DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 102
2. 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.
3. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
4. Claims 1-7, 9-17, 19, and 20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Revie et al., WO Patent No. 2006/129087 A1 (“Revie”).
As to Claim 1, Revie teaches the following:
A surgical system (see “Methods, systems and data processing apparatus and methods are described for use in planning and carrying out a surgical procedure on a joint of a subject.” in Abstract, and figs. 4 and 14), comprising:
a tracking system (“tracking system”) 242 configured to intraoperatively track relative positions of bones (“femur” and “pelvis”) of a joint (“hip”) (see “The image capturing system 240 includes a tracking system 242 which can track and determine the position (in terms of x, y and z co-ordinates) and orientation (in terms of pitch, yaw and roll angles, ψ, φ, θ) of suitably marked entities within the reference frame or co-ordinate system 244 of the tracking system. … A patient 246 who is going to have hip replacement surgery has a first marker 248 attached to their femur and a second 250 marker attached to their pelvis. The system also includes a marked source of X-rays 252 and a marked X- ray film cassette 256 with which X-ray images of the patient's hip can be captured.” in p. 14, ll. 16-26);
a user interface (“interface”) 910 configured to obtain a user input (see “CPU 902 is also coupled to an interface 910 that connects to one or more input/output devices such as such as video monitors, trackballs, mice, keyboards, microphones, touch- sensitive displays, transducer card readers, magnetic or paper tape readers, tablets, styluses, voice or handwriting recognizers, or other well-known input devices such as, of course, other computers.” in p. 27, ll. 13-17) indicating a post-operative value for the joint (see “At step 458, the user can enter commands to increase or decrease the inclination or anteversion of the cup and processing returns to step 456 at which the display is updated to show the changed orientation of the cup and also the changes in the inclination and anteversion angles relative to anatomy and function. At step 460, the user can enter commands to change the position of the cup and processing returns to step 456 at which the display is updated to show the changed position of the cup and also the distance of the centre of the cup from the centre of the acetabulum in the sagittal-inferior, anterior- posterior and medial-lateral directions. As represented by process flow return line 464, stages 458 and 460 can be repeated as many times as necessary and in any order until the user is happy with the planned cup position.” in p. 21, ll. 413, and fig. 10; and see “Then at step 476, the user can enter a command to change the size of the stem and select a different sized stem for use in the planning process. At step 478, the user can enter a command to alter the off set of the femoral implant. At step 480, the user can enter a command to alter the extension of the femoral implant.” in p. 21, l. 31, to p. 22, l. 2, and fig. 11); and
a computer (“processor”) 902 programmed to (see “Figure 14 illustrates a typical computer system that, when appropriately configured or designed, can serve provide the planning, computer aided surgery, IGS and assessment apparatus of this invention. The computer system 900 includes any number of processors 902 (also referred to as central processing units, or CPUs) that are coupled to storage devices including primary storage 906 (typically a random access memory, or RAM), primary storage 904 (typically a read only memory, or ROM). CPU 902 may be of various types including microcontrollers and microprocessors such as programmable devices (e.g., CPLDs and FPGAs) and unprogrammable devices such as gate array ASICs or general purpose microprocessors.” in p. 26, ll. 24-32):
generate, based on the relative positions of the bones and the post-operative value, a planned orientation for an implant to be implanted in the joint (see “At step 462, the user can observe the planned cup position and orientation and if the planned cup configuration is acceptable, then they can enter a command causing the plan for the acetabular cup implant to be stored at step 466. The position and orientation data is stored relative to the anatomical planes of the pelvis. Subsequently the navigation system uses the rigid body of pelvis as a reference frame as the navigation marker is attached to the pelvis during surgery and the pelvis anatomy is registered using the reference marker for navigation purposes. Hence, the plan is stored in the pelvis coordinate system. In an alternative embodiment, the plan can be stored in one reference system and then transformed to the pelvis coordinate system for use during navigated surgery.” in p. 21, ll. 13-22, and fig. 10; and see “At step 482, the user can enter a command indicating that the selected stem is acceptable as the basis of the surgical plan. As represented by process flow return line 490, any of steps 476 to 482 can be repeated any number of times and in any order so as to allow the appropriate stem to be selected.” in p. 22, ll. 3-6, and fig. 11); and
generate a surgical plan based on the planned orientation for the implant (see “Then at step 484, the position of the head and the orientation of the neck axis of the selected stem is determined and at step 486, the anteversion and inclination of the selected stem is displayed to the user with respect to the anatomy of the femur, i.e. the femoral axes, and with respect to function, i.e. the reference direction. If the planned position is determined to be acceptable at step 488, then at step 492 the planned position and orientation data for the stem are stored.” in p. 22, ll. 8-13; and see “At step 510, using the planning data, graphical and visual indications of the planned positions and orientations of the implants are displayed to the surgeon.” in p. 24, ll. 5-6).
As to Claim 2, Revie teaches the following:
a robot (“instruments”), wherein the computer 902 is further programmed to control the robot based on the surgical plan to execute a bone resection adapted to prepare one of the bones of the joint to receive the implant in the planned orientation (see “At step 508, the IGS software generates images of the implants and instruments which are scaled using the respective magnification factors for the two X-ray images and images corresponding to the views of the instruments in the different directions of the X- ray images are overlaid on the X-ray images so that the surgeon is provided with a virtual representation of the positions of the instruments and implants relative to the X-ray images and hence femur and pelvis. … As represented by process flow line 513, as the implants and instruments are manipulated by the surgeon, the display is updated to reflect the current actual position and orientation of the implants together with the planned positions and orientations of the implants.” in p. 23, l. 30, to p. 24, l. 15).
As to Claim 3, Revie teaches the following:
wherein the post-operative value is a desired separation distance between the implant and an additional implant to be implanted in the joint (see “The planning program begins and initially displays the X-ray images 330, 350 to a user. Then at step 452, a virtual acetabular cup implant having a size most closely matching the target size used previously to identify the centre of the acetabulum is selected from a range of real acetabular cup implants. An image of the selected virtual acetabular cup implant is scaled using the respective magnification factors for the images.” in p. 20, ll. 17-21).
As to Claim 4, Revie teaches the following:
wherein the user input indicates a range for the post-operative value (see “Then at step 452, a virtual acetabular cup implant having a size most closely matching the target size used previously to identify the centre of the acetabulum is selected from a range of real acetabular cup implants.” in p. 20, l. 18-20).
As to Claim 5, Revie teaches the following:
wherein the computer 902 is programmed to generate the planned orientation by executing an auto-planning algorithm that uses the relative positions and the post-operative value as inputs (see “At step 510, using the planning data, graphical and visual indications of the planned positions and orientations of the implants are displayed to the surgeon. The displayed information can include the planned position and orientation of the implants relative to local anatomy and also relative to function. Then a virtual representation of the implants can be displayed overlaid on the X-ray images showing the current position of the implants relative to the images and hence body. The images of the implants are scaled to match the X-ray images using the magnification factors and are displayed in different views to reflect the different directions of the X-rays.” in p. 24, ll. 5-12).
As to Claim 6, Revie teaches the following:
wherein the computer 902 is further programmed to generate the planned orientation by executing the auto-planning algorithm for a plurality of iterations until an error based on the post-operative value is below a threshold value (see “As represented by process flow return line 490, any of steps 476 to 482 can be repeated any number of times and in any order so as to allow the appropriate stem to be selected.” in p. 22, ll. 4-6).
As to Claim 7, Revie teaches the following:
wherein executing the auto-planning algorithm comprises handling a tradeoff between achieving the post-operative value and achieving an additional post-operative value (see “The images of the implants are scaled to match the X-ray images using the magnification factors and are displayed in different views to reflect the different directions of the X-rays. As represented by process flow line 513, as the implants and instruments are manipulated by the surgeon, the display is updated to reflect the current actual position and orientation of the implants together with the planned positions and orientations of the implants.” in p. 24, ll. 10-15).
As to Claim 9, Revie teaches the following:
wherein the computer 902 is programmed to generate the planned orientation by determining a target location for a point on a surface of a model of the implant and rotating the model of the implant to fit the point to the target location (see “The displayed information can include the planned position and orientation of the implants relative to local anatomy and also relative to function. Then a virtual representation of the implants can be displayed overlaid on the X-ray images showing the current position of the implants relative to the images and hence body. The images of the implants are scaled to match the X-ray images using the magnification factors and are displayed in different views to reflect the different directions of the X-rays.” in p. 24, ll. 6-12).
As to Claim 10, Revie teaches the following:
wherein the computer 902 is further programmed to generate a planned position for the implant based on the relative positions of the bones and the post-operative value (see “At step 510, using the planning data, graphical and visual indications of the planned positions and orientations of the implants are displayed to the surgeon. The displayed information can include the planned position and orientation of the implants relative to local anatomy and also relative to function. Then a virtual representation of the implants can be displayed overlaid on the X-ray images showing the current position of the implants relative to the images and hence body.” in p. 24, ll. 5-10).
As to Claim 11, Revie teaches the following:
A method executable by a surgical system (see “Methods, systems and data processing apparatus and methods are described for use in planning and carrying out a surgical procedure on a joint of a subject.” in Abstract, and figs. 4 and 14), the method comprising:
intraoperatively tracking relative positions of bones (“femur” and “pelvis”) of a joint (“hip”) (see “The image capturing system 240 includes a tracking system 242 which can track and determine the position (in terms of x, y and z co-ordinates) and orientation (in terms of pitch, yaw and roll angles, ψ, φ, θ) of suitably marked entities within the reference frame or co-ordinate system 244 of the tracking system. … A patient 246 who is going to have hip replacement surgery has a first marker 248 attached to their femur and a second 250 marker attached to their pelvis. The system also includes a marked source of X-rays 252 and a marked X- ray film cassette 256 with which X-ray images of the patient's hip can be captured.” in p. 14, ll. 16-26);
generating, based on the relative positions and a user input indicating a post-operative value for the joint (see “At step 458, the user can enter commands to increase or decrease the inclination or anteversion of the cup and processing returns to step 456 at which the display is updated to show the changed orientation of the cup and also the changes in the inclination and anteversion angles relative to anatomy and function. At step 460, the user can enter commands to change the position of the cup and processing returns to step 456 at which the display is updated to show the changed position of the cup and also the distance of the centre of the cup from the centre of the acetabulum in the sagittal-inferior, anterior- posterior and medial-lateral directions. As represented by process flow return line 464, stages 458 and 460 can be repeated as many times as necessary and in any order until the user is happy with the planned cup position.” in p. 21, ll. 413, and fig. 10; and see “Then at step 476, the user can enter a command to change the size of the stem and select a different sized stem for use in the planning process. At step 478, the user can enter a command to alter the off set of the femoral implant. At step 480, the user can enter a command to alter the extension of the femoral implant.” in p. 21, l. 31, to p. 22, l. 2, and fig. 11), a planned orientation for an implant to be implanted in the joint (see “At step 462, the user can observe the planned cup position and orientation and if the planned cup configuration is acceptable, then they can enter a command causing the plan for the acetabular cup implant to be stored at step 466. The position and orientation data is stored relative to the anatomical planes of the pelvis. Subsequently the navigation system uses the rigid body of pelvis as a reference frame as the navigation marker is attached to the pelvis during surgery and the pelvis anatomy is registered using the reference marker for navigation purposes. Hence, the plan is stored in the pelvis coordinate system. In an alternative embodiment, the plan can be stored in one reference system and then transformed to the pelvis coordinate system for use during navigated surgery.” in p. 21, ll. 13-22, and fig. 10; and see “At step 482, the user can enter a command indicating that the selected stem is acceptable as the basis of the surgical plan. As represented by process flow return line 490, any of steps 476 to 482 can be repeated any number of times and in any order so as to allow the appropriate stem to be selected.” in p. 22, ll. 3-6, and fig. 11); and
guiding a bone resection based on the planned orientation for the implant (see “As represented by process flow line 513, as the implants and instruments are manipulated by the surgeon, the display is updated to reflect the current actual position and orientation of the implants together with the planned positions and orientations of the implants.” in p. 24, ll. 12-15).
As to Claim 12, Revie teaches the following:
wherein the user input indicates a range for the post-operative value (see “Then at step 452, a virtual acetabular cup implant having a size most closely matching the target size used previously to identify the centre of the acetabulum is selected from a range of real acetabular cup implants.” in p. 20, l. 18-20).
As to Claim 13, Revie teaches the following:
wherein guiding the bone resection based on the planned orientation for the implant comprise controlling a robot (“instruments”) to constrain movement of a cutting tool to a control object defined based on the planned orientation (see “At step 508, the IGS software generates images of the implants and instruments which are scaled using the respective magnification factors for the two X-ray images and images corresponding to the views of the instruments in the different directions of the X- ray images are overlaid on the X-ray images so that the surgeon is provided with a virtual representation of the positions of the instruments and implants relative to the X-ray images and hence femur and pelvis. … As represented by process flow line 513, as the implants and instruments are manipulated by the surgeon, the display is updated to reflect the current actual position and orientation of the implants together with the planned positions and orientations of the implants.” in p. 23, l. 30, to p. 24, l. 15).
As to Claim 14, Revie teaches the following:
wherein the post-operative value is a desired separation distance between the implant and an additional implant to be implanted in the joint (see “The planning program begins and initially displays the X-ray images 330, 350 to a user. Then at step 452, a virtual acetabular cup implant having a size most closely matching the target size used previously to identify the centre of the acetabulum is selected from a range of real acetabular cup implants. An image of the selected virtual acetabular cup implant is scaled using the respective magnification factors for the images.” in p. 20, ll. 17-21).
As to Claim 15, Revie teaches the following:
wherein generating the planned orientation comprises executing an auto-planning algorithm that uses the relative positions and the post-operative value as inputs (see “At step 510, using the planning data, graphical and visual indications of the planned positions and orientations of the implants are displayed to the surgeon. The displayed information can include the planned position and orientation of the implants relative to local anatomy and also relative to function. Then a virtual representation of the implants can be displayed overlaid on the X-ray images showing the current position of the implants relative to the images and hence body. The images of the implants are scaled to match the X-ray images using the magnification factors and are displayed in different views to reflect the different directions of the X-rays.” in p. 24, ll. 5-12).
As to Claim 16, Revie teaches the following:
executing the auto-planning algorithm for a plurality of iterations until an error based on the post-operative value is below a threshold value (see “As represented by process flow return line 490, any of steps 476 to 482 can be repeated any number of times and in any order so as to allow the appropriate stem to be selected.” in p. 22, ll. 4-6).
As to Claim 17, Revie teaches the following:
wherein executing the auto-planning algorithm comprises handling a tradeoff between achieving the post-operative value and achieving an additional post-operative value (see “The images of the implants are scaled to match the X-ray images using the magnification factors and are displayed in different views to reflect the different directions of the X-rays. As represented by process flow line 513, as the implants and instruments are manipulated by the surgeon, the display is updated to reflect the current actual position and orientation of the implants together with the planned positions and orientations of the implants.” in p. 24, ll. 10-15).
As to Claim 19, Revie teaches the following:
wherein generating the planned orientation comprises determining a target location for a point on a surface of a model of the implant and rotating the model of the implant to fit the point to the target location (see “The displayed information can include the planned position and orientation of the implants relative to local anatomy and also relative to function. Then a virtual representation of the implants can be displayed overlaid on the X-ray images showing the current position of the implants relative to the images and hence body. The images of the implants are scaled to match the X-ray images using the magnification factors and are displayed in different views to reflect the different directions of the X-rays.” in p. 24, ll. 6-12).
As to Claim 20, Revie teaches the following:
prompting, via a graphical user interface (“interface”) 910, a user to select the post-operative value from a plurality of options for the post-operative value (see “CPU 902 is also coupled to an interface 910 that connects to one or more input/output devices such as such as video monitors, trackballs, mice, keyboards, microphones, touch- sensitive displays, transducer card readers, magnetic or paper tape readers, tablets, styluses, voice or handwriting recognizers, or other well-known input devices such as, of course, other computers.” in p. 27, ll. 13-17; and see “The process 470 also displays the X-ray images to the user and at step 472 a virtual representation of a femoral stem implant having medium size is selected from a range of actual femoral stem implants.” in p. 21, ll. 26-28).
Allowable Subject Matter
5. Claims 8 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
6. The following is a statement of reasons for the indication of allowable subject matter:
As to Claim 8, neither Revie nor the prior art of record teaches the surgical system of base claim 7, including the following, in combination with all other limitations of the base claim:
wherein executing the auto-planning algorithm comprises minimizing a cost function comprising a sum of a first error value associated with the post-operative value and a second error value associated with the additional post-operative value.
As to Claim 18, neither Revie nor the prior art of record teaches the method of base claim 17, including the following, in combination with all other limitations of the base claim:
wherein executing the auto-planning algorithm comprises minimizing a cost function comprising a sum of a first error value associated with the post-operative value and a second error value associated with the additional post-operative value.
Conclusion
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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, Jason M Sims can be reached at 571-272-7540. 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.
/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 12/11/2025
Prosecution Insights