DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 03/05/2026. As indicated by the amendment: claims 18, 22 and 27 have been amended. In response to the amendments of claim 18, 22 and 27, their rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn. In response to the amendment of claim 22, its rejection under 35 U.S.C. 101 has been withdrawn. Claims 2-28 are presently pending in the application.
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.
Claim(s) 2, 5, and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paladini (US 2013/0172739 A1) in view of Sauer et al. (US 2003/0117393 A1).
Regarding claim 2, Paladini discloses a spatial registration system comprising: a gamma ray sensor (12/22; par. [0052]); a ranging sensor (14/24; par. [0046]); one or more processors (30); and data storage (32) having instructions stored thereon that, when executed by the one or more processors (30), cause the spatial registration system to perform operations comprising: obtaining a relative position between the gamma ray sensor and the ranging sensor (par. [0045], [0049] and [0070]-[0071]); creating a three-dimensional (3D) model of a surface of an object scanned by the ranging sensor (par. [0116]-[0120]); determining a spatial position and orientation of the gamma ray sensor with respect to the 3D model (par. [0066] and [0116]-[0120]); and associating scanning data from the gamma ray sensor with the spatial position and orientation to create a spatially registered scan (par. [0116]-[0120]).
However, Paladini does not specifically disclose the system comprising a head-mounted apparatus comprising a display; and visualizing the spatially registered scan via the head-mounted apparatus display. Sauer teaches an analogous system comprising a head-mounted apparatus (24; Fig. 1; par. [0016]) comprising a display (on 24; par. [0016]), wherein the operator visualizes a spatially registered scan via the head-mounted apparatus display (par. [0020] and [0025]-[0026]). It would have been obvious to one having ordinary skill in the art to utilize a head-mounted display for the operator to view the 3D models, as taught by Sauer, in order to eliminate the need for the operator to look back and forth between the monitor and patient during a procedure, such that the operator can better focus on the surgical site and procedure.
Regarding claim 5, Paladini in view of Sauer disclose the spatial registration system of claim 2, wherein the gamma ray sensor (12/22) is rigidly coupled to the ranging sensor (14/24; par. [0046]).
Regarding claim 8, Paladini in view of Sauer disclose the spatial registration system of claim 2, wherein the gamma ray sensor (12/22; par. [0064]) is handheld (Fig. 4).
Regarding claim 9, Paladini in view of Sauer disclose the spatial registration system of claim 2, wherein the gamma ray sensor (12/22) is carried by a robotic arm (36; Fig. 7; par. [0081]-[0084]).
Regarding claim 10, Paladini in view of Sauer disclose the spatial registration system of claim 2, wherein the operations further comprise: constructing a 2D or 3D model of a radioactive tracer with respect to the object using the spatially registered scan (par. [0085]; [0102] and [0116]-[0118]); and visualizing, via the head-mounted apparatus display (Sauer: 24), the 2D or 3D model of the radioactive tracer (par. [0116]-[0119]).
Regarding claim 11, Paladini in view of Sauer disclose the spatial registration system of claim 2, wherein the object includes a body of a patient, and wherein the operations further comprise guiding a human or robotic operator to move a medical instrument to a particular point on or within the patient’s body using the 3D model of the surface of the object (par. [0125]-[0126]).
Claim(s) 3 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paladini in view of Sauer as applied to claim 2 above, and further in view of Morita et al. (US 2005/0289472 A1).
Regarding claim 3, Paladini in view of Sauer disclose the spatial registration system of claim 2, wherein the user’s viewpoint is tracked to provide the augmented stereoscopic view (Sauer: par. [0025]-[0026]), it does not specifically disclose wherein the operations further comprise determining a position and orientation of the head-mounted apparatus relative to the 3D model, and transforming the spatially registered scan based on the position and orientation of the head-mounted apparatus relative to the 3D model. Morita teaches an analogous spatial registration system wherein infrared sensors are provided on the head-mounted apparatus (54) that track the position and orientation of the viewer’s eye (par. [0022]). The processor (16) uses this position and orientation information to determine the point of view and viewing direction of the viewer and displays the stereoscopic images from the point of view and viewing direction of the viewer, such that when the viewer moves its head, an updated view of the 3D image is displayed (par. [0022] and [0027]). It would have been obvious to one having ordinary skill in the art to include the infrared sensors on the head-mounted display of modified Paladini in order to determine the point of view and viewing direction of the viewer such when the viewer moves its head, an updated view of the 3D image is displayed, as taught by Morita, thereby providing the user with accurate imaging.
Regarding claim 6, Paladini in view of Sauer disclose the spatial registration system of claim 2, wherein the user’s viewpoint is tracked to provide the augmented stereoscopic view (Sauer: par. [0025]-[0026]), it does not specifically disclose wherein the head-mounted apparatus comprises a tracking component configured to track a relative position of the gamma ray sensor, the ranging sensor, or both with respect to the head-mounted apparatus. Morita teaches an analogous spatial registration system wherein infrared sensors are provided on the head-mounted apparatus (54) that track the position and orientation of the viewer’s eye (par. [0022]). The processor (16) uses this position and orientation information to determine the point of view and viewing direction of the viewer and displays the stereoscopic images from the point of view and viewing direction of the viewer, such that when the viewer moves its head, an updated view of the 3D image is displayed (par. [0022] and [0027]). It would have been obvious to one having ordinary skill in the art to include the infrared sensors on the head-mounted display of modified Paladini in order to determine the point of view and viewing direction of the viewer such when the viewer moves its head, an updated view of the 3D image, comprising data from the gamma ray sensor and the ranging sensor, is displayed, as taught by Morita, thereby providing the user with accurate imaging.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paladini in view of Sauer as applied to claim 2 above, and further in view of Wendler et al. (US 2010/0266171 A1).
Regarding claim 7, Paladini in view of Sauer disclose the spatial registration system of claim 2, but does not specifically disclose it further comprising a tracking system separate from the head-mounted apparatus, the tracking system configured to determine a relative position of the head-mounted apparatus and the gamma ray sensor, the ranging sensor, or both. Wendler teaches an analogous spatial registration system comprising an external tracking system (200; Fig. 3; par. [0050]-[0051]) configured to determine a relative position of the various instruments and devices that are tracked by the tracking system. Wendler teaches that data from the external tracking system is combined with data from other sensors to generate a three dimensional image (par. [0069]). It would have been obvious to one having ordinary skill to include the external tracking system of Wendler in the system of modified Paladini in order to align data from the sensors with the point of view and viewing direction of the viewer, thereby providing the operator with accurate imaging of the surgical site.
Claim(s) 22-24 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paladini (US 2013/0172739 A1) in view of Sauer et al (US 6,891,518 B2).
Regarding claim 22, Paladini discloses a method of directing a medical procedure, the method comprising: providing a sensor probe (12/22; par. [0052]); providing a ranging sensor (14/24; par. [0046]) rigidly attached (par. [0046]) to the sensor probe(12/22) or adapted to be connected with a part of a body of a user; and calculating a current position and orientation of the sensor probe with respect to an object using data captured by the ranging sensor (par. [0045], [0049] and [0069]-[0071]).
However, Paladini does not specifically disclose providing a head-mounted display; and visualizing on the head-mounted display a location of an item of interest or a previously saved position and orientation of a sensor probe with respect to [[the]] a medical instrument or the sensor probe using the calculated current position and orientation. Sauer teaches an analogous system comprising a head-mounted display (201; Figs. 2a-2b; col. 5, ll. 5-15) and visualizing on the head-mounted display a location of an item of interest (col. 5, ll. 48-65) or a previously saved position and orientation of a sensor probe with respect to the medical instrument or sensor probe using the calculated current position and orientation. It would have been obvious to one having ordinary skill in the art to utilize a head-mounted display for the operator to view the 3D models, as taught by Sauer, in order to eliminate the need for the operator to look back and forth between the monitor and patient during a procedure, such that the operator can better focus on the surgical site and procedure.
Regarding claim 23, Paladini in view of Sauer disclose the method of claim 22, wherein the visualizing includes displaying a graphical guiding element (Sauer: col. 7, ll. 45-48).
Regarding claim 24, Paladini in view of Sauer disclose the method of claim 22, wherein the visualizing involves overlaying models of medical instruments, numerical and graphical indicators (Sauer: col. 7, ll. 45-48), 3-D anatomical models, ultrasound images and/or models over a body of a patient.
Regarding claim 26, Paladini in view of Sauer disclose the method of claim 22, wherein the visualizing is responsive to hand and finger movements of the user (par. [0045] and [0126] – as 12/14 is moved or repositioned for scanning the patient, the captured images displayed changes).
Regarding claim 27, Paladini in view of Sauer disclose the method of claim 22, further comprising moving the medical instrument or sensor probe in response to the visualizing (par. [0126]; Sauer: col. 7, ll. 45-48 – moving in response to graphical guides).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paladini in view of Sauer as applied to claim 22 above, and further in view of Sauer et al. (US 2003/0117393 A1; hereinafter referred to as “Sauer-2”).
Regarding claim 25, Paladini in view of Sauer disclose the method of claim 22, but does not specifically disclose wherein the visualizing includes displaying previously saved protocols or stereotactic markers. Sauer-2 teaches an analogous method wherein visualizing includes displaying stereotactic markers (interpreted as 3D markers) of targets that have been located and recorded by the operator (par. [0028]-[0029]). It would have been obvious to one having ordinary skill in the art to display stereotactic markers of targets that have been located and recorded by the operator in order to verify the target before treatment.
Allowable Subject Matter
Claims 12-21 and 28 allowed. The prior art of record does not disclose, or otherwise render obvious, the spatial registration system comprising a head-mounted apparatus having an inwardly facing display and at least one outwardly facing camera configured to capture images of an object and one ore more images of a sensor probe, wherein a relative position and orientation of the sensor probe with respect to the head-mounted apparatus is based on one or more captured images of the sensor probe, in combination with the other elements to the claim. Although modified Sauer teaches a head-mounted display with outwardly facing cameras, it does not specifically disclose wherein a relative position and orientation of the sensor probe with respect to the head-mounted apparatus is based on one or more captured images of the sensor probe, as now recited in amended claim 12. Accordingly, claims 12-21 and 28 are allowed.
Claim 4 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. Applicant persuasively argues that including the head-mounted display having a ranging sensor mounted thereon of Geisner would introduce an external tracking apparatus, used to create a 3D map of the external environment to track the user’s head position and orientation, to a system of Paladini that is designed not to need such external tracking (see Remarks at pages 9-11). The prior art of record does not cure this deficiency. Accordingly, claim 4 is objected to a being dependent upon a rejected base claim.
Response to Arguments
Applicant's arguments filed 03/05/2026 have been fully considered but they are not persuasive. Regarding independent claim 2, Applicant argues that Paladini does not teach or suggest creating a 3D model of an external surface of an object scanned by the ranging sensor (see Remarks at page 8-9). Applicant contends that the “model in Paladini is a map of internal functional activity, wherein the model in the claims is of an external structural surface” (see Remarks at page 9). In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., creating a 3d model of external surface) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims recite creating a 3d model of a surface of an object, such surface is not limited to an external surface of the object. Accordingly, Paladini reads on the limitation and the rejection is maintained.
Regarding independent claim 22, Applicant argues that Paladini does not teach “calculating a current position and orientation of the sensor probe with respect to an object captured by the ranging sensor” (see Remarks at page 12). Applicant contends that Paladini’s system calculates the probe’s position relative to its own prior positions, not “with respect to an object” as claimed (see Remarks at page 12). The Examiner respectfully disagrees. Paladini discloses the “processor 30 determines locations associated with the detected radiation within the region” and the “radiation detection system 22, through the detector 26, outputs measurements of radiation at different positions of the probe 10 relative to the patient” (see par. [0069]) and the “processor 30 determines the relative positions of the probe 10 using the ultrasound data” (see par. [0070]). Paladini discloses that the relative motion path is used to determine the orientation of the probe 10 or magnetic position sensor attached to the probe may be used with or instead of relative motion (see par. [0066]). It is clear that Paladini teaches determining the position of the probe relative to the patient and the orientation of the probe at this position can be determined using a magnetic position sensor with or instead relative motion. Accordingly, Paladini teaches calculating a current position and orientation of the sensor probe with respect an object (the patient) captured by the ranging sensor as claimed. The rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 RYNAE E BOLER whose telephone number is (571)270-3620. The examiner can normally be reached Mon - Fri 9:00-5:00.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
06/06/26
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