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 § 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.
Claims 1-11, 14-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable Bova et al. (2006/0212044) in view of Lavallee et al. (2022/0370152). Bova et al. disclose the invention substantially as claimed. Bova et al. disclose, at least in figures 4-7 and [0018], [0032], [0047]-[0052], [0055], [0059], [0072]-[0075], [0078]-[0083], and [0089]-[0093]; a method for determining a patient-specific marker arrangement (e.g., for markers such as surgical site markers, external reference markers, optical markers, according to para. [0072] and [0078]) for a tracker (e.g., 200, 300, 400, 500) of a surgical tracking system, wherein the marker arrangement is defined by marker positions, the method comprising: receiving three-dimensional image data of a patient (according to para. [0018], [0032], and [0089]); obtaining, based on the three-dimensional image data, planning data for a surgical intervention (e.g., multistage surgeries {0036], biopsy procedure [0050]); and determining the marker arrangement for the tracker based at least on the obtained planning data (according to para. [0072]); wherein the method further comprises generating manufacturing instructions for manufacturing the marker arrangement as determined based at least on the obtained planning data (according to para. [0093]); wherein the manufacturing instructions comprise at least one of printing instructions and instructions for additive manufacturing (e.g., fused deposition modeling, three-dimensional printing, according to para. [0081] and [0093]; wherein the method further comprises determining a surface of the patient based on the three-dimensional image data (according to para. [0070]), wherein the marker arrangement is determined also based on the determined surface of the patient; wherein determining the marker arrangement comprises virtually arranging one or more markers on the determined surface of the patient (e.g., by registration to scalp, according to para. [0078]); wherein the planning data are indicative of an anatomical region of interest of the patient (e.g., a scalp); wherein determining the marker arrangement comprises virtually arranging one or more markers relative to the anatomical region of interest; wherein the planning data are indicative of a planned trajectory of a surgical instrument (according to para. [0075]); wherein determining the marker arrangement comprises virtually arranging one or more markers relative to the planned trajectory; wherein the planning data are indicative of a planned incision (e.g., a deep incision, according to para. [0075]); wherein the step of determining the marker arrangement comprises virtually arranging one or more markers relative to the planned incision; wherein the tracker comprises a substrate (e.g., materials according to para. [0084]-[0087]) supporting the marker arrangement, the method further comprising determining a shape of the substrate based on the planning data (according to para. [0034]); wherein the three-dimensional image data have been captured by an imaging apparatus (e.g., a CT or MRI scanner, according to para. [0032]), the method further comprising receiving positional data indicative of a position of the imaging apparatus when capturing the three-dimensional image data, wherein the marker arrangement is determined based on the positional data (according to para. [0078]); wherein the step of determining the marker arrangement takes into account a criterion related to a minimum distance between markers (I.e., the “relative positions of the markers…are known,” according to para. [0078]); and wherein the marker arrangement is determined based on the determined region of the three-dimensional image data.
Bova et al. also disclose a computer program product (computer code, according to para. [0059] and [0091]) stored on non-transitory computer-readable medium (e.g., within a Linux workstation, according to para. [0091]) and comprising instructions (e.g., instructions or software, according to para. {0055]) that, when executed on at least one processor (a computer), cause the at least one processor to carry out the steps of: receiving three-dimensional image data of a patient; obtaining, based on the three-dimensional image data, planning data for a surgical intervention; and determining a patient-specific marker arrangement for a tracker of a surgical tracking system based at least on the obtained planning data, wherein the marker arrangement is defined by marker positions (according to para. [0078]).
Bova et al. further disclose an apparatus (e.g., a stereotactic workstation or a Linux workstation, according to para. [0040] and [0091]) for determining a patient-specific marker arrangement for a tracker of a surgical tracking system, wherein the marker arrangement is defined by marker positions, wherein the apparatus is configured to: receive three-dimensional image data of a patient; obtain, based on the three-dimensional image data, planning data for a surgical intervention; and determine the marker arrangement for the tracker based at least on the obtained planning data; and wherein the apparatus further comprises a manufacturing device (e.g., a 3-dimensional printer or modeler, according to para. [0081] and [0083]-[0086]) configured to manufacture the tracker with the determined marker arrangement.
However, Bova et al. do not explicitly disclose that the planning data are indicative of a planned position of a signal generator or signal detector of the surgical tracking system relative to a patient anatomy represented in the three-dimensional image data, wherein the method includes determining a region of the three-dimensional image data that has a line-of-sight to the signal generator or signal detector based on the planning data. Lavallee et al. teach, at least in para. [0108]-[0111] and [0117]-[0119], planning data (pre-operative planning for registered 3D image representing a position of interest in a patient) for a surgical intervention that are indicative of a planned position of a signal generator (e.g., from a tracker in a surgical instrument, according to para. [0111] and [0119]) of a surgical tracking system relative to a patient anatomy represented in three-dimensional image data (i.e., an intraoperative 3D medical image according to para. [0108]) wherein the method includes determining a region of the three-dimensional image data that has a line-of-sight to the signal generator or signal detector based on the planning data (I.e., “[t]he instrument tracker is also in the field of view of the localization camera,” according to para. [0118]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to modify the method of Bova et al., so that the planning data are indicative of a planned position of a signal generator or signal detector of the surgical tracking system, wherein the method includes determining a region of the three-dimensional image data that has a line-of-sight to the signal generator or signal detector. Such modifications would allow optimal positioning of a surgical instrument for implementing a planned surgical procedure.
Response to Amendment
Applicant’s arguments with respect to claims 1-11, 14-18, and 20 have been considered but are moot in view of new grounds of rejection.
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.
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/JULIAN W WOO/Primary Examiner, Art Unit 3771