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/Continuity
Number
Filing Date
Type
Support
Notes
63291906
12/20/2021
provisional
Not vetted
No intervening art
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/30/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 1-13) in the reply filed on 06/30/2025 is acknowledged. Claims 14-42 are withdrawn from consideration.
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.
Claim(s) 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Leung (US 20200197100) in view of Ketcha (US 20170178349) and Yang (US 20130060146).
Regarding claim 1:
Leung teaches: a method of registering initial image data of a spine of a patient to intraoperative data of the spine (¶ [0005] “a method of performing intraoperative registration between intraoperative surface data and pre-operative volumetric image data associated with a subject”) the method comprising:
registering a single target vertebra in the initial image data to the target vertebra in the intraoperative data (¶ [0067] “…registration is performed for a single selected spinal level of interest, resulting in a single registration transform between the pre-operative surface data and intraoperative surface data associated with a single selected spinal level. As a consequence of this local registration that is specific to a single selected spinal level, navigation accuracy can be maintained at the selected spinal level, because the selected spinal level consists of a single rigid body (e.g. a solid vertebrae).”);
estimating a pose of at least one other vertebra of the spine (¶ [0145] “…the position and orientation of the adjacent spinal level, relative to that of the pre-selected spinal level, is known. “; ¶ [0152] – ¶ [0157]; ¶ [0154] “…the inter-level transform from the volumetric frame of reference is a valid approximation of the spatial relationship between adjacent levels in the intraoperative frame of reference”; ¶ [0155] “…the inter-level transform (obtained from the volumetric frame of reference) may be applied to the locations of the intraoperative fiducial points associated with the region associated with the pre-selected spinal level in the intraoperative frame of reference, such that the intraoperative fiducial points are transformed to the region associated with the adjacent spinal level, in a manner similar to the illustration in FIG. 10A. Registration may then be performed between the adjacent segmented surface data and the intraoperative surface data, where the adjacent volumetric fiducial points and adjacent intraoperative fiducial points are used to perform an initial registration, followed by a surface-to-surface registration, to obtain the per-level registration transform.”; ¶ [0157] “This method may be repeated to generate the intraoperative fiducial points for all of the relevant spinal levels (including the first spinal level and the second spinal level), thereby generating a set of per-level intraoperative fiducial points, where errors introduced by the use of the inter-level transforms are iteratively corrected both by using the inter-level registration transforms and snapping the points into the intraoperative surface, as described above.”);
While Leung discloses estimated pose of the other vertebra in ¶[0145] “…the position and orientation of the adjacent spinal level… is known.”);
Leung does not specifically teach: comparing a pose of the at least one other vertebra in the intraoperative data to the estimated pose of the at least one other vertebra to compute a registration metric for the registration of the target vertebra in the initial image data to the target vertebra in the intraoperative data.
However, in the same field of endeavor, Ketcha teaches computing a registration quality metric for a target local registration by an express comparison or analysis using adjacent regions’ pose outputs, including:
metric and registration quality measure (¶ [0030] “assign a confidence measure for the accuracy in registration at each sub-region to detect and correct failures…”); comparison or analysis using adjacent regions (other vertebra regions): (¶ [0030] “…the 6-DOF output from adjacent regions is used to project each label and analyze the point cloud of projected locations to ensure that nearby regions are deforming in a similar manner…”);
confidence reinforced based on the analysis (¶ [0031] “…This point cloud provides information… thus reinforcing the confidence in registration for those regions…”);
Ketcha is directed to the same field of image-guided spinal procedures as Leung and describes a spinal surgery embodiment, including that local rigidity of vertebrae is preserved and that a masked CT registration workflow is performed in intraoperative radiographs (see ¶[0043]–¶[0044]).
Accordingly, Leung provides the “estimated pose” of an adjacent vertebra via the inter-level transform (Leung ¶[0145]), and Ketcha provides the claimed “comparison to compute metric” by expressly using adjacent regions’ 6-DOF outputs (pose outputs) to project each label into the intraoperative image domain and analyze or compare the resulting point cloud of projected locations to ensure nearby regions deform similarly, and by assigning a confidence measure for the accuracy in registration (Ketcha ¶[0030]–¶[0031]).
Further, because Ketcha assigns the confidence measure “at each sub-region,” the confidence measure for the target sub-region corresponds to a registration metric for the registration of the target vertebra (Ketcha ¶[0030]).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Leung to incorporate the teachings of Ketcha by including: comparing a pose of the at least one other vertebra in the intraoperative data to the estimated pose of the at least one other vertebra to compute a registration metric for the registration of the target vertebra… in order to improve reliability and detect registration failure (i.e., by using Ketcha’s adjacent-region 6-DOF output projection and point-cloud analysis to generate and/or reinforce a confidence measure for registration accuracy).
While Leung further implies that the “criterion” in ¶ [0107] corresponds to a threshold, Leung in view of Ketcha does not explicitly disclose if the registration metric is less than a threshold tolerance, retaining the registration of the target vertebra in the initial image data to the target vertebra in the intraoperative data; and if the registration metric is greater than the threshold tolerance, identifying the registration of the target vertebra in the initial image data to the target vertebra in the intraoperative data as an ill-registration.
However, in a related field, Yang also teaches: if the registration metric is less than a threshold tolerance, retaining the registration of the target vertebra in the initial image data to the target vertebra in the intraoperative data (¶ [0159] “The confidence criteria can, for example, be a fixed registration error threshold or variable registration error threshold that can be set, for example, by the surgeon preoperatively or inter-operatively.”, ¶ [0164]-¶ [0167] disclose retaining the registration when it is occurring within a pre-set confidence);
and if the registration metric is greater than the threshold tolerance, identifying the registration of the target vertebra in the initial image data to the target vertebra in the intraoperative data as an ill-registration (¶ [0157] – ¶ [0159] disclose use of confidence criteria to determine if registration is occurring within a pre-set confidence criteria; if not intervention may be sought to provide additional data; Therefore, Yang retains the registration when it is occurring within a pre-set confidence (below threshold), and when it does not meet the pre-set confidence (above threshold when the error does not converge) Yang teaches corrective intervention similar to ill-registration. Also see ¶ [0035] “FIG. 14 is a flow diagram of an example implementation of a method of intraoperative surgical feedback guidance, including error checking and corrective intervention.”; ¶ [0040] “FIG. 19 demonstrates an iterative registration error as it convergences to the pre-defined confidence criteria of one optical topology dataset to a CT surface registration dataset.”; ¶ [0084] “The controller can further include a confidence criteria module to determine if registration is occurring within a pre-set confidence criteria, and if not, intervention may be sought to provide additional data to be used in intraoperatively registering.”).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Leung in view of Ketcha to incorporate the teachings of Yang by including: if the registration metric is less than a threshold tolerance, retaining the registration of the target vertebra in the initial image data to the target vertebra in the intraoperative data; and if the registration metric is greater than the threshold tolerance, identifying the registration of the target vertebra in the initial image data to the target vertebra in the intraoperative data as an ill-registration in order to ensure robust intra-operative registration quality. The result of this combination using known techniques yields to predicable improvement.
Regarding claim 2:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
Leung teaches: wherein the at least one other vertebra is adjacent to the target vertebra (¶ [0147] “…the inter-level transform between the pre-selected spinal level and the adjacent spinal level may be employed to determine locations“; and see ¶ [0152] – ¶ [0157]).
Regarding claim 3:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
Leung teaches: wherein the intraoperative data comprises intraoperative image data (¶ [0065] “…The surface registration provides a registration transform that relates the pre-operative volumetric image data from the pre-operative frame of reference to an intraoperative frame of reference associated with the surface detection system”. Also Yang discloses intraoperative image data in ¶ [0071] – [0073]).
Regarding claim 4:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
wherein the estimated pose is a first estimated pose, wherein the registration metric is a first registration metric, and wherein, if the registration metric is greater than the threshold tolerance (Leung ¶ [0107] “…For example, automatic re-registration implementation may be performed if the motion between any two time points is sufficiently small that a registration quality measure (computed using the previous registration transform to register the pre-operative surface data with the newly acquired intraoperative surface data) satisfies a criterion. In the event that the registration quality measure fails to satisfy the criterion (such as exceeding a registration error metric), the system can prompt the operator to provide new fiducial locations to support the re-registration process.”; Yang ¶ [0157] – [0159] disclose use the confidence criteria during registration, determine if registration is occurring within a pre-set confidence criteria, if not, intervention may be sought to provide additional data to be used in intraoperatively registering), the method further comprises:
reregistering the target vertebra in the initial image data to the target vertebra in the intraoperative data (Leung ¶ [0067] disclose registration is performed for a single selected spinal level … resulting in a single registration transform …utilized at any given time during navigation. The re-registration process in Leung necessarily re-performs the registration of that target level and updates the transform);
estimating a second pose of the at least one other vertebra (Leung ¶ [0150] – ¶ [0157], similarly after re-registering, the pose estimation is performed),;
comparing the pose of the at least one other vertebra in the intraoperative data to the estimated second pose of the at least one other vertebra to compute a second registration metric (Leung [0107]- ¶ [0108] and Yang [0160] – ¶ [0162]);
if the second registration metric is less than the threshold tolerance, retaining the reregistration of the target vertebra in the initial image data to the target vertebra in the intraoperative data; and if the second registration metric is greater than the threshold tolerance, identifying the reregistration of the target vertebra in the initial image data to the target vertebra in the intraoperative data as an ill-registration (Yang ¶ [0159] “The confidence criteria can, for example, be a fixed registration error threshold or variable registration error threshold that can be set, for example, by the surgeon preoperatively or inter-operatively.”, ¶ [0164]-¶ [0167] disclose retaining the registration when it is occurring within a pre-set confidence; ¶ [0157] – ¶ [0159] disclose use of confidence criteria to determine if registration is occurring within a pre-set confidence criteria; if not intervention may be sought to provide additional data; Therefore, Yang retains the registration when it is occurring within a pre-set confidence (below threshold), and when it does not meet the pre-set confidence (above threshold when the error does not converge) Yang teaches corrective intervention similar to ill-registration. Also see ¶ [0035] “FIG. 14 is a flow diagram of an example implementation of a method of intraoperative surgical feedback guidance, including error checking and corrective intervention.”; ¶ [0040] “FIG. 19 demonstrates an iterative registration error as it convergences to the pre-defined confidence criteria of one optical topology dataset to a CT surface registration dataset.”; ¶ [0084] “The controller can further include a confidence criteria module to determine if registration is occurring within a pre-set confidence criteria, and if not, intervention may be sought to provide additional data to be used in intraoperatively registering.”).
Regarding claim 5:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
wherein, if the registration metric is greater than the threshold tolerance, the method further comprises performing the registering, the estimating, and the comparing until the registration metric is less than the threshold tolerance (Leung ¶ [0107] and ¶ [0157] disclose re-registering and iterative correction; Yang ¶ [0160] – ¶ [0162], ¶ [0159], ¶ [0164] – ¶ [0167] disclose iteration until metric less than threshold).
Regarding claim 6:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
continuously performing the registering, the estimating, and the comparing to continuously register the initial image data to the intraoperative data of the spine during a spinal surgical procedure (Leung ¶ [0066] – ¶ [0067] and ¶ [00107] disclose continuous performance of comparing and re-registering and re-estimating as the case evolves. Yang in ¶ [0157] – ¶ [0159] and ¶ [0164] – ¶ [0167] disclose ongoing execution of comparing and accepting or retying logic during the procedure).
Regarding claim 7:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
wherein registering the target vertebra in the initial image data to the target vertebra in the intraoperative data is based on commonly identified points in the initial image data and the intraoperative data (¶ [0108], ¶ [0152], ¶ [0156] disclose registration based on commonly identified points (number of points that are matched; fiducials). Yang in ¶ [0160] – ¶ [0162] RMS of matched points pairs ties registrations to points correspondences between initial (CT) and intra-operative datasets).
Regarding claim 8:
Leung in view of Ketcha and Yang teaches the limitations of claim 7 as applied above.
wherein the commonly identified points comprise a number of points such that the registering is under constrained (¶ [0129] “…if three or more of the same features are detected in both pre-operative surface data and the intraoperative surface data, then the detected features can be employed as fiducial points when performing an initial landmark-based registration prior to surface-to-surface registration” if fewer than three, it is implied to be under constraint; ¶ [0131] “input is received from a user identifying, in the pre-operative surface data, at least three volumetric fiducial points associated with a pre-selected spinal level that is expected to be exposed during the surgical procedure”. Yang in ¶ [0125] discloses that M points >=3 for initial transform, and in ¶ [0129] discusses subsampling/minimum points required. In ¶ [0131] discloses when the surface topology is relatively slowly varying (i.e. smooth), this method can assign more points to prominent surface features. Therefore, it can improve the accuracy of registering surfaces that are mostly smooth with sparse features).
Regarding claim 9:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
wherein the at least one other vertebra comprises a single vertebra (Leung ¶ [0152] – ¶ [0153] and ¶ [0145], disclose computing and using an inter-level transform between the target (selected) level and one adjacent level, and only then repeats for the next level. ).
Regarding claim 10:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
wherein the at least one other vertebra comprises multiple vertebrae (Leung ¶ [0145] – ¶ [0146], ¶ [0152], and ¶ [0156] disclose that the process does not stop at one level, and it continues to other levels to obtain per-level transforms across the chain of adjacent levels. ).
Regarding claim 11:
Leung in view of Ketcha and Yang teaches the limitations of claim 10 as applied above.
wherein the registration metric is a composite value representative of the comparison of the poses of the multiple vertebrae in the intraoperative data to the estimated poses of the multiple vertebrae (Leung ¶ [0108] and ¶ [0146] disclose applying metrics across multiple levels and permitting them to be used “on combination”, and combining per-vertebra comparisons (errors, standard deviations, matched points) into a single composite value that reflects the registration quality across multiple vertebrae. Yang in ¶ [0160] – [0162] and ¶ [0164] – ¶ [0167] disclose computing composite value of RMS which aggregates the differences across all matched point pairs in to a single representative metric).
Regarding claim 12:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
wherein estimating the pose of the at least one other vertebra includes computationally overlaying the initial image data of the at least one other vertebra over the intraoperative data (Leung ¶ [0023] – ¶ [0025] and ¶ [0123] disclose registering pre-operative (initial) to intra-operative data and then displays the results as superimposed/navigational views. Yang ¶ [0102] discloses characterizing the intra-operative output as “co-registered images” generated from the combination of the pre-operative and intra-operative dataset ).
Regarding claim 13:
Leung in view of Ketcha and Yang teaches the limitations of claim 1 as applied above.
wherein the initial image data is medical scan data (Leung ¶ [0065] “The surface registration provides a registration transform that relates the pre-operative volumetric image data from the pre-operative frame of reference to an intraoperative frame of reference associated with the surface detection system”).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WASSIM MAHROUKA whose telephone number is (571)272-2945. The examiner can normally be reached Monday-Thursday 8:00-5:00 EST.
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/WASSIM MAHROUKA/Primary Examiner, Art Unit 2665