DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The abstract of the disclosure is objected to because it contains legal phraseology (“said”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 15-16 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 claims 15-16, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5, 7-15, and 17-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Woo et al. (US 2024/0144498 A1, May 2, 2024) (hereinafter “Woo”).
Regarding claim 1: Woo discloses a method for processing medical image data of a patient’s body, the method being performed by at least one processor and comprising: obtaining medical image data comprising at least two two-dimensional medical images, each depicting, at least, two or more common anatomical elements of the patient’s body from a known viewing direction, the known viewing direction differing between the at least two two-dimensional medical images ([0059]-[0060] - AP and LL are "known viewing direction differing between the at least two two-dimensional medical images"; [0061] - first and second ROIs which are vertebral bones; figs. 4-7); determining, based on the at least two two-dimensional medical images comprised in the medical image data and based on the known viewing directions, a first spatial pattern indicative of first three-dimensional positions of the two or more common anatomical elements ([0063]-[0064]); obtaining a second spatial pattern indicative of second three-dimensional positions of a plurality of anatomical elements of the patient’s body, said plurality of anatomical elements comprising the two or more common anatomical elements ([0063]-[0064]); and determining a mapping between the first spatial pattern and the second spatial pattern to associate at least one of the first three-dimensional positions with at least one of the second three-dimensional positions ([0068]-[0087], figs. 9-13).
Regarding claim 3: Woo discloses the method of claim 1, wherein the second spatial pattern and/or one or more of the second three-dimensional positions are associated with predefined anatomical information, the method further comprising: assigning, based on the determined mapping, at least a part of the predefined anatomical information to one or more of: {a} the associated at least one of the first three-dimensional positions, {b} at least one of the common anatomical elements, {c} one or more of the two-dimensional medical images, {d} the medical image data ([0061], [0064]-[0065] - vertebral bones and/or spinous process is "predefined anatomical information" where spinous process is set as the center of the ROI and is aligned with the center line of the ROI; [0088]-[0092], figs. 13-15).
Regarding claim 5: Woo discloses the method of claim 3, wherein the predefined anatomical information comprises at least one predefined label that is associated with one of the plurality of anatomical elements, and wherein assigning at least a part of the predefined anatomical information comprises assigning the at least one predefined label ([0061], fig. 5).
Regarding claim 7: Woo discloses the method of claim 1, further comprising determining, for at least one of the common anatomical elements, the first three-dimensional position based on a segmentation of the at least one of the common anatomical elements in one or more of the at least two two-dimensional medical images ([0061]-[0063] - identification and extraction of the vertebral bones is "a segmentation" , fig. 5).
Regarding claim 8: Woo discloses the method of claim 1, further comprising: determining, for at least one of the common anatomical elements, a first outline or bounding box in a first one of the two-dimensional medical images and a second outline or bounding box in a second one of the two-dimensional medical images, wherein the first three-dimensional position of the at least one of the common anatomical elements is determined based on {i} the first outline or bounding box and {ii} the second outline or bounding box ([0061]-[0063] - "rectangular region of interest"; figs. 5-7).
Regarding claim 9: Woo discloses the method of claim 8, wherein the first three-dimensional position of the at least one of the common anatomical elements is determined based on {i} a first projection of the first outline or bounding box associated with the first one of the two-dimensional medical images and {ii} a second projection of the second outline or bounding box associated with the second one of the two-dimensional medical images ([0061]-[0063] - vertices of rectangular ROI, [0066], [0068]-[0078], fig. 9).
Regarding claim 10: Woo discloses the method of claim 9, wherein the first three-dimensional position of the at least one of the common anatomical elements is determined based on a three-dimensional position of a virtual intersection volume of the first projection and the second projection ([0061]-[0063] - vertices of rectangular ROI, [0066], [0068]-[0078], fig. 9).
Regarding claim 11: Woo discloses the method of claim 10, wherein a three-dimensional position of a center of the virtual intersection volume is used as the first three-dimensional position of the at least one of the common anatomical elements ([0071]-[0078], figs. 9 and 10).
Regarding claim 12: Woo discloses the method of claim 1, wherein the second spatial pattern is determined based on reference image data of at least the plurality of anatomical elements ([0059] - DRR generated from CT image, [0060] - real AP and LL images acquired, [0061]-[0063] - ROI set using DRR which is "reference image data").
Regarding claim 13: Woo discloses the method of claim 12, wherein at least one or each of the second three-dimensional positions is determined based on a segmentation of one of the plurality of anatomical elements as represented by the reference image data ([0059] - DRR generated from CT image, [0060] - real AP and LL images acquired, [0061]-[0063] - ROI set using DRR which is "reference image data").
Regarding claim 14: Woo discloses the method of claim 12, further comprising determining a registration between the medical image data and the reference image data based on the mapping (figs. 10-14, [0085]-[0090] - registration between AP and LL, which represent both 2D images and DRR images, mapped back to CT volume).
Regarding claim 15: Woo discloses the method of claim 1, wherein the first spatial pattern comprises a first virtual geometrical object defined by the first three-dimensional positions and the second spatial pattern comprises a second virtual geometrical object defined by the second three-dimensional positions, wherein determining the mapping optionally comprises optimizing an alignment between the first virtual geometrical object and the second virtual geometrical object ([0061]-[0064] - in the absence of any further limitations, the identified vertebrae as shown in fig. 5 are "virtual geometrical objects", [0108]).
Regarding claim 17: Woo discloses the method of claim 1, wherein the anatomical elements correspond to vertebrae of the patient’s spine ([0061]-[0063], figs. 5-8).
Regarding claim 18: Woo discloses a system for processing medical image data of a patient’s body, the system comprising at least one processor (processor 13, [0050]) configured to: obtain medical image data comprising at least two two-dimensional medical images, each depicting, at least, two or more common anatomical elements of the patient’s body from a known viewing direction, the known viewing direction differing between the at least two two-dimensional medical images ([0059]-[0060] - AP and LL are "known viewing direction differing between the at least two two-dimensional medical images"; [0061] - first and second ROIs which are vertebral bones; figs. 4-7); determine, based on the at least two two-dimensional medical images comprised in the medical image data and based on the known viewing directions, a first spatial pattern indicative of first three-dimensional positions of the two or more common anatomical elements ([0063]-[0064]); obtain a second spatial pattern indicative of second three-dimensional positions of a plurality of anatomical elements of the patient’s body, said plurality of anatomical elements comprising the two or more common anatomical elements ([0063]-[0064]); and determine a mapping between the first spatial pattern and the second spatial pattern to associate at least one of the first three-dimensional positions with at least one of the second three-dimensional positions ([0068]-[0087], figs. 9-13).
Regarding claim 19: Woo discloses the system of claim 18, further comprising at least one of the following entities: i) a medical imaging apparatus configured to acquire the medical image data and/or the reference image data; and ii) a feedback unit, such as a display, configured to output a visualization (fig. 1).
Regarding claim 20: Woo discloses a non-transitory computer-readable storage medium storing a computer program ([0049]) comprising instructions which, when executed by at least one processor, cause the at least one processor to: obtain medical image data comprising at least two two-dimensional medical images, each depicting, at least, two or more common anatomical elements of the patient’s body from a known viewing direction, the known viewing direction differing between the at least two two-dimensional medical images ([0059]-[0060] - AP and LL are "known viewing direction differing between the at least two two-dimensional medical images"; [0061] - first and second ROIs which are vertebral bones; figs. 4-7); determine, based on the at least two two-dimensional medical images comprised in the medical image data and based on the known viewing directions, a first spatial pattern indicative of first three-dimensional positions of the two or more common anatomical elements ([0063]-[0064]); obtain a second spatial pattern indicative of second three-dimensional positions of a plurality of anatomical elements of the patient’s body, said plurality of anatomical elements comprising the two or more common anatomical elements ([0063]-[0064]); and determine a mapping between the first spatial pattern and the second spatial pattern to associate at least one of the first three-dimensional positions with at least one of the second three-dimensional positions ([0068]-[0087], figs. 9-13).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Woo in view of Cohen et al. (US 2023/0240628 A1, Aug. 3, 2023) (hereinafter “Cohen”).
Regarding claims 2 and 4: Woo discloses the method of claims 1 and 3, including providing a display for surgical navigation and real-time positioning ([0024], [0115], fig. 15) but are silent on the specific content of the display.
Cohen, in the same field of endeavor, discloses a method of registering 2D and 3D images comprising determining a mapping (registration) between the images (fig. 6 and all associated description) including triggering display of a visualization comprising at least one of the two-dimensional medical images and information that is based on the mapping, wherein the information that is based on the mapping comprises an indication of the assigned part of the predefined anatomical information (fig. 6, [0449], figs. 24A-B, [0641]-[0645]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the surgical navigation and guidance of Woo using a display as taught by Cohen in order to provide the user with a visualization of the target site, the anatomy surrounding the target site, and the real-time position of the tool(s) relative to the target site so that the user may successfully navigate the surgical tool(s) during the procedure.
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 16 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799