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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 6-8 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Carver et al (US 20210169664 A1) "Carver".
Regarding Claim 1, Carver teaches a modular implant system comprising (orthopedic surgical instrument system 10, par. [0032], Fig. 1): a baseplate (tibial base trial 12, par. [0032]. Fig. 1);
a bearing insert (tibial bearing trial, par. [0032], Fig. 1) including an articular surface (superior surface 64, par. [0038], Fig. 1) and a plate-contacting surface (inferior surface 62, par. [0038], Fig. 1) opposite the articular surface;
and a latch (locking mechanism including locking bolt 40, threaded end 42, socket 44, post 48, stem 52, pars. [0036] and [0037], Fig. 1) adapted for disposal through a hole (channel 80, par. [0040], Figs. 1 and 4) in the bearing insert,
wherein the baseplate is adapted to receive the bearing insert, and wherein when the plate-contacting surface of the bearing insert is disposed on the baseplate and the latch is disposed through the hole in the bearing insert (par. [0037], Fig. 1), the latch is rotatable from a first position to a second position, the bearing insert being removable from the baseplate when the latch is in the first position, and the bearing insert being held in place on the baseplate when the latch is in the second position (rotation of socket 44 and snap-lock system of post 48 of latch in channel 80 of bearing insert, pars. [0036] and [0042], Figs. 1, 5-8).
Regarding Claim 6, Carver teaches the modular implant system of claim 1, wherein the latch includes a radial projection (post 48 and annular shaped flange 54) on a side surface thereof and the hole is defined by an inner wall (medial edges 90, par. [0039], Fig. 2) including a first indentation (posterior cam surfaces 108, par. [0042], Figs. 2, 5-8) and a second indentation (anterior cam surfaces 110, par. [0042], Figs. 2, 5-8), the radial projection being positioned in the first indentation in the first position and the radial projection being positioned in the second indentation in the second position (pars. [0039] and [0042], Figs. 5-8).
Regarding Claim 7, Carver teaches the modular implant system of claim 6, wherein when the latch is in the second position, the second indentation prevents the latch from being rotated back into the first position (pars. [0041] and [0042]).
Regarding Claim 8, Carver teaches the modular implant system of claim 6, wherein the inner wall includes a third indentation (slot 94, par. [0040], Fig. 2) located such that the second indentation separates the first indentation and the third indentation, the latch being removable from the bearing insert when the radial projection is positioned in the third indentation, and the latch being irremovable from the bearing insert when the latch is in the first indentation and in the second indentation (par. [0042]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carver et al (US 20210169664 A1) "Carver".
Regarding Claim 2, the main embodiment of Carver does not teach a latch with a shaft portion and a tab portion with an elongate dimension. However, another embodiment of Carver teaches the modular implant system of claim 1, wherein the latch includes a length with a shaft portion (stem 52, par. [0037], Fig. 1) and a tab portion (post 48 and annular-shaped flange 54, par. [0037], Fig. 1) extending from the shaft portion, the tab portion having an elongate dimension angled relative to the length of the latch and the elongate dimension being longer than a maximum diameter of the shaft portion (pars. [0006] and [0037], tab portion is annular or ring shaped, but not required to be round). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Carver to include a latch with a shaft portion and a tab portion with an elongate dimension, as taught by another embodiment of Carver, in order to have a secure latch or locking mechanism within the bearing insert (Carver, par. [0037]).
Regarding Claim 13, the main embodiment of Carver teaches a kit (orthopedic surgical instrument system 10, par. [0032], Fig. 1) comprising: a first baseplate (tibial base trial 12, par. [0032]. Fig. 1);
a first bearing insert (tibial bearing trial, par. [0032], Fig. 1), but does not disclose a second baseplate or bearing insert and various attachments of the different baseplates and inserts.
However, another embodiment of Carver discloses a second baseplate or a second bearing insert (par. [0032], there may be multiple inserts and baseplates of different sizes);
and a latch adapted to control engagement between any combination of baseplate and bearing insert from among the first baseplate, the second baseplate, the first bearing insert and the second bearing insert while the latch is disposed in the bearing insert of the combination (locking mechanism including locking bolt 40, threaded end 42, socket 44, post 48, stem 52, pars. [0036] and [0037], Fig. 1),
wherein when the kit includes the second baseplates, the first baseplate and the second baseplate are adapted for attachment to the first bearing insert (pars. [0019] and [0032], there may be multiple inserts and baseplates of different sizes)
and wherein when the kit includes the second bearing insert, the first bearing insert and the second bearing insert are adapted for attachment to the first baseplate (par. [0032], there may be multiple inserts and baseplates of different sizes). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the main embodiment of Carver to include a second baseplate or bearing insert and various attachments of the different baseplates and inserts, as taught by another embodiment of Carver, in order to accommodate a range of patient anatomies (Carver, par. [0032]).
Regarding Claim 14, the main embodiment of Carver further teaches the kit of claim 13, wherein the latch includes a shaft (stem 52, par. [0037], Fig. 1) and a distal tab (post 48, par. [0037], Fig. 1), the latch being rotatable when fully disposed in one of the first bearing insert and the second bearing insert to control whether the distal tab is held in place by a protrusion of one of the first baseplate and the second baseplate, the one of the first baseplate and the second baseplate and the one of the first bearing insert and the second bearing insert being held together when the distal tab is held in place by the protrusion (pars. [0036] and [0037]).
Regarding Claim 15, the main embodiment of Carver further teaches the kit of claim 13, wherein each bearing insert of the first bearing insert and the second bearing insert includes a stepped hole (channel 80, par. [0040], Figs. 1 and 4) adapted to receive the latch such that the latch is fully disposed in the stepped hole (par. [0040], stem 52 is received into channel 80).
Regarding Claim 16, the main embodiment of Carver further teaches the kit of claim 13, wherein the latch further comprises a plurality of latches, each latch of the plurality of latches being disposed in one of the first bearing insert and the second bearing insert (pars. [0032] and [0036]).
Regarding Claim 17, the main embodiment of Carver further teaches the kit of claim 13, wherein each baseplate (tibial base trial 12, par. [0032], Fig. 1) of the first baseplate and the second baseplate further comprises a proximal surface (surface 22, par. [0035], Fig. 1) and a posterior recess (fastener guides 36 near posterior section 32, pars. [0035] and [0036], Fig. 1) on a posterior-side of the proximal surface, the posterior recess sized to receive a protrusion of any one of the first bearing insert and the second bearing insert (fastener guides 36 configured to receive fasteners or guide pins, par. [0036]).
Regarding Claim 18, the main embodiment of Carver further teaches the kit of claim 17, wherein each baseplate of the first baseplate and the second baseplate further comprises an anterior recess (socket 44, pars. [0035] and [0036], Figs. 1 and 9) on the proximal surface sized to receive part of the latch when the latch is in a locked position, each baseplate of the first baseplate and the second baseplate having a first dimension between the posterior recess and the anterior recess (pars. [0035] and [0036], Figs. 1 and 9, locking mechanism including latch components is closer to anterior section than posterior section).
Regarding Claim 19, the main embodiment of Carver further teaches the kit of claim 17, wherein each baseplate of the first baseplate and the second baseplate further comprises a posterior abutment and an anterior abutment on the proximal surface (pars. [0038] and [0039], Fig. 1, inferior surface 62 of tibial bearing insert 14 abuts superior surface 22 of tibial base trial 12, and the abutment spans from the anterior section 74 of the bearing insert that is shaped to match anterior section 30 of the baseplate to the posterior section 76 of the bearing insert that is shaped to match posterior section 32 of the baseplate), an abutment distance between the posterior abutment and the anterior abutment being the same for each baseplate (pars. [0032] and [0039]).
Regarding Claim 20, the main embodiment of Carver further teaches the kit of claim 13, wherein the second baseplate or the second bearing insert further comprises the second baseplate and the second bearing insert (pars. [0032] and [0035]).
Claim(s) 3-5, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Carver et al (US 20210169664 A1) "Carver" in view of Collazo (US 20180008424 A1) "Collazo" .
Regarding Claim 3, Carver does not teach a hole in the bearing insert with upper and lower portions and a smaller cross-section central portion. However, Collazo, in the same field of art, teaches a hinge knee assembly (hinge knee trial assembly 10, par. [0060], Fig. 1) with a tibial trial assembly (tibial trial assembly 12, par. [0060], Fig. 1), wherein the hole (intrabearing recess 66 and elongate opening 74, par. [0067], Figs. 4A and 5A) of the bearing insert (tibial insert 60 and bearing plate 70, pars. [0066] and [0067], Figs. 4A and 5A) includes an upper portion extending from the articular surface (bearing surface 64, par. [0066], Fig. 4A), a lower portion extending from the plate-contacting surface (Fig. 5B) and a central portion therebetween, the central portion having a smaller cross-sectional dimension than the upper and lower portions (par. [0067], Fig. 5B, elongate flange 76 extends into central portion of opening, which creates a smaller cross-sectional dimension compared to the lower and upper portions). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Carver to include a hole in the bearing insert with upper and lower portions and a smaller cross-section central portion, as taught by Collazo, in order to help secure or adjust the latch as needed within the insert without having to disrupt other components of the assembly (Collazo, par. [0067]).
Regarding Claim 4, Carver does not teach concave wall surfaces and projecting wall sections in the central portion. However, Collazo, in the same field of art, teaches a hinge knee assembly (hinge knee trial assembly 10, par. [0060], Fig. 1) with a tibial trial assembly (tibial trial assembly 12, par. [0060], Fig. 1), wherein the upper and lower portions of the hole include concave wall surfaces (Figs. 4A and 5B) and the central portion includes opposing wall sections projecting relative to the concave wall surfaces (elongate flanges 76, par. [0076], Fig. 5B), the tab portion (base 42, par. [0063], Fig. 3A) of the latch (axle component 40) fitting in the central portion when elongate side walls of the tab portion are aligned with surfaces of the opposing wall sections of the central portion. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Carver to include concave wall surfaces and projecting wall sections in the central portion, as taught by Collazo, in order to help secure or adjust the latch as needed within the insert without having to disrupt other components of the assembly (Collazo, par. [0067]).
Regarding Claim 5, Carver further teaches the modular implant system of claim 4, wherein when the latch is disposed in the hole (channel 80), the opposing wall sections prevent removal of the latch from the bearing insert when the tab portion of the latch is disposed in the lower portion of the hole and the elongate side walls of the tab portion are not aligned with the surfaces of the opposing wall sections of the central portion (pars. [0040-0042], Figs. 6-9).
Regarding Claim 9, Carver does not teach a baseplate with a first protrusion defining a first recess and a second protrusion. However, Collazo, in the same field of art, teaches a hinge knee assembly (hinge knee trial assembly 10, par. [0060], Fig. 1) with a tibial trial assembly (tibial trial assembly 12, par. [0060], Fig. 1), wherein the baseplate (baseplate component 20, par. [0061], Fig. 2A) includes a first protrusion (anterior protrusion 34, par. [0062], Fig. 2A) defining a first recess (boss opening 28, par. [0061], Fig. 2A) thereunder such that a second protrusion (par. [0066], Fig. 4B, notch 69 provides clearance for anterior protrusion 34) of the bearing insert is slidable into the first recess to partially prevent sliding of the bearing insert relative to the baseplate. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Carver to include a baseplate with a first protrusion defining a first recess and a second protrusion, as taught by Collazo, in order to connect to the insert and securing mechanisms for the assembly (Collazo, pars. [0062] and [0090]).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Carver et al (US 20210169664 A1) "Carver" in view of Byrd et al (US 10675153 B2) "Byrd".
Regarding Claim 10, Carver does not teach a latch with the same approximate length as the hole of the bearing insert. However, Byrd, in the same field of art, teaches a prosthesis assembly (prosthesis assembly 10, par. (17), Fig. 1B) including a tibial prosthesis (tibial prosthesis 14, par. (17), Fig. 1B), wherein the latch (fastener 30, par. (22), Fig. 1B) has a length approximately equal to the hole (aperture 44, par. (22), Fig. 1B) of the bearing insert (tibial bearing component 26, par. (22), Fig. 1B). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Carver to include a latch with the same approximate length as the hole of the bearing insert, as taught by Byrd, in order to reduce micro-motion of the insert relative to the baseplate (Byrd, par. (22)).
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Carver et al (US 20210169664 A1) "Carver" in view of Cappalletti (US 10792161 B2) "Cappalletti".
Regarding Claim 11, Carver does not teach a plurality of baseplates, each with different sizes. However, Cappalletti, in the same field of art, teaches a knee spacer device (spacer device 1, Description par. (12), Fig. 1) comprising a tibial unit (tibial unit 2, Description par. (12), Fig. 1), wherein the baseplate (tibial unit 2, Description par (12), Fig. 1) is one of a plurality of baseplates (first tibial components 21L0, 21L1, 21L2, Description par (44), Fig. 13), each baseplate of the plurality of baseplates having a different size with respect to the others (Fig. 13). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Carver to include a plurality of baseplates, each with different sizes, as taught by Cappalletti, in order for the device to be adaptable to the anthropomorphic measurements of the tibial ends of the patient (Cappalletti, Description par. (47)).
Regarding Claim 12, Carver does not teach a plurality of bearing inserts, each with different sizes. However, Cappalletti, in the same field of art, teaches a knee spacer device (spacer device 1, Description par. (12), Fig. 1) comprising a tibial unit (tibial unit 2, Description par. (12), Fig. 1), wherein the bearing insert (second tibial component 22, Description par (14), Fig. 1) is one of a plurality of bearing inserts (second tibial components 22S, 22M, 22L, Description par (44), Fig. 13), each bearing insert of the plurality of bearing inserts having a different size with respect to the others (Fig. 13). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Carver to include a plurality of bearing inserts, each with different sizes, as taught by Cappalletti, in order for the device to be adaptable to the anthropomorphic measurements of the tibial ends of the patient (Cappalletti, Description par. (47)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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