DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4, 6-8, 12 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 contains the limitation, “the second transformation”. There is a lack of antecedent basis for this limitation. Appropriate corrections are required.
Claim 6 contains the limitation “apply the transformation” It is unclear what “the transformation” is referring to. There are previously claimed first transformation and second transformation. Appropriate corrections are required.
Claim 7 contains the limitation “apply the transformation” It is unclear what “the transformation” is referring to. There are previously claimed first transformation and second transformation. Appropriate corrections are required.
Claim 8 contains the limitation, “the second transformation”. There is a lack of antecedent basis for this limitation. Appropriate corrections are required.
Claim 12 contains the limitation “the transformation” It is unclear what “the transformation” is referring to. There are previously claimed first transformation and second transformation. Appropriate corrections are required.
Claim 18 contains the limitation, “the second transformation”. There is a lack of antecedent basis for this limitation. Appropriate corrections are required.
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 of this title, 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, 10-11, 13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Borsdorf et al. US2019/0057510 hereinafter referred to as Borsdorf in view of Voronenko et al. USPN 10688320 hereinafter referred to as Voronenko.
As per Claim 1, Borsdorf teaches a device for guidance during medical procedures, the device comprising:
a processor configured to: obtain 3D image data of a region of interest of a subject; and current 2D image data of the region of interest; (Borsdorf, Paragraph [0002], “determining a registration between a three-dimensional (3D) image of a region of interest and a set of at least two two-dimensional (2D) images of the same region of interest”)
register the current 2D image data with the 3D image data (Borsdorf, Paragraph [0002], “determining a registration between a three-dimensional (3D) image of a region of interest and a set of at least two two-dimensional (2D) images of the same region of interest”)
generate a projection image from the 3D image data with the
provide the projection image (Borsdorf, Paragraph [0020], “In one embodiment, an initial registration may be used to perform a forward projection of the 3D image or a data set derived from the 3D image, and this forward projection may be compared to the respective 2D image or a data set determined from the respective 2D image”)
Borsdorf does not teach explicitly teach to determine a first transformation; identify non-linear and linear components of the determined first transformation; to apply the identified linear components of the first transformation to the
as guidance during a medical procedure.
Voronenko teaches to determine a first transformation; identify non-linear and linear components of the determined first transformation; to apply the identified linear components of the first transformation to the
as guidance during a medical procedure. (Voronenko, Column 20, Lines 3-20, “Some variations of method (220) may comprise preprocessing the images used for image-guidance”)
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Voronenko into Borsdorf because by utilizing different types of transformations will result in a desirable display of the images acquired to the user.
Therefore it would have been obvious to one of ordinary skill to combine the two references to obtain the invention in Claim 1.
As per Claim 10, Borsdorf in view of Voronenko teaches the system for guidance during medical interventions, comprising:
the device for guidance during medical procedures according to claim 1; and
an image data source configured to provide the 3D image data of the region of a region of interest of the subject; (Borsdorf, Paragraph [0020] and [0069])
a medical imaging system configured to provide the current 2D image data of the region of interest of the subject; and(Borsdorf, Paragraph [0020] and [0069])
a display arrangement is configured to present the projection image as the guidance during the medical procedure. (Voronenko, Column 20, Lines 3-20, “Some variations of method (220) may comprise preprocessing the images used for image-guidance”)
The rationale applied to the rejection of claim 1 has been incorporated herein.
As per Claim 11, Borsdorf in view of Voronenko teaches the system according to claim 10, wherein the medical imaging system is provided as an X-ray imaging system configured to provide the current 2D image data as 2D X-ray image data; wherein the processor is configured to generate the projection image with a viewing direction aligned to a viewing direction of the 2D X-ray image data; and wherein the X-ray imaging system is configured to further generate the 3D image data of the subject. (Borsdorf, Paragraph [0020] and [0069])
The rationale applied to the rejection of claim 10 has been incorporated herein.
As per Claim 13, Claim 13 claims a method utilizing the device as claimed in Claim 1. Therefore the rejection and rationale are analogous to that made in Claim 1.
As per Claim 15, Claim 15 claims a non-transitory computer readable medium having stored the a computer program comprising instructions which, when executed by a processor executes the method as claimed in Claim 13. Therefore the rejection and rationale are analogous to that made in Claim 13.
Claims 2, 5, 7, 16, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Borsdorf et al. US2019/0057510 hereinafter referred to as Borsdorf in view of Voronenko et al. USPN 10688320 hereinafter referred to as Voronenko as applied to Claims 1, 13 and 15 respectively and further in view of Siewerdsen et al. US2021/0256716 hereinafter referred to as Siewerdsen.
As per Claim 2, Borsdorf in view of Voronenko teaches the device according to claim 1, wherein the data input processor is further configured to:obtain the current 2D image data as 2D X- ray image data; (Borsdorf, Paragraph [0011])
generate the projection image with a viewing direction aligned to a viewing direction of the 2D X-ray image data; (Borsdorf, Paragraph [0020])
Borsdorf in view of Voronenko does not explicitly teach obtain the 3D image data as pre-operative 3D image data;
provide the projection image as a digitally reconstructed radiograph visualization.
Siewardsen teaches obtain the 3D image data as pre-operative 3D image data; (Siewerdsen, Paragraph [0003], “the method comprises in a preoperative stage, obtaining one or more 3D models of one or more structures from one or more CT images using an image processing segmentation technique or a manual segmentation technique; in the preoperative stage”)
provide the projection image as a digitally reconstructed radiograph visualization. (Siewardsen, Paragraph [0003])
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Siewardsen into Borsdorf in view of Voronenko because by providing a radiograph visualization will result in displaying the image data in a desirable manner.
Therefore it would have been obvious to one of ordinary skill to combine the three references to obtain the invention in Claim 2.
As per Claim 5, Borsdorf in view of Voronenko teaches the device according to claim1, wherein the processor is configured to:
Borsdorf in view of Voronenko does not explicitly teach overlay the transformed representation of the device to the generated projection image; provide the transformed representation as a fluoro-like overlay to the generated projection image.
Siewerdsen teaches overlay the transformed representation of the device to the generated projection image; provide the transformed representation as a fluoro-like overlay to the generated projection image. (Siewerdsen, Paragraph [0020], “FIG. 3A, FIG. 3B, and FIG. 3C show a multi-body 3D-2D registration and guidance according to examples of the present teachings. FIG. 3A shows an AP x-ray image, such as a fluoroscopic image, of a pelvis with left innominate fracture (two-body fracture at the ilium wing). The DRR Canny edges 302 of the two fragments, the right innominate and sacrum registration overlaid on the x-ray image, such as a fluoroscopic image, show close alignment”)
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Siewardsen into Borsdorf in view of Voronenko because by providing a fluoro-like overlay will result in displaying the image data in a desirable manner.
Therefore it would have been obvious to one of ordinary skill to combine the three references to obtain the invention in Claim 5.
As per Claim 7, Borsdorf in view of Voronenko teaches the device according to one of the preceding claims claim 1, wherein the data input processor is further configured to: provide obtain a 3D model of the device that is adapted to the segmented representation of the device; (Borsdorf, Paragraph [0016]) and wherein the data processor is configured: to apply the transformation to the 3D model of the device; (Voronenko, Column 20, Lines 3-20) and
Borsdorf in view of Voronenko does not explicitly teach to provide a projection of the model overlaid to the generated projection image.
Siewerdsen teaches to provide a projection of the model overlaid to the generated projection image. (Siewerdsen, Paragraph [0020])
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Siewardsen into Borsdorf in view of Voronenko because by providing an overlay will result in displaying the image data in a desirable manner.
Therefore it would have been obvious to one of ordinary skill to combine the three references to obtain the invention in Claim 7.
As per Claim 16, Claim 16 claims the same limitation as Claim 2 and is dependent on a similarly rejected independent claim. Therefore the rejection and rationale are analogous to that made in Claim 2.
As per Claim 19, Claim 19 claims the same limitation as Claim 2 and is dependent on a similarly rejected independent claim. Therefore the rejection and rationale are analogous to that made in Claim 2.
Claims 3-4, 6, 12, 17-18 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Borsdorf et al. US2019/0057510 hereinafter referred to as Borsdorf in view of Voronenko et al. USPN 10688320 hereinafter referred to as Voronenko as applied to Claims 1, 10, 13 and 15 respectively and further in view of Ben-Yishai US2024/0081921.
As per Claim 3, Borsdorf in view of Voronenko teaches the device according to claim 1, wherein the processor is further configured to:
Borsdorf in view of Voronenko does not explicitly teach obtain the current image comprising image data relating to an interventional device inserted in the region of interest;
perform a segmentation for the current 2D image data to identify a representation of the device;
apply a second transformation to the representation of the device; and to the transformed representation of the device with the generated projection image.
Ben-Yishai teaches obtain the current image comprising image data relating to an interventional device inserted in the region of interest; (Ben-Yishai, Paragraph [0004])
perform a segmentation for the current 2D image data to identify a representation of the device; (Ben-Yishai, Paragraph [0004] and [0117])
apply a second transformation to the representation of the device; and to the transformed representation of the device with the generated projection image. (Ben-Yishai, Paragraph [0005], “In another example, a body part that is being operated on and which is present in a model employed during the procedure, may move relative to another body part present in the model, and that was used for registration (e.g., brain shift during brain surgery). In such cases, an initially determined transformation between coordinate systems may be erroneous in the area being operated on”)
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Ben-Yishai into Borsdorf in view of Voronenko because by providing tracking of a device and also utilizing transformation of image data will result in displaying desirable data to the user.
Therefore it would have been obvious to one of ordinary skill to combine the three references to obtain the invention in Claim 3.
As per Claim 4, Borsdorf in view of Voronenko teaches the device according to claim 1,
non-linear component(Voronenko, Column 20, Lines 3-20, “In some variations T may be non-linear, and the dose and fluence prediction equations may need to be updated based on this.”)
Borsdorf in view of Voronenko does not explicitly teach wherein the processor is configured to provide the second transformation as an inverse of the component of the first transformation.
Ben-Yishai teaches wherein the processor is configured to provide the second transformation as an inverse of the component of the first transformation. (Ben-Yishai, Paragraph [0005])
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Ben-Yishai into Borsdorf in view of Voronenko because by providing tracking of a device and also utilizing transformation of image data will result in displaying desirable data to the user.
Therefore it would have been obvious to one of ordinary skill to combine the three references to obtain the invention in Claim 4.
As per Claim 6, Borsdorf in view of Voronenko teaches the device according to claim 1,wherein the processor is further configured to:
Borsdorf in view of Voronenko does not explicitly teach provide the representation of the device comprising a segmented image portion of the 2D image;
and apply the transformation to the segmented image portion.
Ben-Yishai teaches provide the representation of the device comprising a segmented image portion of the 2D image; (Ben-Yishai, Paragraph [0004] and [0117])
and apply the transformation to the segmented image portion. (Ben-Yishai, Paragraph [0005])
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Ben-Yishai into Borsdorf in view of Voronenko because by providing tracking of a device and also utilizing transformation of image data will result in displaying desirable data to the user.
Therefore it would have been obvious to one of ordinary skill to combine the three references to obtain the invention in Claim 6.
As per Claim 8, Borsdorf in view of Voronenko teaches the device according to claim 1,wherein the data input processor is further configured to:
Borsdorf in view of Voronenko does not explicitly teach obtain tracking data of an external tracking device tracking an interventional device inserted in the region;
track the interventional device in relation to the subject based on the tracking data; to align the coordinate space of the tracked device with an imaging coordinate space; to apply the second transformation to a graphical representation of the device; and to the transformed representation of the device with the generated projection image.
Ben-Yishai teaches obtain tracking data of an external tracking device tracking an interventional device inserted in the region; (Ben-Yishai, Paragraph [0200], [0028], [0005])
track the interventional device in relation to the subject based on the tracking data; to align the coordinate space of the tracked device with an imaging coordinate space; to apply the second transformation to a graphical representation of the device; and to the transformed representation of the device with the generated projection image. (Ben-Yishai, Paragraph [0200], [0028], [0005])
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Ben-Yishai into Borsdorf in view of Voronenko because by providing tracking of a device and also utilizing transformation of image data will result in displaying desirable data to the user.
Therefore it would have been obvious to one of ordinary skill to combine the three references to obtain the invention in Claim 8.
As per Claim 12, Borsdorf in view of Voronenko teaches the system according to claim 10,
Borsdorf in view of Voronenko does not explicitly teach wherein the processor is further configured to obtain external tracking comprising at least one of electromagnetic tracking and optical tracking of an interventional device;
wherein the electromagnetic tracking is applied for registration and determination of the transformation when subject remains in place; and wherein the current 2D image data is used for registration and determination of the transformation when relative movement occurs.
Ben-Yishai teaches wherein the processor is further configured to obtain external tracking comprising at least one of electromagnetic tracking and optical tracking of an interventional device; (Ben-Yishai, Paragraph [0200], [0028])
wherein the electromagnetic tracking is applied for registration and determination of the transformation when subject remains in place; and wherein the current 2D image data is used for registration and determination of the transformation when relative movement occurs. (Ben-Yishai, Paragraph [0200], [0028], [0005])
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Ben-Yishai into Borsdorf in view of Voronenko because by providing tracking of a device and also utilizing transformation of image data will result in displaying desirable data to the user.
Therefore it would have been obvious to one of ordinary skill to combine the three references to obtain the invention in Claim 12.
As per Claim 17, Claim 17 claims the same limitation as Claim 3 and is dependent on a similarly rejected independent claim. Therefore the rejection and rationale are analogous to that made in Claim 3.
As per Claim 18, Claim 18 claims the same limitation as Claim 8 and is dependent on a similarly rejected independent claim. Therefore the rejection and rationale are analogous to that made in Claim 8.
As per Claim 20, Claim 20 claims the same limitation as Claim 3 and is dependent on a similarly rejected independent claim. Therefore the rejection and rationale are analogous to that made in Claim 3.
As per Claim 21, Claim 21 claims the same limitation as Claim 8 and is dependent on a similarly rejected independent claim. Therefore the rejection and rationale are analogous to that made in Claim 8.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Borsdorf et al. US2019/0057510 hereinafter referred to as Borsdorf in view of Voronenko et al. USPN 10688320 hereinafter referred to as Voronenko as applied to Claim 1 and further in view of Bydlon et al. US2022/0079683 hereinafter referred to as Bydlon.
As per Claim 9, Borsdorf in view of Voronenko teaches the device according to claim 1,
Borsdorf in view of Voronenko does not explicitly teach wherein the region of interest comprises anatomical structures comprising at least one of the group of: airways, lungs, hearts and cardiac vascular structures.
Bydlon teaches wherein the region of interest comprises anatomical structures comprising at least one of the group of: airways, lungs, hearts and cardiac vascular structures. (Bydlon, Paragraph [0059], “Referring to FIG. 2, tracking system 200 is provided for registering an OSS device with a previously obtained 3D representation of a region of interest. The tracking system 200 includes an optical shape sensing device 100 acting as an interventional instrument, such as a catheter and/or a guidewire, as discussed above with reference to FIG. 1. The optical shape sensing device 100 is insertable within a passage 255 in a region of interest 256, which includes at least a portion of an object 250 (e.g., the heart) of a subject (e.g., patient)”)
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to implement the teachings of Bydlon into Borsdorf in view of Voronenko because by providing tracking of a device through regions of interests such as the claimed group above will result in displaying desirable data to the user.
Therefore it would have been obvious to one of ordinary skill to combine the three references to obtain the invention in Claim 9.
Conclusion
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/MING Y HON/Primary Examiner, Art Unit 2666
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