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 Objections
Claims 5, 10, 13, 16, 20-21, 23, and 25 objected to because of the following informalities:
Claim 5, line 2, “couple” should read “coupled”.
Claim 10, line 4, “a proximal end” should read “a second proximal end”.
Claim 10, line 4, “a distal end” should read “a second distal end”.
Claim 10, line 5, “the proximal end” should read “the second proximal end”.
Claim 10, line 39, “the human knee joint” should read “a human knee joint”.
Claim 10, line 41, “the anatomical alignment of the femur and the tibia” should read “an anatomical alignment of the human femur and the human tibia”.
Claim 13, line 3, “the facsimile skeletal joint” should read “a facsimile skeletal joint”.
Claim 16, line 6, “the second end of the second rod assembly” should read “a second end of a second rod assembly”.
Claim 16, line 7, “a fixture” should read “the fixture”.
Claim 16, line 8, “a range of motion of the human hip joint” should read “the range of motion of the human hip joint”.
Claim 16, line 11, “a range of motion of the human hip joint” should read “the range of motion of the human hip joint”.
Claim 16, line 12, “a position” should read “the position”.
Claim 16, line 13, “a range of motion of the human knee joint” should read “the range of motion of the human knee joint”.
Claim 20, line 4, “the modified first and/or second facsimile bone members” should read “the first and/or second facsimile bone members”.
Claim 21, line 1, “the first holding member” should read “a first holding member”.
Claim 21 is objected to because the use of multiple conjunctions “and/either,” makes it unclear whether both terms are to be considered or if only one of them is to be considered. For the purpose of examination, the Examiner will reasonably interpret the terms in the alternative only. Appropriate correction is required.
Claim 23, line 4, “the claws” should read “the pair of two opposing claws”.
Claim 25, line 2, “a ball joint assembly” should read “the ball joint assembly”.
Claim 25, line 3, “the anatomical configuration of the pelvic socket and rotation of the human hip” should read “an anatomical configuration of a pelvic socket and rotation of the human hip”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by McAllister et al. (US 20070212672 A1; hereinafter McAllister).
Regarding claim 1, McAllister discloses an anatomical model (instructional apparatus 10; Fig 1) comprising: first and second facsimile bone members having adjacent interconnected portions to define a facsimile skeletal joint (artificial femur 18 and artificial part of a tibia 20; Fig 1); a rod assembly comprising a rod having oppositely-disposed first and second ends (clamp support post 42; Fig 1), the first end of the rod having a clamping assembly mounted thereto (clamp support post 42 acting as a rod with a clamp 48; Fig 1), the clamping assembly comprising first and second clamping members for clamping a portion of the first facsimile bone member therebetween (jaws 60 and 62; Fig 2), the clamping assembly comprising a clamping mechanism operable to collapse the first and second clamping members toward each other (adjust jaws towards each other; ¶33) to capture and compress the portion of the first facsimile bone member therebetween (designed for gripping bone in the socket 90; ¶33) and prevent the first facsimile bone member from being removed either axially or transversely from the rod assembly (firm grip between grip members 72 and 74 to hold bone, which would prevent it from being removed axially or transversely; 33), and operable to expand the first and second clamping members away from each other to release the portion of the first facsimile bone member therebetween (with the "T" handle bar you can adjust the grip to pull jaws closer or away; ¶33) and allow the first facsimile bone member to be removed both axially and transversely from the rod assembly (by design the clamp 48 can be adjusted to hold the bone or be released; abstract).
Claim Rejections - 35 USC § 103
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over McAllister in view of Owen Thompson Fink (US 20230115780 A1; hereinafter Fink).
Regarding claim 2, McAllister discloses further comprising a first holding assembly (socket 38; Fig 1) configured to be secured to a fixture (secured to a base plate 36; Fig 1), couple with the second end of the rod assembly (coupled to clamp support post 42 as shown in Fig 1), and providing a range of motion of the rod assembly (clamp support post 42 is slidable within the socket 38 providing a range of motion; ¶27). McAllister does not explicitly disclose providing a range of motion of the rod assembly that mimics a range of motion of the human hip joint, but McAllister does teach manipulating ligaments and positions of the joints in ¶9-12 and includes hip joints in ¶25, which can affect the range of motion of the hip.
However, Fink teaches providing a range of motion of the rod assembly that mimics a range of motion of the human hip joint (providing smooth motion of a healthy hip in a normal anatomy; ¶25).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Fink for the benefit of having a limb model with realistic range of motion for improving the training of trainees in a realistic surgical environment.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over McAllister in view of Fink in view of Browne-Wilkinson (US 20060051728 A1; hereinafter Browne).
Regarding claim 3, McAllister discloses wherein the first holding assembly includes a locking mechanism (screw 40; Fig 1). McAllister does not explicitly disclose the locking mechanism to be configured to selectively fix an articulatory position of the rod assembly.
However, Browne teaches the locking mechanism to be configured to selectively fix an articulatory position of the rod assembly (the holding mechanism can fix the thigh portion at the required angle; ¶26).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of having a model with realistic range of motion and possible different positions for improving the training of trainees in a realistic environment.
Claims 4 is rejected under 35 U.S.C. 103 as being unpatentable over McAllister.
Regarding claim 4, McAllister does not explicitly disclose further comprising a second rod assembly comprising a second rod having oppositely-disposed first and second ends, the first end of the second rod having a second clamping assembly mounted thereto, the second clamping assembly comprising first and second clamping members for clamping a portion of the second facsimile bone member therebetween, the second clamping assembly comprising a second clamping mechanism operable to collapse the first and second clamping members of the second clamping assembly toward each other to capture and compress the portion of the second facsimile bone member therebetween and allow the second facsimile bone member to be removed both axially and transversely from the second rod assembly.
However, since the second rod assembly has the same structure as the first rod assembly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister with a second rod assembly comprising a second rod having oppositely-disposed first and second ends, the first end of the second rod having a second clamping assembly mounted thereto, the second clamping assembly comprising first and second clamping members for clamping a portion of the second facsimile bone member therebetween, the second clamping assembly comprising a second clamping mechanism operable to collapse the first and second clamping members of the second clamping assembly toward each other to capture and compress the portion of the second facsimile bone member therebetween and allow the second facsimile bone member to be removed both axially and transversely from the second rod assembly since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04, VI, B Duplication of Parts. In this case there is no new and unexpected result.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over McAllister in view of HAO WANJUN et al. (CN111223375A; hereinafter Hao).
Regarding claim 5, McAllister, as modified by Brown above, discloses an anatomical model comprising a second holding assembly (socket 38; Fig 1) configured to be secured to the fixture (secured to a base plate 36; Fig 1), coupled with the second end of the second rod assembly (coupled to clamp support post 42 as shown in Fig 1). However, McAllister does not explicitly disclose providing a range of motion of the second rod assembly relative to the rod assembly.
However, Hao teaches providing a range of motion of the second rod assembly relative to the rod assembly (the movement of one supporting rod device 12 in Fig 1 can drive the movement of the other supporting device; ¶35).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Hao for the benefit of implementing realistic motion with joined limbs to form the knee. The rod assemblies act as extensions of the femur and tibia, and when there is motion on one, it affects the other. Therefore, the motion of femur and tibia are dependent on each other.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over McAllister in view of Hao in view of Browne.
Regarding claim 6, McAllister discloses wherein the second holding assembly includes a locking mechanism (screw 40; Fig 1). McAllister does not explicitly teach configured to selectively fix an articulatory position of the second rod assembly.
However, Browne teaches the locking mechanism to be configured to selectively fix an articulatory position of the rod assembly (the holding mechanism can fix the thigh portion at the required angle; ¶26).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of having a model with realistic range of motion and possible different positions for improving the training of trainees in a realistic environment.
Regarding claim 7, McAllister does not explicitly teach or disclose wherein the second holding assembly comprises a locking mechanism disposed on a track that enables flexion about the facsimile skeletal joint.
However, Browne teaches wherein the second holding assembly comprises a locking mechanism (holding mechanism 5; Fig 1) disposed on a track (foot plate acting as a track; Fig1) that enables flexion about the facsimile skeletal joint (enables flexion through receiving notches 8; ¶26).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of simulating anterior-posterior translation, which is the sliding movement of the lower leg relative to the upper one. By using a track, it is possible to simulate this type of movement.
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over McAllister in view of Bohl et al. (US 20200360090 A1; hereinafter Bohl).
Regarding claim 8, McAllister does not explicitly teach or disclose wherein the first and second facsimile bone members include exterior and interior portions that mimic properties of cortical and cancellous layers of human bones, respectively.
However, Bohl teaches wherein the first and second facsimile bone members include exterior and interior portions that mimic properties of cortical and cancellous layers of human bones, respectively (anatomical bone models can mimic corticocancellous architecture of human bone; ¶71).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Bohl for the benefit of providing a very high level of human realism during training of surgical procedures. This will allow trainees to be trained in a more realistic scenario.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over McAllister in view of NIKOU et al. (WO2020186194A1; hereinafter Nikou).
Regarding claim 9, McAllister does not explicitly teach or disclose wherein the anatomical model is configured for practicing robotic assisted knee arthroplasty surgery.
However, Nikou teaches wherein the anatomical model (3D model of the relevant bone or joint, like the femur; ¶55) is configured for practicing robotic assisted knee arthroplasty surgery (Computer assisted surgical model is used for arthroplasty knee surgery; ¶36).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Nikou for the benefit of generating a realistic 3D model of a bone or joint because it provides a more flexible environment for the training that can be repeated multiple times. Furthermore, more scenarios can be modified or measured in a virtual environment.
Claims 10-13, 16-17, and 19-25 are rejected under 35 U.S.C. 103 as being unpatentable over McAllister in view of Fink in view of Browne in view of Hao.
Regarding claim 10, McAllister discloses an anatomical model (instructional apparatus; Fig 1) comprising: a first facsimile bone member having a proximal end and a distal end wherein the distal end includes a facsimile distal portion of a human femur (artificial femur 18; Fig 1); a second facsimile bone member having a proximal end and a distal end wherein the proximal end includes a facsimile proximal portion of a human tibia (artificial part of a tibia 20; Fig 1); the upper leg member comprising a first rod assembly comprising a first rod having oppositely-disposed first and second ends (clamp support post 42; Fig 1), the first end of the first rod having a first clamping assembly mounted thereto (clamp support post 42 acting as a rod with a clamp 48; Fig 1), the first clamping assembly comprising first and second clamping members for clamping a portion of the first facsimile bone member therebetween (jaws 60 and 62; Fig 2), the first clamping assembly comprising a first clamping mechanism operable to collapse the first and second clamping members toward each other (adjust jaws towards each other; ¶33) to capture and compress the portion of the first facsimile bone member therebetween (designed for gripping bone in the socket 90; ¶33) and prevent the first facsimile bone member from being removed either axially or transversely from the first rod assembly (firm grip between grip members 72 and 74 to hold bone; 33), and operable to expand the first and second clamping members away from each other to release the portion of the first facsimile bone member therebetween (with the "T" handle bar you can adjust the grip to pull jaws closer or away; ¶33) and allow the first facsimile bone member to be removed both axially and transversely from the first rod assembly (by design the clamp 48 can be adjusted to hold the bone or be released; abstract); a first holding assembly configured to be secured to a fixture (socket 38; Fig 1), couple with the second end of the first rod assembly (coupled to clamp support post 42 as shown in Fig 1) and providing a range of motion of the rod assembly (clamp support post 42 is slidable within the socket 38 providing a range of motion; ¶27); and a second holding assembly configured to be secured to the fixture (suction cup 22; Fig 1).
McAllister does not explicitly disclose an upper leg member representative of a portion of a human thigh, a lower leg member representative of a portion of a human lower leg and a human foot, the lower leg member comprising a second rod assembly comprising a second rod having oppositely-disposed first and second ends, the first end of the second rod having a second clamping assembly mounted thereto, the second clamping assembly comprising first and second clamping members for clamping a portion of the second facsimile bone member therebetween, the second clamping assembly comprising a second clamping mechanism operable to collapse the first and second clamping members toward each other to capture and compress the portion of the second facsimile bone member therebetween and prevent the second facsimile bone member from being removed either axially or transversely from the second rod assembly, and operable to expand the first and second clamping members away from each other to release the portion of the second facsimile bone member therebetween and allow the second facsimile bone member to be removed both axially and transversely from the second rod assembly; first and second ligament members disposed at and secured to lateral and medial sides of the first facsimile bone member and to lateral and medial sides of the second facsimile bone member to couple the first and second facsimile bone members and at least partially define a knee joint of the anatomical model, wherein the knee joint is configured for articulation that mimics articulation of the human knee joint, wherein adjacent ends of the first and second facsimile bone members are aligned in a manner that mimics the anatomical alignment of the femur and the tibia in the human knee joint during articulation of the knee joint, and the first and second ligament members mimic tension properties of the human lateral and medial collateral ligaments during articulation of the knee joint; and the first holding assembly able to provide a range of motion of the first rod assembly that mimics a range of motion of the human hip joint and the second holding assembly able provide a range of motion of the second rod assembly relative to the rod assembly.
In regards to the lower leg member comprising a second rod assembly comprising a second rod having oppositely-disposed first and second ends, the first end of the second rod having a second clamping assembly mounted thereto, the second clamping assembly comprising first and second clamping members for clamping a portion of the second facsimile bone member therebetween, the second clamping assembly comprising a second clamping mechanism operable to collapse the first and second clamping members toward each other to capture and compress the portion of the second facsimile bone member therebetween and prevent the second facsimile bone member from being removed either axially or transversely from the second rod assembly, and operable to expand the first and second clamping members away from each other to release the portion of the second facsimile bone member therebetween and allow the second facsimile bone member to be removed both axially and transversely from the second rod assembly.
The second rod assembly is a duplication of parts because it has the same structure as first rod assembly. Instead of a second rod assembly, McAllister uses a Suction cup 22 (Fig 1) to hold a knee joint in a desired location and orientation (¶21). In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.). The second rod assembly has the same structure as the first rod assembly and McAllister uses a Suction cup 22 (Fig 1) to hold a knee joint in a desired location and orientation (¶21). McAllister teaches that the suction cup 22 can be replaced by another device used to support the tibia and keep it in a desired location (¶22). Furthermore, the structure of the first rod assembly, disclosed in claim 1 by McAllister, is designed to also hold other limbs or joints securely (abstract). Therefore, the same structure of the first rod assembly can be duplicated to be applied to the second rod assembly to support the tibia and keep it in a desired location.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of McAllister for the benefit of supporting the tibia and keeping it in a desired location so that a surgical procedure can be performed on the joint because the clamp assembly 14 (Fig 1) is designed to hold different limbs as stated in the abstract of McAllister.
Browne teaches an upper leg member representative of a portion of a human thigh (human thigh shown in Fig 1), a lower leg member representative of a portion of a human lower leg and a human foot (Fig 1); first and second ligament members disposed at and secured to lateral and medial sides of the first facsimile bone member (ligament portion ends 21 and 22; Fig 3 and Fig 4) and to lateral and medial sides of the second facsimile bone member to couple the first and second facsimile bone members and at least partially define a knee joint of the anatomical model (separate arrangements for ligaments defining the knee joint; ¶36), wherein the knee joint is configured for articulation that mimics articulation of the human knee joint (¶11), wherein adjacent ends of the first and second facsimile bone members are aligned in a manner that mimics the anatomical alignment of the femur and the tibia in the human knee joint during articulation of the knee joint (alignments of femur with tibia in a manner that mimics anatomical alignment shown in Fig 1), and the first and second ligament members mimic tension properties of the human lateral and medial collateral ligaments during articulation of the knee joint (¶10-11 ).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of having a model with realistic structure of joints and ligaments for training trainees in a realistic environment.
Fink teaches the first holding assembly able to provide a range of motion of the first rod assembly that mimics a range of motion of the human hip joint (providing smooth motion of a healthy hip in a normal anatomy; ¶25).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Fink for the benefit of having a limb model with realistic range of motion for improving the training of trainees in a realistic surgical environment.
Hao teaches the second holding assembly able provide a range of motion of the second rod assembly relative to the rod assembly (the movement of one supporting rod device 12 in Fig 1 can drive the movement of the other supporting device; ¶35).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Hao for the benefit of implementing realistic motion with joined limbs to form the knee. The rod assemblies act as extensions of the femur and tibia, and when there is motion on one, it affects the other. Therefore, the motion of femur and tibia are dependent on each other.
Regarding claim 11, McAllister discloses wherein the first holding assembly includes a locking mechanism (screw 40; Fig 1). McAllister does not explicitly disclose the locking mechanism to be configured to selectively fix an articulatory position of the rod assembly.
However, Browne teaches the locking mechanism to be configured to selectively fix an articulatory position of the rod assembly (the holding mechanism can fix the thigh portion at the required angle; ¶26).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of having a model with realistic range of motion and possible different positions for improving the training of trainees in a realistic environment.
Regarding claim 12, McAllister teaches wherein the second holding assembly includes a locking mechanism (screw 40; Fig 1). McAllister does not explicitly teach or disclose the second locking mechanism to be configured to selectively fix an articulatory position of the second rod assembly.
However, Browne teaches the second locking mechanism to be configured to selectively fix an articulatory position of the second rod assembly (the holding mechanism can fix the thigh portion at the required angle; ¶26).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of having a model with realistic range of motion and possible different positions for improving the training of trainees in a realistic environment.
Regarding claim 13, McAllister does not explicitly teach or disclose wherein the second holding assembly comprises a locking mechanism disposed on a track that enables flexion about the facsimile skeletal joint.
However, Browne teaches wherein the second holding assembly comprises a locking mechanism (holding mechanism 5; Fig 1) disposed on a track (foot plate acting as a track; Fig1) that enables flexion about the facsimile skeletal joint (enables flexion through receiving notches 8; ¶26).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of simulating anterior-posterior translation, which is the sliding movement of the lower leg relative to the upper one. By using a track, it is possible to simulate this type of movement.
Regarding claim 16, McAllister discloses a method of using the anatomical model of claim 1, the method comprising: coupling the second end of the first rod assembly to a fixture (secured to a base plate 36; Fig 1) to provide a range of motion of the first rod assembly (clamp support post 42 is slidable within the socket 38 providing a range of motion; ¶27); and manually manipulating the anatomical model to adjust relative positions of the first facsimile bone member and the second facsimile bone member by articulating at least the first rod assembly (clamp support post 42 can be moved within the socket; ¶27). McAllister does not explicitly disclose providing a range of motion of the first rod assembly that mimics a range of motion of the human hip joint; optionally coupling the second end of the second rod assembly to a fixture to provide a range of motion of the first and second rod assemblies that mimics a range of motion of the human hip joint; to a position within a range of motion of the human hip joint and optionally articulating the second rod assembly to a position within a range of motion of the human knee joint.
Regarding optionally coupling the second end of the second rod assembly to a fixture to provide a range of motion of the first and second rod assemblies. The second rod assembly is a duplication of parts because has the same structure of the first rod assembly. Instead of a second rod assembly, McAllister uses a Suction cup 22 (Fig 1) to hold a knee joint in a desired location and orientation (¶21). In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) (Claims at issue were directed to a water-tight masonry structure wherein a water seal of flexible material fills the joints which form between adjacent pours of concrete. The claimed water seal has a "web" which lies in the joint, and a plurality of "ribs" projecting outwardly from each side of the web into one of the adjacent concrete slabs. The prior art disclosed a flexible water stop for preventing passage of water between masses of concrete in the shape of a plus sign (+). Although the reference did not disclose a plurality of ribs, the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.). McAllister teaches that the suction cup 22 can be replaced by another device used to support the tibia and keep it in a desired location (¶22). Furthermore, the structure of the first rod assembly, disclosed in claim 1 by McAllister, is designed to also hold other limbs or joints securely (abstract). Therefore, the same structure of the first rod assembly can be duplicated to be applied to the second rod assembly to support the tibia and keep it in a desired location.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of McAllister for the benefit of supporting the tibia and keeping it in a desired location so that a surgical procedure can be performed on the joint because the clamp assembly 14 (Fig 1) is designed to hold different limbs as stated in the abstract of McAllister.
Fink teaches providing a range of motion of the first rod assembly that mimics a range of motion of the human hip joint (providing smooth motion of a healthy hip in a normal anatomy; ¶25) and a range of motion of the first and second rod assemblies (Both the femur and tibia are connected with the knee joint as previously shown in Fig 1 of McAllister and both the femur and tibia can have a rod assembly to keep them in a desired location as previously stated) that mimics a range of motion of the human hip joint (providing smooth motion of a healthy hip in a normal anatomy; ¶25).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Fink for the benefit of having a limb model with realistic range of motion for improving the training of trainees in a realistic surgical environment.
Browne teaches manually manipulating the anatomical model to adjust relative positions of the first facsimile bone member and the second facsimile bone member by articulating at least the first rod assembly to a position within a range of motion of the human hip joint (manipulating ligaments and positions of the joints ¶9-12 and includes hip joints in ¶25)
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of having a model with realistic structure and position of joints and ligaments for training trainees in a realistic environment.
Hao teaches optionally articulating the second rod assembly to a position within a range of motion of the human knee joint (movement of supporting devices 12 as shown in Fig 2 to simulate movement of knee joint; ¶51)
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Hao for the benefit of implementing realistic motion with joined limbs to form the knee and thus, improving surgical training for trainees.
Regarding claim 17, McAllister does not explicitly disclose wherein articulation of the first rod assembly is limited by the position of the second rod assembly.
However, Hao teaches wherein articulation of the first rod assembly is limited by the position of the second rod assembly (the movement of one supporting rod device 12 in Fig 1 can drive the movement of the other supporting device 12; ¶35).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Hao for the benefit of implementing realistic motion with joined limbs to form the knee. The rod assemblies act as extensions of the femur and tibia, and when there is motion on one, it affects the other. Therefore, the motion of femur and tibia are dependent on each other.
Regarding claim 19, McAllister discloses further comprising cutting one or both of the first and second facsimile bone members, detaching and/or reattaching one or both of the first and second ligament members, and/or securing one or more orthopaedic prostheses to the anatomical model (cutting across femur and tibia; ¶38).
Regarding claim 20, McAllister discloses using the anatomical model for activities that cause permanent modification of the first and/or second facsimile bone members (activities such as surgical training activities cause permanent modifications; ¶11); and removing and replacing the modified first and/or second facsimile bone members with identical replacements (joint replacements; abstract).
Regarding claim 21, McAllister discloses wherein the first holding member comprises: a mount body (socket 38; Fig 1); and a mounting member releasably attached to the mount body with a screw (screw 40; Fig 1); wherein the mounting member comprises a table clamp assembly that can be interchangeably attached to the mount body with the screw (table clamp assembly shown in Fig 1), and wherein the table clamp assembly is configured to clamp to an edge of a table (clamped to a table as shown in Fig 1). McAllister does not explicitly disclose a mount body attached to a track; wherein the mounting member comprises a rail clamp assembly and wherein the rail clamp assembly is configured to clamp to a rail slide mount.
However, Hao teaches a mount body attached to a track (moving device 18; Fig 2); wherein the mounting member comprises a rail clamp assembly (rail clamp assembly shown in Fig 1) and wherein the rail clamp assembly is configured to clamp to a rail slide mount (Fig 1 showing clamp with moving slide 18).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Hao for the benefit of simulating anterior-posterior translation, which is the sliding movement of the lower leg relative to the upper one. By using a track, it is possible to simulate this type of movement.
Regarding claim 22, McAllister discloses that a height of the first holding member comprising the clamp can be adjusted with the screw (clamp support is slidable in the socket 38 and held by screw; ¶27). McAllister the clamp to be a rail clamp assembly.
However, Hao teaches the clamp to be a rail clamp assembly (shown in Fig 1 or 2).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Hao because using a rail clamp has similar structure to a clamp assembly and the same purpose of fixing equipment to a structure.
Regarding claim 23, McAllister discloses wherein the clamp assembly comprises: a pair of two opposing claws (Fig 8 shows both opposing claws; ¶35); and a clamp screw configured to shift the claws toward and away from each other (by adjusting the screw you can bring them toward or away from each other; ¶35). McAllister does not explicitly disclose the clamp assembly to be a rail clamp assembly, and the rail clamp assembly to clamp onto a rail slide mount.
However, Hao teaches clamp assembly to be a rail clamp assembly (moving member 163; Fig 2), and the rail clamp assembly to clamp onto a rail slide mount (shown in Fig 1 or 2).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Hao because using a rail clamp has similar structure to a clamp assembly and the same purpose of fixing equipment to a structure.
Regarding claim 24, McAllister does not explicitly disclose a mounting assembly comprising the first holding assembly and the second holding assembly disposed at opposite ends of a track, and a talus block assembly slidably mounted to the track, wherein the talus block assembly includes a ball joint assembly coupled to a boot, wherein the boot is configured to capture the human foot portion of the lower leg member.
However, Browne teaches a talus block assembly slidably mounted to the track (foot portion 4 on a slidable track shown in Fig 1), wherein the talus block assembly includes a ball joint assembly coupled to a boot (there is a screw clamp 9 coupled to the boot in ¶26 and screw clamp can have a ball 49 to adjust position in ¶35), wherein the boot is configured to capture the human foot portion of the lower leg member (holding the foot portion; ¶26).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of implementing a ball joint because it would provide with three axes of rotation that are necessary to mimic the human ankle joint.
Hao teaches a mounting assembly comprising the first holding assembly and the second holding assembly disposed at opposite ends of a track (shown in Fig 1).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Hao for the benefit of simulating anterior-posterior translation, which is the sliding movement of the lower leg relative to the upper one. By disposing a first and second holding assembly on opposite ends of a track, it is possible to simulate this type of movement.
Regarding claim 25, McAllister does not explicitly disclose wherein the first holding assembly a ball joint assembly disposed at a non-orthogonal angle relative to the track to mimic the anatomical configuration of the pelvic socket and rotation of the human hip.
However, Browne teaches wherein the first holding assembly a ball joint assembly disposed at a non-orthogonal angle (ball is rotated within the socket, creating different angles; ¶35) relative to a fixture to mimic the anatomical configuration of the pelvic socket and rotation of the human hip (rotating the ball to be positioned at the correct anatomical angle; ¶35).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Browne for the benefit of implementing a ball joint because it would provide with three axes of rotation that are necessary to mimic the human ankle joint.
Hao teaches that instead of a fixture, a track can be used (track shown in Fig 1).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Hao for the benefit of simulating anterior-posterior translation, which is the sliding movement of the lower leg relative to the upper one. By using a track, it is possible to simulate this type of movement.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over McAllister in view of Fink in view of Browne in view of Hao in view of Bohl.
Regarding claim 14, McAllister does not explicitly teach or disclose wherein the first and second facsimile bone members include exterior and interior portions that mimic properties of cortical and cancellous layers of human bones, respectively.
However, Bohl teaches wherein the first and second facsimile bone members include exterior and interior portions that mimic properties of cortical and cancellous layers of human bones, respectively (anatomical bone models can mimic corticocancellous architecture of human bone; ¶71).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Bohl for the benefit of providing a very high level of human realism during training of surgical procedures. This will allow trainees to be trained in a more realistic scenario.
Claim 15 and 18 is rejected under 35 U.S.C. 103 as being unpatentable over McAllister in view of Fink in view of Browne in view of Hao in view of Nikou.
Regarding claim 15, McAllister does not explicitly teach or disclose wherein the anatomical model is configured for practicing robotic assisted knee arthroplasty surgery.
However, Nikou teaches wherein the anatomical model (3D model of the relevant bone or joint, like the femur; ¶55) is configured for practicing robotic assisted knee arthroplasty surgery (Computer assisted surgical model is used for arthroplasty knee surgery; ¶36).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Nikou for the benefit of generating a realistic 3D model of a bone or joint because it provides a more flexible environment for the training that can be repeated multiple times. Furthermore, more scenarios can be modified or measured in a virtual environment.
Regarding claim 18, McAllister does not explicitly teach or disclose wherein the anatomical model is manipulated such that the first and second facsimile bone members are positioned at anatomical orientations for practicing robotic assisted knee arthroplasty surgery.
However, Nikou teaches wherein the anatomical model is manipulated such that the first and second facsimile bone members are positioned at anatomical orientations for practicing robotic assisted knee arthroplasty surgery (Computer assisted surgical model is used for arthroplasty knee surgery would inherently be oriented for this procedure; ¶36).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McAllister to implement the teachings of Nikou for the benefit of generating a realistic 3D model of a bone or joint because it provides a more flexible environment for the training that can be repeated multiple times. Furthermore, more scenarios can be modified or measured in a virtual environment.
Conclusion
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/JOSE ANGELES/Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715