam, or position of the area detector. See also [0034] and [0052].);
determining, by the at least one processor, imaging parameter data based on the patient data, the imaging parameter data describing a patient-specific setting of the at least one imaging parameter of the imaging device (See Paysan [0033] certain radiography imaging parameters of the device may be automatically calibrated (or alternatively, suggested) to produce or emphasize certain qualities of generated images. [0035] the system uses all of the patient data from pre-treatment steps in order to optimize radiography imaging parameters for a patient positioning image capture. [0039] imaging category is also used based on the patient’s anatomical region of interest. This imaging category is understood to be at least one imaging parameter that is based on the patient data.), wherein the determining the imaging parameter data comprises:
determining, by the at least one processor and based on a first subset of information relating to the patient, an initial value of the patient-specific setting of the at least one imaging parameter (See Paysan [0037]-[0038] the system can use patient data to determine preset imaging parameters using expert models and physical models. [0037] database of different cases with unique parameters to use as presets (i.e., “initial value”).), wherein the first subset of information relating to the patient comprises at least one of: a type of disease of the patient; and/or a type of treatment procedure associated with the disease of the patient (See Paysan [0039] the system can use the patients disease of the patient or treatment/therapy plan for the patient as part of the selecting the initial parameters, using the expert and physical models described in [0037]-[0038].); and
issuing, by the at least one processor, a control signal to the imaging device, the issued control signal automatically setting the at least one imaging parameter of the imaging device based on the determined optimized value of the patient-specific setting 9See Paysan [0053] the values for the imaging parameters may be automatically applied to the imaging system.);
automatically configuring the imaging device for acquiring image data of the patient based on the setting of the at least one imaging parameter by automatically adjusting the setting of the at least one imaging parameter of the imaging device based on the determined optimized value provided in the issued control signal (See Paysan [0053] the values for the imaging parameters may be automatically applied to the imaging system.);
acquiring, at the at least one processor, current position data describing a current position of the imaging device with respect to the patient's anatomy (See Paysan [0005] this paragraph describes the use of imaging a patient beforehand to confirm current patient positioning. [0030] the system also generates parameters based on imaging that is performed for patient positioning prior to treatment. Therefore, the system can determine the current patient position with respect to the imaging device.);
determining, by the at least one processor, target position data based on the current position data and the imaging parameter data, the target position data describing a target position of the imaging device with respect to the patient's anatomy for acquiring image data of the patient with the determined patient-specific setting of the at least one imaging parameter (See Paysan [0039] the target anatomical region can be part of the imaging parameters. This is understood to include target position data. Further, [0033] discusses that the image parameter data can include the position of the couch on which the patient is imaged. This is also understood to include target position data.).
Paysan does not disclose:
optimizing the initial value of the patient-specific setting of the at least one imaging parameter by determining, by the at least one processor based on the determined initial value and based on a second subset of information relating to the patient, an optimized value of the patient-specific setting of one or more of the at least one imaging parameter, the optimized value replacing the initial value, wherein the second subset of information relating to the patient comprises at least one of: a position, size and/or shape of anatomical structures of interest; and/or a position, size and/or shape of at least one predefined object coupled to the patient's anatomy;
issuing, by the at least one processor, the control signal to the imaging device, the issued control signal controlling repositioning of the imaging device by controlling, based on the current position data and the target position data, locomotion of a motorized carrier of the imaging device to transport the imaging device to the target position.
Darrow teaches:
optimizing the initial value of the patient-specific setting of the at least one imaging parameter by determining, by the at least one processor based on the determined initial value and based on a second subset of information relating to the patient, an optimized value of the patient-specific setting of one or more of the at least one imaging parameter, the optimized value replacing the initial value (See Darrow [0056] the system can perform an initial scan to identify the position of anatomy of interest. [0057] the system can use the information from the initial scan to optimize implementation of the desired imaging task by selectively configuring one or more imaging parameters using the processed imaging data. Updating the imaging protocol may include selectively configuring spatial resolution, temporal resolution, and/or image contrast as desired for one or more subsequent scans. Updating the imaging protocol may include determining a suitable scan sequence, image reconstruction technique and/or a type, frequency and/or timing of audio-visual output such as display rendering and color highlighting based on the feedback sought from the navigation subsystem during the medical procedure. See also [0058].), wherein the second subset of information relating to the patient comprises at least one of: a position, size and/or shape of anatomical structures of interest; and/or a position, size and/or shape of at least one predefined object coupled to the patient's anatomy (See Darrow [0056] the system can perform an initial scan to identify the position of anatomy of interest. [0057] the system can use the information from the initial scan to optimize implementation of the desired imaging task by selectively configuring one or more imaging parameters using the processed imaging data. );
The system of Darrow is applicable to the disclosure of Paysan as they both share characteristics and capabilities, namely, they are directed to automating imaging parameters of imaging devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paysan to include an parameter optimization stage as taught by Darrow. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Paysan in order to optimize implementation of the desired imaging task based on the determined anatomical labeling information (see Darrow [0007]).
Gerken teaches:
issuing, by the at least one processor, the control signal to the imaging device, the issued control signal controlling repositioning of the imaging device by controlling, based on the current position data and the target position data, locomotion of a motorized carrier of the imaging device to transport the imaging device to the target position (See Gerken [0002] the system includes automatic control of imaging device [0021] the operating parameter can be gantry tilt (moving the imaging device). [0044] the gantry is controlled by signals issued by the computer. Therefore, the system includes some type of motor for moving the imaging device to a target position. [0025] the system includes a navigation device for detecting the position of at least one of the medical imaging device, an anatomical body part and an instrument.).
The system of Gerken is applicable to the disclosure of Paysan in view of Darrow as they both share characteristics and capabilities, namely, they are directed to automating imaging parameters of imaging devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Paysan in view of Darrow to include apply the parameters to capture an image, including a motorized carrier as taught by Gerken. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Paysan in order to provide automatic control of a medical imaging device so that complicated manual operation of the medical imaging device under sterile conditions can be avoided and costly surgical time can be reduced (see Gerken [0002]).
Regarding claim 14, Paysan in view of Darrow and Gerken discloses the method of claim 1 as discussed above. Claim 14 recites a system that performs a method substantially similar to the method of claim 1. Accordingly, claim 14 are rejected based on the same analysis.
Regarding claim 16, Paysan in view of Darrow and Gerken discloses the method of claim 3 as discussed above. Paysan further discloses a method, comprising:
the selecting the dataset of the patient comprises selecting the dataset including a patient's name and/or ID (See Paysan [0055] the system can use patient records for gathering patient data. These patient records must include some form of ID for them to be connected to that patient.) .
Regarding claim 17, Paysan in view of Darrow and Gerken discloses the method of claim 1 as discussed above. Paysan further discloses a method, comprising:
the acquiring the current position data comprises acquiring current position data based on the patient data (See Paysan [0005] this paragraph describes the use of imaging a patient beforehand to confirm current patient positioning. [0030] the system also generates parameters based on imaging that is performed for patient positioning prior to treatment. Therefore, the system can determine the current patient position with respect to the imaging device.).
Regarding claims 25-28, Paysan in view of Darrow and Gerken discloses the method of claims 2-3, 10, and 16 as discussed above. Claims 25-28 recite a system that performs a method substantially similar to the method of claims 2-3, 10, and 16. Accordingly, claims 25-28 are rejected based on the same analysis.
Response to Arguments
35 U.S.C. §101
Applicant's arguments filed 10 February 2026, with respect to the 35 U.S.C. §101 rejection of the claims, have been fully considered and they are persuasive. Examiner notes, that under Step 2A Prong One, the claims as currently amended are not an example of a mental process or mathematical calculation. Further, it cannot be considered to be a method of organizing human activity, because the instruction to move the motorized carrier cannot be interpreted to be sent to a human, as the instructions are explicitly sent to a motorized carrier for moving the imaging device. Accordingly, the 35 U.S.C. §101 rejection of the claims has been withdrawn.
35 U.S.C. §103
Applicant's arguments filed 10 February 2026, with respect to the 35 U.S.C. §103 rejection of the claims, have been fully considered but they are not persuasive. Applicant argues that the combination of references does not teach, suggest, or fairly disclose the automatic setting of imaging parameters based on the optimization process recited in the claims (see Applicant Remarks ). This is no persuasive. The Paysan reference discloses in [0039] a system that can use the disease of the patient or treatment/therapy plan for the patient as part of the selecting imaging parameters, using the expert and physical models described in [0037]-[0038]. The Darrow reference teaches a system can perform an initial scan to identify the position of anatomy of interest (see Darrow [0056]). The Darrow system can use the information from the initial scan to optimize implementation of the desired imaging task by selectively configuring one or more imaging parameters using the processed imaging data (see Darrow [0057]). This combination of references teaches “optimizing the initial value of the patient-specific setting of the at least one imaging parameter” using a “first subset of information relating to the patient comprises at least one of: a type of disease of the patient; and/or a type of treatment procedure associated with the disease of the patient.” Accordingly, the claims remain rejected as being obvious over Paysan in view of Darrow and Gerken.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wu et al. (U.S. 2018/0129896) discloses a system and method for real time positioning of x-ray imaging via automatic detection of landmarks or interest in a patient.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN L HANKS whose telephone number is (571)270-5080. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.L.H./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684