DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The Amendment filed 2/2/2026 has been entered. The previous drawing objection is withdrawn in light of applicant’s amendments. The previous objection to the claims is withdrawn in light of applicant’s amendments. The previous rejection under 35 USC 112(d) is withdrawn in light of the cancellation of claims 18 and 19. Claims 1-15 and 17 are currently pending in this application.
Claim Objections
Claims 1, 9, 11, and 15 are objected to because of the following informalities:
Claim 1 recites “a tibia bone” in line 3, which appears to be referring to – the tibia bone –, as recited earlier in the claim.
Claim 9 recites “an intramedullary path” in lines 1-2, which appears to be referring to – the in-line guide path –, as recited in claim 1.
Claim 11 recites “the platform” in line 10, which appears to be referring to – the first artificial surface –, as shown in fig. 15A.
Claim 15 recites “a talus bone” in line 20, which appears to be referring to – the talus bone –, as recited earlier in the claim.
Claim 15 recites “coupling the second prothesis to the talus bone, the second prosthesis comprising a second artificial joint surface configured to articulate with the first artificial joint surface” in lines 28-30 which appears to be redundant because these limitations are already required in lines 20-22.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-8, 14, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites the limitation "the platform" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether claim 6 is meant to depend from claim 4.
Claim 8 recites “a second external feature into the in-line guide path formed in the talus bone” in lines 5-6. The in-line guide path is defined in claim 1 as being through a calcaneus bone and a talus bone. Therefore, it is unclear whether applicant intended for the second external feature to inserted into a portion of the in-line guide path formed in the talus bone.
Claim 14 recites “a first stem component including a first external feature; and a second stem component including a second external feature”. It is unclear whether these limitations are referring to the components of the multipiece stem and the internal and external hex, recited in claim 11, or separate/additional components and features.
Claim 15 recites “a collar” and “a complementary recess” in lines 23 and 25, respectively. It is unclear whether these limitations are referring to the 3rd and 4th engagement features, recited earlier in the claim, or separate/additional components.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-4 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US Patent Application Publication No. 2002/0055744 A1 to Reiley (Reiley).
Regarding at least claim 1
Reiley teaches an intramedullary guidance systems and methods that align the talus and tibia for the installation of one or more ankle prostheses components, and also maintain that alignment during the installation using intramedullary guidance (abstract). Reiley meets the limitations of method, comprising: coupling a first prosthesis (tibia prosthesis; fig. 15) to a tibia bone (16), wherein the first prosthesis comprises a stem (150) configured to be disposed in an intramedullary path (28) formed in a tibia bone (paragraph 0071 discloses inserting the stem into the reamed intramedullary passage) and a first artificial joint surface (articulating surface of dome; 155) configured to be attached to the stem (paragraph 0076 discloses attaching the tibial stem 150 to which the articulating surface of the concave dome 155 is attached); establishing an in-line guide path through a calcaneus bone and a talus bone into the intramedullary path formed in the tibia bone under fluoroscopic visualization to thereby preserve a guide path coaxial with a major axis of the tibia bone (paragraph 0053 discloses non-invasive visualization of the procedure that is accomplished through fluoroscopy and fig. 11 shows establishment of an in-line guide path through the calcaneus bone and talus bone into the intramedullary path of the tibia bone); coupling a second prosthesis (talar prosthesis) to the talus bone (15), wherein the second prosthesis comprises a second artificial joint surface (articulating surface of cap; 160); and coupling the first artificial joint surface to the second artificial joint surface (paragraph 0076 discloses that the articulating surface of the dome of the first prosthesis articulates with the articulating surface of the cap of the second prosthesis), wherein the first artificial joint surface and the second artificial joint surface form a ball-and-socket joint including mating concave and convex surfaces (the articulating concave surface of the dome and the articulating convex surface of the cap form a ball-and-socket joint that includes mating concave and convex surfaces as claimed) arranged in concentric relationship resulting from the in-line guide path thereby reducing at least one of varus/valgus and anteversion/retroversion error within the ball-and-socket joint (the in-line guide path of Reiley is construed to meet the limitation that the relationship in which the mating concave and convex surfaces are arranged is concentric thereby reducing at least one of varus/valgus and anteversion/retroversion error within the joint, in the same way as applicant’s).
Regarding at least claim 2
Reiley teaches the method of claim 1, wherein the first artificial joint surface comprises a concave dome (155) and the second artificial joint surface comprises a convex dome (160) configured to mate with the concave dome (paragraph 0076).
Regarding at least claim 3
Reiley teaches the method of claim 1, wherein the second prosthesis (talar prosthesis) comprises a peg configured to be installed in a reamed-out pocket of the talus bone (stem; 110 is construed to be a peg that is installed in a reamed-out pocket of the talus bone as shown in fig. 14).
Regarding at least claim 4
Reiley teaches the method of claim 1, comprising: coupling the stem (150) to a platform (body of dome; 155) configured to be coupled to the first artificial joint surface (articulating surface of dome; 155), wherein the platform is fixedly coupled to the stem (paragraph 0076 discloses a morse taper connection between the stem and the platform); and coupling the first artificial joint surface to the platform (the articulating surface of the dome is integrally coupled to the body of the dome).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4-7, 15, and 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reiley in view of the English translation of DE 101 23 124 C1 to Grundei et al. (Grundei).
Regarding at least claim 4
Reiley teaches the method of claim 1. In a separate interpretation from above, Reiley is interpreted as not teaching coupling the stem to a platform configured to be coupled to the first artificial joint surface, wherein the platform is fixedly coupled to the stem; and coupling the first artificial joint surface to the platform.
Grundei teaches an ankle endoprosthesis that includes a tibial part, a talus part, and a plateau part that detachably connects to the tibial part (page 1, lines 1-5 of English translation).
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Grundei also teaches that the plateau part (first artificial joint surface; 3) is formed from a swivel base (12) which cooperates with the underside of the tibia component (1). More specifically, the swivel base (12) is pushed into the surrounding boundary edge (11) of the platform until pin (10) reaches the end of slot (15), as shown in fig. 4, to allow rotation about the pivot axis of the pin (page 2, lines 36-37 of the English translation) to thereby reduce joint-internal stresses (page 1, lines 26-35 of the English translation).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify coupling the stem of Reiley to a platform configured to be coupled to the first artificial joint surface, wherein the platform is fixedly coupled to the stem; and coupling the first artificial joint surface to the platform, in order to allow rotation of the first artificial joint surface relative to the platform to thereby reduce joint-internal stresses, as taught by Grundei.
Regarding at least claim 5
Reiley in view of Grundei teaches the method of claim 4, including coupling the first artificial joint surface to a platform, as explained above. Grundei also teaches coupling the first artificial joint surface (3) to the platform (defined by tibia component as shown in annotated fig. 1 above) wherein coupling the first artificial joint surface to the platform comprises inserting the first artificial joint surface into a cylindrical collar (pin; 10) extending away from the stem when the platform is fixedly coupled to the stem (page 2, lines 36-37 of the English translation; collar/pin is shown in fig. 1 extending away from the stem), and wherein the cylindrical collar provides a rotational fit between the platform and the first artificial joint surface (page 1, lines 26-35 of the English translation).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include coupling the first artificial joint surface of Reiley to the platform of Grundei wherein coupling the first artificial joint surface to the platform comprises inserting the first artificial joint surface into a cylindrical collar extending away from the stem when the platform is fixedly coupled to the stem, and wherein the cylindrical collar provides a rotational fit between the platform and the first artificial joint surface, in order to allow rotation between the platform and the stem to reduce joint-internal stresses, as taught by Grundei.
Regarding at least claim 6
Reiley teaches the method of claim 1, including the first artificial joint surface. However, Reiley does not teach wherein the first artificial joint surface is coupled to the platform by a non-interference fit.
Grundei teaches an ankle endoprosthesis that includes a tibial part, a talus part, and a plateau part that detachably connects to the tibial part (page 1, lines 1-5 of English translation).
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Grundei also teaches that the plateau part (first artificial joint surface; 3) is formed from a swivel base (12) which cooperates with the underside of the tibia component (1). More specifically, the swivel base (12) is pushed into the surrounding boundary edge (11) of the platform until pin (10) reaches the end of slot (15), as shown in fig. 4, to allow rotation about the pivot axis of the pin (page 2, lines 36-37 of the English translation) to thereby reduce joint-internal stresses (page 1, lines 26-35 of the English translation).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Reiley to include coupling the first artificial joint surface to the platform by a non-interference fit, in order to allow rotation of the first artificial joint surface relative to the platform to thereby reduce joint-internal stresses, as taught by Grundei.
Regarding at least claim 7
Reiley in view of Grundei teaches the method of claim 6. Grundei also teaches wherein coupling the first artificial joint surface to the platform comprises inserting a tab (pin; 10) defined by the platform into a hole (slot; 15) defined by the first artificial joint surface, wherein the hole has a first diameter and the tab has a second diameter, and wherein the second diameter is less than the first diameter (since the pin is disclosed as being capable of sliding within the slot, it is construed that the pin has a diameter that is less than the diameter of the slot; page 2, lines 36-37 of the English translation).
Regarding at least claim 15
Reiley teaches an intramedullary guidance systems and methods that align the talus and tibia for the installation of one or more ankle prostheses components, and also maintain that alignment during the installation using intramedullary guidance (abstract). Reiley meets the limitations of a method, comprising: coupling a first prosthesis (upper prosthesis body) to a tibia bone (16), the first prosthesis comprising a stem (150) having a first end and a second end (fig. 15 shows that the stem has a first posterior end and a second superior end), the first end of the stem including a first engagement feature (Morse taper; 115b), the stem having a circular cross-sectional geometry sized and configured to be disposed in an intramedullary path formed in the tibia bone (fig. 15 shows that the stem has a circular cross-sectional geometry and is sized and configured to be disposed in the intramedullary path formed in the tibia); establishing an in-line guide path through a calcaneus bone and a talus bone into the tibia bone under fluoroscopic visualization to thereby preserve the intramedullary path coaxial with a major axis of the tibia bone (fig. 5 shows establishment of an in-liner guide path; 28 through the calcaneus and talus and into the tibia bone and paragraph 0053 discloses non-invasive visualization accomplished through fluoroscopy which ensures that the path is coaxial with a major axis of the tibia bone as claimed); and a first artificial joint surface (155); and a second prosthesis (lower prosthesis body), comprising: a second artificial joint surface (160) configured to be attached to a talus bone (15) (fig. 14) and to articulate with the first artificial joint surface, wherein the first artificial joint surface and the second artificial joint surface include mating concave and convex surfaces (paragraph 0076 discloses articulation between the concave first artificial joint surface and the convex second artificial joint surface), coupling the second prosthesis to the talus bone (15), the second prosthesis comprising a second artificial joint surface (160) configured to articulate with the first artificial joint surface (paragraph 0076); and coupling the first artificial joint surface to the second artificial joint surface, wherein the first artificial joint surface and the second artificial joint surface form a ball-and-socket joint including, wherein the first artificial joint surface comprises a concave dome and the second artificial joint surface comprises a convex dome configured to mate with the concave dome (paragraph 0076 discloses articulation between the concave dome; 155 which is the first artificial surface and the convex cap; 160 which is the second artificial surface such that the surfaces form a ball-and-socket joint as claimed) and being arranged in concentric relationship resulting from the in- line guide path thereby reducing at least one of varus/valgus and anteversion/retroversion error within the ball-and-socket joint (the in-line guide path of Reiley is construed to meet the limitation that the relationship in which the mating concave and convex surfaces are arranged is concentric thereby reducing at least one of varus/valgus and anteversion/retroversion error within the joint, in the same way as applicant’s).
However, Reiley does not teach a platform having a second engagement feature located on a first side of the platform and a third engagement feature located on a second side of the platform, the second engagement feature of the platform being complementary to the first engagement feature of the stem for coupling the stem to the platform, or that the first artificial joint surface coupled to the platform and including a fourth engagement feature, the fourth engagement feature of the first artificial joint surface being complementary to the third engagement feature of the platform for coupling the first artificial joint surface to the platform, wherein the coupling between the first artificial joint surface and the platform is such that the first artificial joint surface may translate relative to the platform when the prosthesis system is implanted in a patient; wherein the platform comprises a collar extending away from the stem when the platform is fixedly coupled to the stem, and wherein the collar is configured to be received in a complementary recess defined by the first artificial joint surface to provide a rotational fit between the platform and the first artificial joint surface.
Grundei teaches an ankle endoprosthesis that includes a tibial part, a talus part, and a plateau part that detachably connects to the tibial part (page 1, lines 1-5 of English translation).
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Grundei also teaches that the plateau part (first artificial joint surface; 3) is formed from a swivel base (12) which cooperates with the underside of the tibia component (1). More specifically, the swivel base (12) is pushed into the surrounding boundary edge (11) of the platform (see annotated fig. 1 above) until pin (10) reaches the end of slot (15), as shown in fig. 4, to allow rotation about the pivot axis of the pin (page 2, lines 36-37 of the English translation) to thereby reduce joint-internal stresses (page 1, lines 26-35 of the English translation). It can be seen that Grundei meets the limitations of a platform (see annotated fig. 1 above) having a second engagement feature located on a first side (top side) of the platform (the platform is fixedly coupled to the stem as shown in fig. 1 and it is therefore construed that the platform has a second engagement feature, such as a fixed connection, on its first side) and a third engagement feature (pin; 10) located on a second side (underside) of the platform, and the first artificial joint surface coupled to the platform and including a fourth engagement feature (slot; 15), the fourth engagement feature of the first artificial joint surface being complementary to the third engagement feature of the platform for coupling the first artificial joint surface to the platform (page 2, lines 36-37 of the English translation), wherein the coupling between the first artificial joint surface and the platform is such that the first artificial joint surface may translate relative to the platform when the prosthesis system is implanted in a patient (page 2, lines 36-37 of the English translation); wherein the platform comprises a collar (boundary edge; 11) extending away from the stem when the platform is fixedly coupled to the stem (fig. 1 shows that the boundary edge extends away from the stem when the stem and platform are fixedly coupled), and wherein the collar is configured to be received in a complementary recess defined by the first artificial joint surface (boundary edge is received in recessed edges as shown in fig. 5) to provide a rotational fit between the platform and the first artificial joint surface (page 2, lines 36-37 of the English translation discloses rotation between the platform and the first artificial joint surface, which includes the boundary edge and the recessed edges).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling between the first artificial joint surface and the tibial stem to include a platform having a second engagement feature located on a first side of the platform and a third engagement feature located on a second side of the platform, the second engagement feature of the platform being complementary to the first engagement feature of the stem for coupling the stem to the platform, or that the first artificial joint surface coupled to the platform and including a fourth engagement feature, the fourth engagement feature of the first artificial joint surface being complementary to the third engagement feature of the platform for coupling the first artificial joint surface to the platform, wherein the coupling between the first artificial joint surface and the platform is such that the first artificial joint surface may translate relative to the platform when the prosthesis system is implanted in a patient; wherein the platform comprises a collar extending away from the stem when the platform is fixedly coupled to the stem, and wherein the collar is configured to be received in a complementary recess defined by the first artificial joint surface to provide a rotational fit between the platform and the first artificial joint surface, in order to allow rotation between the platform and the stem to reduce joint-internal stresses, as taught by Grundei.
It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the fixed connection between the platform and the tibia stem, as taught by Grundei, with a Morse taper connection, as disclosed in paragraph 0076 of Reiley, such that the second engagement feature of the platform is complementary to the first engagement feature of the stem for coupling the stem to the platform since both connections prevent movement between the two components and particularly since the substitution of one known coupling configuration for another would yield predictable results to one of ordinary skill in the art in this case.
Regarding at least claim 17
Reiley in view of Grundei teaches the method of claim 15. Reiley also teaches that the second prosthesis comprises a peg (110) configured to be installed in a reamed-out pocket of the talus bone (paragraph 0082 discloses that the stem may be of variable lengths, from 2cm to 12cm; at least the stem of 2 cm is construed to be a peg that is installed as claimed by applicant, particularly since a peg is defined as: a small projecting piece used as a support).
Claim 8-10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reiley in view of US Patent No. 6,102,956 A to Kranz (Kranz).
Regarding at least claim 8
Reiley teaches the method of claim 1, wherein the first prosthesis (tibia prosthesis) is coupled to the tibia bone (16). Reiley also teaches that the tibial stem (150) may be variable lengths depending upon the size of the patient, his or her dimensions, and the anticipated future mobility of the patient (paragraph 0070) and contemplates formation of a multi-component prosthesis (paragraph 0092).
However, Reiley does not explicitly teach that coupling the tibia prosthesis to the bone comprises: inserting a first stem component including a first external feature into the intramedullary path formed in the tibia bone; inserting a second stem component including a second external feature into the in-line guide path formed in the talus bone; and coupling the first stem component to the second stem component by rotation of the second stem component relative to the first stem component.
Kranz teaches a modular endoprosthesis having a plurality of shaft elements fitted to one another (fig. 1), for the purpose of varying the length depending on the anatomical requirements of the individual patient (col. 3, lines 27-31).
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It would have been obvious to one having ordinary skill at the time of the invention to modify the coupling of the tibia prosthesis of Reiley, which may be variable lengths, to include inserting a first stem component including a first external feature into the intramedullary path formed in the tibia bone; inserting a second stem component including a second external feature into the intramedullary in-line guide path formed in the second talus bone; and coupling the first stem component to the second stem component by rotation of the second stem component relative to the first stem component, in order to vary the length depending on the anatomical requirements of the individual patient, as taught by Kranz.
Regarding at least claim 9
Reiley in view of Kranz teaches the method of claim 8. Kranz also teaches that the shaft elements include a threaded bore (5, 12, 13) extending along the longitudinal axis (20) in which a screw (tool) can be screwed in to force the elements apart, in order to separate them when desired (col. 4, lines 44-51).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling of the tibial prosthesis to the tibia bone of Reiley in view of Kranz to further include inserting a tool through an intramedullary path defined by the talus bone and into an internally threaded hole defined by the second stem component, wherein the tool is configured to rotate the second stem component relative to the first stem component, in order to allow separation of the components from one another when desired.
Regarding at least claim 10
Reiley in view of Kranz teaches the method of claim 8. Reiley also teaches coupling the first artificial joint surface (155) to the stem (150) in situ (Reiley discloses attaching the dome 155 to the lower surface of the stem 150 which is previously fixed to the tibia as disclosed in paragraphs 0076 and 0074).
Claim 11-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reiley in view of Kranz and Grundei, and further in view of US Patent Application Publication No. 2004/0002768 A1 to Parks et al. (Parks).
Regarding at least claim 11
Reiley meets the limitations of a prosthesis system, comprising: a first prosthesis (upper prosthetic body; 170), comprising: a stem (150) sized and configured to be disposed in an intramedullary path formed in a first bone (16), a first artificial joint surface (155) configured to be attached to the stem (fig. 10), and a second prosthesis (lower prosthetic body; fig. 14), comprising: a second artificial joint surface (160) configured to be attached to a second bone and to articulate with the first artificial joint surface (paragraph 0076 discloses articulation of the first artificial joint surface with the second artificial joint surface).
However, Reiley does not teach that the stem is a multipiece stem including a superior component, at least one mid component, and an inferior component, each component sized to be individually inserted and sequentially joined in situ within an intramedullary canal of a bone, at least one component including an internal hex and at least one component including an external hex for tool engagement.
Kranz teaches a modular endoprosthesis having a plurality of shaft elements fitted to one another, thereby forming a multipiece stem that includes a superior component (2), at least one mid component (3), and an inferior component (4), as shown in fig. 1, for the purpose of varying the length depending on the anatomical requirements of the individual patient (col. 3, lines 27-31).
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Kranz also teaches that the endoprosthesis is assembled in the implanted state (col. 4, lines 22-34), for the purpose of corresponding to the natural shape of the femur, and that the shaft elements (1, 2, 3, and 4) include a threaded bore (5, 12, 13) extending along the longitudinal axis (20) in which a screw (tool) can be screwed in to force the elements apart, in order to separate them when desired (col. 4, lines 44-51).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tibial prosthesis of Reiley such that the stem is a multipiece stem including a superior component, at least one mid component, and an inferior component, each component sized to be individually inserted and sequentially joined in situ within an intramedullary canal of a bone, in order to allow for varying the length depending on the anatomical requirements of the individual patient and to ensure that the components correspond to the natural shape of the femur, as taught by Kranz. It also would have been obvious to one having ordinary skill in the art to specify that at least one component including an internal hex and at least one component including an external hex for tool engagement, in order to allow a screw (tool) to be inserted within each of the shaft elements for separation when desired, as taught by Kranz.
However, Reiley, modified by Kranz, does not teach a platform that is fixed to the multipiece stem, the platform including a posterior stop flange arranged so as to cooperate with the platform to thereby limit posterior over-travel during translation.
Grundei teaches an ankle endoprosthesis that includes a tibial part, a talus part, and a plateau part that detachably connects to the tibial part (page 1, lines 1-5 of English translation).
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Grundei also teaches that the plateau part (first artificial joint surface; 3) is formed from a swivel base (12) which cooperates with the underside of the tibia component (1). More specifically, the swivel base (12) is pushed into the surrounding boundary edge (11) of the platform until pin (posterior stop flange; 10) reaches the end of slot (15), as shown in fig. 4, to allow rotation about the pivot axis of the pin (page 2, lines 36-37 of the English translation) to thereby reduce joint-internal stresses (page 1, lines 26-35 of the English translation).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection between the multipiece stem of Kranz with the first artificial joint surface of Reiley to include a platform including a posterior stop flange arranged so as to cooperate with the platform to thereby limit posterior over-travel during translation, in order to allow rotation between the platform and the stem to reduce joint-internal stresses, as taught by Grundei.
However, Reiley, modified by Kranz and Grundei, does not teach wherein the first artificial joint surface and the second artificial joint surface are each defined by a first arc that is swept along a second arc, wherein the second arc is perpendicular to the first arc.
Parks teaches an ankle joint prosthesis adapted to involve the patient’s distal tibia and talus (abstract).
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Parks also teaches a tibial component (40) with protruding surfaces (46) disposed within similarly shaped recesses in the first bone/tibia’s prepared surface, a mobile bearing with an articulating bottom surface (64), and a talar component (50) with an articulating second artificial joint surface (52) that articulates with the bottom surface (paragraph 0082 discloses that the bottom surface 64 and top surface 52 are configured to articulate with one another). Further, Parks teaches that the bottom surface (64) is configured with a saddle-shaped configuration with concave curvature (a first arc) in the anterior to posterior direction and convex curvature (second arc) in the lateral to [medial] direction so as to match with the second artificial joint surface (52), which presumably has a convex curvature (first arc) in the anterior to posterior direction and a concave curvature (second arc) in the lateral to medial direction, for the purpose of allowing for internal and external rotation motions (paragraph 0045 and paragraph 0082).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the joint surfaces of Reiley, which are intended to retain the foot’s natural motion, such that the first artificial joint surface and the second artificial joint surface are each defined by a first arc that is swept along a second arc, wherein the second arc is perpendicular to the first arc, in order to allow for internal and external rotation motions, as taught by Parks.
Parks also teaches wherein a trough defined by the first artificial joint surface is configured to nest within a trough defined by the second artificial joint surface (the concave curvature of the first artificial joint surface is construed to be a trough nested within a trough of the concave curvature of the second artificial joint surface as disclosed in paragraph 0045 and paragraph 0082).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the joint surfaces of Reiley, which are intended to retain the foot’s natural motion, wherein a trough defined by the first artificial joint surface is configured to nest within a trough defined by the second artificial joint surface, in order to allow for internal and external rotation motions, as taught by Parks.
Regarding at least claim 12
Reiley in view of Kranz, Grundei and Parks teaches the prosthesis system of claim 11. Reiley teaches the artificial joint surfaces, as explained above. Parks also teaches wherein a trough defined by the first artificial joint surface is configured to nest within a trough defined by the second artificial joint surface (the concave curvature of the first artificial joint surface is construed to be a trough nested within a trough of the concave curvature of the second artificial joint surface as disclosed in paragraph 0045 and paragraph 0082).
It would have been obvious to one having ordinary skill in the art at the time of the invention to further modify the joint surfaces of Reiley, which are intended to retain the foot’s natural motion, wherein a trough defined by the first artificial joint surface is configured to nest within a trough defined by the second artificial joint surface, in order to allow for internal and external rotation motions, as taught by Parks.
Regarding at least claim 13
Reiley in view of Kranz, Grundei and Parks teaches the prosthesis system of claim 11. Reiley teaches the joint surfaces, as explained above. Parks also teaches wherein at least one of the first arc or the second arc has a constant radius (the radius of at least one of the curvatures/arcs is shown to have a constant radius; fig. 15).
It would have been obvious to one having ordinary skill in the art at the time of the invention to further modify the joint surfaces of Reiley, which are intended to retain the foot’s natural motion, wherein at least one of the first arc or the second arc has a constant radius, in order to allow for internal and external rotation motions, as taught by Parks.
Claim 14 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Reiley in view of Kranz, Grundei, and Parks, as applied to claim 11 above, and further in view of US Patent No. 5,108,437 A to Kenna (Kenna).
Regarding at least claim 14
Reiley in view of Kranz, Grundei, and Parks teaches the prosthesis system of claim 11. Reiley also teaches that the stem may be variable lengths, depending on the size of the patient, his or her bone dimensions, and the anticipated future mobility of the patient (col. 8, lines 17-25). However, Reiley does not teach wherein the stem comprises: a first stem component including a first external feature; and a second stem component including a second external feature, wherein the second stem component is configured to be coupled to the first stem component by rotation of the second stem component relative to the first stem component.
Kenna teaches a modular prosthesis that includes multiple segments that can be assembled together so as to produce a prosthesis as required by the patient (abstract) and to precisely fit in the intramedullary canal (col. 1, lines 47-52). The segments are joined to one another with key and groove fittings (col. 5, lines 9-21). Fig. 8 shows a cross-sectional view of the portion of the device shown in fig. 7, with the key shown in its locked position, after having been rotated in a counterclockwise direction (col. 2, lines 41-46).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the stem of Reiley, which may be variable lengths, depending on the size of the patient, his or her bone dimensions, and the anticipated future mobility of the patient, to includes a first stem component including a first external feature; and a second stem component including a second external feature, wherein the second stem component is configured to be coupled to the first stem component by rotation of the second stem component relative to the first stem component, in order to produce a prosthesis that can be assembled together as required by the patient, as taught by Kenna.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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