DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/16/2025 has been entered.
Response to Arguments
Applicant has amended claim 10, as such the objection to claim 10 is withdrawn; claims 10-16 are currently pending.
Applicant’s arguments, filed 10/16/2025, with respect to the amendment overcoming the 35 U.S.C. 101 rejection have been fully considered and are persuasive. The 35 U.S.C. 101 of 10-16 has been withdrawn.
Applicant’s arguments with respect to the 35 U.S.C. 103 rejection of claim(s) 10-16 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.
As such this action is made NON-FINAL.
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.
Claim(s) 10, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks (Pub. No. US20140357989A1) in view of Hladio (Pub. No. US20180064496A1) and Mewes (Pub. No. US20180147727A1).
Regarding claim 10, Hendriks discloses A method of performing an accuracy check of a tracked instrument, the method comprising: (Hendriks ¶64-65; a method for improving the accuracy of an interventional instrument is disclosed.) determining a first virtual position within a virtual space of an emitter of an imaging device; determining a first virtual position within the virtual space of a detector of the image device; (Although not expressly stated, Hendriks ¶56; projection data and corresponding computed tomography image data set are disclosed. Relative positions of emitters and detectors must be known to perform computed tomography. ¶67 describes registering optical images with obtained fluoroscopic computed tomography images. Therefore the position of the detector and emitter within the optical space (virtual position) would be known. Further, ¶18 describes a fluoroscopy imaging unit position (which would include the emitter and detector) being determining using a 3d reference coordinate system.) determining a first virtual position within the virtual space of the tracked instrument while the tracked instrument is at a first physical position between the emitter and the detector and is outside of a patient; (Hendriks ¶53-54; determining the position of the tip by placing the tip outside of the patient is disclosed. Additionally, a “second part” of the instrument is disclosed with markers and it is outside the patient, even as the “first part” is within the patient/subject.) determining a first expected image of the tracked instrument based on the first virtual position of the emitter, the first virtual position of the detector, the first virtual position of the tracked instrument (Hendriks ¶66; determining the position of the instrument is disclosed. The position is “inferred” from the fluoroscopy image. ) , and a computer model of the tracked instrument; (Hendriks ¶24-25; determining the relationship of between the ends of the interventional instrument. ¶19 also explains that the position is calculated using the spatial relation (considered a computer model).) obtaining a first image of the tracked instrument while it is positioned at the first physical position between the emitter and the detector; (Hendriks ¶66 subsequent images are taken of the instrument between the emitter and detector as it is inserted.) determining a second virtual position within the virtual space of the emitter of the imaging device; determining a second virtual position within the virtual space of the detector of the imaging device; (Although not expressly stated, Hendriks ¶56; projection data and corresponding computed tomography image data set are disclosed. Relative positions of emitters and detectors must be known to perform computed tomography. ¶67 describes registering optical images with obtained fluoroscopic computed tomography images. Therefore the position of the detector and emitter within the optical space (virtual position) would be known. ¶66 states that preferentially two fluoroscopy images are taken at different angles (i.e. second position of the emitter and detector.) and that the processes is repeated over time (i.e. second position of the emitter and detector). Further, ¶18 describes a fluoroscopy imaging unit position (which would include the emitter and detector) being determining using a 3d reference coordinate system.) determining a second virtual position within the virtual space of the tracked instrument while the tracked instrument is at a second physical position between the emitter and the detector and is outside of a patient; (Hendriks ¶54; determining the position of a first and second part of the tracked instrument is disclosed. The “second part” of the instrument is disclosed with markers and it is outside the patient, even as the “first part” is within the patient/subject. Hendriks ¶66; determining the position of the instrument is disclosed. The position is “inferred” from the fluoroscopy image. This process is repeated as the instrument is inserted and possibly deviates/ bends from where it is expected to be.) determining a second expected image of the tracked instrument based on the second virtual position of the emitter, the second virtual position of the detector, the second virtual position of the tracked instrument, (Hendriks ¶66; determining the position of the instrument is disclosed. The position is “inferred” from the fluoroscopy image. ) and the computer model of the tracked instrument; (Hendricks ¶19 also explains that the position is calculated using the spatial relation (considered a computer model).) obtaining a second image of the tracked instrument while it is positioned between the emitter and the detector, the second image being different than the first image; and (Hendriks ¶66 subsequent images are taken of the instrument between the emitter and detector as it is inserted.) determining whether the tracked instrument is physically accurate relative to the computer model of the tracked instrument based on the first expected image, the second expected image, the first image, and the second image. (Hendriks ¶66; the deformation of the instrument can be determined providing more accurate optical guidance (i.e. correction is performed on inaccurate predictions.)
Although Hendriks does not expressly state, determining a first virtual position within a virtual space of an emitter of an imaging device; determining a first virtual position within the virtual space of a detector of the image device; or determining a second virtual position within the virtual space of the emitter of the imaging device; determining a second virtual position within the virtual space of the detector of the imaging device; It would have been obvious, before the effective filing date of the claimed invention, to one of ordinary skill in the art to include the virtual position of the emitter and detector because Hendriks ¶56; projection data and corresponding computed tomography image data set are disclosed. Relative positions of emitters and detectors must be known to perform computed tomography. ¶67 describes registering optical images with obtained fluoroscopic computed tomography images. Therefore the position of the detector and emitter within the optical space (virtual position) would be known. ¶66 states that preferentially two fluoroscopy images are taken at different angles (i.e. second position of the emitter and detector.) and that the processes is repeated over time (i.e. second position of the emitter and detector). Further, ¶18 describes a fluoroscopy imaging unit position (which would include the emitter and detector) being determining using a 3d reference coordinate system.
Hendriks discloses an initially provided spatial relation of the surgical instrument (¶24), but not explicitly that the spatial relation is a 3D CAD model. Additionally Hendriks discloses a display that shows the surgical instrument in the image set (¶57, 62) but not explicitly outputting to a display device an indication that the tracked instrument is not physically accurate based on the determination that the tracked instrument is physically inaccurate relative to the 3D CAD model of the tracked instrument.
Hladio, however, discloses a (Hladio ¶55; a prior information is used to perform pose solving. This a prior information can be a CAD model.) outputting to a display device an indication that the tracked instrument is not physically accurate based on the determination that the tracked instrument is physically inaccurate relative to the (Hladio ¶62; an alert is displayed when the surgical instrument is out of calibration.)
It would have been obvious, before the effective filing date of the claimed invention, to one of ordinary skill in the art to modify the method of Hendriks with the teachings of Hladio by including a CAD model of the surgical instruments to compare to while tracking in order to have a detailed representation of the surgical tool to compare with. It would have been further obvious to include displaying an alert when the tool is out of calibration so that the user can take appropriate steps (Hladio ¶62).
The combination of Hendriks and Hladio does not explicitly disclose a 3D CAD model.
Mewes, however, discloses a 3D CAD model (Mewes ¶45; a 3D CAD model of a robot tool is used to estimate position.)
It would have been obvious, before the effective filing date of the claimed invention, to one of ordinary skill in the art to modify the method of the combination of Hendriks and Hladio with the teachings of Mewes by utilizing a 3D CAD model of the surgical instruments to compare with while tracking in order to have a 3D representation of the tool to compare with because the tracking space is in 3D.
Regarding claim 14 the combination of Hendriks, Hladio, and Mewes discloses the claim limitations with regards to claim 10, as described above. They further disclose wherein the first virtual position of the tracked instrument is different than the second virtual position of the tracked instrument, (Hendriks ¶66; as the instrument is being inserted and it is determined that tracking is not accurate, more images can be obtained meaning that the instrument has moved between frames.) wherein the first virtual position of the emitter is the second virtual position of the emitter, and wherein the first virtual position of the detector is the second virtual position of the detector. (Hendriks ¶66; preferentially two view fluoroscopic views are taken of the instrument, however it also indicates taking images over time therefore, it would have been obvious to have images taken from the same emitter and detector position to obtain positional information more quickly when necessary.)
Claim(s) 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks (Pub. No. US20140357989A1) in view of Hladio (Pub. No. US20180064496A1), Mewes (Pub. No. US20180147727A1), and Mueller (Pub. No. EP3628263A1).
Regarding claim 11, Hendriks discloses the claim limitations with regards to claim 10. Hendriks further discloses wherein the imaging device includes the emitter and the detector, (Hendriks ¶49; an x-ray source (emitter) and detection unit are disclosed. ¶51 Also discloses the possible use of infrared cameras, which have emitters and detectors as well.) wherein determining the first virtual position of the detector includes: capturing an image of a reference element coupled to the imaging device; (Hendriks ¶55; registration can be performed by determining the position of the image providing unit (see Fig. it includes the x-ray source (element 12) and detector (element 13) this is done by imaging markers (refence element coupled to the imaging device) that can be detected by the instrument position providing unit.) determining a virtual position of the reference element coupled to the imaging device based on the image of the reference element coupled to the imaging device, the virtual position of the refence element coupled to the imaging device including a virtual location and a virtual pose of the reference element coupled to the imaging device; and (Hendriks ¶55; registration can be performed by determining the position of the image providing unit (see Fig. it includes the x-ray source (element 12) and detector (element 13) this is done by imaging markers (refence element coupled to the imaging device) that can be detected by the instrument position providing unit. ¶69 the pose of the image providing unit is used to convert the position to the 3d reference coordinate system.) determining the virtual position of the detector based on predetermined information indicating a position of the detector relative to the reference element coupled to the imaging device and the virtual position of the reference element coupled to the imaging device, the virtual position of the detector including a virtual location and a virtual pose of the detector, (Hendriks ¶69 the pose of the image providing unit is used to convert the position to the 3d reference coordinate system, which from ¶55 can be done using markers (reference elements couple to the imaging device).) wherein determining the first virtual position of the emitter includes: determining the virtual position of the emitter based on predetermined information indicating a position of the emitter relative to the detector and the virtual position of the detector, the virtual position of the emitter including a virtual location and a virtual pose of the emitter, and (Hendriks ¶55; registration can be performed by determining the position of the image providing unit (see Fig. it includes the x-ray source (element 12) and detector (element 13) this is done by imaging markers (refence element coupled to the imaging device) that can be detected by the instrument position providing unit. ¶69 the pose of the image providing unit is used to convert the position to the 3d reference coordinate system.) wherein determining the first virtual position of the tracked instrument includes: determining information about a shape of the tracked instrument relative to a reference element coupled to the tracked instrument; (Hendriks ¶24-25; markers attached to the tracked instrument are utilized in determining the positioning of the tip of the interventional instrument.) capturing an image of the reference element coupled to the tracked instrument; (Hendricks ¶26; images of the “second part” of the instrument with markers.) determining a virtual position of the reference element coupled to the tracked instrument relative to a dynamic reference base (DRB) based on the image of the reference element coupled to the tracked instrument, the virtual position of the refence element coupled to the tracked instrument including a virtual location and a virtual pose of the reference element coupled to the tracked instrument; and (Hendriks ¶24-26; markers on the tracked instrument are used to determine the position and pose of the instrument.) determining the first virtual position of the tracked instrument based on the shape of the tracked instrument and the reference element coupled to the tracked instrument, the virtual position of the tracked instrument including a virtual location and a virtual pose of the tracked instrument. (Hendriks ¶24-26; markers on the tracked instrument are used to determine the position and pose of the instrument.)
Hendriks does not explicitly disclose a dynamic reference base (DRB) attached to a patient.
Mueller, however discloses a dynamic reference base (DRB) attached to a patient (Mueller ¶45-46; reference markers are attached to the subject’s anatomy. This allows tracking of patient movement and ¶6 explains it provides better tool guidance.)
It would have been obvious, before the effective filing date of the claimed invention, to one of ordinary skill in the art to modify the method of Hendriks with the teachings of Mueller by including reference markers attached to the patient in order to provide better tool guidance (Mueller ¶6).
Regarding claim 12, the combination of Hendriks, Hladio, Mewes, and Mueller discloses the claim limitations with regards to claim 11, as described above. They further disclose wherein determining the information about the shape of the tracked instrument includes determining an intended position of a tip of the tracked instrument relative to the reference element coupled to the tracked instrument, and (Hendriks ¶66 the expected tip position is compared to the images tip position. This is determined using the markers on the second part of the interventional instrument (see ¶68).) wherein the first expected image, the second expected image, the first image, and the second image each include an image of the tip. (Hendriks ¶66 during insertion of the instrument images are taken. Therefore the images of the tracked instrument would include the interventional instrument tip.)
Regarding claim 13, the combination of Hendriks, Hladio, Mewes, and Mueller discloses the claim limitations with regards to claim 11, as described above. They further disclose wherein the first virtual position of the tracked instrument is the second virtual position of the tracked instrument, and (Hendriks ¶66; two fluoroscopy images taken at two different angles being preferred is disclosed (i.e. the instrument is held still while two different views are obtained so that a 3D reconstruction can be calculated).) wherein the imaging device includes at least one of a C-arm and a O-arm, (Hendriks ¶49; the fluoroscopic system being a c-arm x-ray system is disclosed.) the method further comprising: responsive to obtaining the first image, rotating the imaging device such that the second virtual position of the emitter is different than the first virtual position of the emitter and that the second virtual position of the detector is different than the first virtual position of the detector. (Hendriks ¶66; two fluoroscopy images taken at two different angles being preferred is disclosed (i.e. the instrument is held still while two different views are obtained so that a 3D reconstruction can be calculated).)
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hendriks (Pub. No. US20140357989A1) in view of Hladio (Pub. No. US20180064496A1), Mewes (Pub. No. US20180147727A1), and Sztuk (Patent No. US 12073015B1).
Regarding claim 15, the combination of Hendriks, Hladio, and Mewes discloses the claim limitations with regards to claim 10, as described above. They further disclose wherein determining whether the tracked instrument is accurate includes determining that a difference between the first expected image and/or the second expected image and the first image and/or the second image exceeds a predetermined threshold, (Hladio ¶62; a difference between calculated tip position (expected position) and detected tip position (actual position) is calculated. If it is within a tolerance range calibration is verified.)
Although the combination of Hendriks, Hladio, and Mewes discloses altering the user that the needle is out of calibration, the user decides the appropriate action to take (Hladio ¶62).
Sztuk, however, discloses the method further comprising: outputting an indication that the tracked instrument is not suitable for use. (Sztuk Col 29 line 54-Col 30 line 3; when a certain threshold difference is met the user is prompted to send the item back to the factory (i.e. not suitable for use. See also Sztuk Col28 line 24- Col 29 line19 and Col 29 line 56-Col 30 line 3.)
It would have been obvious, before the effective filing date of the claimed invention, to one of ordinary skill in the art to modify the method of the combination of Hendriks, Hladio, and Mewes with the teachings of Sztuk by including indicating to the user should when to send the tool back in order to indicate to a user when recalibration will work versus needing to use a different tool (Sztuk Col 29 line 54- Col 30 line 3).
Regarding claim 16, the combination of Hendriks, Hladio, and Mewes discloses the claim limitations with regards to claim 10, as described above. wherein determining whether the tracked instrument is accurate includes determining that a difference between the first expected image and/or the second expected image and the first image and/or the second image exceeds a predetermined threshold, (Hladio ¶62; a difference between calculated tip position (expected position) and detected tip position (actual position) is calculated. If it is within a tolerance range calibration is verified.)
Although the combination of Hendriks, Hladio, and Mewes discloses altering the user that the needle is out of calibration, the user decides the appropriate action to take (Hladio ¶62).
Sztuk, however, discloses the method further comprising: calibrating a tracking system used to track the tracked instrument using at least one of the first expected image, the second expected image, the first image, and the second image. (Sztuk Col 29 line 54-Col 30 line 3; when a certain threshold the user is prompted to attempt recalibration of the system. See also Sztuk Col28 line 24- Col 29 line19 and Col 29 line 56-Col 30 line 3.)
It would have been obvious, before the effective filing date of the claimed invention, to one of ordinary skill in the art to modify the method of the combination of Hendriks, Hladio, and Mewes with the teachings of Sztuk by including indicating to the user when recalibration is necessary in order to indicate to a user when recalibration will work versus needing to use a different tool (Sztuk Col 29 line 54- Col 30 line 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEREDITH TAYLOR whose telephone number is (571)270-5805. The examiner can normally be reached M-Th 7:30-5. Examiner’s email is Meredith.taylor@uspto.gov.
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/MEREDITH TAYLOR/Examiner, Art Unit 2671
/VINCENT RUDOLPH/Supervisory Patent Examiner, Art Unit 2671
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