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 § 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.
Claims 1-3 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lang et al. (US Patent No. 11,553,969), hereinafter ‘Lang’.
Regarding claim 1, Lang teaches a system for computer assisted navigation during a total hip arthroplasty (THA) surgery (col. 1, ll. 28-29, computer assisted surgery, col. 206, ll. 20-23, total hip replacement), comprising a computer platform including a processor and a memory (col 123, ll. 3-10, computer, processor, memory chips), operative to:
obtain a point cloud of a surface of an acetabulum of a patient (col. 187, ll. 50-57, point cloud) with a navigated instrument during the THA surgery (col. 271, ll. 55-58, use pointer to generate point cloud), wherein the point cloud includes a plurality of data points detected and captured on the surface of the acetabulum by the navigated instrument (col. 67, ll. 28, portion or entire acetabulum used as anatomic landmark);
create an acquired surface of the acetabulum based on the point cloud (col. 222, ll. 5-6, generating surface from point cloud);
extract an acetabular center of rotation (CoR) from the acquired surface (Fig. 22C, steps 716-720, define center of acetabulum and center of rotation); and
register a location of the acetabular CoR (col. 220, ll. 3-4, determine center of rotation of the hip joint).
Regarding claim 2, Lang teaches the system of claim 1, further comprising:
wherein the computer platform is further operative to:
identify a position of the pelvis relative to a reference element rigidly affixed thereto (col. 270, ll. 35-42, tracking markers rigidly attached to pelvis to determine pose).
Regarding claim 3, Lang teaches the system of claim 1, further comprising:
a camera tracking system in signal communication with the computer platform (col. 269, ll. 67, optical video navigation systems), the camera tracking system being adapted to intra-operatively track a pose of the navigated instrument (col. 270, ll. 25-29, pose is tracked and displayed) relative to a defined coordinate system (col. 270, ll. 6-8, pose is position/orientation relative to a coordinate system); and
a navigation controller adapted to generate navigation information for navigating the navigated instrument (col. 213, ll. 31-32, surgical navigation system).
Regarding claim 15, Lang teaches the system of claim 1, further comprising:
wherein the computer platform is further operative to: extract an additional landmark, selected from a fitting sphere or an acetabular diameter, from the acquired surface (Fig. 21, col. 212 ll. 67- col. 213 ll. 7, radius of patient's acetabular fossa).
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lang et al. (US Patent No. 11,553,969) in view of Arata et al. (US Pre-Grant Publication 2008/0004633), hereinafter ‘Arata’.
Regarding claim 4, Lang teaches the system of claim 3, further comprising:
a display for displaying navigational guidance to a user via a user interface, wherein the display is in signal communication with the computer platform (Fig. 25E, col. 219, ll. 61-66, user interface).
Lang discloses displaying a projected path for a pointer (col. 163, ll. 39-43), but does not explicitly disclose the guidance is to assist the user in obtaining the point cloud.
Arata discloses a surgical system including a painted portion of a patient bone (abstract, Fig. 18), further comprising:
wherein the navigational guidance is adapted to assist the user to obtain the point cloud ([0080], programs and processes that automatically prompt a user to perform tasks such as painting or touching points on a bone).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Lang to incorporate the teachings of Arata to include guidance to assist the user in obtaining the point cloud. Doing so would enable comprehensive intraoperative surgical planning, as recognized by Arata [0053].
Regarding claim 5, Lang teaches the system of claim 3, further comprising:
a surgical robot having a robotic arm (col. 197, ll. 12-15, robotic arm with attached instrument); and
an end effector coupled to the robotic arm (col. 197, ll. 15-17, robotic arm can move with 2, 4, or 6 degrees of freedom); and
wherein the navigation controller is adapted to control translation, rotation, and orientation of the robotic arm and the end effector (see Figs. 27A, 27B, col. 22, ll. 23-27, bone removal executed using robot guidance/surgical navigation system).
Lang does not disclose that the end effector is adapted to receive, translate, and orient the navigated instrument of claim 1, i.e. a pointer to obtain a point cloud.
Arata discloses a surgical system including a painted portion of a patient bone (abstract, Fig. 18), further comprising:
an end effector (end effector 35, Fig. 4) coupled to the robotic arm (arm 33, Fig. 2A), wherein the end effector is adapted to receive, translate, and orient the navigated instrument ([0063], coupling between arm and tool, enables user to perform various activities such as registration/surgical planning).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Lang to incorporate the teachings of Arata to include an end effector to control the instrument to obtain a point cloud. Doing so would enable comprehensive intraoperative surgical planning, as recognized by Arata [0053].
Claims 6-9, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lang et al. (US Patent No. 11,553,969) in view of Walen et al. (US Pre-Grant Publication 2021/0212769), hereinafter ‘Walen’.
Regarding claim 6, Lang teaches the system of claim 1, further comprising:
wherein the navigated instrument includes:
a stylus (col. 187, ll. 53-55, pointer);
an instrument reference element affixed to the stylus, wherein the instrument reference element includes a tracking array having a plurality of tracking fiducials affixed thereto (col. 187, ll. 50-55, pointer with attached optical markers).
Lang does not specifically disclose a ball tip at the distal end of the stylus and data points that correspond to the ball tip’s center.
Walen teaches a system/method for tracking objects near a target site during a surgical procedure (abstract), further comprising:
a ball tip disposed at a distal end of the stylus (Fig. 13, spherical aspect, [0170], tool tip includes spherical aspect),
wherein each data point in the plurality of data points corresponds to a center of the ball tip (Fig. 13, centerpoint 194) during acquisition of the data point ([0170], center of spherical aspect).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Lang to incorporate the teachings of Walen to include a ball tip at the distal end of the stylus and data points that correspond to the ball tip’s center. Doing so would allow for the monitoring of a position of the instrument tool tip relative to the bone, as recognized by Walen [0021].
Regarding claim 7, Walen and Lang teach the system of claim 6. Lang teaches the system further comprising:
wherein the point cloud is obtained by painting the surface of the acetabulum with the ball tip of the stylus, thereby acquiring the plurality of data points (col. 187, ll. 50-57, painting portions of the joint with a pointer and generating a point cloud).
Regarding claim 8, Walen and Lang teach the system of claim 6. Lang teaches the system further comprising:
wherein the point cloud is obtained by individually contacting a plurality of points on the surface of the acetabulum with the ball tip of the stylus, thereby acquiring each data point in the plurality of data points (col. 187, ll. 50-57, touching select landmarks of the joint with a pointer and generating a point cloud).
Regarding claim 9, Walen and Lang teach the system of claim 6. Lang teaches the system further comprising:
wherein a definition of the acquired surface is independent of an orientation of the stylus relative to the surface of the acetabulum at a time of capturing of each data point in the plurality of data points (col 257, ll. 46-60, change in pointer coordinates computed to find the coordinate correction).
Regarding claim 16, see rejection of similarly worded claim 1. Lang further teaches:
A computer program product comprising a non-transitory computer readable medium storing instructions executable by at least one processor to perform operations for computer assisted navigation during a total hip arthroplasty (THA) surgery (col. 189, ll. 9-15, use processor to display virtual surgical guide);
wherein the navigated instrument includes a stylus having an instrument reference element disposed thereon (col. 187, ll. 50-55, pointer with attached optical markers).
Lang does not specifically disclose a ball tip at the distal end of the stylus.
Walen teaches a system/method for tracking objects near a target site during a surgical procedure (abstract), further comprising:
a ball tip disposed at a distal end of the stylus (Fig. 13, spherical aspect, [0170], tool tip includes spherical aspect).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Lang to incorporate the teachings of Walen to include a ball tip at the distal end of the stylus. Doing so would allow for the monitoring of a position of the instrument tool tip relative to the bone, as recognized by Walen [0021].
Regarding claim 19, see rejection of similarly worded claim 16. Lang further teaches:
A method of identifying and registering an acetabular center of rotation (CoR) (Fig. 22C, steps 716-720, define center of acetabulum and center of rotation); and
obtaining a point cloud of a surface of an acetabulum of a pelvis of a patient (col. 207, ll. 18-19, pelvic side, col. 187, ll. 50-57, painting portions of the joint with a pointer and generating a point cloud).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lang et al. (US Patent No. 11,553,969) in view of Walen et al. (US Pre-Grant Publication 2021/0212769), further in view of Morvan et al. (US Pre-Grant Publication 2025/0345116), hereinafter ‘Morvan’.
Regarding claim 14, Lang and Walen teach the system of claim 6, but do not teach identifying and removing outlier data points.
Morvan teaches a method for predicting tool alignment based on point clouds (abstract), further comprising:
wherein the computer platform is further operative to:
identify a data point in the acquired plurality of data points as an outlier; and
remove the outlier from the acquired surface of the acetabulum, wherein the acquired surface of the acetabulum is defined by a majority of the acquired plurality of data points ([0068], computing system removes outlier points).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Lang and Walen to incorporate the teachings of Morvan to include identifying and removing outliers. Doing so would ease fitting of the plane or line, as recognized by Morvan [0068].
Claims 10-13, 17-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lang et al. (US Patent No. 11,553,969) in view of Walen et al. (US Pre-Grant Publication 2021/0212769), further in view of Krueger et al. (US Pre-Grant Publication 2014/0314297), hereinafter ‘Krueger’.
Regarding claim 10, Lang and Walen teach the system of claim 6, further comprising:
wherein the computer platform is further operative to:
collect a location of the center point of the ball tip for each data point in the acquired plurality of data points (Walen, Fig. 13, centerpoint 194, [0170]); and
fit together the collected ball tip center point locations using a sphere fitting algorithm to produce a fitting sphere (Lang, col. 72, ll. 20-34, 3D virtual space such as a sphere can be oriented to coincide with patient anatomy).
Lang and Walen do not specifically teach that a surface of the fitting sphere is offset from the surface of the acetabulum by the ball tip radius.
Krueger teaches a method for assigning position values to an image of a body part (abstract), further comprising:
wherein a surface of the fitting sphere (virtual model surface 28, Fig. 2) is offset from the surface of the acetabulum (surface 24, Fig. 2) by a distance corresponding to a radius of the ball tip (Fig. 2, [0022-0023], virtual model surface is calculated and corresponds to the radius of the scanning tip 20).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Lang and Walen to incorporate the teachings of Krueger to include offsetting the fitting sphere surface from the acetabulum surface by the ball tip radius. Doing so would allow for the position to be determined regardless of the angle at which the scanning instrument is placed on the surface, as recognized by Krueger [0022].
Regarding claim 11, Lang, Walen, and Krueger teach the system of claim 10. Lang teaches the system further comprising:
wherein the surface of the fitting sphere corresponds to the acquired surface, and the acetabular CoR corresponds to a center of the fitting sphere (Fig. 22D, steps 716 and 720, col. 220, ll. 3-6, determining center of rotation using center of acetabulum).
Regarding claim 12, Lang, Walen, and Krueger teach the system of claim 11. Walen teaches points of contact in relation to the center of the spherical aspect (see Fig. 13, [0172]), but does not specifically teach wherein the surfaces are matched by calculating a ball tip sphere radius vector.
Krueger teaches a method for assigning position values to an image of a body part (abstract), further comprising:
wherein the computer platform is further operative to:
match the acquired surface to the surface of the acetabulum by calculating a ball tip sphere radius vector from the acquired surface to the surface of the acetabulum for the center point of the ball tip of each of the plurality of data points (arrows in Fig. 2, [0023], the length of the surface normal corresponds to the radius of the scanning tip).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Lang and Walen to incorporate the teachings of Krueger to include matching the fitting sphere surface from the acetabulum surface by the ball tip radius. Doing so would allow for the position to be determined regardless of the angle at which the scanning instrument is placed on the surface, as recognized by Krueger [0022].
Regarding claim 13, Lang, Walen, and Krueger teach the system of claim 11. Lang teaches the system further comprising:
generate a digital model corresponding to the surface of the acetabulum by connecting the translated acquired data points (col. 180, ll. 17-20, estimate 3D shape by interpolating surfaces between points).
Walen teaches points of contact in relation to the center of the spherical aspect (see Fig. 13, [0172]), but does not specifically teach wherein the data points are translated by the ball tip sphere radius vector.
Krueger teaches a method for assigning position values to an image of a body part (abstract), further comprising:
wherein the computer platform is further operative to:
translate each data point along the ball tip sphere radius vector by a distance corresponding to the radius of the ball tip in a direction away from the instrument reference element on the stylus ([0013], uniform transformation prescription for position values, Fig. 2); and
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Lang and Walen to incorporate the teachings of Krueger to include translating the data point along the ball tip radius. Doing so would allow for the position to be determined regardless of the angle at which the scanning instrument is placed on the surface, as recognized by Krueger [0022].
Regarding claim 17, Lang and Walen teach the product of claim 16. See rejection of similarly worded claims 10-11.
Regarding claim 18, Lang, Walen, and Krueger teach the product of claim 17. See rejection of similarly worded claims 12-13.
Regarding claim 20, Lang and Walen teach the method of claim 19. See rejection of similarly worded claims 10-13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sha et al. (US Pre-Grant Publication 2024/0307088) teaches systems/methods for tracking and aligning a surgical instrument. See sphere fitting algorithm in [0071], sufficient to use in a 35 USC 103 rejection of claims 10-13, 18, 20.
Lavallee (US Pre-Grant Publication 2015/0230877) teaches a system/method for determining a position of a joint prosthesis. See Fig. 2B, [0077], discusses radius/center offset.
Stifter et al. (US Pre-Grant Publication 2005/0149050) teaches the determination of a spatial/angular position of a joint replacement implant. See [0056], shifting sensed surface by radius of spherical probe.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
August 18, 2026
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