Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to amendments filed July 31, 2024.
Claims 1-22 have been canceled.
Claims 23-43 have been added.
Claims 23-43 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 23-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-8, 10-12, 15-17, 19, and 22-23 of U.S. Patent No. 12056337B2 (hereinafter referred to as “reference patent 1”) in view of Axelson et al. (US Publication 20090043556A1). An exemplary mapping of pending claims 23-30 and claims 1-3 and 6-8 of reference patent 1 in view of Axelson is presented below, similar mappings can be made to pending claims 31-43 and claims 10-12, 15-17, 19, and 22-23 of reference patent 1 in view of Axelson.
Regarding claim 23, reference patent 1 recites:
A method of generating a surgical plan for implanting a surgical implant, the method comprising (A method of determining a pose of a surgical implant, the method comprising)(claim 1):
providing a user interface on a display, the user interface comprising (providing a user interface on a display, the user interface comprising)(claim 1):
a virtual implant corresponding to the surgical implant (virtual implant ... wherein the virtual implant corresponds to the surgical implant)(claim 1),
a first user control for controlling a pose of the virtual implant (a user control for controlling a pose of the virtual implant)(claim 1),
a gap curve displayed in association with the virtual implant, wherein the gap curve defines a relationship between a gap between a first bone and a second bone of a joint and each degree of flexion of the joint, wherein the virtual implant corresponds to the surgical implant (a gap curve displayed in association with the virtual implant, wherein the gap curve defines a relationship between a gap between a first bone and a second bone of a joint and each degree of flexion of the joint, wherein the virtual implant corresponds to the surgical implant)(claim 1);
receiving a user input via the first user control … (receiving a user input via the user control)(claim 1);
updating the pose of the virtual implant and the gap curve based on the received user input (updating the pose of the virtual implant and the gap curve based on the received user input)(claim 1); and
generating the surgical plan to place the surgical implant based on the updated pose of the virtual implant (generating a surgical plan to place the surgical implant based on the updated pose of the virtual implant)(claim 1).
Reference patent 1 does not recite a user control for controlling characteristics of the virtual implant. However, Axelson teaches a user control for controlling characteristics of a virtual implant (The surgeon, in one embodiment, selects a type of prosthesis ... the surgeon may first define a target reconstruction position based on design parameters ... Using the increase/decrease arrow control button pairs 246, the surgeon may manually alter each design parameter as desired)([0054], [0055], and [0065]; a surgeon interacts with user interface elements to control characteristics (e.g., type, baseline parameters, etc.) of an implant).
It would have been obvious to person of ordinary skill in the art before the effective filling date of the claimed invention to have a user controlling virtual implant characteristics, as disclosed by Axelson, within claim 1 of reference patent 1 to define implant parameters. This would improve surgical planning as it allows a surgeon to use personal experience and knowledge in creating a surgical plan.
Regarding claim 24, reference patent 1 in view of Axelson recites:
The method of claim 23, wherein the first user control comprises one or more of a left input, a right input, a superior input, an inferior input, a posterior input, an anterior input, a clockwise input, and a counter-clockwise input (reference patent 1 - The method of claim 1, wherein the user control comprises one or more of a left input, a right input, a superior input, an inferior input, a posterior input, an anterior input, a clockwise input, and a counter-clockwise input)(claim 2).
Regarding claim 25, reference patent 1 in view of Axelson recites:
The method of claim 23, wherein the user interface further comprises a third user control to select a type of the virtual implant from a plurality of types of virtual implants (reference patent 1 - the The method of claim 1, wherein the user control comprises a user control configured to select a type of virtual implant from a plurality of types of virtual implants)(claim 3).
Regarding claim 26, reference patent 1 in view of Axelson recites:
The method of claim 23, further comprising: Preliminary Amendment receiving location information pertaining to one or more positions of a joint of a patient as the joint is moved through a range of motion; and determining the gap curve based at least in part on the one or more positions of the joint (reference patent 1 - The method of claim 1, further comprising: receiving location information pertaining to one or more positions of a joint of a patient as the joint is moved through a range of motion; and determining a mapping of the gap curve based at least in part on the one or more positions of the joint)(claim 6).
Regarding claim 27, reference patent 1 in view of Axelson recites:
The method of claim 23, wherein the gap curve comprises a graph defining the relationship between the gap between the first bone and the second bone of the joint and each degree of flexion of the joint (reference patent 1 - The method of claim 1, wherein the gap curve comprises a graph defining the relationship between the gap between the first bone and the second bone of the joint and each degree of flexion of the joint)(claim 7).
Regarding claim 28, reference patent 1 in view of Axelson recites:
The method of claim 23, wherein: the first bone comprises a tibia; the second bone comprises a femur; and the surgical implant is selected from the group consisting of a tibial implant and a femoral implant (reference patent 1 - The method of claim 1, wherein: the first bone comprises a tibia; the second bone comprises a femur; and the virtual implant is selected from the group consisting of a tibial implant and a femoral implant)(claim 8).
Regarding claim 29, reference patent 1 in view of Axelson recites:
The method of claim 23, wherein the characteristic comprises a kinematic axis of the virtual implant (Axelson - Increase/decrease arrow control button pairs 246 are displayed, which may be selected by the surgeon, for ... flexion)([0065]; flexion is a parameter in a sagittal plane (i.e., kinematic axis)).
Regarding claim 30, reference patent 1 in view of Axelson recites:
The method of claim 23, wherein the characteristic comprises a mechanical axis of the virtual implant (Axelson - Increase/decrease arrow control button pairs 246 are displayed, which may be selected by the surgeon, for ... varus/valgus)([0065]; varus/valgus is a parameter in a corona plane (i.e., mechanical axis)).
Claims 23-26, 28-34, 36-40, and 42-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 8, 10-12, 15, 17, 19, and 22 of U.S. Patent No. 11669232B2 (hereinafter referred to as “reference patent 2”) in view of Axelson. An exemplary mapping of pending claims 23-26 and 28-30 and claims 1-3, 6, and 8 of reference patent 2 in view of Axelson is presented below, similar mappings can be made to pending claims 31-34, 36-40, and 42-43 and claims 10-12, 15, 17, 19, and 22 of reference patent 2 in view of Axelson.
Regarding claim 23, reference patent 2 recites:
A method of generating a surgical plan for implanting a surgical implant, the method comprising (A method of determining a pose of a surgical implant, the method comprising)(claim 1):
providing a user interface on a display, the user interface comprising (providing a user interface on a display, the user interface comprising a plurality of views)(claim 1):
a virtual implant corresponding to the surgical implant (virtual implant ... wherein the virtual implant corresponds to the surgical implant)(claim 1),
a first user control for controlling a pose of the virtual implant (a plurality of user controls for refining a position of the virtual implant)(claim 1),
a gap curve displayed in association with the virtual implant, wherein the gap curve defines a relationship between a gap between a first bone and a second bone of a joint and each degree of flexion of the joint, wherein the virtual implant corresponds to the surgical implant (wherein at least one of the plurality of views includes a mapping of a plurality of points creating a gap curve, wherein the gap curve indicates how a gap between a first bone and a second bone of a joint changes with each degree of flexion of the joint)(claim 1);
receiving a user input via the first user control … (receiving a user input pertaining to one of the plurality of user controls)(claim 1);
updating the pose of the virtual implant and the gap curve based on the received user input (updating the location of the virtual implant within the plurality of views and the mapping of the gap curve within the at least one view based on the received user input)(claim 1); and
generating the surgical plan to place the surgical implant based on the updated pose of the virtual implant (generating a surgical plan to place the surgical implant based on the updated location of the virtual implant)(claim 1).
Reference patent 2 does not recite a user control for controlling characteristics of the virtual implant. However, Axelson teaches a user control for controlling characteristics of a virtual implant (The surgeon, in one embodiment, selects a type of prosthesis ... the surgeon may first define a target reconstruction position based on design parameters ... Using the increase/decrease arrow control button pairs 246, the surgeon may manually alter each design parameter as desired)([0054], [0055], and [0065]; a surgeon interacts with user interface elements to control characteristics (e.g., type, baseline parameters, etc.) of an implant).
It would have been obvious to person of ordinary skill in the art before the effective filling date of the claimed invention to have a user controlling virtual implant characteristics, as disclosed by Axelson, within claim 1 of reference patent 2 to define implant parameters. This would improve surgical planning as it allows a surgeon to use personal experience and knowledge in creating a surgical plan.
Regarding claim 24, reference patent 2 in view of Axelson recites:
The method of claim 23, wherein the first user control comprises one or more of a left input, a right input, a superior input, an inferior input, a posterior input, an anterior input, a clockwise input, and a counter-clockwise input (reference patent 2 – The method of claim 1, wherein the plurality of user controls comprise one or more of a left input, a right input, a superior input, an inferior input, a posterior input, an anterior input, a clockwise input, and a counter-clockwise input)(claim 2).
Regarding claim 25, reference patent 2 in view of Axelson recites:
The method of claim 23, wherein the user interface further comprises a third user control to select a type of the virtual implant from a plurality of types of virtual implants (reference patent 2 – The method of claim 1, wherein the plurality of user controls comprise a user control configured to select a type of virtual implant from a plurality of types of virtual implants)(claim 3).
Regarding claim 26, reference patent 2 in view of Axelson recites:
The method of claim 23, further comprising: Preliminary Amendment receiving location information pertaining to one or more positions of a joint of a patient as the joint is moved through a range of motion; and determining the gap curve based at least in part on the one or more positions of the joint (reference patent 2 - The method of claim 1, further comprising: receiving location information pertaining to one or more positions of a joint of a patient as the joint is moved through a range of motion; and determining a mapping of the gap curve based at least in part on the one or more positions of the joint)(claim 6).
Regarding claim 28, reference patent 2 in view of Axelson recites:
The method of claim 23, wherein: the first bone comprises a tibia; the second bone comprises a femur; and the surgical implant is selected from the group consisting of a tibial implant and a femoral implant (reference patent 2 – The method of claim 1, wherein: the first bone comprises a tibia; the second bone comprises a femur; and the implant comprises a tibial implant)(claim 8).
Regarding claim 29, reference patent 2 in view of Axelson recites:
The method of claim 23, wherein the characteristic comprises a kinematic axis of the virtual implant (Axelson - Increase/decrease arrow control button pairs 246 are displayed, which may be selected by the surgeon, for ... flexion)([0065]; flexion is a parameter in a sagittal plane (i.e., kinematic axis)).
Regarding claim 30, reference patent 2 in view of Axelson recites:
The method of claim 23, wherein the characteristic comprises a mechanical axis of the virtual implant (Axelson - Increase/decrease arrow control button pairs 246 are displayed, which may be selected by the surgeon, for ... varus/valgus)([0065]; varus/valgus is a parameter in a corona plane (i.e., mechanical axis)).
Claims 27, 35, and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 19 of reference patent 2-Axelson in view of Vorhis et al. (US Publication 20090209884A1). An exemplary mapping of pending claim 27 and claim 1 of reference patent 2-Axelson in view of Vorhis, similar mappings can be made to pending claims 35 and 41 and claims 10 and 19 of reference patent 2-Axelson in view of Vorhis.
Regarding claim 27, reference patent 2-Axelson recites:
The method of claim 23, wherein the gap curve defines a relationship between the gap between the first bone and the second bone of the joint and each degree of flexion of the joint (reference patent 2 - the gap curve indicates how a gap between a first bone and a second bone of a joint changes with each degree of flexion of the joint)(claim 1).
Reference patent 2-Axelson does not recite the gap curve comprise a graph. However, Vorhis teaches a gap curve comprising a graph (FIG. 9 shows an example of a computer display of an overlap analysis of the positions of the implant models 20, 30 at a pose with a flexion angle θ of 90 degrees)([0075]).
It would have been obvious to person of ordinary skill in the art before the effective filling date of the claimed invention to have a gap curve graph, as disclosed by Vorhis, within claim 1 of reference patent 2-Axelson to visualize a gap trend over time. This would improve surgical planning as it allows a surgeon to track relationship between a gap and bones.
Claims 23-26, 28-34, 36-40, and 42-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 8, 10-12, 15, 17, 19, and 22 of U.S. Patent No. 11188204B2 (hereinafter referred to as “reference patent 3”) in view of Axelson. An exemplary mapping of pending claims 23-26 and 28-30 and claims 1-3, 6, and 8 of reference patent 3 in view of Axelson is presented below, similar mappings can be made to pending claims 31-34, 36-40, and 42-43 and claims 10-12, 15, 17, 19, and 22 of reference patent 3 in view of Axelson.
Regarding claim 23, reference patent 3 recites:
A method of generating a surgical plan for implanting a surgical implant, the method comprising (A method of determining a pose of a surgical implant, the method comprising)(claim 1):
providing a user interface on a display, the user interface comprising (providing a user interface on a display, the user interface comprising a plurality of views)(claim 1):
a virtual implant corresponding to the surgical implant (virtual implant)(claim 1),
a first user control for controlling a pose of the virtual implant (a plurality of user controls for refining a position of the virtual implant)(claim 1),
a gap curve displayed in association with the virtual implant, wherein the gap curve defines a relationship between a gap between a first bone and a second bone of a joint and each degree of flexion of the joint, wherein the virtual implant corresponds to the surgical implant (wherein at least one of the plurality of views includes a two-dimensional mapping of a plurality of points creating a gap curve)(claim 1; a gap curve is a spacing between an implant and bones as the joint flexes);
receiving a user input via the first user control … (receiving a user input pertaining to one of the plurality of user controls)(claim 1);
updating the pose of the virtual implant and the gap curve based on the received user input (updating the location of the virtual implant within the plurality of views and the mapping of the gap curve within the at least one view based on the received user input)(claim 1); and
generating the surgical plan to place the surgical implant based on the updated pose of the virtual implant (implementing a surgical plan to place an implant based on the location of the virtual implant)(claim 1).
Reference patent 3 does not recite a user control for controlling characteristics of the virtual implant. However, Axelson teaches a user control for controlling characteristics of a virtual implant (The surgeon, in one embodiment, selects a type of prosthesis ... the surgeon may first define a target reconstruction position based on design parameters ... Using the increase/decrease arrow control button pairs 246, the surgeon may manually alter each design parameter as desired)([0054], [0055], and [0065]; a surgeon interacts with user interface elements to control characteristics (e.g., type, baseline parameters, etc.) of an implant).
It would have been obvious to person of ordinary skill in the art before the effective filling date of the claimed invention to have a user controlling virtual implant characteristics, as disclosed by Axelson, within claim 1 of reference patent 3 to define implant parameters. This would improve surgical planning as it allows a surgeon to use personal experience and knowledge in creating a surgical plan.
Regarding claim 24, reference patent 3 in view of Axelson recites:
The method of claim 23, wherein the first user control comprises one or more of a left input, a right input, a superior input, an inferior input, a posterior input, an anterior input, a clockwise input, and a counter-clockwise input (reference patent 3 – The method of claim 1, wherein the plurality of user controls comprise one or more of a left input, a right input, a superior input, an inferior input, a posterior input, an anterior input, a clockwise input, and a counter-clockwise input)(claim 2).
Regarding claim 25, reference patent 3 in view of Axelson recites:
The method of claim 23, wherein the user interface further comprises a third user control to select a type of the virtual implant from a plurality of types of virtual implants (reference patent 3 – The method of claim 1, wherein the plurality of user controls comprise a user control configured to select a type of virtual implant from a plurality of types of virtual implants)(claim 3).
Regarding claim 26, reference patent 3 in view of Axelson recites:
The method of claim 23, further comprising: Preliminary Amendment receiving location information pertaining to one or more positions of a joint of a patient as the joint is moved through a range of motion; and determining the gap curve based at least in part on the one or more positions of the joint (reference patent 3 - The method of claim 1, further comprising: receiving location information pertaining to one or more positions of a joint of a patient as the joint is moved through a range of motion; and determining a mapping of the gap curve based at least in part on the one or more positions of the joint)(claim 6).
Regarding claim 28, reference patent 3 in view of Axelson recites:
The method of claim 23, wherein: the first bone comprises a tibia; the second bone comprises a femur (Axelson - a computer assisted surgical navigation system 42 are associated with the femur 32 and the tibia 34 such that the tracking devices 38 move with the femur 32 and the tibia 34, respectively)([0050]); and the surgical implant is selected from the group consisting of a tibial implant and a femoral implant (reference patent 3 – The method of claim 1, wherein the implant comprises a tibial implant)(claim 8).
Regarding claim 29, reference patent 3 in view of Axelson recites:
The method of claim 23, wherein the characteristic comprises a kinematic axis of the virtual implant (Axelson - Increase/decrease arrow control button pairs 246 are displayed, which may be selected by the surgeon, for ... flexion)([0065]; flexion is a parameter in a sagittal plane (i.e., kinematic axis)).
Regarding claim 30, reference patent 3 in view of Axelson recites:
The method of claim 23, wherein the characteristic comprises a mechanical axis of the virtual implant (Axelson - Increase/decrease arrow control button pairs 246 are displayed, which may be selected by the surgeon, for ... varus/valgus)([0065]; varus/valgus is a parameter in a corona plane (i.e., mechanical axis)).
Claims 27, 35, and 41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 19 of reference patent 3-Axelson in view of Vorhis. An exemplary mapping of pending claim 27 and claim 1 of reference patent 3-Axelson in view of Vorhis, similar mappings can be made to pending claims 35 and 41 and claims 10 and 19 of reference patent 3-Axelson in view of Vorhis.
Regarding claim 27, reference patent 3-Axelson recites:
The method of claim 23, wherein the gap curve defines the relationship between the gap between the first bone and the second bone of the joint and each degree of flexion of the joint (reference patent 3 – mapping of a plurality of points creating a gap curve)(claim 1; a gap curve is a spacing between an implant and bones as the joint flexes).
Reference patent 3-Axelson does not recite the gap curve comprise a graph. However, Vorhis teaches a gap curve comprising a graph (FIG. 9 shows an example of a computer display of an overlap analysis of the positions of the implant models 20, 30 at a pose with a flexion angle θ of 90 degrees)([0075]).
It would have been obvious to person of ordinary skill in the art before the effective filling date of the claimed invention to have a gap curve graph, as disclosed by Vorhis, within claim 1 of reference patent 3-Axelson to visualize a gap trend over time. This would improve surgical planning as it allows a surgeon to track relationship between a gap and bones.
Conclusion
The prior art made of record on form PTO-892 and not relied upon is considered pertinent to applicant's disclosure. Applicant is required under 37 C.F.R. § 1.111(c) to consider the reference fully when responding to this action. The document cited therein and enumerated below teaches a method and apparatus for planning a surgery.
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/YONGJIA PAN/Primary Examiner, Art Unit 2118
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