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.
Specification
The disclosure is objected to because of the following informalities:
a. In paragraph 0004, line 2, “may be selectable” should read “selectable”
b. In paragraph 0004, line 3, “prothesis” should read “prosthesis”
c. In paragraph 0009, line 14, “in response inserting” should read “in response to inserting”
d. In paragraph 0038, lines 12- 13, “other configured dimensioned” should read “other configured dimensions”
e. In paragraph 0039, line 5, “A crown of fins interspersed” should read “A crown of interspersed fins”
f. In paragraph 0040, lines 4-5, “the surgeon or assistance” should read “the surgeon or assistant”
g. In paragraph 0050, line 7, “response inserting” should read “response to inserting”
h. In paragraph 0050, line 10, “set of extended recess” should read “set of extended recesses”
i. In paragraph 0058, line 14, “in response inserting” should read “in response to inserting”
j. In paragraph 0080, line 5, “143-2 may be established” should read “143-2 may be established by”
k. In paragraph 0092, line 1, “in width a direction” should read “in width in a direction”
l. In paragraph 0113, line 6, “may establish configured” should read “may establish the configured”
m. In paragraph 0122, line 10, “Step 380C” should read “Step 580C”
n. In paragraph 0126, line 1, “with reference to continuing reference” should read “with continuing reference to”
o. In paragraph 0127, line 5, “Step 380C-1 may include” should read “Step 580C-1 may include”
p. In paragraph 0127, line 11, “Step 380C may include” should read “Step 380C may include”
q. In paragraph 0128, line 2, “step 380C-2 in response” should read “step 580C-2 in response”
r. In paragraph 0129, line 1, “step 380C-2” should read “step 580C-2”
s. In paragraph 0133, line 2, “repairing bone defects restoring” should read “repairing bone defects by restoring”
Appropriate correction is required.
Claim Objections
Claims 10 and 14 are objected to because of the following informalities:
In claim 10, line 8, “in response inserting” should read “in response to inserting”
In claim 10, line 12, “set of extended recess” should read “set of extended recesses”
In claim 14, line 14, “in response inserting” should read “in response to inserting”
Appropriate correction is required.
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.
Claim(s) 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Early et al. (US 11607314) and further in view of Fritzinger et al. (US 11653933).
Regarding claim 1, Early et al. discloses a component for an orthopaedic procedure comprising:
a main body extending along a longitudinal axis between a first end and a second end, the main body implantable in tissue, and the main body including a cavity extending inwardly from the first end (see Figs. 7 and 8 illustrating a bone fixation device (10) with multiple distinct sections (140, 144, 148, 152 and 156) creating tiers, distributed along a longitudinal axis; and a plate member (52) at one end and a top surface portion (38) providing an internal interface defined by the surfaces to inherently create cavities); wherein: the main body has a stepped geometry established by a plurality of tiers including a first tier having a first tapered periphery and a second tier having a second tapered periphery, and the second tapered periphery is established by circumferential faces of a first set of abutments distributed about the longitudinal axis (see Figs 7-9 illustrating the distinct sections (140, 144, 148, 152, and 156) creating tiers and a stepped geometry where the width or profile of the fixation device (10) changes at each transition point between the sections; a form of staples (140) acting as the first tier and an upper portion (144) acting as the second tier, with both tiers establishing the decreasing diameter required for insertion into bone; and fixation members (56) extending laterally with a circumferential distribution from the device (10), functioning as abutments). Early et al. fails to disclose wherein: the cavity includes a first cavity level and a second cavity level distributed along the longitudinal axis, the first cavity level includes a periphery dimensioned to complement a profile of the first tapered periphery, the second cavity level includes a periphery dimensioned to complement a profile of the second tapered periphery, a set of cavity cutouts extend outwardly from the periphery of the second cavity level, and the set of cavity cutouts are dimensioned to complement a profile of the first set of abutments.
Fritzinger et al. also discloses s femoral cutting block (10) with a bone-facing surface containing an internal cavity, internal interfaces, a pair of posterior guide bosses (140), and negative contours (see Fig. 8 illustrating the femoral cutting block (10) with customized cavities and complementary profiles). Fritzinger et al. teaches a customized patient-specific negative contour (step 230) which created a cavity periphery dimensioned to complement a profile, and can be distributed at different levels to ensure a secure fit; and how to map a cavity to a problematic region, thereby creating cutouts through keyed interlocking of surface (176) and the outer edge (172) (see Col. 10, lines 57-67; Col. 11, lines 1-3, lines 63-67; Col. 12, lines 1-9 disclosing the stepped geometry and cavity levels). 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 provided Early et al.’s fixation device (10) with distinct sections and fixation members (56) to provide the male side of the interlocking connection, wherein cavity levels, complimentary peripheries and a keyed locking interface that wrap around protrusions or abutments to create a matching female interface as taught by Fritzinger et al. Doing so would create a perfectly mated, non-rotational interface, that is modularly versatile.
Regarding claim 2, Early et al. in view of Fritzinger et al., discloses the component as recited in claim 1, but fails to disclose wherein:
the first tier includes a tapered protrusion establishing the first tapered periphery, and the tapered protrusion extends to the second end.
Fritzinger et al. also discloses a pair of guide bodies (22) and fixation pins creating physical protrusions that extend from the base plate (146) of the femoral cutting block (10) (see Col. 9, lines 1-10 disclosing the components of the femoral cutting block (10)). Fritzinger et al. teaches that a protrusion like a guide body (22) should tapered to facilitate lead-in when being inserted into a corresponding cavity or bone site, with extensions from the proximal first end of the base plate (146) to the distal second end of a bone-facing surface (36) (see Col. 9, lines 1-10, lines 22-31 disclosing the components of the femoral cutting block; and Figs. 1, 5 and 15 illustrating the tapered protrusions established by guide bodies and pins, along with converging side walls forming the outer boundary or tapered periphery). 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 provided Early et al.’s multi-tiered body with a longitudinal axis, wherein adding a tapered protrusion that extends to the second end provides a continuous mechanical lead that ensures the entire tier is properly aligned during insertion as taught by Fritzinger et al. Doing so would provide a means to achieve a high-stability, self-aligning modular interlocking system for orthopaedic implants.
Regarding claim 3, Early et al. in view of Fritzinger et al., discloses the component as recited in claim 1, but fails to disclose wherein:
the plurality of tiers includes a third tier having a periphery established by a circumferential wall and a second set of abutments extending axially from the circumferential wall towards the second end, and the second set of abutments are distributed about the longitudinal axis; and
wherein the circumferential wall includes first and second sets of recesses extending from the first end, the first set of recesses are interspersed with the second set of recesses, the first set of recesses have a first contour dimensioned to complement a profile of the second set of abutments, and the second set of recesses have a second, different contour dimensioned to complement a lesser portion of the profile of the second set of abutments.
Fritzinger et al. also discloses a femoral block (10) that interfaces with bone and accepts modular guide components (see Col. 9, lines 1-10 disclosing the components of the femoral cutting block (10)). Fritzinger et al. teaches step 230 adds thickness within the outer boundary to define a base plate, inherently creating a distinct structural level (e.g. third tier) along the perimeter of the base plate that forms a circumferential wall; axial abutments around a longitudinal axis; customized patient-specific contours established by step 230 to make an elongated opening (110) and inner walls (112) which form interspersed recesses; and a keyed assembly ensuring the parts can only be joined in one orientation and provides clearance where a full fit is not required for stability (see Col. 10, lines 57-63; Col. 11, lines 63-67; Col. 12, lines 1-9; Col. 12, lines 10-30 disclosing steps 222, 230, 232 and 234 which inherently creates a third tier, a circumferential wall, axial abutments and interspersed recesses). 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 provided Early et al.’s multi-tiered body along a longitudinal axis, wherein a base plate can be modified as a third tier, along with negative contours that specifically mirror the profiles of external members during implantation as taught by Fritzinger et al. Doing so would transform axial/lateral abutments into a precision-locked interface, in order to achieve a high-strength, non-rotational fit.
Regarding claims 4-5, Early et al. in view of Fritzinger et al., discloses the component as recited in claim 3, but fails to disclose wherein:
the first set of recesses extend a first distance, and the second set of recesses extend a second distance that is less than the first distance relative to the longitudinal axis;
a first set of cutouts are interspersed with the first set of abutments about the longitudinal axis; and
the first set of recesses are at least partially circumferentially aligned with the second set of abutments, and the second set of recesses are at least partially circumferentially aligned with the first set of cutouts relative to the longitudinal axis; and the first set of abutments are at least partially circumferentially aligned with the second set of abutments relative to the longitudinal axis.
Fritzinger et al. also discloses a guide body (100) with an elongated opening (110) and a number of inner walls (112) arranged around the central portion of the femoral cutting block (10) allowing for integration with specific regions. Fritzinger et al. teaches adding thickness only where necessary to accommodate, thereby creating one set of recesses extending a first distance (deep fit) and a second set extending a shorter distance (shallow feature) to maintain a low profile; alternating structural protrusions with the elongated opening (110) and inner walls (112) to create interspersed cutouts and abutments in order to prevent rotational errors; and the guide bosses (140) are aligned with the specific structural walls of the guide body (100) to ensure the alignment of the first and second set of abutments along a single circumferential path (see Col. 11, lines 63-67; Col. 12, lines 1-9 disclosing step 230 which uses depth optimization to create varying recess distances to accommodate different anatomical protrusions varied by height; Figs. 1 and 15 illustrating the guide bodies (140) and the elongated opening (110) and inner walls (112) arranged at different angular intervals around the longitudinal axis, leading to interspersed cutouts and abutments that are circumferentially aligned). 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 provided Early et al.’s multi-tiered body along a longitudinal axis, wherein varying the depths within the structure established by an opening (110) and inner wall (112) in order to match irregular profiles while minimizing overall device thickness as taught by Fritzinger et al. Doing so would provide an interface that seats securely at multiple depths to distribute mechanical force.
Regarding claim 6, Early et al. in view of Fritzinger et al., discloses the component as recited in claim 1, but fails to disclose wherein: the main body is dimensioned to interconnect a stem component insertable in bone and an articulation component adapted to mate with an opposed articular surface of an adjacent implant or an adjacent bone.
Fritzinger et al. discloses a base (146) that physically supports and aligns guide bodies (22), drill slot (142) acting as a drill guide, and an elongated opening (110) and inner walls (112) acting as negative contours (see Figs. 9-10 illustrating the base (146) as an interconnect between components). Fritzinger et al. teaches the base (146) can serve as a functional intermediary to provide the mechanical integrity needed to bridge a guide boss (140) and an elongated opening (110) acting as the negative contour, inherently creating the stem component and the articulation zone (see Col. 11, lines 14-62, lines 63-67; Col. 12, lines 1-2; disclosing steps 226, 228 and 230 used to inherently create an interconnect with the body, a stem and articulation component). 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 provided Early et al.’s ’s multi-tiered body along a longitudinal axis, wherein guide bosses (140) can function as stem-like fixation pins with an opening (110) and inner walls (112) functioning as negative contours in order to provide a mating interface for an articular surface as taught by Fritzinger et al. Doing so would provide the technical means to achieve a three-part modular assembly: fixation side, structural bridge and a joint side.
Claim(s) 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Early et al. (US 11607314) in view of Fritzinger et al. (US 11653933) and further in view of Burrows et al. (US 6048365).
Regarding claim 7, Early et al. in view of Fritzinger et al. discloses an orthopaedic implant system comprising: a set of components stackable to establish an assembly, each of the components comprising: a main body extending along an axis between a first end and a second end, and a cavity extending inwardly from the first end (see Col. 2, lines 27-32; Col. 5, lines 17-20 disclosing the implant having a tapered member with a longitudinally extending body defining its upper surface (38) acting as the proximal first end and the lower surface portion acting as the distal second end; Figs. 1 and 2 illustrating the upper surface designed to receive a secondary component through an internal cavity extending inwardly); wherein the main body has a stepped geometry established by a plurality of tiers distributed along the axis, the plurality of tiers include a first tier having a first tapered periphery and a second tier having a second tapered periphery, and the second tapered periphery is established by a first set of abutments (see Col. 7, lines 13-35 disclosing an upper (144) and lower portion (148) functioning as tiers with tapered peripheries; Fig. 1 illustrating the plurality of tiers and stepped geometry established by the staple (140), upper (144) and lower (148) portions, along with their associated peripheries; and abutment surfaces established by fixation members (56) that extend radially and axially from the main body, with second tapered periphery of the upper portion (144) being established by the abutment surfaces).
Furthermore, Fritzinger et al. discloses wherein: the cavity includes a first cavity level and a second cavity level distributed along the axis, a set of cavity cutouts extend outwardly from a periphery of the second cavity level (see Col. 7, lines 25-30; Col. 8, lines 30-40 disclosing a base plate (22) with a bone-facing surface (52) and an elongated opening (110) establishing a primary depth within the main body of the implant, and inner wall (112) and an opening (114) representing a distinct secondary level of depth; Fig. 8 illustrating internal cavities (112 and 114) where cutouts would be located). Fritzinger et al. fails to disclose wherein: each adjacent pair of the components is configurable to establish a collapsed configuration and an extended configuration of a respective portion of the assembly, the collapsed configuration is established in response to inserting the first set of abutments into the set of cavity cutouts to establish a keyed interface such that a first Morse taper connection is established between a periphery of the first cavity level and the first tapered periphery, but the extended configuration is established in response to engagement between the periphery of the second cavity level to establish a second Morse taper connection that blocks engagement between the periphery of the first cavity level and the first tapered periphery.
Burrows et al. also discloses modular components of femoral hip stems (10/110) and a femoral head prosthesis (12/112), a male (16) and female (22) conical tapered surface, a cylindrical pin (30), cylindrical recesses (32) and a Morse taper connection established by the conical tapered surfaces (16 and 22) (see Col. 3, lines 38-67 disclosing the modular components, with conical tapered surfaces forming cavities along with its closed interior end (28) and cylindrical collar (24) terminating in an end face, thereby creating a periphery). Burrows et al. teaches the cylindrical pin (30) is matched with a corresponding recess (32) allowing for the male and female conical surfaces (16 and 22) to form the primary Morse taper and to fully engage in a collapsed configuration; and a keyed interface between the pin (30) and the end face (18) of the stem before the tapered surfaces can mate in an extended state, which establishes a mechanical block that limits the depth of the assembly (see Col. 3, lines 51-59; Col. 4, lines 1-6, lines 59-66 disclosing the collapsed and extended configurations, a Morse taper connection and recesses (32) that function as cavity cutouts in the end face of the stem). 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 the longitudinally extending body of Early et al., as modified by Fritzinger et al., with the mechanical logic required to transition between different assembly depths, in order to have a collapsed and extended configuration as taught by Burrows et al. Doing so would provide a means to adjust the length of an implant simply by rotating the components and using a Morse taper to ensure implant stability and load bearing in both short and long positions.
Regarding claim 8, Early et al. in view of Fritzinger et al. and Burrows et al., discloses the system as recited in claim 7, furthermore Burrows et al. also discloses wherein: the first tapered periphery of the first tier is established by a tapered protrusion terminating at the second end (see Col. 3, lines 37-40 disclosing a neck (14), a male conical taper surface (16) and a distal end face (18) forming a protrusion and periphery). Burrows et al. teaches the conical taper surfaces (16 and 22) on the periphery of the protrusion, creates high axial stability. 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 a tapered member featuring the plurality of tiers of Early et al., as modified by Fritzinger et al. with components (14, 16 and 18) forming the tapered protrusion as taught by Burrows et al. Doing so would provide a means for an adjustable-length modular assembly that can be secured in multiple functional positions via self-locking tapers.
Regarding claims 9, 10 and 12, Early et al. in view of Fritzinger et al. and Burrows et al., discloses the system as recited in claim 7, furthermore Burrows et al. also discloses wherein: circumferentially opposed engagement faces bounding the respective cavity cutouts are dimensioned to limit relative rotation between the adjacent components in the collapsed configuration, but not in the extended configuration, in response to engagement between the first set of abutments and the respective engagement faces; wherein: the plurality of tiers includes a third tier, the third tier includes a second set of abutments circumferentially distributed about the axis and a circumferential wall having a plurality of recesses extending from the first end, and the plurality of recesses include a set of extended recesses interspersed with a set of collapsed recesses; and
the collapsed configuration is established in response inserting the second set of abutments of the adjacent component into the set of collapsed recesses, but the extended configuration is established in response to inserting the second set of abutments of the adjacent component into the set of extended recess; wherein: the second set of abutments are at least partially circumferentially aligned with the set of collapsed recesses, but are circumferentially offset from the set of extended recesses relative to the axis (see Col. 4, lines 22-66 disclosing the circumferential engagement faces that form the lateral boundaries of the recesses (32, 132, 232 ,432) inherently creating cavity cutouts disposed in the end face (18) of the stem which includes a neck (14), which together forms a circumferential boundary, and a plurality of tiers established by the tapered surfaces and the corresponding pins/recess levels; Fig. 12 illustrating the non-round recess (432) used to establish a keyed rotational interface with a corresponding pin (530) that forms a set of abutments, thereby limiting rotation). Burrows et al. teaches when the outer edges of the corresponding pin (530) are received by the recess (432), it creates a collapsed configuration against the modular head (412) relative to the stem (510), and when the pin (530) is not aligned with the recess (432), it engages the planar end face (18) of the stem to create an extended configuration (see Col. 4, lines 62-66 disclosing components establishing the extended and collapsed configurations; Figs. 9 and 10 illustrating the interactions between the components). 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 the multi-tier body with the adjustable length of Early et al., as modified by Fritzinger et al., with engagement faces selectively limiting the rotation in a collapsed or extended state as taught by Burrows et al. Doing so would allow the user to test different assembly heights of the modular implant.
Regarding claim 11, Early et al. in view of Fritzinger et al. and Burrows et al., discloses the system as recited in claim 10, furthermore Burrows et al. also discloses wherein: the set of collapsed recesses have a first contour dimensioned to complement a profile of the second set of abutments, and the set of extended recesses have a second, different contour dimensioned to complement a lesser portion of the profile of the second set of abutments (see Col. 3, lines 60-67; Col. 4, lines 1-6, lines 27-33 disclosing a complementary match and a mismatch between a recess (32) and a pin (130/230) creating a set of abutments, thereby establishing a first and second contour, and engagement of the pin (the distal tip establishing the lesser portion) with the end face (18/118) that limits entry of the pin). Burrows et al. teaches that differential contouring established by the recess (32) and pins (130/230), can prevent engagement with at l least one but not all of the available mating parts (see Col. 6, lines 35-38 disclosing selective assembly logic). 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 the multi-tier body with the adjustable length of Early et al., as modified by Fritzinger et al., with complementary and mismatched contours to control assembly depth as taught by Burrows et al. Doing so would create a system where rotating the implant selects between a deep-seated (complementary contour) and a shallow-seated (mismatched contour) position.
Regarding claim 13, Early et al. in view of Fritzinger et al. and Burrows et al., discloses the system as recited in claim 7, furthermore Burrows et al. also discloses a stem component insertable into bone (see Col. 3, lines 38-41 disclosing the hip stem (10) and its components);
an articulation component adapted to mate with an opposed articular surface of an adjacent implant or an adjacent bone (see Col. 3, lines 38-46 disclosing the articulating components of the hip stem (10)); and
wherein the assembly interconnects the stem component and the articulation component in an installed position (see Col. 3, lines 38-46 disclosing interconnecting components of the male (16) and female (22) conical taper surfaces). Burrows et al. teaches the stem (10) provides a stable male conical taper surface (16) as a standardized modular platform, along with a female conical taper surface (22) that provides depth of placement within the head (12) in order to adjust the length of the neck (14) without changing the stem (10) itself. 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 the interconnecting structure of Early et al., as modified by Fritzinger et al., with a modular femoral head prothesis (12) features a generally convex spherical articulating surface (20) as taught by Burrows et al. Doing so would a means for a patient-customized modular orthopedic assembly that can be mechanically secured in multiple functional positions, while preventing improper component pairings.
Claim(s) 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Early et al. (US 11607314) and further in view of Burrows et al. (US 6048365).
Regarding claim 14, Early et al. in view of Burrows et al., discloses a method of installing an orthopaedic implant system, comprising:
selecting components from a set of components (see Col. 7, lines 18-25 disclosing components of the fixation device (10) that can be chosen to achieve desired dimensions);
wherein each of the components comprises a main body having a stepped geometry established by a plurality of tiers distributed along an axis between a first end and a second end, the plurality of tiers including a first tier having a first tapered periphery and a second tier having a second tapered periphery, the second tapered periphery established by a first set of abutments, and the main body including a cavity having a first cavity level and a second cavity level distributed along the axis, and a set of cavity cutouts extend outwardly from a periphery of the second cavity level (see Col. 5, lines 9-23; Col. 7, lines 8-20; Col. 8, lines 10-19 disclosing an upper (144) and lower (148) portion acting as tiers with conical surfaces serving as the first tapered periphery, the radially extending fixation members (56) establishing abutments that must inherently have dimensioned cutouts to form the second periphery of the second tier level; Figs. 1 and 1A illustrate internal cavity levels with multiple depths or levels distributed along the axis).
Early et al. fails to disclose wherein: each adjacent pair of the components are configurable to establish a collapsed configuration and an extended configuration of a respective portion of an assembly;
wherein the collapsed configuration is established in response inserting the first set of abutments of the adjacent component into the set of cavity cutouts to establish a keyed interface and then engaging a periphery of the first cavity level with the first tapered periphery of the adjacent component to establish a first Morse taper connection, but the extended configuration is established in response to engagement between the periphery of the second cavity level and the first set of abutments of the adjacent component to establish a second Morse taper connection; and
configuring each adjacent pair of the selected components in the collapsed configuration or the extended configuration to establish the respective portion of the assembly.
Burrows et al. also discloses a stem (10) and a head (12) acting as adjacent pairs of modular components, along with pins (30/130) being on one component and a recess (32) on the other; the engagement of the male (16) and female (22) conical taper surfaces with the pins (30/130); and the engagement of the pins (30/130) with the planar end face (18) of the stem neck (14) (see Col. 3, lines 37-59 disclosing the modular components and their engagements). Burrows et al. teaches the stem (10) and head (12) are configurable into a fully seated and a blocked state, which determines the rotational orientation of the components allowing for a collapsed state when the pin is aligned with the recess and an extended state when it is misaligned. 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 provided Early et al.’s multi-tiered body distributed along a longitudinal axis, wherein a keyed methodology is used to toggle between two assembly states. Doing so would provide a means to create a rationally-selectable, multi-positional implant system that ensures mechanical stability at every height.
Regarding claims 15 and 16, Early et al. in view of Burrows et al., discloses the method as recited in claim 14, but fails to disclose wherein: the extended configuration is established such that the second Morse taper connection blocks engagement between the periphery of the first cavity level and the first tapered periphery of the adjacent component; and wherein: the step of establishing the keyed interface occurs such that circumferentially opposed engagement faces bounding the respective cavity cutouts limit relative rotation between the adjacent components with respect to the axis.
Burrows et al. also discloses the pin (30/130) abuts with the planar end face (18) of the neck (14) on the hip stem (10) (see Col. 3, lines 55-67; Col. 4, lines 1-6 disclosing the interaction between these components). Burrows et al. teaches that physical engagement between the pin (30/130) and the end face (18) creates a stable axial support that functions as the second Morse taper connection; and the interaction between the pin (30/130) and a recess (32) acting as a cavity cutout, creates a circumferential engagement that limits rotation). 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 provided the multi-tiered body of Early et al., wherein a pin (30/130) and an end face (18) provides a secondary connection in order to block the primary connection as taught by Burrows et al. Doing so would ensure the implant stays at its extended height and prevent accidental seating.
Regarding claim 17, Early et al. in view of Burrows et al., discloses the method as recited in claim 14, but fails to disclose wherein: the plurality of tiers includes a third tier, the second tier interconnects the first and third tiers, the third tier includes at least one abutment established along a periphery of the main body, and the main body includes at least one extended recess and at least one collapsed recess extending from the first end; and
the collapsed configuration is established in response to inserting the at least one abutment of the adjacent component into the at least one collapsed recess, but the extended configuration is established in response to inserting the at least one abutment of the adjacent component into the at least one extended recess.
Burrows et al. also discloses a hierarchical structure consisting of a stem (10), a neck (14), a modular head (12), a pin (30) and a recess (32) (see Col. 3, lines 37-67 disclosing the components of the implant). Burrows et al. teaches the neck (14) forming tier 1 and the head (12) forming tier 3, interconnects at a tapered surface (16 and 22) to form the second tier; and a recess (32) with sufficient diameter and depth to receive a pin (30/130) without interference, thereby creating a collapsed recess; and a recess (32/232) can be shorter causing a pin (/30130) that is larger, to bottom out, thereby creating an extended recess (see Col. 3, line 67; Col. 4, lines 1-6, lines 22-43 disclosing the physical structure of the recess (32) and its technical application in a collapsed and extended configuration). 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 provided Early et al.’s multi-tiered body distributed along a longitudinal axis with peripheral abutments provided by fixation members (56), wherein different assembly states are modified using different types of recesses as taught by Burrows et al. Doing so would allow the implant to be positioned into a short or long position via rotation.
Regarding claim 18, Early et al. in view of Burrows et al., discloses the method as recited in claim 17, but fails to disclose wherein: the first set of abutments are at least partially circumferentially aligned with a second set of abutments relative to the axis.
Burrows et al. also discloses multiple pins (e.g., 30, 130, 230) arranged at specific angular positions around the central axis of the taper (see Fig. 1 illustrating the arrangement of the pin (30) with the taper). Burrows et al. teaches when the modular head (12) is placed on the stem (10), the pin (30) of the head creates a first set of abutments, and is positioned in the same rotational plane as the features of the stem (10) which creates a second set of abutments to allow entry into the corresponding recesses (232) (see Fig. 5 illustrating in interactions involved in making a first and second set of abutments). 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 provided Early et al.’s modular body with radially extending fixation members (56) that act as abutments defining a specific tier, wherein pins and recesses must be circumferentially aligned to establish a predetermined rotational orientation as taught by Burrows et al. Doing so would provide a means for a multi-axial fixation system that allows a single set of modular components to be locked in different height configurations while maintaining high rotational stability.
Regarding claim 19, Early et al. in view of Burrows et al., discloses the method as recited in claim 14, but fails to disclose wherein:
the selecting step includes selecting at least three of the components from the set of components; and
the configuring step includes configuring an adjacent pair of the selected components in the collapsed configuration but configuring another adjacent pair of the selected components in the extended configuration to establish the respective portions of the assembly.
Burrows et al. also discloses a set of modular components: a stem (10), a neck (14) and an articulating head (12) with multiple taper junctions (stem-to-neck and neck-to-head) (see Col. 3, lines 37-40 disclosing the modular components designed to be stacked along a common axis to form a single prothesis). Burrows et al. teaches the modularity of the components allows for independent control over length and offset; and by configuring the lower junction (stem-to-neck) achieves a collapsed state, and by configuring the upper junction (neck-to-head) achieves an extended state. 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 provided Early et al.’s modular system with multiple extension members to build a tiered assembly, wherein multiple junctions are used to configure the orientation of the implant as taught by Burrows et al. Doing so would provide a means to create a multi-stage modular implant system that allows for stackable adjustment to reach a precise anatomical target without increasing the number of physical parts in the surgical kit.
Regarding claim 20, Early et al. in view of Burrows et al., discloses the method as recited in claim 14, but fails to disclose further comprising:
securing one of the selected components of the assembly to a stem component;
inserting the stem component into bone; and
securing another one of the selected components of the assembly to an articulation component, wherein the articulation component is adapted to mate with an opposed articular surface of an adjacent implant or an adjacent bone.
Burrows et al. also discloses a stem (10) component insertable into bone (see Col. 3, lines 38-46 disclosing the hip stem (10) and its articulating and interconnecting components). Burrows et al. teaches the stem (10) provides a stable male conical taper surface (16) as a standardized modular platform, along with a female conical taper surface (22) that provides depth of placement within the head (12) in order to adjust the length of the neck (14) without changing the stem (10) itself. 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 provided the interconnecting structure of Early et al., wherein a modular femoral head prothesis (12) features a generally convex spherical articulating surface (20) as taught by Burrows et al. Doing so would a means for a patient-customized modular orthopedic assembly that can be mechanically secured in multiple functional positions, while preventing improper component pairings.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights