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 .
Election/Restrictions
Applicant’s election without traverse of Invention I directed to claim 1-19 in the reply filed on 01/12/2026 is acknowledged.
Claim 20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/12/2026.
Response to Arguments
Applicant’s arguments, see pages 1-3, filed on 01/12/206, with respect to claims 1-20 have been fully considered and are persuasive.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mitschke et al. (US PAP 2003/0219102 A1) in view of Fields (US PAP 2021/0321877 A1) and Essenreiter et al. (US PAP 202/0286222 A1).
With respect to claim 1, Mitschke et al. teaches a system comprising (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035): a medical imaging device (1) comprising an x-ray source (3) and an x-ray detector (4) configured to generate a plurality of images based on x-rays received at the x-ray detector (4) from the x-ray source (3) (see Fig.1; paragraphs 0016-0022); a fixture (21) coupled to the medical imaging device (1) between the x-ray source (3) and the x-ray detector (4); a calibration phantom (22) coupled to the fixture (21) and configured to calibrate the medical imaging device; and a medical navigation system (10) operatively coupled with the medical imaging device (1) (see Fig.1; paragraphs 0016-0022),
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the fixture (21), and the calibration phantom (22), wherein the medical navigation system (10) is configured to register the plurality of images from the medical imaging device to a three-dimensional tracking space (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) but fails to explicitly mention that the calibration phantom configured to calibrate the medical imaging device based on known, simulated bone mineral density (BMD) of material disposed therein, wherein the calibration phantom comprises a first material having a first simulated BMD, and a second material having a second simulated BMD.
Fields teaches that it is known (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) to employ a calibration phantom (100) associated with an X-ray imaging system (0032) and a medical navigation system (950) operatively coupled with the medical imaging device; wherein the calibration phantom (100) comprises the different fiducial marker components (140, 150 and 160) and configured to calibrate the medical imaging device (see paragraph 0035); and a medical navigation system (10) operatively coupled with the medical imaging device (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099)
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which explicitly teaches the calibration phantom configured to calibrate the medical imaging device based on known, simulated bone mineral density (BMD) of material disposed therein, wherein the calibration phantom comprises a first material having a first simulated BMD, and a second material having a second simulated BMD and a medical navigation system operatively coupled with the medical imaging device (see paragraph 0055), wherein the medical navigation system is configured to register the plurality of images from the medical imaging device to a three-dimensional tracking space (see abstract; paragraphs 0023, 0036-0039 and 0078) in order to provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
Essenreiter et al. teaches an apparatus for automatic image registration scans for image-guided surgery (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) which explicitly teaches a calibration phantom (1 and 9) configured to calibrate the medical imaging apparatus,
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wherein the calibration phantom (1 and 9) comprises the different multiple marker devices (4 and 12), wherein the medical navigation system (20) is configured to register the plurality of images from the medical imaging device to a three-dimensional tracking space
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in order to provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
Mitschke et al., Fields and Essenreiter et al. disclose related methods/apparatuses for using the calibration phantoms configured to calibrate the X-ray medical imaging devices.
It 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 to provide teaching that the calibration phantom configured to calibrate the medical imaging device based on known, simulated bone mineral density (BMD) of material disposed therein, wherein the calibration phantom comprises a first material having a first simulated BMD, and a second material having a second simulated BMD as suggested by Fields and the teachings of the automatic image registration scans for image-guided surgery using the calibration phantom with the different multiple markers devices as suggested by Essenreiter et al. in the apparatus of Mitschke et al., since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
It would have been obvious to treat Mitschke et al., Fields and Essenreiter et al. as related art whereby an improvement on one of the systems/methods would readily be apparent as an improvement on either of the systems.
The Examiner’s conclusion that claim 1 would have been obvious is based on the fact that all the claimed elements were known in the prior art, that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and that the combination teaches nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. 398, 82 USPQ2d at 1385 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim 2, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 1, wherein Fields clearly teaches (see paragraph 0042) that each of the first material and the second material of the calibration phantom comprises at least one of hydroxyapatite, plastic, polymer, metal, or a combination of these materials, since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
In addition, it 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 to use the calibration phantom comprising at least one of hydroxyapatite, plastic, polymer, metal, or a combination of these materials in the apparatus of Mitschke et al. as modified by Fields and Essenreiter et al., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
With respect to claim 3, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 1, wherein that the fixture includes at least one of a registration fixture, a patient attachment instrument, a merge fixture, or combinations thereof (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035).
With respect to claim 4, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 1, wherein the fixture includes a registration fixture comprising: a frame configured to be coupled with the medical imaging device; an engagement portion disposed in the frame and configured to couple the calibration phantom with the frame; and an x-ray opaque fiducial pattern disposed on the frame and operatively coupled with the medical imaging device (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035).
With respect to claim 5, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 4, wherein Fields teaches that the calibration phantom comprises: a first calibration phantom shaped and dimensioned to contain the first material therein and to engage a first portion of the engagement portion of the fixture; and a second calibration phantom shaped and dimensioned to contain the second material therein and to engage a second portion of the engagement portion of the fixture (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099), since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
With respect to claim 6, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 4, wherein fields teaches that the registration fixture is configured to create at least one shadow corresponding to the x-ray opaque fiducial pattern, the first material, the second material, or combinations thereof, in at least one of the plurality of images from the medical imaging device (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099), since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
With respect to claim 7, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 4, wherein Fields teaches that the x-ray opaque fiducial pattern comprises a plurality of radiopaque markers disposed in the frame of the registration fixture (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099), since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
With respect to claim 8, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 7, wherein Fields teaches that the plurality of radiopaque markers comprises a first set of radiopaque markers disposed in the frame and arranged in a first plane, and a second set of radiopaque markers disposed in the frame and arranged in a second plane offset from the first plane (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099), since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
With respect to claim 9, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 1, wherein the medical imaging device includes a computed tomography (CT) scanner (1) comprising an arm (5) having the x-ray source (3) at a first end thereof, and the x-ray detector (4) at a second end thereof opposite the first end (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035).
With respect to claim 10, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 1, wherein the Fields discloses that the fixture includes a merge fixture comprising a body which extends between a first surface configured to matingly engage a vertebrae of a spine and a second surface (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099), since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
With respect to claim 11, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 10, wherein the merge fixture comprises an engagement portion configured to couple the calibration phantom with the body of the merge fixture (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035).
With respect to claim 12, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 10, Essenreiter et al. further teaches a dynamic reference base including a plurality of reflective fiducials and a clamp, wherein the merge fixture comprises a post extending superiorly from the second surface and configured to be received within the clamp (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104), since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
With respect to claim 13, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 10, wherein the calibration phantom is at least partially disposed within the body of the merge fixture (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035).
With respect to claim 14, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 10, wherein Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. further disclose that the merge fixture comprises an aperture disposed in the body and configured to matingly engage at least one of a bone screw, a bone pin, a bone spike, or combinations thereof, to fixedly coupled the merge fixture with the vertebrae (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
With respect to claim 15, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the system of claim 10, wherein the merge fixture comprises a light emitting diode (LED) configured to transmit electromagnetic signals therefrom, and wherein the medical navigation system comprises an optical sensor configured to determine a location of the merge fixture in the three-dimensional tracking space based on electromagnetic signals transmitted from the LED to the optical sensor (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035).
With respect to claim 16, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) teaches a registration fixture for use with a medical navigation system for registration of a plurality of images to a three-dimensional tracking space comprising:
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a frame (21) configured to be coupled with a medical imaging device (1); an x-ray opaque fiducial pattern (22 ) comprising a plurality of radiopaque markers disposed in the frame (21) and operatively coupled with the medical imaging device (1), wherein the x-ray opaque fiducial pattern comprises a plurality of radiopaque markers disposed in the frame of the registration fixture (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) but fails to explicitly mention that a first calibration phantom comprising a first material having a first simulated bone mineral density (BMD) disposed in the frame; and a second calibration phantom comprising a second material having a second simulated BMD disposed in the frame.
Fields teaches that it is known (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) to employ a calibration phantom (100) associated with an X-ray imaging system (0032) and a medical navigation system (950) operatively coupled with the medical imaging device; wherein the calibration phantom (100) comprises the different fiducial marker components (140, 150 and 160) and configured to calibrate the medical imaging device (see paragraph 0035); and a medical navigation system (10) operatively coupled with the medical imaging device (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099)
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which explicitly teaches the calibration phantom configured to calibrate the medical imaging device based on known, simulated bone mineral density (BMD) of material disposed therein, wherein the calibration phantom comprises a first material having a first simulated BMD, and a second material having a second simulated BMD and a medical navigation system operatively coupled with the medical imaging device (see paragraph 0055), wherein the medical navigation system is configured to register the plurality of images from the medical imaging device to a three-dimensional tracking space (see abstract; paragraphs 0023, 0036-0039 and 0078) in order to provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
Essenreiter et al. teaches an apparatus for automatic image registration scans for image-guided surgery (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) which explicitly teaches a calibration phantom (1 and 9) configured to calibrate the medical imaging apparatus,
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wherein the calibration phantom (1 and 9) comprises the different multiple marker devices (4 and 12), wherein the medical navigation system (20) is configured to register the plurality of images from the medical imaging device to a three-dimensional tracking space
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in order to provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
Mitschke et al., Fields and Essenreiter et al. disclose related methods/apparatuses for using the calibration phantoms configured to calibrate the X-ray medical imaging devices.
It 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 to provide teaching that the calibration phantom configured to calibrate the medical imaging device based on known, simulated bone mineral density (BMD) of material disposed therein, wherein the calibration phantom comprises a first material having a first simulated BMD, and a second material having a second simulated BMD as suggested by Fields and the teachings of the automatic image registration scans for image-guided surgery using the calibration phantom with the different multiple markers devices as suggested by Essenreiter et al. in the apparatus of Mitschke et al., since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
It would have been obvious to treat Mitschke et al., Fields and Essenreiter et al. as related art whereby an improvement on one of the systems/methods would readily be apparent as an improvement on either of the systems.
The Examiner’s conclusion that claim 16 would have been obvious is based on the fact that all the claimed elements were known in the prior art, that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and that the combination teaches nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. 398, 82 USPQ2d at 1385 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson ’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim 17, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the registration fixture of claim 16, wherein Fields clearly teaches that the first calibration phantom and the second calibration phantom are configured to calibrate the medical imaging device based on known, simulated values of the first simulated BMD and the second simulated BMD corresponding to shadows in at least one of the plurality of images (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099), since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
With respect to claim 18, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the registration fixture of claim 16, wherein Essenreiter et al. clearly teaches a plurality of reflective markers disposed on the frame and configured to be tracked by the medical navigation system in the three-dimensional tracking space (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104), since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
With respect to claim 19, Mitschke et al. (see abstract; Figs. 1-3; paragraph 0004 and 0016-0035) as modified by Fields (see abstract; Figs. 1-13; paragraphs 0035,0039, 0041, 0050, 0054, 0055, 0077, 0078, 0084-0086, 0094, 0098 and 0099) and Essenreiter et al. (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104) teaches the registration fixture of claim 16, wherein Essenreiter et al. clearly teaches that the plurality of radiopaque markers comprises a first set of radiopaque markers disposed in the frame and arranged in a first plane, and a second set of radiopaque markers disposed in the frame and arranged in a second plane offset from the first plane (see abstracts; Fig. 1-10; paragraphs 0003, 0008, 0010-0013, 0028, 0059, 0102 and 0104), since such a modification would provide user with the capabilities to more accurately calibrate the imaging system in relation to anatomical structure of a patient for further imaging and/or assisting with the surgical procedures.
Conclusion
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Irakli Kiknadze
/IRAKLI KIKNADZE/ Primary Examiner, Art Unit 2884 /I.K./ February 14, 2026