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 .
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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, 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.
Claims 1 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dick (US 20060036397 A1) “Dick” in view of Lui (US 20180168735 A1) “Lui”.
1. Dick teaches: A computer-implemented method (“METHOD AND DEVICE FOR ASCERTAINING A POSITION OF A CHARACTERISTIC POINT” [TITLE] with a “computer system” [0019]) for determining a surface registration between a first soft tissue surface defined based on mechanically acquired first surface data ("various points on the surface of the body (e.g., on the skin or on a substance lying on the skin, wherein the skin is not injured or pierced) that are in the general area of the characteristic point 28 can be identified by the tip 27 of the instrument 26, and those points can be recorded." [0034] FIG 3.) wherein the first surface data comprise a first set of points mechanically acquired by contacting the soft tissue with a pointing device ("pointer or probe" [0026]; “using the tip 27 of the instrument 26, a plurality of points can be recorded by moving the tip 27 of the instrument 26 to an area of the skin lying over or around a characteristic point 28, e.g., a characteristic point 28 of the hip 30 of FIG. 2. Once the tip 27 is on or near the characteristic point 28, the tip 27 is pressed onto the skin and the instrument 26 is pivoted 32 about the tip 27, thus signifying to the system 10 that the present point should be recorded.” [0029]);
Dick does not explicitly teach a second soft tissue surface defined based on image data;
applying a correction model on the first surface data to obtain corrected first surface data, wherein the correction model is configured to shift relative positions of two or more points in the first set; and determining a first surface registration between the first and the second soft tissue surfaces based at least in part on the corrected first surface data.
However, in a similar field of endeavor, Lui teaches: a second soft tissue surface defined based on image data ("extracting a surface from the patient image" [0008]);
applying a correction model on the first surface data to obtain corrected first surface data, wherein the correction model is configured to shift relative positions of two or more points in the first set ("the processor instead computes a transform that minimizes the deviation in alignment between the extracted fiducials from the patient image and the fiducial points on the patient."; [0071]); and determining a first surface registration between the first and the second soft tissue surfaces based at least in part on the corrected first surface data ( two spaces become coupled with the transform enabling the registration of objects from the physical space to the image space. [0066] by "iteratively applying a cost minimization function to the initial set of fiducial points with arguments being the sum of spatial deviances" [0071] as shown in FIGs 7 and 9.) .
The points on the first surface which have been probed by Dick yielding a physical space representation can be modified by Lui to further include a patient image.
The motivation for the combination is provided by Lui “help reduce visible occlusions of the patient image”
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
12. The method of claim 1, wherein multiple different correction models configured to shift relative positions of two or more points in the first set are provided, and wherein the method further comprises: applying each of the different correction models to the first surface data to obtain different versions of the corrected first surface data, wherein the first surface registration is determined based at least in part on the different versions of the first surface data ("a subsequent iteration may produce the transform 802 that when applied to the fiducial points 708 produces the alignment of points"; “The processor may then execute the cost minimization function to compare the sum of the deviances” [0071 of Lui].).
The points in the first set can be processed with different correction models to provide different versions of surface data.
The motivation for the combination is provided by Lui to iterate “and select the one with the lowest value for the next iteration and so on until the deviation value falls below a certain threshold value”. [0071].
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
13. The method of claim 12, wherein a surface registration is determined for each of the different versions of the first surface data and the first surface registration is determined based on respective registration accuracies of the surface registrations determined for the different versions of the first surface data (to "select the one with the lowest value for the next iteration and so on until the deviation value falls below a certain threshold value”. [0071] of Lui.) .
The registration of data can be modified by Lui to achieve more accurate results.
The motivation for the combination is provided by Lui “for improvements upon existing systems through the addition of refinement steps used to increase the accuracy of registration” [ABSTRACT].
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
14. The method of claim 13, wherein the respective registration accuracies are based on distances between each registered point and the second soft tissue surface for the respective registration (FIG. 5 of Lui shows accuracies based on distances between registered points. [0062-0065].
The distances of registration of data can be modified by Lui to achieve more accurate results.
The motivation for the combination is provided by Lui “for improvements upon existing systems through the addition of refinement steps used to increase the accuracy of registration” [ABSTRACT].
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
15. The method of claim 1, further comprising: obtaining second surface data, wherein the second surface data comprise a second set of points mechanically acquired by contacting the soft tissue with the pointing device; applying the correction model on the second surface data to obtain corrected second surface data, wherein the correction model is configured to shift relative positions of two or more points in the second set; and determining a second surface registration between the first and the second soft tissue surfaces based at least in part on the corrected first surface data, the corrected second surface data, and the first surface registration ("a subsequent iteration may produce the transform 802 that when applied to the fiducial points 708 produces the alignment of points"; “The processor may then execute the cost minimization function to compare the sum of the deviances”; to "select the one with the lowest value for the next iteration and so on until the deviation value falls below a certain threshold value”. [0071] of Lui.) .
The data from the surface can be modified to include a second set of data.
The motivation for the combination is provided by Lui “for improvements upon existing systems through the addition of refinement steps used to increase the accuracy of registration” [ABSTRACT].
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
16. The method of claim 15, further comprising reapplying the correction model on the first surface data to obtain revised corrected first surface data, wherein the second surface registration is determined based at least in part on the revised corrected first surface data, the corrected second surface data, and the first surface registration (“The processor may then execute the cost minimization function to compare the sum of the deviances”; to "select the one with the lowest value for the next iteration and so on until the deviation value falls below a certain threshold value”. [0071] of Lui.) .
The data from the surface can be modified to include corrections to the data.
The motivation for the combination is provided by Lui “for improvements upon existing systems through the addition of refinement steps used to increase the accuracy of registration” [ABSTRACT].
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
17. The non-transitory computer storage medium of claim 17 has been analyzed in view of the “computer readable medium” [0010] and “processor [0011] of Dick and further in view of claim 1. Claim 17 is rejected in a similar manner to claim 1.
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
18. The surgical system of claim 18 has been analyzed in view of the system in FIG. 1 of Dick [0014] and further in view of claim 1. Claim 18 is rejected in a similar manner to claim 1.
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
19. The surgical system of claim 18, further comprising a pointing device configured to mechanically acquire the first set of points ("one or more characteristic points or landmarks of a body structure are identified to the navigation system. More particularly, a tip of a pointer" [0006] of Dick.) .
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
20. The surgical system of claim 19, further comprising: a tracker attached or attachable to the pointing device; and a surgical tracking system configured to track the tracker ("FIG. 1 schematically shows a medical navigation system 10 for implementing the method in accordance with the invention." [0021] of Dick. “The markers are coupled to the reference star 22, and the reference star is coupled to the body structure 24, the system can determine the three-dimensional position of the body structure 24” [0023] of Dick.) .
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Dick (US 20060036397 A1) “Dick” in view of Lui (US 20180168735 A1) “Lui” and further in view of Gliner (US 2020/0226759 A1) “Gliner”
2. Dick and Lui teach the method of claim 1, having a correction model.
Dick and Lui do not explicitly teach wherein the correction model is configured to determine a correction vector for at least one of the points in the first set, wherein the correction vector defines a shift relative to one or more further points in the first set.
However in a similar field of endeavor, Gliner teaches: wherein the correction model is configured to determine a correction vector for at least one of the points in the first set, wherein the correction vector defines a shift relative to one or more further points in the first set (" assigning a weight to each respective component of the Euclidean distance vector, and registering the first and second coordinate systems includes using, at each predefined location, the assigned weights to each of the respective components" [0008]) .
The first and second set of data from Dick and Lui can be modified by Gliner to include a correction vector for registration of mechanical data to image data.
The motivation for the combination is provided by Gliner “the processor carries out the registration using the respective weights, by applying a suitable registration method, such as the iterative closest point (ICP) method. The registration process typically estimates a transformation between the two coordinate systems, in which measurements at locations having small distance to the closest bone tissue are given high weight, and vice versa. Due to their high accuracy, the disclosed techniques enable, for example, improved navigation of a sinuplasty surgical tool, which is inserted into the patient head and comprises another position sensor of the position-tracking system.” [0021-0022].
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
6. The method of claim 2, wherein a maximum length of the correction vector is predefined ("The processor may then execute the cost minimization function to compare the sum of the deviances for each result 1030 and 1035 and select the one with the lowest value for the next iteration and so on, until the deviation value falls below a certain threshold value or meets some alternately defined criteria." [0078] of Lui. The threshold is a maximum length of the correction vector.) .
The points on the first surface yielding a physical space representation can be modified by Lui to further limit the length of a correction vector.
The motivation for the combination is provided by Lui “help reduce visible occlusions of the patient image”.
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Dick (US 20060036397 A1) “Dick” in view of Lui (US 20180168735 A1) “Lui” in view of Gliner (US 2020/0226759 A1) “Gliner” and further in view of Stopp (US 2025/0040993 A1) “Stopp”.
3. Dick, Lui, and Gliner teach: The method of claim 2
Dick, Lui, and Gliner do not explicitly teach: wherein an earlier surface registration has been determined prior to the first surface registration and based at least in part on the first surface data, and wherein the correction vector is determined based at least in part on the earlier surface registration.
However, in an analogous field of endeavor, Stopp teaches: wherein an earlier surface registration has been determined prior to the first surface registration and based at least in part on the first surface data, and wherein the correction vector is determined based at least in part on the earlier surface registration ("the contour has moved with respect to its initial registered position, indicating that the registration is invalid, the method according to the first aspect may further include the step of determining, based on the deviation data, deviation-characteristics data describing at least one characteristic of the spatial relation between the current spatial position described in the matching data and the spatial position described in the observation data" [0033]) .
The registration of Dick, Lui, and Gliner can be modified by Stopp to correct earlier registered position data.
The motivation for the combination is provided by Stopp “it is crucial that the patient model remains correctly registered for the entire duration of the procedure, so that medical appliances and instruments are correctly operated with respect to the patient's anatomy” [0002],
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
4. The method of claim 2, wherein the correction vector is oriented normal to the first soft tissue surface (FIG. 2 of Stopp shows that a probe can be positioned normal to a surface.") .
At the time of the Applicants invention there had been a recognized need to probe a surface.
There are a finite number of angles for which to probe the surface.
One having ordinary skill in the art could probe the surface normal the surface to reduce the likelihood of angular positional deviations of the probe with a reasonable expectation of success.
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dick (US 20060036397 A1) “Dick” in view of Lui (US 20180168735 A1) “Lui” in view of Gliner (US 2020/0226759 A1) “Gliner” and further in view of Williamson (US 2008/0118115 A1) “Williamson”.
5. Dick, Lui, and Gliner teach the method of claim 2.
Dick, Lui, and Gliner do not explicitly teach:
wherein: obtaining the first surface data comprises determining, for at least one of the points in the first set, an angle between the pointing device and a surface normal of the first soft tissue surface when the pointing device contacts the soft tissue at the respective point, and the correction vector is determined based at least in part on the angle determined for the point associated with the respective correction vector.
However, Williamson in an analogous field of endeavor teaches: obtaining the first surface data comprises determining, for at least one of the points in the first set, an angle between the pointing device and a surface normal of the first soft tissue surface when the pointing device contacts the soft tissue at the respective point, and the correction vector is determined based at least in part on the angle determined for the point associated with the respective correction vector (" probe angle and probe depth are used to access a site in the brain, generally in conjunction with previously compiled three-dimensional diagnostic images" [0010]) .
The probe of Dick can be modified by Williamson to determine an angle between the probe and a surface.
The motivation for the combination is provided by Williamson “to establish a surface boundary for a region of interest depict in the image and configured to determine a position of the tool or implant with respect to the surface boundary” [ABSTRACT].
Therefore, the Applicant’s claimed invention would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention and the claim is rejected.
Allowable Subject Matter
Claims 7-11 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.
The closest reference of record is Dick (US 20060036397 A1). In the Applicant’s dependent claims 7-11 the reference of Dick does not teach: wherein at least one of the points in the first set is associated with a respective point on a hard tissue surface located beneath the soft tissue surface, wherein the step of obtaining the first surface data comprises determining, for the at least one of the points in the first set, a distance between the respective point in the first set and the associated point on the hard tissue surface, and wherein the correction vector is determined based at least in part on the distance determined for the point in the first set associated with the correction vector.
Dick fails to directly anticipate or render the above underlined limitations obvious (to be used with other claimed limitations).
Relevant Prior Art
US 2019/0060004 A1
Abstract
A surgical navigation system and method for identifying positions on a patient, including a processor, and a tracking system for tracking a pointer tool. The processor is programmed to initialize a surface trace acquisition, continuously record the positions of the pointer tool during the surface, conduct trace acquisition, combine the positions recorded during the surface trace acquisition into a surface trace, receive a patient image of the patient, extract a surface from the patient image, compute a registration transform between the surface traces and the surface for patient registration, segment the patient image into a regions where each region contains an anatomical landmark, determine a spatial distribution of surface traces among the regions; determine whether the spatial distribution in relation to each region minimizes deviance below a threshold, and if the determination is exceeding the threshold, provide information relating to such region.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TED W BARNES whose telephone number is (571)270-1785. The examiner can normally be reached Mon-Fri. 8:00-5:00.
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/TED W. BARNES/ Ph.D. Electrical Engineering
Primary Examiner
Art Unit 2682
/TED W BARNES/ Primary Examiner, Art Unit 2682
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