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 .
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.
Response to Arguments
Applicant’s arguments, see Remarks filed 6/3/26, with respect to the rejection(s) of claim(s) 1 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tornier (6334874) and Rauscher (6899736).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tornier (6334874) in view of Rauscher (6899736).
With regards to claim 1, Tornier discloses a prosthesis for a fractured long bone (FIG 5), the prosthesis comprising: a stem part (FIG 2) comprising: a rod (26), configured for being inserted into a medullary cavity of a diaphyseal fragment of the fractured long bone (col 3 line 26 “intended to engage in the humeral canal”), for securing the stem part to the diaphyseal fragment (inserting the rod 26 into the medullary cavity secures the stem part to the diaphyseal fragment); and an epiphyseal end (24), fixedly secured to the rod by means of a plurality of linker legs (44a, 44b, 36) of the stem part, so that a gap (38) is formed between the epiphyseal end and the rod along said plurality of linker legs (see Fig. 3); wherein the stem part (FIG 2) defines a main axis passing through the rod, the gap and the epiphyseal end (see annotated FIG 3 below), and wherein a first through-opening is delineated by two linker legs of the plurality of linker legs such that the gap may be accessed via the first through-opening (see annotated FIG 3 below).
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Tornier fails to disclose at least one exterior part configured to be at least partially located at the periphery of the stem part, along the plurality of linker legs, said at least one exterior part comprising an axial through-opening, the stem part being configured to be inserted through the axial through-opening along the main axis so as to be at least partially wrapped by the exterior part for securing the exterior part to the stem part.
Rauscher also discloses a prosthesis for a bone comprising a stem (FIG 10). Rauscher teaches at least one exterior part (27, 21) configured to be at least partially located at the periphery of the stem part (FIG 10), said at least one exterior part comprising an axial through-opening (FIG 15), the stem part being configured to be inserted through the axial through-opening along the main axis (FIG 16) so as to be at least partially wrapped by the exterior part (27, 21) for securing the exterior part to the stem part (FIG 15) . Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include at least one exterior part configured to be at least partially located at the periphery of the stem part, along the plurality of linker legs, said at least one exterior part comprising an axial through-opening, the stem part being configured to be inserted through the axial through-opening along the main axis so as to be at least partially wrapped by the exterior part for securing the exterior part to the stem part, as taught by Rauscher, in order to promote the ingrowth of bone fragments (abstract).
With regards to claim 6, Tornier as modified by Rauscher discloses the prosthesis of claim 1, comprising at least two exterior parts (Rauscher 27, 21), wherein the at least two exterior parts being secured to each other, so that the exterior parts are mechanically secured to the stem part (Rauscher FIG 10).
Claim(s) 2, 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tornier (6334874) in view of Rauscher (6899736) as applied to claim 1 above, and further in view of Longobardi (WO2021178418A1).
With regards to claim 2, Tornier as modified by Rauscher discloses the prosthesis of claim 1, but fails to disclose that the exterior part comprises polyethylene, poly-ether-ether-ketone, a mesh metallic material, a porous metallic material, or a biomaterial.
Longobardi also discloses a bone prothesis (FIG 5A) and teaches that it is known in the art to form components of a prosthetic femur polyethylene ([0021]), as there is a lower rate of failure for this material ([0005]). Note that the prior art does not need to disclose the limitation “poly-ether-ether-ketone, a mesh metallic material, a porous metallic material, or a biomaterial” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “or”. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tornier’s long bone prosthesis to include that the exterior part comprises polyethylene, as taught by Longobardi, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
With regards to claim 7, Tornier as modified by Rauscher discloses the prosthesis of claim 6, but fails to disclose that the at least two exterior parts comprise polyethylene, poly-ether-ether-ketone, a mesh metallic material, a porous metallic material, or a biomaterial.
Longobardi also discloses a bone prothesis (FIG 5A) and teaches that it is known in the art to form components of a prosthetic femur polyethylene ([0021]), as there is a lower rate of failure for this material ([0005]). Note that the prior art does not need to disclose the limitation “poly-ether-ether-ketone, a mesh metallic material, a porous metallic material, or a biomaterial” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “or”. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Tornier’s long bone prosthesis such that the exterior parts comprise polyethylene, as taught by Longobardi, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 3, 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tornier (6334874) in view of Rauscher (6899736) as applied to claim 1 above, and further in view of Boux (CA 3027299 A1).
With regards to claim 3, Tornier as modified by Rauscher discloses the prosthesis of claim 1, but fails to disclose that the exterior part comprises at least one of the following composites: a composite of hydroxyapatite and tricalciumphosphate, a composite of polylactide-co-glycolide and tricalciumphosphate, a composite of poly-L-lactide and tricalciumphosphate.
Boux also discloses a long bone prosthesis (FIG 1) and teaches that it is known in the art to form an exterior component (32B) of bone prosthesis from composite of hydroxyapatite and tricalciumphosphate for the purpose of providing bioabsorbability (page 10). Note that the prior art does not need to disclose the limitation “a composite of polylactide-co-glycolide and tricalciumphosphate, a composite of poly-L-lactide and tricalciumphosphate” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “at least one of”. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tornier’s long bone prosthesis such that the exterior part comprises a composite of hydroxyapatite and tricalciumphosphate, as taught by Boux, in order to provide the implant with the capability of adapting to the shape and density of bone (page 10).
With regards to claim 8, Tornier as modified by Rauscher discloses the prosthesis of claim 6, but fails to disclose that the at least two exterior parts comprise at least one of the following composites: a composite of hydroxyapatite and tricalciumphosphate, a composite of polylactide-co-glycolide and tricalciumphosphate, a composite of poly-L-lactide and tricalciumphosphate.
Boux also discloses a long bone prosthesis (FIG 1) and teaches that it is known in the art to form an exterior component (32B) of bone prosthesis from composite of hydroxyapatite and tricalciumphosphate for the purpose of providing bioabsorbability (page 10). Note that the prior art does not need to disclose the limitation “a composite of polylactide-co-glycolide and tricalciumphosphate, a composite of poly-L-lactide and tricalciumphosphate” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “at least one of”. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Tournier’s long bone prosthesis such that the exterior parts comprise a composite of hydroxyapatite and tricalciumphosphate, as taught by Boux, in order to provide the implant with the capability of adapting to the shape and density of bone (page 10).
Claim(s) 4, 9 is rejected under 35 U.S.C. 103 as being unpatentable over Tornier (6334874) in view of Rauscher (6899736), as applied to claim 1 above, and further in view of Cima (USPAP 20070088442).
With regards to claim 4, Tornier as modified by Rauscher discloses the prosthesis of claim 1, but fails to disclose that the exterior part comprises a degradable polymer or degradable metal.
Cima discloses a long bone prosthesis (FIG 1C) and teaches that it is known in the art to form an exterior surface of bone prosthesis from a degradable polymer as an alternative to metals and ceramics ([0124]), in order to provide a porous surface for bone ingrowth for stable fixation and controlled drug delivery. Note that the prior art does not need to disclose the limitation “degradable metal” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “or”. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tournier’s long bone prosthesis such that the exterior part comprises a degradable polymer, as taught by Cima, in order to achieve better bone ingrowth for enhanced stability and delayed delivery of drugs ([0125]).
With regards to claim 9, Tornier as modified by Rauscher discloses the prosthesis of claim 6, but fails to disclose that the at least two exterior parts comprise a degradable polymer or degradable metal.
Cima discloses a long bone prosthesis (FIG 1C) and teaches that it is known in the art to form an exterior surface of bone prosthesis from a degradable polymer as an alternative to metals and ceramics ([0124]), in order to provide a porous surface for bone ingrowth for stable fixation and controlled drug delivery. Note that the prior art does not need to disclose the limitation “degradable metal” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “or”. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Tournier’s long bone prosthesis such that the exterior parts comprise a degradable polymer, as taught by Cima, in order to achieve better bone ingrowth for enhanced stability and delayed delivery of drugs ([0125]).
Claim(s) 5, 10, 11, 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tornier (6334874) in view of Rauscher (6899736) as applied to claims 1 and 6 above, and further in view of Cyprien (USPAP 20040230311).
With regards to claim 5, Tornier as modified by Rauscher discloses the prosthesis of claim 1, wherein the exterior part (Rauscher 27, 21) comprises a peripheral shell (Rauscher FIG 15), but fails to disclose that at least one bone graft core is received within the peripheral shell.
Cyprien discloses a prosthesis for a fractured long bone (64) comprising a stem part (22), a rod (30), at least one linker leg (24), and a gap formed between the epiphyseal end and the rod along said at least one linker leg (see FIG 6). Cyprien teaches that a bone graft core (50) is received in the gap along the linker leg (24). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tornier’s long bone prosthesis such that at least one bone graft core is received within the peripheral shell, as taught by Cyprien, in order to improve union of separated bone fragments ([0008]).
With regards to claim 10, Tornier as modified by Rauscher discloses the prosthesis of claim 6, wherein the exterior part (Rauscher 27, 21) comprises a peripheral shell (Rauscher FIG 15), but fails to disclose that at least one bone graft core is received within the peripheral shell.
Cyprien discloses a prosthesis for a fractured long bone (64) comprising a stem part (22), a rod (30), at least one linker leg (24), and a gap formed between the epiphyseal end and the rod along said at least one linker leg (see FIG 6). Cyprien teaches that a bone graft core (50) is received in the gap along the linker leg (24). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Tornier’s long bone prosthesis such that at least one bone graft core is received within the peripheral shell (given that Tornier’s peripheral shell covers the gap along the linker leg), as taught by Cyprien, in order to improve union of separated bone fragments ([0008]).
With regards to claim 11, Tornier as modified by Rauscher disclose the prosthesis of claim 1, but fails to disclose that an implant distinct from the stem part that comprises an internal part located at least partially within the gap, and at least one fastener for fastening epiphyseal fragments of the fractured long bone to the stem part, said at least one fastener being secured to the internal part.
Cyprien discloses a prosthesis for a fractured long bone (64) comprising a stem part (22), a rod (30), at least one linker leg (24), and a gap formed between the epiphyseal end and the rod along said at least one linker leg (see FIG 6). Cyprien teaches an implant distinct (50) from the stem part (22) and comprising: an internal part located at least partially within the gap (50). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Tornier’s long bone prosthesis to include an implant distinct from the stem part that comprises an internal part located at least partially within the gap, as taught by Cyprien, in order to improve union of the separated bone fragments ([0008]).
Cyprien further teaches that a fastener, such as sutures or wires, can be used to attach epiphyseal fragments to the prosthesis [0008]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tornier’s long bone prosthesis to include at least one fastener for fastening epiphyseal fragments of the fractured long bone to the stem part, said at least one fastener being secured to the internal part, or whatever position is appropriate or expedient depending on a particular patient’s bone fragments, as taught by Cyprien, in order to secure bone fragments to the prosthesis for healing of the bone ([0008]).
With regards to claim 19, Tornier as modified by Rauscher disclose the prosthesis of claim 6, but fail to disclose that it further comprises an implant distinct from the stem part that comprises an internal part sized and configured to be located at least partially within the gap, and at least one fastener for fastening epiphyseal fragments of the fractured long bone to the stem part, said at least one fastener sized and configured to be secured to the internal part.
Cyprien discloses a prosthesis for a fractured long bone (64) comprising a stem part (22), a rod (30), at least one linker leg (24), and a gap formed between the epiphyseal end and the rod along said at least one linker leg (see FIG 6). Cyprien teaches an implant distinct (50) from the stem part (22) and comprising: an internal part sized and configured to be at least partially within the gap (50). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Tornier’s long bone prosthesis to include an implant distinct from the stem part that comprises an internal part sized and configured to be located at least partially within the gap, as taught by Cyprien, in order to improve union of the separated bone fragments ([0008]).
Cyprien further teaches that a fastener, such as sutures or wires, can be used to attach epiphyseal fragments to the prosthesis [0008]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tornier’s long bone prosthesis to include at least one fastener for fastening epiphyseal fragments of the fractured long bone to the stem part, said at least one fastener being secured to the internal part, or whatever position is appropriate or expedient depending on a particular patient’s bone fragments, as taught by Cyprien, in order to secure bone fragments to the prosthesis for healing of the bone ([0008]).
Claim(s) 12 -14, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tornier (6334874) in view of Rauscher (6899736) and Cyprien (USPAP 20040230311), as applied to claims 11 and 19 above, and further in view of Boyer (USPAP 20010039457).
With regards to claim 12 Tornier as modified by Rauscher and Cyprien discloses the prosthesis of claim 11, but fails to disclose that the internal part comprises an elastic tongue allowing snap-fitting of the internal part into the gap, for securing the internal part to the gap.
Boyer discloses a bone plug prosthesis (4C) and teaches an elastic tongue allowing snap-fitting of the internal part into the gap, for securing the internal part to the gap (snap-fitting of lip 310 of cap 290 in groove 216 of sleeve 202). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the internal part of the modified Tornier’s prosthesis to include an elastic tongue allowing snap-fitting of the internal part into the gap, as taught by Boyer, in order for securing the internal part ([0098]).
With regards to claim 13, Tornier as modified by Rauscher and Cyprien disclose the prosthesis of claim 11, but fail to disclose the internal part comprises an expansible body. Boyer teaches that a prosthetic component configured for insertion into a cavity can be expandable from a retracted configuration allowing insertion of the expansible body into the gap and an expanded configuration preventing extraction of the expansible body from the gap (see description of the cap 180 being expandable [0090]; Fig. 2H). It would have therefore been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the internal part of the modified Tornier’s prosthesis to be expandable in order to provide a closer fit and enhanced stability ([0090]).
With regards to claim 14, Tornier as modified by Rauscher and Cyprien discloses the prosthesis of claim 11, but fails to disclose that the internal part comprises a peripheral shell and at least one bone graft core received within the peripheral shell.
Boyer further teaches that the internal part (plug 260) comprises a peripheral shell (262) and at least one bone graft core (264 received within the peripheral shell ([0096]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the internal part of the Tornier’s prosthesis to include a peripheral shell and a bone graft core, as taught by Boyer, in order to prevent the release of blood or other fluids from within the plug ([0096]).
With regards to claim 20, Tornier as modified by Rauscher and Cyprien disclose the prosthesis of claim 19, but fails to disclose that the internal part comprises an elastic tongue allowing snap-fitting of the internal part into the gap, for securing the internal part to the gap.
Boyer discloses a bone plug prosthesis (4C) and teaches an elastic tongue allowing snap-fitting of the internal part into the gap, for securing the internal part to the gap (snap-fitting of lip 310 of cap 290 in groove 216 of sleeve 202). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the internal part of the modified Tornier’s prosthesis to include an elastic tongue allowing snap-fitting of the internal part into the gap, as taught by Boyer, in order for securing the internal part ([0098]).
Claim(s) 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tornier (6334874) in view of Rauscher (6899736) as applied to claims 1 and 6 above and further in view of Ricci (20080015616).
With regard to claim 15, Tornier as modified by Rauscher disclose the prosthesis of claim 1, but fails to disclose a plurality of barbs positioned along the exterior part.
Ricci discloses a long bone prosthesis (FIG 20) and teaches that the plurality of barbs (ridges) are spaced apart by grooves on a proximal portion of the prosthesis (Fig. 7-14; [0024], [0067]) for the purpose of facilitating bone growth in a desired axis about the surface of the prosthesis (abstract; [0027]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Tornier’s long bone prosthesis to include a plurality of barbs spaced apart by grooves on a proximal portion of the prosthesis, as taught by Ricci, in order to promote cell growth and secure fixation of the implant to bone tissue ([0049]).
With regards to claim 16, Tornier as modified by Rauscher and Ricci discloses the prosthesis of claim 15, wherein the plurality of barbs are spaced apart by grooves on a proximal portion of the prosthesis (Fig. 7-14; [0024], [0067]), wherein the barbs protrude outwardly from a lateral side of the prosthesis (Fig. 7-14; [0024], [0067]).
With regards to claim 17, Tornier as modified by Rauscher discloses the prosthesis of claim 6, but fails to disclose a plurality of barbs positioned along each of the at least two exterior parts.
Ricci discloses a long bone prosthesis (FIG 20) and teaches that the plurality of barbs (ridges) that are spaced apart by grooves on a proximal portion of the prosthesis (Fig. 7-14; [0024], [0067]) for the purpose of facilitating bone growth in a desired axis about the surface of the prosthesis (abstract; [0027]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Tornier’s long bone prosthesis to include a plurality of barbs spaced apart by grooves on a proximal portion of the prosthesis, as taught by Ricci, in order to promote cell growth and secure fixation of the implant to bone tissue [0049].
With regards to claim 18, Tornier as modified by Rauscher and Ricci discloses the prosthesis of claim 17, wherein the plurality of barbs are spaced apart by grooves on a proximal portion of the prosthesis (Fig. 7-14; [0024], [0067]), wherein the barbs protrude outwardly from a lateral side of the prosthesis (Fig. 7-14; [0024], [0067]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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