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 .
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, 3-4, 8-10, 12-13 and 17-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more. Independent claims 1, 10 and 19 recite the limitations “determining a registration seed; and registering the 3D mesh based on the MRI image to the fluoroscopy image using the registration seed” which falls under the grouping of Mental Processes because a person can mentally determine registration seeds or landmarks and manually align the images using a computer and an input device. The claim further recites “obtaining the fluoroscopy image” which a data gathering step and considered insignificant extra solution activity. The claim does not recite additional limitations that would integrate the abstract idea into a practical application nor provide an inventive concept.
Dependent claims 3 and 12 recite “wherein the fluoroscopy image comprises a tracked biplanar fluoroscopy image” which identifies the image gathered in the data gathering step.
Dependent claims 4 and 13 recite “wherein determining the registration seed comprises determining the registration seed based on user input” which falls under the grouping of Mental Processes because a person can mentally determine the seed or landmark and manually input the seed using an input device.
Dependent claims 8 and 17 recite “transmitting information associated with a registration between the 3D mesh and the fluoroscopy image to a surgical navigation system” which is a data output step that is considered an insignificant extra-solution activity.
Dependent claims 9 and 18 recite “wherein the anatomical feature comprise a spine” which merely states the object of interest in the images that are gathered during the data gathering step.
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 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, 3-4, 6, 8-10, 12-13, 15, 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over D11 and further in view of D22 or in view of D3.3
With regard to claim 1, D1 teach obtaining the fluoroscopy image (see abstract, § 1 ¶ 1); see § 1 ¶ 1: overlaying or registering a 3D mesh extracted from pre-operative 3D volume (CT or MRI) over the intra-operative fluoroscopic images).
D1 teaches registering the images using a bisection method by aligning groups of pixels, but fails to explicitly teach registration using a registration seed. However, D2 teach the missing feature (see ¶¶ 32, 67, 95, 130: registration seeds; see also D3 ¶ 202: registration based on initial seed points).
One skilled in the art before the effective filing date would have found it obvious to combine the teachings to arrive at the claimed invention. In particular, it would have been obvious to incorporate known teachings of registering images based on initial seed points as taught by D2 or D3 into the configuration of D1 by substituting the registration method described in D1 with the seed-based method as taught by D2 and D3, yielding predictable and enhanced results by matching or aligning based on seed points or landmarks.
With regard to claim 3, D1 fails to explicitly teach wherein the fluoroscopy image comprises a tracked biplanar fluoroscopy image, however Examiner take Official Notice to the fact that biplanar fluoroscopy imaging is extremely well known in the art before the effective filing date and would have been particularly obvious to incorporate known teachings of tracked biplanar fluoroscopy image into the configuration of D1 instead of the regular fluoroscopy image described in D1, yielding predictable and enhanced results because the biplanar fluoroscopy uses two X-ray systems (e.g., front/back and side) simultaneously, offering superior, real-time 3D views of complex structures like brain or heart vessels.
With regard to claim 4, D2 and D3 teach registration seed, but fail to explicitly teach wherein determining the registration seed comprises determining the registration seed based on user input, however Examiner takes Official Notice to the fact that user input registration seed is extremely well known in the art before the effective filing date and would have been particularly obvious to incorporate known teaching of allowing the user to input the seed, yielding predictable and enhanced results by reducing the computational expense of automatically detecting seed points or landmark points and instead have the user identify the initial seed point for faster processing and to ensure that accurate seed or landmark is selected based on user expertise.
With regard to claim 6, D2 and D3 fail to explicitly teach wherein determining the registration seed comprises estimating the registration seed using a neural network with the 3D mesh based on the MRI and the fluoroscopy image as input, however Examiner takes Official Notice to the fact that determining landmarks or seed points using a neural network is well known in the art before the effective filing date and would have been particularly obvious to incorporate known teachings into the configuration of D1 yielding predictable and enhanced estimation of seed or landmark points using neural network.
With regard to claim 8, D1 implicitly teach transmitting information associated with a registration between the 3D mesh and the fluoroscopy image to a surgical navigation system (see § 1 ¶ 1: overlaying a 3D mesh extracted from pre-operative 3D volume (CT or MRI) over the intra-operative fluoroscopic images – intra operative fluoroscopy imaging is used during surgical operation to provide guidance to the surgeon).
With regard to claim 9, D1 teach wherein the anatomical feature comprises a see fig. 3). It would have been obvious to apply the teachings of D1 to other objects of interest including the spine. Alternatively, see D2 ¶ 203: spine.
With regard to claims 10 and 19, see discussion of claim 1.
With regard to claims 12-13, 15, 17 and 18, see discussion of corresponding claims above.
Claims 2, 5, 7, 11, 14, 16 and 20 are 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.
Conclusion
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/AVINASH YENTRAPATI/Primary Examiner, Art Unit 2672
1 Thivierge-Gaulin, David, et al. "3D-2D registration based on mesh-derived image bisection." International workshop on biomedical image registration. Berlin, Heidelberg: Springer Berlin Heidelberg, 2012.
2 US Publication No. 2020/0098117.
3 US Publication No. 2011/0107270.