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 Objections
Claims 6 and 18 are objected to because of the following informalities: claims 6 and 18 recite “the first and second vectors” while the claims now recite only a vector parallel to the planar surface and a vector orthogonal to the planar surface. Therefore, “the first and second vectors” lacks antecedent basis in the claims. Claim clarity would be improved by using consistent terminology.
Appropriate correction is required.
Drawings
The drawings are objected to because figs. 5 and 7-10 include elements which are not black and white line drawings. See MPEP 608.02.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 9-13, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walker et al. (US 2014/0264081 A1, Sep. 18, 2014) (hereinafter “Walker”).
Regarding claim 1: Walker discloses a method for registering an image space with a sensor space, comprising: receiving sensor data from a sensor disposed on an instrument within an anatomy supported by a support structure with a planar surface ([0047], fig. 4, step 208, sensor data from tool sensor connected to catheter/tool 18; fig. 1A - the patient is depicted lying on a table which is "a support structure with a planar surface"); determining a position of the instrument in a sensor coordinate space based on the received sensor data ([0047], fig. 4, step 208, sensor reference frame FRF); receiving image data captured by an imaging system external to the anatomy while the instrument is disposed within the anatomy ([0045]-[0046], fig. 4, step 204); determining a position of the instrument in an image coordinate space based on the received image data ([0044], [0046]-[0047], fig. 4, step 208, fluoroscopy reference frame FF); estimating, in each of the sensor coordinate space and the image coordinate space, a vector originating at the position of the instrument and parallel to the planar surface of the support structure ([0053], fig. 5; see coordinate system axes or "vectors" for all of TRF, RRF, SRF, FRF, FF, PRR shown in fig. 1A where each coordinate frames has an axes or "vector" parallel with the table surface; both the SRF and FRF are "at the position of the instrument" since they are attached to catheter 18 - see [0047] "reference frame FRF for a sensor disposed within the surgical tool", additionally other locations such as the tip of the catheter 18 may be used as in [0046] and [0057]; the "parallel" and "orthogonal" vectors are merely the axes of the coordinate system, and registration maps the two different coordinate systems to a single common coordinate system which means that the "vectors" (axes) will be aligned); and determining a mapping that transforms the position of the instrument and the estimated vector in the image coordinate space to the position of the instrument and the estimated vector, respectively, in the sensor coordinate space ([0047], [0051] - either the sensor reference frame is mapped to the image reference frame or the image reference frame is mapped to the sensor reference frame). Examiner notes that throughout the claims, the previously recited “first” and “second” coordinate spaces have been replaced by “sensor” (corresponding to “first”) and “image” (corresponding to “second”) coordinate frames, with the exception of the final limitation of both claims 1 and 13 which are reversed so that “first” corresponds to “image” and “second” corresponds to “sensor.” It is not apparent whether this is an intentional reversal or if it is inadvertent.
Regarding claim 9: Walker discloses the method of claim 1, further comprising: receiving additional sensor data from one or more additional sensors proximate to the anatomy ([0080]); determining positions of the one or more additional sensors in the sensor coordinate space based on the received additional sensor data ([0081]); and determining positions of the one or more additional sensors in the image coordinate space based on the received image data, the mapping between the sensor coordinate space and the image coordinate space further being determined based at least in part on the positions of the one or more additional sensors in the sensor coordinate space and the positions of the one or more additional sensors in the image coordinate space ([0081]-[0082]).
Regarding claim 10: Walker discloses the method of claim 9, wherein at least one of the one or more additional sensors is disposed on the instrument ([0080], fig. 9).
Regarding claim 11: Walker discloses the method of claim 9, wherein at least one of the one or more additional sensors is positioned at a predetermined location external to the anatomy ([0080] - proximal end 904, fig. 9).
Regarding claim 12: Walker discloses the method of claim 9, wherein the positions of the one or more additional sensors in the image coordinate space are determined based on two or more two-dimensional (2D) images captured by the imaging system ([0081], [0084]; [0039] – registration is performed using multiple fluoro images).
Regarding claim 13: Walker discloses a controller for a medical system, comprising: a processing system ([0100]-[0104]); and a memory storing instructions that, when executed by the processing system ([0100]-[0104]), cause the controller to: receive sensor data from a sensor disposed on an instrument within an anatomy supported by a support structure with a planar surface ([0047], fig. 4, step 208, sensor data from tool sensor connected to catheter/tool 18; fig. 1A - the patient is depicted lying on a table which is "a support structure with a planar surface"); determine a position of the instrument in a sensor coordinate space based on the received sensor data ([0047], fig. 4, step 208, sensor reference frame FRF); receive image data captured by an imaging system external to the anatomy while the instrument is disposed within the anatomy ([0045]-[0046], fig. 4, step 204); determine a position of the instrument in an image coordinate space based on the received image data ([0044], [0046]-[0047], fig. 4, step 208, fluoroscopy reference frame FF); estimate, in each of the sensor coordinate space and the image coordinate space, a vector originating at the position of the instrument and parallel to the planar surface of the support structure ([0053], fig. 5; see coordinate system axes or "vectors" for all of TRF, RRF, SRF, FRF, FF, PRR shown in fig. 1A where each coordinate frames has an axes or "vector" parallel with the table surface; both the SRF and FRF are "at the position of the instrument" since they are attached to catheter 18 - see [0047] "reference frame FRF for a sensor disposed within the surgical tool", additionally other locations such as the tip of the catheter 18 may be used as in [0046] and [0057]; the "parallel" and "orthogonal" vectors are merely the axes of the coordinate system, and registration maps the two different coordinate systems to a single common coordinate system which means that the "vectors" (axes) will be aligned); and determine a mapping that transforms the position of the instrument and the estimated vector in the image coordinate space and the position of the instrument in the sensor coordinate space ([0047], [0051] - either the sensor reference frame is mapped to the image reference frame or the image reference frame is mapped to the sensor reference frame).
Examiner notes that throughout the claims, the previously recited “first” and “second” coordinate spaces have been replaced by “sensor” (corresponding to “first”) and “image” (corresponding to “second”) coordinate frames, with the exception of the final limitation of both claims 1 and 13 which are reversed so that “first” corresponds to “image” and “second” corresponds to “sensor.” It is not apparent whether this is an intentional reversal or if it is inadvertent.
Regarding claim 20: Walker discloses the controller of claim 13 wherein execution of the instructions further causes the controller to: receive additional sensor data from one or more additional sensors proximate to the anatomy ([0080]); determine positions of the one or more additional sensors in the sensor coordinate space based on the received additional sensor data ([0081]); and determine positions of the one or more additional sensors in the image coordinate space based on the received image data, the mapping between the sensor coordinate space and the image coordinate space further being determined based at least in part on the positions of the one or more additional sensors in the sensor coordinate space and the positions of the one or more additional sensors in the image coordinate space ([0081]-[0082]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker in view of Johnson et al. (US 2017/0215825 A1, Aug. 3, 2017) (hereinafter “Johnson”).
Regarding claim 2: Walker discloses the method of claim 1, including acquisition of both CT (“pre-operative model” or “3D model”) and fluoroscopy images which may be registered to one another ([0037], [0066]), but is silent on any description of the imaging system including wherein the imaging system is a cone beam computed tomography (CBCT) system.
Johnson, in the same problem solving area of CT and fluoroscopy imaging, discloses a multi-modal system designed for surgery which comprises three imaging modalities include fluoroscopy, 2D Radiography, and Cone-beam CT ([0020]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to perform the method of claim 1 using a multi-modal imaging system (including CBCT, which therefore is a “CBCT system”) as taught by Johnson in order to improve efficiency by performing all imaging using the same system without having to move the patient and in view of Johnson’s disclosure that the system was particularly designed for surgery.
Regarding claim 14: Walker discloses the controller of claim 13, including using the controller for acquisition of both CT (“pre-operative model” or “3D model”) and fluoroscopy images which may be registered to one another ([0037], [0066]), but is silent on any description of the imaging system including wherein the imaging system is a cone beam computed tomography (CBCT) system.
Johnson, in the same problem solving area of CT and fluoroscopy imaging, discloses a multi-modal system designed for surgery which comprises three imaging modalities include fluoroscopy, 2D Radiography, and Cone-beam CT ([0020]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the controller of claim 13 with a multi-modal imaging system (including CBCT, which therefore is a “CBCT system”) as taught by Johnson in order to improve efficiency by performing all imaging using the same system without having to move the patient and in view of Johnson’s disclosure that the system was particularly designed for surgery.
Claim(s) 3-5, 7, 8, 15-17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker in view of Eichler et al. (US 2016/0287133 A1, Oct. 6, 2016) (hereinafter “Eichler”).
Regarding claim 3: Walker discloses the method of claim 1, wherein the sensor may be an electromagnetic (EM) sensor disposed within an EM field ([0028] - various sensors including EM sensors may be used, where EM sensors operate using a generated EM field) but is silent on any details regarding the corresponding EM field generator.
Eichler, in the same field of endeavor, discloses navigating a catheter using EM sensors and image guidance ([0016], [0024], [0033]), using EM sensors (sensors 46, 52; [0033]) disposed within an EM field produced by a field generator coupled to a support structure at a known angle, the support structure having a planar surface which supports the anatomy ([0027], fig. 1). Eichler further teaches that the disclosed field generator can be placed on or in the patient table (therefore establishing a fixed coordinate system) without interfering with the imaging system or image quality ([0008]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to perform the method of claim 1 using the sensors and field generator of Eichler in order to provide instrument position tracking without interfering with the imaging system or image quality.
Regarding claim 4: Walker and Eichler disclose the method of claim 3. Eichler further discloses wherein the field generator is a tabletop field generator or a window field generator (WFG) having a planar surface that is parallel to the planar surface of the support structure ([0027] - "generator assembly 44 may be located on top of table 20").
Regarding claim 5: Walker and Eichler disclose the method of claim 3. Walker further discloses wherein the determining of the mapping further comprises: estimating, in each of the sensor coordinate space and the image coordinate space, a vector orthogonal to the planar surface of the support structure ([0053], fig. 5; see coordinate system axes or "vectors" for all of TRF, RRF, SRF, FRF, FF, PRR shown in fig. 1A where each coordinate frames has an axes or "vector" orthogonal the table surface; the "parallel" and "orthogonal" vectors are merely the axes of the coordinate system, and registration maps the two different coordinate systems to a single common coordinate system which means that the "vectors" (axes) will be aligned).
Regarding claim 7: Walker and Eichler disclose the method of claim 3. Eichler further discloses wherein the field generator is further coupled to a fiducial board including one or more fiducial markers disposed at predetermined positions relative to the field generator ([0035], [0037]).
Regarding claim 8: Walker and Eichler disclose the method of claim 7. Eichler further discloses determining a position of each of the one or more fiducial markers in the image coordinate space based on the received image data, the mapping between the sensor coordinate space and the image coordinate space further being determined based at least in part on the positions of the one or more fiducial markers in the image coordinate space and the predetermined positions of the one or more fiducial markers relative to the field generator ([0035], [0037]-[0038]).
Regarding claim 15: Walker discloses the controller of claim 13, wherein the sensor may be an electromagnetic (EM) sensor disposed within an EM field ([0028] - various sensors including EM sensors may be used, where EM sensors operate using a generated EM field) but is silent on any details regarding the corresponding EM field generator.
Eichler, in the same field of endeavor, discloses navigating a catheter using EM sensors and image guidance ([0016], [0024], [0033]), using EM sensors (sensors 46, 52; [0033]) disposed within an EM field produced by a field generator coupled to a support structure at a known angle, the support structure having a planar surface which supports the anatomy ([0027], fig. 1). Eichler further teaches that the disclosed field generator can be placed on or in the patient table (therefore establishing a fixed coordinate system) without interfering with the imaging system or image quality ([0008]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the controller of claim 13 with the sensors and field generator of Eichler in order to provide instrument position tracking without interfering with the imaging system or image quality.
Regarding claim 16: Walker and Eichler disclose the controller of claim 15. Eichler further discloses wherein the field generator is a tabletop field generator or a window field generator (WFG) having a planar surface that is parallel to the planar surface of the support structure ([0027] - "generator assembly 44 may be located on top of table 20").
Regarding claim 17: Walker and Eichler disclose the controller of claim 15. Walker further discloses wherein the determining of the mapping further comprises: estimating, in each of the sensor coordinate space and the image coordinate space, a vector orthogonal to the planar surface of the support structure ([0053], fig. 5; see coordinate system axes or "vectors" for all of TRF, RRF, SRF, FRF, FF, PRR shown in fig. 1A where each coordinate frames has an axes or "vector" orthogonal the table surface; the "parallel" and "orthogonal" vectors are merely the axes of the coordinate system, and registration maps the two different coordinate systems to a single common coordinate system which means that the "vectors" (axes) will be aligned).
Regarding claim 19: Walker and Eichler disclose the controller of claim 15. Eichler further discloses wherein the field generator is further coupled to a fiducial board including one or more fiducial markers disposed at predetermined positions relative to the field generator ([0035], [0037]), execution of the instructions further causing the controller to: determine a position of each of the one or more fiducial markers in the image coordinate space based on the received image data, the mapping between the sensor coordinate space and the image coordinate space further being determined based at least in part on the positions of the one or more fiducial markers in the image coordinate space and the predetermined positions of the one or more fiducial markers relative to the field generator ([0035], [0037]-[0038]).
Claim(s) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker and Eichler as applied to claims 5 and 17 above, and further in view of Belson (US 2007/0135803 A1, Jun. 14, 2007) (hereinafter “Belson”).
Regarding claim 6: Walker and Eichler disclose the method of claim 5. Walker further discloses wherein the determining of the transformation matrix comprises: determining a heading of the instrument in the sensor coordinate space based on the received sensor data ([0028]-[0029], [0033] - position and orientation or "heading"); determining a heading of the instrument in the image coordinate space based on the received image data ([0028]-[0029], [0033] - position and orientation or "heading"); and registering the position and orientation of the instrument in the sensor and image coordinate systems into a single common coordinate system ([0036]-[0037], [0047], [0053], [0078] - "Inherently, though, registration is the method of positioning and orienting a sensor frame in a reference frame.").
However, Walker is silent on the details of the transformation matrix including determining a rotation matrix and a translation matrix that transform the position of the instrument, the heading of the instrument, and the first and second vectors in the image coordinate space to the position of the instrument, the heading of the instrument, and the first and second vectors, respectively, in the sensor coordinate space.
Belson, in the same field of endeavor, discloses registering the position and orientation of an instrument across multiple coordinate systems including generating a transformation matrix that accounts for all translations, rotations, and scaling (magnification) factors ([0594]). It is noted that “…transform the position of the instrument, the heading of the instrument, and the first and second vectors in the image coordinate space to the position of the instrument, the heading of the instrument, and the first and second vectors, respectively, in the sensor coordinate space” is simply a description of 3D registration which includes the position and orientation of the tool where the "first and second vectors" are merely the axes of the coordinate systems, and registration maps (via a transformation matrix) the two different coordinate systems to a single common coordinate system which means that the "first and second vector" (axes) will be aligned.
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to perform the position and orientation registration of Walker using a translation matrix and a rotation matrix (i.e. a matrix that includes both the translation and rotation) as taught by Belson in order to provide a complete, one-step registration to improve efficiency.
Regarding claim 18: Walker and Eichler disclose the controller of claim 17. Walker further discloses wherein the determining of the transformation matrix comprises: determining a heading of the instrument in the sensor coordinate space based on the received sensor data ([0028]-[0029], [0033] - position and orientation or "heading"); determining a heading of the instrument in the image coordinate space based on the received image data ([0028]-[0029], [0033] - position and orientation or "heading"); and registering the position and orientation of the instrument in the sensor and image coordinate systems into a single common coordinate system ([0036]-[0037], [0047], [0053], [0078] - "Inherently, though, registration is the method of positioning and orienting a sensor frame in a reference frame.").
However, Walker is silent on the details of the transformation matrix including determining a rotation matrix and a translation matrix that transform the position of the instrument, the heading of the instrument, and the first and second vectors in the image coordinate space to the position of the instrument, the heading of the instrument, and the first and second vectors, respectively, in the sensor coordinate space.
Belson, in the same field of endeavor, discloses registering the position and orientation of an instrument across multiple coordinate systems including generating a transformation matrix that accounts for all translations, rotations, and scaling (magnification) factors ([0594]). It is noted that “…transform the position of the instrument, the heading of the instrument, and the first and second vectors in the image coordinate space to the position of the instrument, the heading of the instrument, and the first and second vectors, respectively, in the sensor coordinate space” is simply a description of 3D registration which includes the position and orientation of the tool where the "first and second vectors" are merely the axes of the coordinate systems, and registration maps (via a transformation matrix) the two different coordinate systems to a single common coordinate system which means that the "first and second vector" (axes) will be aligned.
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to perform the position and orientation registration of Walker using a translation matrix and a rotation matrix (i.e. a matrix that includes both the translation and rotation) as taught by Belson in order to provide a complete, one-step registration to improve efficiency.
Response to Arguments
Objection to claim 20 is withdrawn in light of the amendments to the claims.
Applicant has failed to properly respond to the objection to the drawings. Applicant has “replaced” the original figures only with identical figures and has not provided any arguments as to why the drawings should not be corrected. Applicant is reminded that objections to the drawings cannot be held in abeyance and failure to properly address objections to the drawings is a non-compliant response. If the drawings are not properly addressed in the next reply the next reply will be treated as non-compliant.
Applicant’s arguments with respect to prior art rejections of claims 1-20, filed 04/01, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Walker et al. (US 2023/0107693 A1, Apr. 6, 2023) – discloses every limitation of at least claim 1
Wong et al. (US 2014/0276937 A1, Sep. 18, 2014) – discloses every limitation of at least claim 1
Walker et al. (US 2014/0275988 A1, Sep. 18, 2014) – discloses every limitation of at least claim 1
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 CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
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