DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a) and under 35 U.S.C. 365(c) is acknowledged.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities: In Claim 1, line 7, “obtaining at one 2D X-ray image” should be “obtaining at least one 2D X-ray image”. Similarly, in claim 4, line 3, “the at one 2D X-ray image” should be “the at least one 2D X-ray image”. Appropriate correction is required.
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 1-13 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.
Regarding Claim 1, there is a broad limitation and narrow limitation in the same claim. As such, it cannot be determined if the narrower limitation is required or not. Specifically, the step of “registering the registration phantom with the 3D medical image using said at least three radiopaque fiducials” is the broader limitation and “determining the position of each of said at least three radiopaque fiducials relative to the 3D medical image based on the determined position of each of said radiopaque fiducials in each 2D X-ray image and on a projection matrix of the X-ray imaging system” is the narrower limitation. Both of these steps are considered to be “registration” steps of the phantom/fiducials with the 3D medical image. During examination, the following claim interpretation is used:
“determining the position of each of said at least three radiopaque fiducials relative to the 3D medical image based on the determined position of each of said radiopaque fiducials in each 2D X-ray image and on a projection matrix of the X-ray imaging system, thereby registering the registration phantom with the 3D medical image
Regarding Claim 3, the limitation “wherein the 3D medical image is reconstructed from a set of 2D images acquired by the X-ray imaging system and the at least one 2D image is selected from said set of 2D images” seems to contradict the parent claim 1. Claim 1 requires “said set of radiopaque fiducials not being detectable in the 3D image”. It would then follow that the radiopaque fiducials also cannot be detected in the 2D images that make up the 3D image (e.g. as shown in Figure 1B by the dotted circle/3D image volume). The scope sought by claim 3 cannot be determined.
Regarding Claim 10, the claim contains the analogous broad/narrow issue as for claim 1 above.
Claims 2, 4-9, 11-13 are rejected based on their dependency upon a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120201421 to Hartmann.
Regarding Claim 1, Hartmann teaches a method for registering a 3D medical image obtained by an X-ray imaging system with a registration phantom (fiducials assembly 100 is a type of registration phantom, X-ray imaging system 26, 28, Figure 9), wherein the registration phantom is positioned onto the patient (attached to the spine, as in Figure 9A) and comprises a set of radiopaque fiducials having a known position in a coordinate system of said registration phantom (140a, 140b, 140c, 140d are radiopaque fiducials having a fixed and known position with respect to each other and other components of the registration phantom), said set of radiopaque fiducials not being detectable in the 3D image (par. 0094), the method comprising:
obtaining at [least] one 2D X-ray image acquired by the X-ray imaging system wherein at least three radiopaque fiducials of the registration phantom are detectable in each 2D image (par. 0095; Figure 6, step 178);
for each obtained 2D X-ray image, registering the 2D X-ray image with the registration phantom by detecting and determining the position of the at least three radiopaque fiducials in the respective 2D image (Figure 6, step 180; par. 0095);
determining the position of each of said at least three radiopaque fiducials relative to the 3D medical image based on the determined position of each of said radiopaque fiducials in each 2D X-ray image and on a projection matrix of the X-ray imaging system (par. 0097, 0108, taking the NO path 320, Figure 12), thereby registering the registration phantom with the 3D medical image [using said at least three radiopaque fiducials] (step 314, Figure 12).
Regarding Claim 2, Hartmann further teaches wherein determining the position of each of said at least three radiopaque fiducials relative to the 3D medical image comprises using the projection matrix to compute, for each 2D X-ray image, back-projection rays from the determined positions of said radiopaque fiducials in the 2D X-ray image (synthetic digital radiograph reconstruction (SDRR) is determined from the 2D X-ray projections, one of ordinary skill recognizes this implicitly relies on back projection to form the SDRR, par. 0108).
Regarding Claim 3, Hartmann further teaches wherein the 3D medical image is reconstructed from a set of 2D images acquired by the X-ray imaging system and the at least one 2D image is selected from said set of 2D images (a 3D image is formed from the 2D images, step 308, Figure 12; see rejection under USC 112(b) above).
Regarding Claim 5, Hartmann further teaches wherein the 3D medical image is reconstructed from a set of 2D images acquired by the X-ray imaging system and the 2D images are acquired with the X-ray imaging system before reconstructing the 3D medical image (the 2D X-ray images are acquired in step 304 before reconstructing the 3D image in step 308, Figure 12).
Regarding Claim 6, Hartmann further teaches wherein a single 2D X-ray image in which at least three radiopaque fiducials of the registration phantom are detectable is obtained (a single 2D image can be used, par. 0095).
Regarding Claim 7, Hartmann further teaches wherein determining the position of each of said at least three radiopaque fiducials relative to the 3D medical image comprises using the projection matrix to compute, for each 2D X-ray image, back-projection rays from the determined positions of said radiopaque fiducials in the 2D X-ray image, and wherein determining the position of each of said at least three radiopaque fiducials relative to the 3D medical image comprises determining the position of each radiopaque fiducial on a respective back-projection ray based on the known position of said radiopaque fiducials in the coordinate system of the registration phantom (synthetic digital radiograph reconstruction (SDRR) is determined from the 2D X-ray projections, one of ordinary skill recognizes this implicitly relies on back projection to form the SDRR, par. 0108).
Regarding Claim 8, Hartmann further teaches wherein at least two 2D X-ray images in which at least three radiopaque fiducials of the registration phantom are detectable are obtained (par. 0095, Figures 9A, 9B, 9C).
Regarding Claim 9, Hartmann further teaches wherein determining the position of each of said at least three radiopaque fiducials relative to the 3D medical image comprises using the projection matrix to compute, for each 2D X-ray image, back-projection rays from the determined positions of said radiopaque fiducials in the 2D X-ray image, and wherein back-projection rays are computed for each radiopaque fiducial for each of the at least two 2D X-ray images, and the position of each radiopaque fiducial relative to the 3D medical image is determined from an intersection between the respective back-projection rays computed for each 2D X-ray image (synthetic digital radiograph reconstruction (SDRR) is determined from the 2D X-ray projections, one of ordinary skill recognizes this implicitly relies on back projection to form the SDRR and by definition, back-projection relies on intersection of all the back-projected rays, par. 0108).
Claim 10 is rejected for the same reasoning as for Claim 1 above.
Regarding Claim 11, Hartmann further teaches wherein the X-ray imaging system is a motorized C-arm (par. 0041).
Regarding Claim 12, Hartmann further teaches a radiotransparent base configured to be attached to the patient’s anatomy (base 102, Figure 3A), said base comprising a fixation system for removably attaching the registration phantom to the base (elements 130, 122 releasably interlock the registration phantom to the base 102).
Regarding Claim 13, Hartmann further teaches a localization system (94, Figure 2) and at least one tracker adapted to be tracked by the localization system (tracker 150, Figure 4A, 4B), the base comprising a fixation system for removably attaching the tracker to the base (122 as in Figure 4B, steps 182, 184, Figure 6).
Allowable Subject Matter
Claim 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or suggest the subject matter of claim 4 wherein a 3D X-ray image is reconstructed from a set of 2D images and then a separate set of 2D images is obtained after reconstructing the 3D X-ray medical image, in combination with the limitations of claim 1, especially wherein the set of radiopaque fiducials is not detected in the 3D X-ray medical image and subsequent registration steps. This gives the advantage of providing supplemental 2D imaging for obese patients, wherein the fiducial tracker may be out of frame of the 3D imaging volume, and still maintaining the high resolution for the 3D image of the medically relevant volume of interest. While Hartmann teaches that the fiducials do not need to be present in each 2D image (or 3D image) in par. 0094, Hartmann does not teach first reconstructing a 3D image and then taking additional 2D images for registration. Instead, Hartmann reconstructs the 3D image from the 2D images (steps 304, 308, Figure 12) and uses the 3D image to determine if further processing is required (steps from 320, 322, 324, 326, 330) to register the images.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 20230146679 to Lavallee teaches projections used to register fiducials, US 8737708 to Hartmann, 20110071389, 8503745 to Simon teach using out of frame fiducials (in a 3D image) to provide registration from their 2D projection information.
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ANGELA M. HOFFA
Primary Examiner
Art Unit 3799
/Angela M Hoffa/Primary Examiner, Art Unit 3799