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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/21/2024, 07/26/2024, and 08/15/2024 have been considered by the examiner.
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 1-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., abstract idea – mental process) without significantly more.
Step (1) Are the claims directed to a process, machine, manufacture, or composition of matter;
Step (2A) Prong One: Are the claims directed to a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea;
Prong Two: If the claims are directed to a judicial exception under Prong One, then is the judicial exception integrated into a practical application;
Step (2B) If the claims are directed to a judicial exception and do not integrate the judicial exception, do the claims provide an inventive concept.
Step 1:
Claim 1 recites a method. Therefore, the claim is directed to the statutory categories of process.
Step 2A:
Prong One:
Claim 1 recites:
“detecting a first body structure in the first image”. Under its broadest reasonable interpretation in light of the specification, the limitation encompasses a mental process of detecting a body structure from an image which is practically capable of being performed in the human mind with the assistance of pen and paper.
“determining a first position of the imaging system relative to the first body structure based on the first image”. Under its broadest reasonable interpretation in light of the specification, the limitation encompasses a mental process of determining a position of the system relative to the body structure which is practically capable of being performed in the human mind with the assistance of pen and paper.
Prong Two:
This judicial exception is not integrated into a practical application. The additional elements of “A method of positioning an imaging system comprising: positioning the imaging system;” and “determining a distance to a target image position based on the relative position; and moving the imaging system toward the target image position” amount to no more than mere necessary data gathering and applying because, under its broadest reasonable interpretation, it is simply using generic hardware to perform the abstract idea. Thus, they are insignificant extra-solution activity. Even when viewed in combination, these additional elements do not integrate the abstract idea into a practical application and the claim is thus directed to the abstract idea.
Step (2B):
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitations “A method of positioning an imaging system comprising: positioning the imaging system;” and “determining a distance to a target image position based on the relative position; and moving the imaging system toward the target image position” amount to no more than mere data gathering with general purpose hardware and provide no inventive concept. These elements, individually and in combination, are well-understood, routine, conventional activity. As such, the claim is ineligible.
Step 1:
Claims 2 and 3 recite a method. Therefore, the claims are directed to the statutory categories of process.
Step 2A:
Prong One:
Claim 2 and 3 merely narrow the previously recited abstract idea limitations. For the reasons described above, this judicial exception is not meaningfully integrated into a practical application, or significantly more than the abstract idea. The claims disclose similar limitations described for the independent claims above and do not provide anything more than the mental process and mathematical calculation that are practically capable of being performed in the human mind with the assistance of pen and paper.
Prong Two:
These judicial exceptions are not integrated into a practical application nor includes additional elements that are sufficient to amount to significantly more. Thus, the claims are ineligible.
Step 1:
Claim 4 recites a method. Therefore, the claim is directed to the statutory categories of process.
Step 2A:
Prong One:
Claim 4 recites:
“segmenting the first image to identify the first body structure.”. Under its broadest reasonable interpretation in light of the specification, the limitation encompasses a mental process of separating and identifying the body structure from the image which is practically capable of being performed in the human mind with the assistance of pen and paper.
Prong Two:
These judicial exceptions are not integrated into a practical application nor includes additional elements that are sufficient to amount to significantly more. Thus, the claim in ineligible.
Step 1:
Claims 5 and 6 recite a method. Therefore, the claims are directed to the statutory categories of process.
Step 2A:
Prong One:
Claim 5 and 6 merely narrow the previously recited abstract idea limitations. For the reasons described above, this judicial exception is not meaningfully integrated into a practical application, or significantly more than the abstract idea. The claims disclose similar limitations described for the independent claims above and do not provide anything more than the mental process and mathematical calculation that are practically capable of being performed in the human mind with the assistance of pen and paper.
Prong Two:
These judicial exceptions are not integrated into a practical application nor includes additional elements that are sufficient to amount to significantly more. Thus, the claims are ineligible.
Step 1:
Claim 7 recites a method. Therefore, the claim is directed to the statutory categories of process.
Step 2A:
Prong One:
Claim 7 recites:
“ determining a size of the first body structure based on a three-dimensional image”. Under its broadest reasonable interpretation in light of the specification, the limitation encompasses a mental process of determining the size of the body structure from a three-dimensional image which is practically capable of being performed in the human mind with the assistance of pen and paper.
Prong Two:
This judicial exception is not integrated into a practical application. The additional elements of “ wherein determining the distance comprises determining the distance based on the size.” amount to no more than mere necessary data gathering and applying because, under its broadest reasonable interpretation, it is simply using generic hardware to perform the abstract idea. Thus, they are insignificant extra-solution activity. Even when viewed in combination, these additional elements do not integrate the abstract idea into a practical application and the claim is thus directed to the abstract idea.
Step (2B):
Claim 7 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitations “ wherein determining the distance comprises determining the distance based on the size.” amount to no more than mere data gathering with general purpose hardware and provide no inventive concept. These elements, individually and in combination, are well-understood, routine, conventional activity. As such, the claim is ineligible.
Step 1:
Claims 8-15 recite a method. Therefore, the claims are directed to the statutory categories of process.
Step 2A:
Prong One:
Claim 8-15 merely narrow the previously recited abstract idea limitations. For the reasons described above, this judicial exception is not meaningfully integrated into a practical application, or significantly more than the abstract idea. The claims disclose similar limitations described for the independent claims above and do not provide anything more than the mental process and mathematical calculation that are practically capable of being performed in the human mind with the assistance of pen and paper.
Prong Two:
These judicial exceptions are not integrated into a practical application nor includes additional elements that are sufficient to amount to significantly more. Thus, the claims are ineligible.
Step 1:
Claim 16 recites a system. Therefore, the claim is directed to the statutory categories of machine.
Step 2A:
Prong One:
Claim 16 recites:
“detect a first body structure in the first image”. Under its broadest reasonable interpretation in light of the specification, the limitation encompasses a mental process of detecting a body structure from an image which is practically capable of being performed in the human mind with the assistance of pen and paper.
“determine a first position of the imaging system relative to the first body structure based on the first image” Under its broadest reasonable interpretation in light of the specification, the limitation encompasses a mental process of determining a position of the system relative to the body structure which is practically capable of being performed in the human mind with the assistance of pen and paper.
Prong Two:
This judicial exception is not integrated into a practical application. The additional elements of “A system to move an imaging system, the system comprising: a controller configured to execute instructions to, acquire a first image” and “determine a distance to a target image position based on the relative position; and move the imaging system toward the target image position” amount to no more than mere necessary data gathering and applying because, under its broadest reasonable interpretation, it is simply using generic hardware to perform the abstract idea. Thus, they are insignificant extra-solution activity. Even when viewed in combination, these additional elements do not integrate the abstract idea into a practical application and the claim is thus directed to the abstract idea.
Step (2B):
Claim 16 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitations “A system to move an imaging system, the system comprising: a controller configured to execute instructions to, acquire a first image” and “determine a distance to a target image position based on the relative position; and move the imaging system toward the target image position” amount to no more than mere data gathering with general purpose hardware and provide no inventive concept. These elements, individually and in combination, are well-understood, routine, conventional activity. As such, the claim is ineligible.
Step 1:
Claims 17-27 recite a system. Therefore, the claims are directed to the statutory categories of machine.
Step 2A:
Prong One:
Claim 17-27 merely narrow the previously recited abstract idea limitations. For the reasons described above, this judicial exception is not meaningfully integrated into a practical application, or significantly more than the abstract idea. The claims disclose similar limitations described for the independent claims above and do not provide anything more than the mental process and mathematical calculation that are practically capable of being performed in the human mind with the assistance of pen and paper.
Prong Two:
These judicial exceptions are not integrated into a practical application nor includes additional elements that are sufficient to amount to significantly more. Thus, the claims are ineligible.
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.
Claims 1-3, 5, 8-10, 15-22, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verdonck et al. (US 20020054662 A1) (hereinafter, “Verdonck”) in view of Helm et al. (WO 2020139868 A1) (hereinafter, “Helm”).
Regarding claim 1, Verdonck discloses a method of positioning an imaging system comprising: positioning the imaging system (Paragraph [0001] “a method for imaging the anatomical parts of the human anatomy by means of an X-ray apparatus…the X-ray detector being movable with respect to each other and with respect to the patient so as to enable the acquisition of projection images of the anatomy from different positions and/or orientations.”);
acquiring a first image (initial projection image equates to a first image) (Paragraph [0008] “one initial projection image can be used to reposition the X-ray apparatus automatically for subsequent optimum imaging of the region of interest of anatomical parts.”);
detecting a first body structure (vertebral column equates to a first body structure) in the first image (Paragraph [0001] “imaging the anatomical parts of the human anatomy by means…to an X-ray apparatus having an X-ray source and an X-ray detect or facing the X-ray source”; Paragraph [0037] “at least one initial projection image which preferably includes the vertebral column 20 completely. The overview image is determined from several initial projection images of different portions of the spinal column...the spinal axis line 21 is detected by known measures, and the lateral tilt angles .alpha. of the vertebrae of interest are measured by means of known methods.”);
a target image position (Paragraph [0015] “Optimum imaging parameters are thus determined for the vertebrae from their position and/or orientation in the initial image. This determination of the optimum imaging parameters can be done for each single vertebra or groups of vertebrae”; Paragraph [0045] “detector positions are controlled by image information in order to obtain an optimum view of specific parts of the spinal column automatically. The image information can be used for automatic optimum adjustment of the collimation, the exposure parameters and the projection orientation”);
and moving the imaging system toward the target image position (Paragraph [0010] “the apex vertebrae of a scoliotic curve of the spine, the X-ray apparatus can then automatically acquire snapshots of all parts of interest. It can be translated automatically to align each part with the line-of-sight or it can be zoomed in for optical magnification by reducing the source-object distance or by increasing the detector-object distance.”; Paragraph [0045] “detector positions are controlled by image information in order to obtain an optimum view of specific parts of the spinal column automatically. The image information can be used for automatic optimum adjustment of the collimation, the exposure parameters and the projection orientation”).
However, Verdonck fails to teach determining a first position of the imaging system relative to the first body structure based on the first image; determining a distance to [a target image position] based on the relative position.
Helm teaches determining a first position of the imaging system relative to the first body structure based on the first image (Paragraph [0042] “Accordingly, the imaging device 36 can be tracked relative to the subject 28 as can the instrument 144 to allow for initial registration, automatic registration, or continued registration of the subject 28 relative to the image 40.”);
determining a distance to [a target image position] based on the relative position (Paragraph [0089] “The distance 668 may be used or be identified as the distance d of movement of the imaging system and may be used to alter or determine a plane of focus for each of the intermediate images”; Paragraph [0090] “determining the distance d, which may be a translation distance and is related to the slot filter spacing (e.g. distance 412), focus plane and region of interest in the subject to be imaged”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck’s reference to include determining a first position of the imaging system relative to the first body structure based on the first image; determining a distance to [a target image position] based on the relative position taught by Helm’s reference. The motivation for doing so would have been to allow for registration of the navigation space within a domain and identify the distance of movement for the imaging system to alter or determine a plane of focus as suggested by Helm (see Helm, Paragraph [0039] and Paragraph [0089]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Helm with Verdonck to obtain the invention specified in claim 1.
Regarding claim 2, which claim 1 is incorporated, Verdonck discloses wherein acquiring the first image comprises acquiring the first image comprising a first two-dimensional image (projection image equates to a first two-dimensional image) (Paragraph [0013] “one initial projection image is taken as a lateral or a frontal image. The selection of the direction of the initial projection image depends on the direction of the projection images to be taken and on the specific curvature of the anatomy to be examined.”; Paragraph [0037] “the invention at first a lateral overview image, preferably with a low X-ray dose, is acquired as the at least one initial projection image which preferably includes the vertebral column 20 completely.”).
Regarding claim 3, which claim 1 is incorporated, Verdonck discloses acquiring a second image (snapshots of all parts of interest equates to a second image) at the target position (Paragraph [0010] “the apex vertebrae of a scoliotic curve of the spine, the X-ray apparatus can then automatically acquire snapshots of all parts of interest. It can be translated automatically to align each part with the line-of-sight or it can be zoomed in for optical magnification by reducing the source-object distance or by increasing the detector-object distance.”; Paragraph [0045] “detector positions are controlled by image information in order to obtain an optimum view of specific parts of the spinal column automatically. The image information can be used for automatic optimum adjustment of the collimation, the exposure parameters and the projection orientation”).
Regarding claim 5, which claim 1 is incorporated, Verdonck discloses the target image position based on an anatomical map (Paragraph [0020] “In order to determine the positions and/or orientations of the vertebrae in the initial projection image anatomical landmarks of the vertebrae, in particular the corners and pedicles of the vertebrae, are used.”).
However, Verdonck fails to teach wherein determining the distance comprises determining the distance [to the target image position based on an anatomical map].
Helm teaches wherein determining the distance comprises determining the distance [to the target image position based on an anatomical map] (Paragraph [0089] “The distance 668 may be used or be identified as the distance d of movement of the imaging system and may be used to alter or determine a plane of focus for each of the intermediate images”; Paragraph [0090] “determining the distance d, which may be a translation distance and is related to the slot filter spacing (e.g. distance 412), focus plane and region of interest in the subject to be imaged“).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck’s reference to include determining the distance comprises determining the distance [to the target image position based on an anatomical map] taught by Helm’s reference. The motivation for doing so would have been to identify the distance of movement for the imaging system to alter or determine a plane of focus as suggested by Helm (see Helm, Paragraph [0089]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Helm with Verdonck to obtain the invention specified in claim 5.
Regarding claim 8, which claim 1 is incorporated, Verdonck discloses wherein determining the first body structure comprises determining at least one of an end plate, an edge of an end plate, a full vertebra, a partial vertebra, a skull, a limb, or an organ (Paragraph [0022] “the tilt angles of the vertebrae are determined from the at least one initial projection image and that the projection lines are set parallel to the end plates of the vertebrae.”; Paragraph [0023] “The invention can in general be used for imaging different anatomical parts of the human anatomy. In particular, the invention is suitable for imaging the hip, the lower limbs”).
Regarding claim 9, which claim 1 is incorporated, Verdonck discloses the target image position based on the relative position [comprises determining the distance] to the target image position relative to a second body structure (Paragraph [0010] In a preferred embodiment the optimum exposure and/or collimator settings are determined from the positions, orientations and/or the appearance of the anatomical parts in the at least one initial projection image.”; Paragraph [0015] “Optimum imaging parameters are thus determined for the vertebrae from their position and/or orientation in the initial image. This determination of the optimum imaging parameters can be done for each single vertebra or groups of vertebrae”; Paragraph [0042] “the spinal axis line is shown therein, that is, completely or at least the region of interest of the spinal axis line. From the overview image the spinal axis line is detected or indicated and/or the frontal tilt angles .beta. of some or all vertebrae of interest are measured. Using of this information or the tilt angles .beta. a set of projection lines 188, 189, 190, 191 perpendicular to the spinal axis line is generated. Preferably, one projection line per vertebra is generated.”).
However, Verdonck fails to teach determining the distance.
Helm teaches determining the distance (Paragraph [0089] “The distance 668 may be used or be identified as the distance d of movement of the imaging system and may be used to alter or determine a plane of focus for each of the intermediate images”; Paragraph [0090] “determining the distance d, which may be a translation distance and is related to the slot filter spacing (e.g. distance 412), focus plane and region of interest in the subject to be imaged”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck’s reference to include determining the distance taught by Helm’s reference. The motivation for doing so would have been to identify the distance of movement for the imaging system to alter or determine a plane of focus as suggested by Helm (see Helm, Paragraph [0089]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Helm with Verdonck to obtain the invention specified in claim 9.
Regarding claim 10, which claim 1 is incorporated, Verdonck discloses wherein moving the imaging system toward the target image position comprises moving the imaging system to the target image position (Paragraph [0010] “the apex vertebrae of a scoliotic curve of the spine, the X-ray apparatus can then automatically acquire snapshots of all parts of interest. It can be translated automatically to align each part with the line-of-sight or it can be zoomed in for optical magnification by reducing the source-object distance or by increasing the detector-object distance.”; Paragraph [0045] “detector positions are controlled by image information in order to obtain an optimum view of specific parts of the spinal column automatically. The image information can be used for automatic optimum adjustment of the collimation, the exposure parameters and the projection orientation”).
Regarding claim 15, which claim 1 is incorporated, Verdonck fails to teach wherein moving the imaging system comprises moving an O-arm of the imaging system.
Helm teaches wherein moving the imaging system comprises moving an O-arm of the imaging system (Paragraph [0028] “can include an O-Arm ® imaging system sold by Medtronic Navigation, Inc. having a place of business in Louisville, CO, USA. The imaging system 36, including the O-Arm ® imaging system, or other appropriate imaging systems may be in use during a selected procedure”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck’s reference to include wherein moving the imaging system comprises moving an O-arm of the imaging system taught by Helm’s reference. The motivation for doing so would have been to generate and create images, such as 3D models, with the image data as suggested by Helm (see Helm, Paragraph [0027]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Helm with Verdonck to obtain the invention specified in claim 15.
Regarding claim 16, Verdonck discloses a system to move an imaging system (Paragraph [0001] “a method for imaging the anatomical parts of the human anatomy by means of an X-ray apparatus…the X-ray detector being movable with respect to each other and with respect to the patient so as to enable the acquisition of projection images of the anatomy from different positions and/or orientations.”),
the system comprising: a controller (controller equates to control unit) configured to execute instructions to (Paragraph [0034] The X-ray apparatus, in particular the movement of the C-arm 3 and of the patient table 8, is controlled by a control unit 17.”),
acquire a first image (initial projection image equates to first image) (Paragraph [0008] “one initial projection image can be used to reposition the X-ray apparatus automatically for subsequent optimum imaging of the region of interest of anatomical parts.”);
detect a first body structure (vertebral column equates to first body structure) in the first image (Paragraph [0037] “at least one initial projection image which preferably includes the vertebral column 20 completely. The overview image is determined from several initial projection images of different portions of the spinal column 20.”);
a target image position (Paragraph [0015] “Optimum imaging parameters are thus determined for the vertebrae from their position and/or orientation in the initial image. This determination of the optimum imaging parameters can be done for each single vertebra or groups of vertebrae”; Paragraph [0045] “detector positions are controlled by image information in order to obtain an optimum view of specific parts of the spinal column automatically. The image information can be used for automatic optimum adjustment of the collimation, the exposure parameters and the projection orientation”);
and move the imaging system toward the target image position (Paragraph [0010] “the apex vertebrae of a scoliotic curve of the spine, the X-ray apparatus can then automatically acquire snapshots of all parts of interest. It can be translated automatically to align each part with the line-of-sight or it can be zoomed in for optical magnification by reducing the source-object distance or by increasing the detector-object distance.”; Paragraph [0045] “detector positions are controlled by image information in order to obtain an optimum view of specific parts of the spinal column automatically. The image information can be used for automatic optimum adjustment of the collimation, the exposure parameters and the projection orientation”).
However, Verdonck fails to teach determine a first position of the imaging system relative to the first body structure based on the first image; determine a distance to [a target image position] based on the relative position.
Helm teaches determine a first position of the imaging system relative to the first body structure based on the first image (Paragraph [0042] “ Accordingly, the imaging device 36 can be tracked relative to the subject 28 as can the instrument 144 to allow for initial registration, automatic registration, or continued registration of the subject 28 relative to the image 40.”);
determine a distance to [a target image position] based on the relative position (Paragraph [0089] “The distance 668 may be used or be identified as the distance d of movement of the imaging system and may be used to alter or determine a plane of focus for each of the intermediate images”; Paragraph [0090] “determining the distance d, which may be a translation distance and is related to the slot filter spacing (e.g. distance 412), focus plane and region of interest in the subject to be imaged”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck’s reference to include determine a first position of the imaging system relative to the first body structure based on the first image; determine a distance to [a target image position] based on the relative position taught by Helm’s reference. The motivation for doing so would have been to allow for registration of the navigation space within a domain and identify the distance of movement for the imaging system to alter or determine a plane of focus as suggested by Helm (see Helm, Paragraph [0089]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Helm with Verdonck to obtain the invention specified in claim 16.
Regarding claim 17 (drawn to a system) claim 17 is rejected the same as claim 2 and the argument similar to that presented above for claim 2 are equally applicable to the claim 17, and all the other limitations similar to claim 2 are not repeated herein, but incorporated by reference.
Regarding claim 18, which claim 17 is incorporated, Verdonck discloses wherein the controller is configured to execute instructions to acquire a second image at the target image position based on the first image (Paragraph [0010] “the apex vertebrae of a scoliotic curve of the spine, the X-ray apparatus can then automatically acquire snapshots of all parts of interest. It can be translated automatically to align each part with the line-of-sight or it can be zoomed in for optical magnification by reducing the source-object distance or by increasing the detector-object distance.”; Paragraph [0045] “detector positions are controlled by image information in order to obtain an optimum view of specific parts of the spinal column automatically. The image information can be used for automatic optimum adjustment of the collimation, the exposure parameters and the projection orientation”).
Regarding claim 19, which claim 16 is incorporated, Verdonck discloses wherein the body structure comprises a vertebrate (Paragraph [0037] “at least one initial projection image which preferably includes the vertebral column 20 completely. The overview image is determined from several initial projection images of different portions of the spinal column 20.”).
Regarding claim 20 (drawn to a system) claim 20 is rejected the same as claim 8 and the argument similar to that presented above for claim 8 are equally applicable to the claim 20, and all the other limitations similar to claim 8 are not repeated herein, but incorporated by reference.
Regarding claim 21 (drawn to a system) claim 21 is rejected the same as claim 9 and the argument similar to that presented above for claim 9 are equally applicable to the claim 21, and all the other limitations similar to claim 9 are not repeated herein, but incorporated by reference.
Regarding claim 22 (drawn to a system) claim 22 is rejected the same as claim 5 and the argument similar to that presented above for claim 5 are equally applicable to the claim 22, and all the other limitations similar to claim 5 are not repeated herein, but incorporated by reference.
Regarding claim 24, which claim 16 is incorporated, Verdonck discloses wherein the controller is configured to execute instructions to move the imaging system to the target image position (Paragraph [0010] “the apex vertebrae of a scoliotic curve of the spine, the X-ray apparatus can then automatically acquire snapshots of all parts of interest. It can be translated automatically to align each part with the line-of-sight or it can be zoomed in for optical magnification by reducing the source-object distance or by increasing the detector-object distance.”; Paragraph [0045] “detector positions are controlled by image information in order to obtain an optimum view of specific parts of the spinal column automatically. The image information can be used for automatic optimum adjustment of the collimation, the exposure parameters and the projection orientation”).
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Verdonck et al. (US 2002/0054662 A1) (hereinafter, “Verdonck”) in view of Helm et al. (WO 2020/139868 A1) (hereinafter, “Helm”) further in view of Helm et al. (US 2012/0099768 A1) (hereinafter, “Helm 768”).
Regarding claim 4, which claim 1 is incorporated, Verdonck and Helm fail to teach segmenting the first image to identify the first body structure.
Helm 768 teaches segmenting the first image to identify the first body structure (Paragraph [0038] “A 104 is used to generate the x-rays as opposed to the power source B 106 to generate the x-rays the information detected at the detector 38 can be used to identify or segregate the different types of anatomy or contrast agent being imaged.”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include segmenting the first image to identify the first body structure taught by Helm 786 reference. The motivation for doing so would have been to segregate the different types of anatomy as suggested by Helm 786 (see Helm 786, Paragraph [0038]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Helm 786 with Verdonck and Helm to obtain the invention specified in claim 4.
Regarding claim 6, which claim 1 is incorporated, Verdonck and Helm fail to teach determining the distance to the target image position includes determining a non-linear path.
Helm 786 teaches determining the distance to the target image position includes determining a non-linear path (Paragraph [0035] “the path can be substantially non-symmetrical and/or non-linear based on movements of the imaging system 16, including the gantry 34 and the detector 38 together.”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include determining the distance to the target image position includes determining a non-linear path taught by Helm 786 reference. The motivation for doing so would have been to allow the imaging system to follow the optimal path as suggested by Helm 786 (see Helm 786, Paragraph [0035]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Helm 786 with Verdonck and Helm to obtain the invention specified in claim 6.
Claims 7 and 23 is rejected under 35 U.S.C. 103 as being unpatentable over Verdonck et al. (US 2002/0054662 A1) (hereinafter, “Verdonck”) in view of Helm et al. (WO 2020/139868 A1) (hereinafter, “Helm”) further in view of Cardelino et al. (US 20140357985 A1) (hereinafter, “Cardelino”).
Regarding claim 7, which claim 1 is incorporated, Verdonck fails to teach determining a size of the first body structure based on a three-dimensional image and wherein determining the distance comprises determining the distance based on the size.
Helm teaches determining the distance comprises determining the distance [based on the size] (Paragraph [0089] “The distance 668 may be used or be identified as the distance d of movement of the imaging system and may be used to alter or determine a plane of focus for each of the intermediate images”; Paragraph [0090] “determining the distance d, which may be a translation distance and is related to the slot filter spacing (e.g. distance 412), focus plane and region of interest in the subject to be imaged “).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck’s reference to include determining the distance comprises determining the distance [based on the size] taught by Helm’s reference. The motivation for doing so would have been to identify the distance of movement for the imaging system to alter or determine a plane of focus as suggested by Helm (see Helm, Paragraph [0089]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results.
However, Verdonck and Helm fail to teach determining a size of the first body structure based on a three-dimensional image.
Cardelino teaches determining a size of the first body structure based on a three-dimensional image (Paragraph [0029] “a bone model is calculated by the computer using the x-ray image, wherein the bone model is generated, in particular, from a parameterized model data record, which is adapted to the bone, or wherein the bone model is calculated, in particular, by registering the x-ray image with an anatomical atlas.”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include determining a size of the first body structure based on a three-dimensional image taught by Cardelino’s reference. The motivation for doing so would have been to determine the orientation along an axis of the instrument as suggested by Cardelino (see Cardelino, Paragraph [0066]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Cardelino with Verdonck and Helm to obtain the invention specified in claim 7.
Regarding claim 23 (drawn to a system) claim 23 is rejected the same as claim 7 and the argument similar to that presented above for claim 7 are equally applicable to the claim 23, and all the other limitations similar to claim 7 are not repeated herein, but incorporated by reference.
Claims 11-14 and 25-27 is rejected under 35 U.S.C. 103 as being unpatentable over Verdonck et al. (US 2002/0054662 A1) (hereinafter, “Verdonck”) in view of Helm et al. (WO 2020/139868 A1) (hereinafter, “Helm”) further in view of Koertge (EP 1,834,586 B1).
Regarding claim 11, which claim 1 is incorporated, Verdonck and Helm fail to teach wherein moving the imaging system toward the target image position comprises moving the imaging system while monitoring a safety system and generating a safety signal and changing the moving of the imaging system based on the safety signal.
Koertge teaches wherein moving the imaging system toward the target image position comprises moving the imaging system while monitoring a safety system and generating a safety signal and changing the moving of the imaging system based on the safety signal (Paragraph [0027] “The collision control unit 112 is configured to monitor the actual positions of the C-arm 28, the patient table 24 and the source-image distance (SID) when a collision state is entered.”; Paragraph [0041] “At step 308, a warning is displayed to the operator indicating that a collision zone is entered in an embodiment that employs collision zones or that a collision has occurred in an embodiment that employs collision states.”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include wherein moving the imaging system toward the target image position comprises moving the imaging system while monitoring a safety system and generating a safety signal and changing the moving of the imaging system based on the safety signal taught by Koertge ‘s reference. The motivation for doing so would have been to detect and resolve collision states for imaging systems as suggested by Koertge (see Koertge, Paragraph [0057]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Koertge with Verdonck and Helm to obtain the invention specified in claim 11.
Regarding claim 12, which claim 1 is incorporated, Verdonck and Helm fail to teach wherein changing the moving of the imaging system comprises slowing the moving in response to a collision avoidance signal from a collision sensor.
Koertge teaches teach wherein changing the moving of the imaging system comprises slowing the moving in response to a collision avoidance signal from a collision sensor (Paragraph [0028] “Whenever the x-ray diagnostic system 10 enters a collision zone, the velocity of the axes currently in motion of the x-ray system are reduced… a "collision state" may be detected by one or more system collision sensors 126.”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include wherein changing the moving of the imaging system comprises slowing the moving in response to a collision avoidance signal from a collision sensor taught by Koertge ‘s reference. The motivation for doing so would have been to detect and resolve collision states for imaging systems as suggested by Koertge (see Koertge, Paragraph [0057]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Koertge with Verdonck and Helm to obtain the invention specified in claim 12.
Regarding claim 13, which claim 1 is incorporated, Verdonck and Helm fail to teach wherein changing the moving of the imaging system comprises stopping the moving of the imaging system in response to a collision avoidance signal from a mechanical switch.
Koertge teaches wherein changing the moving of the imaging system comprises stopping the moving of the imaging system in response to a collision avoidance signal from a mechanical switch (the joystick equates to a mechanical switch) (Paragraph [0022] “an operator 102 interfaces with the x-ray diagnostic system 10 via a user interface 124, which comprises a joystick and a dead man's switch. The C-arm 28 is controlled externally by the operator 102 using the joystick. Manipulation of the joystick 124 by the operator 102 creates control data (signals) which are sent to the motion control module 110 via interface connector 220… to control the various motors M1 122a, M2 122b, M3 122c, M4 122d and M5 122e of the x-ray diagnostic system 10, via the second (F2) data interface 116, to move the C-arm 28.”; Paragraph [0042] “the system 10 is automatically switched from normal mode to resolve mode in which all of the motor drives M1-M5 are stopped. To switch the system 10 from normal to resolve mode, the collision control module 112 sends a signal to the motion control module 110 to stop all motion.”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include wherein changing the moving of the imaging system comprises stopping the moving of the imaging system in response to a collision avoidance signal from a mechanical switch taught by Koertge ‘s reference. The motivation for doing so would have been to detect and resolve collision states for imaging systems as suggested by Koertge (see Koertge, Paragraph [0057]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Koertge with Verdonck and Helm to obtain the invention specified in claim 13.
Regarding claim 14, which claim 1 is incorporated, Verdonck and Helm fail to teach wherein changing the moving of the imaging system comprises slowing or increasing the moving of the imaging system in response to a collision avoidance signal from a mechanical switch.
Koertge teaches wherein changing the moving of the imaging system comprises slowing or increasing the moving of the imaging system in response to a collision avoidance signal from a mechanical switch (Paragraph [0027] “Whenever the x-ray diagnostic system 10 enters a collision zone, the velocity of the axes currently in motion of the x-ray system are reduced.”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include wherein changing the moving of the imaging system comprises slowing or increasing the moving of the imaging system in response to a collision avoidance signal from a mechanical switch taught by Koertge ‘s reference. The motivation for doing so would have been to detect and resolve collision states for imaging systems as suggested by Koertge (see Koertge, Paragraph [0057]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Koertge with Verdonck and Helm to obtain the invention specified in claim 14.
Regarding claim 25, which claim 16 is incorporated, Verdonck and Helm fail to teach a safety system and generating a safety signal therefrom, the controller is configured to execute instructions to change the moving of the imaging system based on the safety signal.
Koertge teaches a safety system and generating a safety signal therefrom, the controller is configured to execute instructions to change the moving of the imaging system based on the safety signal (Paragraph [0005] “resolving the collision state by reversing the movement of the x-ray imaging apparatus along the same path”; Paragraph [0027] “The collision control unit 112 is configured to monitor the actual positions of the C-arm 28, the patient table 24 and the source-image distance (SID) when a collision state is entered.”; Paragraph [0035] “they control the various system motors M1-M5 to produce a reverse trajectory of the most recent movements of the C-arm 28…which led to the occurrence of entering the collision state in the first instance...” Paragraph [0041] “a warning is displayed to the operator indicating that a collision zone is entered in an embodiment that employs collision zones…”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include a safety system and generating a safety signal therefrom, the controller is configured to execute instructions to change the moving of the imaging system based on the safety signal taught by Koertge ‘s reference. The motivation for doing so would have been to detect and resolve collision states for imaging systems as suggested by Koertge (see Koertge, Paragraph [0057]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Koertge with Verdonck and Helm to obtain the invention specified in claim 25.
Regarding claim 26, which claim 25 is incorporated, Verdonck and Helm fail to teach wherein the safety system comprises a collision sensor.
Koertge teaches teach wherein the safety system comprises a collision sensor (Paragraph [0028] “a "collision state" may be detected by one or more system collision sensors 126.”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include teach wherein the safety system comprises a collision sensor taught by Koertge ‘s reference. The motivation for doing so would have been to detect and resolve collision states for imaging systems as suggested by Koertge (see Koertge, Paragraph [0057]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Koertge with Verdonck and Helm to obtain the invention specified in claim 26.
Regarding claim 27, which claim 25 is incorporated, Verdonck and Helm fail to teach wherein the safety system comprises a mechanical switch.
Koertge teaches wherein the safety system comprises a mechanical switch (Paragraph [0022] “an operator 102 interfaces with the x-ray diagnostic system 10 via a user interface 124, which comprises a joystick and a dead man's switch. The C-arm 28 is controlled externally by the operator 102 using the joystick. Manipulation of the joystick 124 by the operator 102 creates control data (signals) which are sent to the motion control module 110 via interface connector 220… to control the various motors M1 122a, M2 122b, M3 122c, M4 122d and M5 122e of the x-ray diagnostic system 10, via the second (F2) data interface 116, to move the C-arm 28.”).
Therefore, it would have been obvious to one of ordinary skill of the art before the effective
filing date to modify Verdonck in view of Helm to include teach wherein the safety system comprises a mechanical switch taught by Koertge ‘s reference. The motivation for doing so would have been to detect and resolve collision states for imaging systems as suggested by Koertge (see Koertge, Paragraph [0057]).
Further, one skilled in the art could have combined the elements described above by known methods with no change to the respective functions, and the combination would have yielded nothing more that predictable results. Therefore, it would have been obvious to combine Koertge with Verdonck and Helm to obtain the invention specified in claim 27.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Young et al. (WO 2018/109127 A1) discloses an X-ray imaging system that may automatically adjust its parameters to ensure that the anatomical region is interest is within the field of view.
Johnson et al. (US 2024/0020862 A1) discloses an imaging device used to take 2D images of the patient anatomy. The imaging device includes tracking markers trackable by a tracking device that allows for automatic or semi-automatic positioning of the system.
Homan et al. (WO 2020/193706 A1) discloses positioning an X-ray imaging system for spine interventions, by determining a region of interest within the spine of the subject being imaged.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UROOJ FATIMA whose telephone number is (571)272-2096. The examiner can normally be reached M-F 8:00-5:00.
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, Henok Shiferaw can be reached at (571) 272-4637. 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.
/UROOJ FATIMA/Examiner, Art Unit 2676
/Henok Shiferaw/Supervisory Patent Examiner, Art Unit 2676