DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 8, 18, 19, and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7 and 18, and all dependents thereof, recite the limitation “wherein the landmarks comprise a single landmark… a surface comprising the landmarks.” The parent claims, claims 1 and 12 respectively, set forth “landmark locations” and “landmarks.” Since “landmarks” and “landmark locations” are set forth only in plural, with no allowance for only a single landmark (e.g. ‘at least one landmark’ would encompass either one or more than one) it is unclear whether claims 7 and 18 are attempting to redefine plural landmarks to only be one single landmark, or if “landmarks comprise a single landmark” refers to the set of (plural) landmarks including individual landmarks. It is noted that “comprise” is open-ended and therefore does not preclude the presence of multiple, individual/separate landmarks. For the purpose of further examination these claims will be interpreted to mean that the plural landmarks of claims 1 and 12 comprise a set of individual landmarks.
Claim 24 recites the limitation “wherein the landmarks comprise a deformation of the first anatomical structure.” However, claim 12 sets forth the landmarks as being “rigidly positioned" relative to the first anatomical structure so it is unclear what "comprise a deformation of the first anatomical structure" is meant to convey. It is unclear what it might mean to “rigidly position” a deformation of the first anatomical structure relative to the first anatomical structure.
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) 1, 4-7, 9-12, 15-18, and 20-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suzhou Xiaowei Changxing Robot Co ltd. (CN 115607279 A, Jan. 17, 2023) (hereinafter “Suzhou”) in view of Paradis et al. (US 2009/0125117 A1, May 14, 2009) (hereinafter “Paradis”) with Jansen et al. (US 2004/0230199 A1, Nov. 18, 2004) as incorporated by reference to Paradis at paragraph [0042].
Regarding claim 1: Suzhou discloses a computer-implemented method comprising: receiving, by a processor, a predefined model of a first anatomical structure (pg. 5, paragraph 4 - "The doctor imports the patient’s preoperative plan planning into the computer."); acquiring, using a tracking system, a plurality of point probe locations of a trackable point probe, wherein each of the plurality of point probe locations is on the first anatomical structure and is acquired relative to a tracking marker affixed to the second anatomical structure (pg. 5, paragraph 6 - "The doctor uses the optical tracking probe to take the feature points of the patient's pelvis and femur. The optical tracking system uses the pelvis and femur markers as references…"; markers 22 and 23 as shown in fig. 2); registering, by the processor, a position and orientation of the first anatomical structure relative to the tracking marker based the plurality of point probe locations (pg. 5, paragraph 6 - "The computer obtains the corresponding relationship between the actual orientation of the pelvis and the femur and its CT image orientation through the fast registration algorithm of the present invention, and links the actual orientation of the pelvis and the femur with the corresponding markers installed on the pelvis and the femur, thereby Enables pelvic markers and femoral markers to track the actual position of the bones in real time."); acquiring, using the tracking system, landmark locations associated with landmarks rigidly positioned relative to the first anatomical structure (pg. 5, step s110 and final paragraph; the landmarks are "multiple marker points on the negative model" as shown in fig. 8); registering, by the processor, a position and orientation of the landmarks relative to the tracking marker based on the landmark locations (pg. 6, paragraph 6 - "On this basis, the first coordinates of the marker points on the negative model 3D model image in the image coordinate system can be determined according to the transformation relationship between the design coordinate system and the image coordinate system."); generating, by the processor, a transformation matrix between the known positions, landmarks and orientations (pg. 8, paragraph 6 - "...the pose coordinates of a fixed point on the patient in the robot coordinate system can usually be determined first, and then the Based on the pose of the target part of the patient relative to a fixed point on the patient's body, the pose coordinates of the target part of the patient in the robot coordinate system can be obtained through the coordinate transformation method. ..."; step S130); and acquiring, using the tracking system, updated landmark locations of the landmarks (while Suzhou doesn't explicitly describe this step, however based on the provided definition of surgical navigation [pg. 1, first paragraph] and the description of the optical tracking system being used to "track the actual position of the bones in real time" [pg. 5, paragraph 6] this step is considered to be implicitly disclosed since not updating the tracked and registered locations during surgery when the patient or the bones may move would not provide a suitable result).
While Suzhou is directed to the tracking and registration of the patient during a hip surgery, Suzhou is generally silent on the details of the surgery itself including determining an alignment axis of the first anatomical structure and a center of rotation of the first anatomical structure with respect to a second anatomical structure; registering the center of rotation of the joint using the transformation matrix; and determining at least one of a length and an offset associated with the first anatomical structure based on the transformation matrix, the updated landmark locations, and the predefined model.
Paradis, in the same field of endeavor, discloses a computer-implemented method comprising: receiving, by a processor, a predefined model of a first anatomical structure (fig. 2, step 108; [0049]); determining, by the processor, an alignment axis of the first anatomical structure and a center of rotation of the first anatomical structure with respect to a second anatomical structure ([0053]-[0054], [0069]; and in Jansen as incorporated by reference - [0089]-[0090]); acquiring, using a tracking system, a plurality of point probe locations of a trackable point probe, wherein each of the plurality of point probe locations is on the first anatomical structure and is acquired relative to a tracking marker affixed to the second anatomical structure ([0046]-[0047]; and in Jansen as incorporated by reference - [0043], [0049], [0087], registration tool/pointer) registering, by the processor, a position and orientation of the first anatomical structure relative to the tracking marker based the plurality of point probe locations ([0053]-[0054]); acquiring, using the tracking system, landmark locations associated with landmarks rigidly positioned relative to the first anatomical structure (Jansen as incorporated by reference - [0065], landmark points on the edge of the pelvic implant); and determining, by the processor, at least one of a length and an offset associated with the first anatomical structure based on the registration and tracked locations, and the predefined model ([0058]-[0059]). Paradis also discloses that failure to accurately determine leg length and offset measurements may lead to patient dissatisfaction, discomfort, or impairment ([0007]).
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 modify the method of Suzhou by including the steps of determining the axis and center of rotation, registering the axis and center of rotation to the other elements including the trackers and landmarks of Suzhou (using the registration transformation matrix of Suzhou), and, at least one of a length and an offset associated with the first anatomical structure based on the registration, the tracked locations, the landmarks, and the pre-operative model as taught by Paradis in order to provide accurate intraoperative measurements that may improve patient outcome in view of the teachings of Paradis.
Regarding claim 4: Suzhou and Paradis disclose the computer-implemented method of claim 1. Suzhou further discloses wherein the landmarks comprise a geometric shape configured to be reliably captured by the trackable point probe at a plurality of locations along an edge of the geometric shape (pg. 8, paragraphs 1-2 - the negative model can be combined with a set of marker balls affixed to a target, where the marker balls “comprise a geometric shape” and would be capable of performing the claimed function).
Regarding claim 5: Suzhou and Paradis disclose the computer-implemented method of claim 1. Suzhou further discloses wherein the landmarks comprise at least three landmarks (figs. 6 and 8-14).
Regarding claim 6: Suzhou and Paradis disclose the computer-implemented method of claim 5. Suzhou further discloses wherein the at least three landmarks are arranged on a surface in an at least partially asymmetrical configuration, such that an orientation of the at least three landmarks is unambiguous (pg. 6, paragraph 7 - "The number of marked points on the negative model is at least three, and these marked points are not on the same straight line, and the pose of the negative model can be uniquely located through these marked points.").
Regarding claim 7, as best understood based on limitations which are indefinite: Suzhou and Paradis disclose the computer-implemented method of claim 1. Suzhou further discloses wherein the landmarks comprise a single landmark, and wherein acquiring the updated landmark locations of the landmarks further comprises acquiring the updated landmark locations at a normal to a surface comprising the landmarks (figs. 6 and 8-14 - in various embodiments there are individual markers which are placed "at a normal to a surface comprising the landmarks").
Regarding claim 9: Suzhou and Paradis disclose the computer-implemented method of claim 1. Paradis further discloses wherein determining at least one of the length and the offset associated with the first anatomical structure based on the transformation matrix, the updated landmark locations, and the predefined model further comprises aligning, by the processor, a virtual representation of the first anatomical structure, based on the updated landmark locations, to the predefined model along the alignment axis based on a rotation along the center of rotation ([0071]-[0077]; Jansen as incorporated by reference - [0063]-[0064]).
Regarding claim 10: Suzhou and Paradis disclose the computer-implemented method of claim 1. Paradis further discloses wherein the alignment axis is an axis of a femur shaft associated with the first anatomical structure (fig. 1, [0053]-[0054]).
Regarding claim 11: Suzhou and Paradis disclose the computer-implemented method of claim 1. Suzhou further discloses wherein the alignment axis is an axis of a rigid body affixed to the first anatomical structure comprising the landmarks (an axis of rotation of the negative model would correspond to an axis of rotation of the bone to which it is fixed).
Regarding claim 12: Suzhou discloses a system comprising: a tracking system (pg. 13, paragraph 4); a tracking marker configured to affix to a second anatomical structure (fig. 2, tracking markers 22 and 23); a trackable point probe (pg. 13, paragraph 4); a processor in communication with the tracking system (pg. 13, paragraph 4); and a non-transitory, processor-readable storage medium, wherein the non-transitory, processor-readable storage medium comprises one or more programming instructions (pg. 13, paragraphs 5-6) that, when executed, cause the processor to: receive a predefined model of a first anatomical structure (pg. 5, paragraph 4 - "The doctor imports the patient’s preoperative plan planning into the computer."); acquiring, using the tracking system, a plurality of point probe locations of a trackable point probe, wherein each of the plurality of point probe locations is on the first anatomical structure and is acquired relative to a tracking marker affixed to the second anatomical structure (pg. 5, paragraph 6 - "The doctor uses the optical tracking probe to take the feature points of the patient's pelvis and femur. The optical tracking system uses the pelvis and femur markers as references…"; markers 22 and 23 as shown in fig. 2); register a position and orientation of the first anatomical structure relative to the tracking marker based the plurality of point probe locations (pg. 5, paragraph 6 - "The computer obtains the corresponding relationship between the actual orientation of the pelvis and the femur and its CT image orientation through the fast registration algorithm of the present invention, and links the actual orientation of the pelvis and the femur with the corresponding markers installed on the pelvis and the femur, thereby Enables pelvic markers and femoral markers to track the actual position of the bones in real time."); acquiring, using the tracking system, landmark locations associated with landmarks rigidly positioned relative to the first anatomical structure (pg. 5, step s110 and final paragraph; the landmarks are "multiple marker points on the negative model" as shown in fig. 8); register a position and orientation of the landmarks relative to the tracking marker based on the landmark locations (pg. 6, paragraph 6 - "On this basis, the first coordinates of the marker points on the negative model 3D model image in the image coordinate system can be determined according to the transformation relationship between the design coordinate system and the image coordinate system."); generate a transformation matrix between the known positions, landmarks and orientations (pg. 8, paragraph 6 - "...the pose coordinates of a fixed point on the patient in the robot coordinate system can usually be determined first, and then the Based on the pose of the target part of the patient relative to a fixed point on the patient's body, the pose coordinates of the target part of the patient in the robot coordinate system can be obtained through the coordinate transformation method. ..."; step S130); and acquiring, using the tracking system, updated landmark locations of the landmarks (while Suzhou doesn't explicitly describe this step, however based on the provided definition of surgical navigation [pg. 1, first paragraph] and the description of the optical tracking system being used to "track the actual position of the bones in real time" [pg. 5, paragraph 6] this step is considered to be implicitly disclosed since not updating the tracked and registered locations during surgery when the patient or the bones may move would not provide a suitable result).
While Suzhou is directed to the tracking and registration of the patient during a hip surgery, Suzhou is generally silent on the details of the surgery itself including determining an alignment axis of the first anatomical structure and a center of rotation of the first anatomical structure with respect to a second anatomical structure; registering the center of rotation of the joint using the transformation matrix; and determining at least one of a length and an offset associated with the first anatomical structure based on the transformation matrix, the updated landmark locations, and the predefined model.
Paradis, in the same field of endeavor, discloses system comprising: a tracking system (sensor apparatus 204); a tracking marker configured to affix to a second anatomical structure ([0046]-[0047] – tracking markers); a trackable point probe (tool 208, which includes a registration tool); a processor in communication with the tracking system (controller device 202); and a non-transitory, processor-readable storage medium, wherein the non-transitory, processor-readable storage medium comprises one or more programming instructions (CAS system 200, [0079]-[0081]; as well as controller 52 which described as a PC in Jansen as incorporated by reference) that, when executed, cause the processor to: receive a predefined model of a first anatomical structure (fig. 2, step 108; [0049]); determine an alignment axis of the first anatomical structure and a center of rotation of the first anatomical structure with respect to a second anatomical structure ([0053]-[0054], [0069]; and in Jansen as incorporated by reference - [0089]-[0090]); acquiring, using the tracking system, a plurality of point probe locations of a trackable point probe, wherein each of the plurality of point probe locations is on the first anatomical structure and is acquired relative to a tracking marker affixed to the second anatomical structure ([0046]-[0047]; and in Jansen as incorporated by reference - [0043], [0049], [0087], registration tool/pointer) register a position and orientation of the first anatomical structure relative to the tracking marker based the plurality of point probe locations ([0053]-[0054]); acquiring, using the tracking system, landmark locations associated with landmarks rigidly positioned relative to the first anatomical structure (Jansen as incorporated by reference - [0065], landmark points on the edge of the pelvic implant); and determine at least one of a length and an offset associated with the first anatomical structure based on the registration and tracked locations, and the predefined model ([0058]-[0059]). Paradis also discloses that failure to accurately determine leg length and offset measurements may lead to patient dissatisfaction, discomfort, or impairment ([0007]).
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 modify the system of Suzhou by including the steps of determining the axis and center of rotation, registering the axis and center of rotation to the other elements including the trackers and landmarks of Suzhou (using the registration transformation matrix of Suzhou), and, at least one of a length and an offset associated with the first anatomical structure based on the registration, the tracked locations, the landmarks, and the pre-operative model as taught by Paradis in order to provide accurate intraoperative measurements that may improve patient outcome in view of the teachings of Paradis.
Regarding claim 15: Suzhou and Paradis disclose the system of claim 12. Suzhou further discloses wherein the landmarks comprise a geometric shape configured to be reliably captured by the trackable point probe at a plurality of locations along an edge of the geometric shape (pg. 8, paragraphs 1-2 - the negative model can be combined with a set of marker balls affixed to a target, where the marker balls “comprise a geometric shape” and would be capable of performing the claimed function).
Regarding claim 16: Suzhou and Paradis disclose the system of claim 12. Suzhou further discloses wherein the landmarks comprise at least three landmarks (figs. 6 and 8-14).
Regarding claim 17: Suzhou and Paradis disclose the system of claim 16. Suzhou further discloses wherein the at least three landmarks are arranged on a surface in an at least partially asymmetrical configuration, such that an orientation of the at least three landmarks is unambiguous (pg. 6, paragraph 7 - "The number of marked points on the negative model is at least three, and these marked points are not on the same straight line, and the pose of the negative model can be uniquely located through these marked points.").
Regarding claim 18, as best understood based on limitations which are indefinite: Suzhou and Paradis disclose the system of claim 12. Suzhou further discloses wherein the landmarks comprise a single landmark, and wherein acquiring the updated landmark locations of the landmarks further comprises acquiring the updated landmark locations at a normal to a surface comprising the landmarks (figs. 6 and 8-14 - in various embodiments there are individual markers which are placed "at a normal to a surface comprising the landmarks").
Regarding claim 20: Suzhou and Paradis disclose the system of claim 12. Paradis further discloses wherein the one or more programming instructions that cause the processor to determine at least one of the length and the offset associated with the first anatomical structure based on the transformation matrix, the updated landmark locations, and the predefined model further comprise one or more programming instructions that cause the processor to align a virtual representation of the first anatomical structure, based on the updated landmark locations, to the predefined model along the alignment axis based on a rotation along the center of rotation ([0071]-[0077]; Jansen as incorporated by reference - [0063]-[0064]).
Regarding claim 21: Suzhou and Paradis disclose the system of claim 12. Paradis further discloses wherein the alignment axis is an axis of a femur shaft associated with the first anatomical structure (fig. 1, [0053]-[0054]).
Regarding claim 22: Suzhou and Paradis disclose the system of claim 12, Suzhou further discloses a rigid body affixed to the first anatomical structure, the rigid body comprising the landmarks (negative model as shown in figs. 6 and 8-14).
Regarding claim 23: Suzhou and Paradis disclose the system of claim 22. Suzhou further discloses wherein the alignment axis is an axis of the rigid body (an axis of rotation of the negative model would correspond to an axis of rotation of the bone to which it is fixed).
Regarding claim 24, as best understood based on limitations which are indefinite: Suzhou and Paradis disclose the system of claim 12. Suzhou further discloses wherein the landmarks comprise a deformation of the first anatomical structure (pg. 10, final paragraph - the material of the negative model may cause deformation of the target).
Claim(s) 2, 3, 8, 13, 14, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suzhou and Paradis as applied to claims 1, 7, 12, and 18 above, and further in view of Solar et al. (US 2004/0167391 A1, Aug. 26, 2004) (hereinafter “Solar”).
Regarding claims 2, 3, 8, 13, 14, and 19 Suzhou and Paradis disclose the method and system of claims 1, 7, 12, and 18. Suzhou further discloses that the landmarks may be a set of marker balls affixed to the negative model (pg. 8, paragraphs 1-2). Suzhou and Paradis are silent on the marker balls comprising a divot configured to be reliably captured by the trackable point probe; a groove configured to be reliably captured by the trackable point probe at a plurality of locations along the groove; or are configured to receive a point probe in a single orientation.
Solar, in the same field of endeavor, discloses various embodiments of fiducial markers respectively comprising a divot configured to be reliably captured by the trackable point probe (fig. 1A, [0059], [0061]); comprising a groove configured to be reliably captured by the trackable point probe at a plurality of locations along the groove (figs. 11-13, slot 1108); and configured to receive a point probe in a single orientation (fig. 1A, [0059], [0061]). Solar further discloses that these various shapes allow positioning of a probe point at the center of mass of the fiducial which aids in registration ([0061]).
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 modify the marker balls of Suzhou and Paradis to include one or more of the various shape embodiments of Solar in order to improve the accuracy of the registration in view of the further teachings of Solar.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Dozeman et al. (US 2025/0221782 A1, Jul. 10, 2025) – substantially discloses the limitations of at least claims 1 and 12.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
Prosecution Insights