Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 7, 11-12, 16, 19, and 37 are objected to because of the following informalities.
• Claim 7, line 2, “the implant” should read as “the orthopaedic implant”.
• Claim 11, line 2, “a transparency” should read as “the transparency”.
• Claim 12, lines 1-2, “a transparency” should read as “the transparency”.
• Claim 12, line 2, “a transparency” should read as “the transparency”.
• Claim 16, line 2, “a viewing portal” should read as “the viewing portal”.
• Claim 19, line 5, “an orthopaedic implant” should read as “the orthopaedic implant”.
• Claim 37, line 11, “a transparency” should read as “the transparency”.
Appropriate correction is required.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7, 11-13, 17, and 23 are rejected under 35 U.S.C. 103 as being unpatentable under US 20170281355 A1 (“Winslow”) in view of US 20220249168 A1 (“Besier”).
In regard to claim 1, Winslow discloses
a main body representative of anatomy, wherein the main body includes a bone component ([0024], “the bone component … can include main body”), the bone component including an exterior having ([0022], “in FIGS. 1-2, a bone model … can include a bone component”) a surface contour representative of a bone, the bone component comprising ([0022], “The bone component … can include a … surface”): a first portion establishing the exterior and comprising a first material ([0027], “The main body … can comprise a flexible, resilient material”);
and a second portion ([0022], “a bone model … can include … an implant component”) adjacent to the first portion, the second portion including ([0020], “FIG. 8 is a … view of the bone model” See Annotated Winslow FIG. 8.)
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a second material that differs from the first material, and the second material is transparent or translucent for viewing an interior of the bone component ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”).
Winslow does not disclose
A system for an orthopaedic procedure comprising: a physical anatomical model including
However, in an analogous art of orthopedic procedure planning, Besier discloses
A system for an orthopaedic procedure comprising ([0066], “The … description focuses on … planning an orthopedic procedure”): a physical anatomical model including ([0019], “the method includes ... a patient anatomical model”)
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, a system for an orthopaedic procedure comprising: a physical anatomical model including, of Besier into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding an orthopedic planning procedure and a patient anatomical model.
In regard to claim 2, Winslow discloses
wherein the second material is transparent ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”).
In regard to claim 3, Winslow discloses
wherein the second material is translucent ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”).
In regard to claim 4, Winslow discloses
wherein the second material establishes ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”) a viewing portal to the interior of the bone component ([0020], “FIG. 8 is a … view of a bone model” See Annotated Winslow FIG. 8.), the interior of the bone component includes an internal cavity at least partially aligned with the viewing portal ([0015], “FIG. 3 is a … view of a bone component”), the internal cavity dimensioned to at least partially receive an orthopaedic implant ([0033], “the bone component … can further comprise a latch hole … and the implant component … can further comprise a corresponding latch hole”).
In regard to claim 5, Winslow discloses
wherein the internal cavity extends at least partially through the first portion of the bone component ([0018], “FIG. 6 is a front … view of a bone model” See Annotated Winslow FIG. 6.).
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In regard to claim 6, Winslow discloses
wherein the internal cavity includes a deployment region dimensioned to ([0018], “FIG. 6 is a front … view of a bone model” See Annotated Winslow FIG. 6.) at least partially receive a portion of the orthopaedic implant movable between an undeployed state and a deployed state, the deployment region at least partially aligned with ([0026], “the implant component … can be slid on the bone component … at various offset positions”) the viewing portal ([0020], “FIG. 8 is a … view of a bone model” See Annotated Winslow FIG. 8.).
In regard to claim 7, Winslow discloses
wherein the deployment region includes a conical void associated with ([0018], “FIG. 6 is a front … view of a bone model” See Annotated Winslow FIG. 6.) a geometry of the portion of the implant in the deployed state ([0032], “the implant component … can comprise an engagement feature”).
In regard to claim 11, Winslow discloses
wherein the first material has a transparency that is less than a transparency of ([0027], “The main body … can comprise a flexible, resilient material”) the second material ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”), and the first material is substantially opaque ([0027], “The main body … can comprise a flexible, resilient material”).
In regard to claim 12, Winslow discloses
wherein the first material has a transparency that is less than a transparency of ([0027], “The main body … can comprise a flexible, resilient material”) the second material ([0027], “The main body … can comprise a flexible, resilient material”), and the first portion is distal to the second portion ([0020], “FIG. 8 is a … view of a bone model” See Annotated Winslow FIG. 8.).
In regard to claim 13, Winslow discloses
wherein the first portion includes a joint region of the bone component, the joint region representative of an orthopaedic joint ([0023], “the bone model ... can be used to simulate ... replacement of ... knee joints”).
In regard to claim 17, Winslow does not disclose
further comprising: a soft tissue component on the bone component, wherein the soft tissue component is representative of soft tissue.
However, in an analogous art of orthopedic procedure planning, Besier discloses
further comprising: a soft tissue component on the bone component, wherein the soft tissue component is representative of soft tissue ([0066], “Those skilled in the art will understand that modelling of anatomical structures … includes … connective tissue”).
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, further comprising: a soft tissue component on the bone component, wherein the soft tissue component is representative of soft tissue, of Besier into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding an anatomical structure modelling and connective tissue.
In regard to claim 23, Winslow discloses
and forming the physical anatomical model, the physical anatomical model including a body associated with an anatomical profile of a bone ([0024], “the bone component … can include main body”), at least a first portion of the body including a first material that is transparent or translucent for viewing an interior portion of the body ([0027], “The main body … can comprise a flexible, resilient material”).
Winslow does not disclose
A method of rehearsing for a surgical procedure comprising: accessing a virtual anatomical model associated with an anatomy;
generating a configuration associated with a physical anatomical model that is representative of the virtual anatomical model;
However, in an analogous art of orthopedic procedure planning, Besier discloses
A method of rehearsing for a surgical procedure comprising ([0009], “It is an object of the … disclosure to provide a method … for pre-planning or planning an orthopedic operative procedure”): accessing a virtual anatomical model associated with an anatomy ([0066], “The method includes … a virtual implant component relative to a digital model of the patient's anatomy”);
generating a configuration associated with a physical anatomical model that is representative of the virtual anatomical model ([0019], “the method includes ... a patient anatomical model”);
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, a method of rehearsing for a surgical procedure comprising: accessing a virtual anatomical model associated with an anatomy; generating a configuration associated with a physical anatomical model that is representative of the virtual anatomical model, of Besier into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding an orthopedic operative procedure, a virtual implant component, and a patient anatomical model.
Claims 8, 14, 16, 18-19, 25, and 37-38 are rejected under 35 U.S.C. 103 as being unpatentable under Winslow in view of Besier, and in further view of US 20230165482 A1 (“Mahfouz”).
In regard to claim 8, Winslow discloses
and the second portion is ([0022], “in FIGS. 1-2, a bone model … can include … an implant component”) adjacent to an intermediate portion and/or a proximal portion of the bone component ([0020], “FIG. 8 is a … view of the bone model” See Annotated Winslow FIG. 8.).
Winslow does not disclose
wherein the bone is a fibula
However, in an analogous art of orthopedics, Mahfouz discloses
wherein the bone is a fibula ([0173], “FIG. 156 comprises bone models of the … fibula”)
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, wherein the bone is a fibula, of Mahfouz into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding a fibula bone model.
In regard to claim 14, Winslow does not disclose
further comprising: a light source at least partially embedded in the main body;
and wherein the light source is operable to illuminate the interior.
However, in an analogous art of orthopedics, Mahfouz discloses
further comprising: a light source at least partially embedded in the main body ([0362], “the … system may include … indicator lights”);
and wherein the light source is operable to illuminate the interior ([0365], “the … system may include … indicator lights indicating … whether the surgical saw is correctly oriented”).
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, further comprising: a light source at least partially embedded in the main body; and wherein the light source is operable to illuminate the interior, of Mahfouz into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding indicator lights and a surgical saw.
In regard to claim 16, Winslow discloses
wherein the second material establishes ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”) a viewing portal to the interior of the bone component ([0020], “FIG. 8 is a … view of a bone model” See Annotated Winslow FIG. 8.), and an opaque material surrounds a perimeter of the viewing portal ([0027], “The main body … can comprise a flexible, resilient material”).
In regard to claim 18, Winslow does not disclose
wherein: the bone component includes a fracture path that establishes one or more localized regions;
and wherein the bone component is severable along the fracture path to establish one or more fragments associated with a respective one of the one or more localized regions.
However, in an analogous art of orthopedics, Mahfouz discloses
wherein: the bone component includes a fracture path that establishes one or more localized regions ([0461], “the software … detects … fracture sites from the 3D virtual surface representation for each fractured bone component”);
and wherein the bone component is severable along the fracture path to establish one or more fragments associated with a respective one of the one or more localized regions ([0461], “the software … detects … fracture sites from the 3D virtual surface representation for each fractured bone component … and extracts the contours from each fracture site.”).
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, wherein: the bone component includes a fracture path that establishes one or more localized regions; and wherein the bone component is severable along the fracture path to establish one or more fragments associated with a respective one of the one or more localized regions, of Mahfouz into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding software, fracture sites and their associated contours, and a fractured bone component.
In regard to claim 19, Winslow discloses
wherein the interior of the bone component includes an internal cavity that extends through ([0015], “FIG. 3 is a … view of a bone component”) a viewing portal established by ([0020], “FIG. 8 is a … view of a bone model” See Annotated Winslow FIG. 8.) the second material ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”), and the internal cavity is dimensioned to at least partially receive an orthopaedic implant ([0033], “the bone component … can further comprise a latch hole … and the implant component … can further comprise a corresponding latch hole”).
Winslow does not disclose
the fracture path and is at least partially aligned with
However, in an analogous art of orthopedics, Mahfouz discloses
the fracture path and is at least partially aligned with ([0461], “the software … detects … fracture sites from the 3D virtual surface representation for each fractured bone component”)
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, the fracture path and is at least partially aligned with, of Mahfouz into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding software, fracture sites, and a fractured bone component.
In regard to claim 25, Winslow does not disclose
comprising: illuminating the interior portion.
However, in an analogous art of orthopedics, Mahfouz discloses
comprising: illuminating the interior portion ([0365], “the … system may include … indicator lights indicating … whether the surgical saw is correctly oriented”).
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, comprising: illuminating the interior portion, of Mahfouz into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding indicator lights and a surgical saw.
In regard to claim 37, Winslow discloses
a main body representative of anatomy, wherein the main body includes a bone component ([0024], “the bone component … can include main body”), the bone component including an exterior having ([0022], “in FIGS. 1-2, a bone model … can include a bone component”) a surface contour representative of a bone, the bone component comprising ([0022], “The bone component … can include a … surface”): a first portion establishing the exterior and comprising a first material ([0027], “The main body … can comprise a flexible, resilient material”);
and a second portion ([0022], “a bone model … can include … an implant component”) adjacent to the first portion, the second portion including ([0020], “FIG. 8 is a … view of the bone model” See Annotated Winslow FIG. 8.) a second material that differs from the first material, and the second material is transparent or translucent for viewing an interior of the bone component ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”), the first material has a transparency that is less than a transparency of ([0027], “The main body … can comprise a flexible, resilient material”) the second material ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”), the second material establishing ([0030], “the implant component … can be formed from … injection molded polymers, 3D printed polymers and other … low resiliency materials.”) a viewing portal to the interior of the bone component ([0020], “FIG. 8 is a … view of a bone model” See Annotated Winslow FIG. 8.), the interior of the bone component includes an internal cavity at least partially aligned with the viewing portal ([0015], “FIG. 3 is a … view of a bone component”), the internal cavity dimensioned to at least partially receive an orthopaedic implant ([0033], “the bone component … can further comprise a latch hole … and the implant component … can further comprise a corresponding latch hole”)
Winslow does not disclose
A system for an orthopaedic procedure comprising: a physical anatomical model including
However, in an analogous art of orthopedic procedure planning, Besier discloses
A system for an orthopaedic procedure comprising ([0066], “The … description focuses on … planning an orthopedic procedure”): a physical anatomical model including ([0019], “the method includes ... a patient anatomical model”)
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, a system for an orthopaedic procedure comprising: a physical anatomical model including, of Besier into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding an orthopedic planning procedure and a patient anatomical model.
Winslow does not disclose
and a light source at least partially embedded in the bone component and operable to illuminate the interior.
However, in an analogous art of orthopedics, Mahfouz discloses
and a light source at least partially embedded in the bone component ([0362], “the … system may include … indicator lights”);
and operable to illuminate the interior ([0365], “the … system may include … indicator lights indicating … whether the surgical saw is correctly oriented”).
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, and a light source at least partially embedded in the bone component and operable to illuminate the interior, of Mahfouz into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding indicator lights and a surgical saw.
In regard to claim 38, Winslow discloses
and the internal cavity extend through ([0015], “FIG. 3 is a … view of a bone component”)
Winslow does not disclose
wherein: the bone component includes a fracture path that establishes one or more localized regions;
the bone component is severable along the fracture path to establish one or more fragments associated with a respective one of the one or more localized regions;
the fracture path.
However, in an analogous art of orthopedics, Mahfouz discloses
wherein: the bone component includes a fracture path that establishes one or more localized regions ([0461], “the software … detects … fracture sites from the 3D virtual surface representation for each fractured bone component”);
the bone component is severable along the fracture path to establish one or more fragments associated with a respective one of the one or more localized regions ([0461], “the software … detects … fracture sites from the 3D virtual surface representation for each fractured bone component … and extracts the contours from each fracture site.”).
the fracture path ([0461], “the software … detects … fracture sites from the 3D virtual surface representation for each fractured bone component”).
Therefore, it would have been obvious to one of ordinary skill in the art (PHOSITA) before the effective filing date to have added the missing claimed limitations, the claim limitations, wherein: the bone component includes a fracture path that establishes one or more localized regions; the bone component is severable along the fracture path to establish one or more fragments associated with a respective one of the one or more localized regions, and the fracture path, of Mahfouz into using bone models to trial medical implants in arthroplasty surgical procedures of Winslow, nor would it render Winslow unsuitable for its intended purpose of using bone models to trial medical implants in arthroplasty surgical procedures; rather it would enhance using bone models to trial medical implants in arthroplasty surgical procedures by adding software, fracture sites and their associated contours, and a fractured bone component.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to
Applicant’s disclosure. The following references have been cited to further show the
state of the art.
• US 20080286736 A1 (“Browne-Wilkinson”)
Browne-Wilkinson discloses orthopaedic skeletal joint demonstration aids for demonstrating surgical joint replacement techniques.
• US 20200069372 A1 (“Dufour”)
Dufour discloses image-based navigation and bone modelling in orthopedic computer-assisted surgery.
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the organization where this application or proceeding is assigned is (571) 273-8300.
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/LISA H ANTOINE/
Examiner, Art Unit 3715
/JAMES B HULL/Primary Examiner, Art Unit 3715
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