Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 10 is objected to because of the following informalities: “femoal” should be changed to “femoral”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: “tibila” should be changed to “tibial”. Appropriate correction is required.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: specification should be amended to include the “wherein a part of the femoral element defined by the intermediate portion and the front portion has a progressively narrowing width in a direction toward the front terminal portion” limitation in claim 3.
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.
Claims 1, 4-6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Heldreth et al. (2012/0271428) “Heldreth” in view of Kang (2015/0257889).
Regarding claim 1, Heldreth discloses a femoral element of a spacer device 12 for a knee joint 10 (Figs. 1 and 6) , the femoral element having a substantially C-shaped longitudinal profile (as shown in Fig. 6) and comprising: a front portion; a rear condylar portion 52/54 ; and an intermediate portion connecting the front and the rear portions (the front, middle and rear portions shown in Fig. 6), wherein the rear portion comprises a rear terminal portion having two lobes (condyles 52/54), wherein the lobes of the rear terminal portion are straight and extend upwardly in a direction parallel to a craniocaudal axis, or are curved with a radius of curvature larger than a radius of curvature of a subsequent portion of the femoral element (Fig. 6 and par. 0053 disclose the different radii of curvature at curved surface sections 104, 106 and 108); except for wherein a width of each lobe in a latero-lateral direction increases by less than 30% progressing in a direction opposite to a free end of the lobe.
However, Kang teaches a similar femoral element 10 (Figs. 1 and 14) comprising a width 146 of each lobe (condyles 118/120; par. 0045) in a latero-lateral direction increases by progressing in a direction opposite to a free end of the lobe (the curved portion of the condyles at the tip 140 increases in width towards the midpoint 146; par. 0045). Therefore, 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 femoral component in Heldreth to include a width of each lobe in a latero-lateral direction increases by progressing in a direction opposite to a free end of the lobe, as taught and suggested by Kang, for enhancing flexion of the knee (par. 0049 of Kang).
Furthermore, Heldreth in view of Kang is silent regarding the width increases by less than 30%. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the width increases by less than 30%, since these are result effective variables that contribute to the overall enhancement of knee flexion, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Regarding claim 4, Heldreth discloses wherein the femoral element 12 has a lower surface that is convex (articulating surface; Fig. 6) and an upper surface that is concave (femoral bone contacting surface having the post; Fig. 6), the upper surface having a middle segment that is planar (the planar section having the post; Fig. 6).
Regarding claims 5-6, Heldreth is silent regarding wherein the upper surface comprises a plurality of segments , the plurality of segments comprising an end front segment defining an angle of 90°-110° in relation to the planar middle segment, a successive second segment defining an angle of 130°-140° in relation to the planar middle segment, the planar middle segment, and a rear end segment defining an angle of 90°-110° in relation to the planar middle segment; wherein an end front segment of the upper surface is straight. However, Kang teaches a similar femoral component 10 comprising an upper surface (surface of the anterior-posterior box; par. 0041; Figs. 1-2) comprises a plurality of segments (the four straight segments forming the spacing in between planar surfaces 164, 166, 168, 140 and 170; Figs. 1-2 and par. 0041) and wherein an end front segment of the upper surface is straight (the segment between planar surfaces 164 and 166 is straight (Fig. 2). Therefore, 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 femoral component in Heldreth to include the upper surface comprises a plurality of segments; wherein an end front segment of the upper surface is straight, as taught and suggested by Kang, for better engagement at the bone contacting interface whilst allowing for enhanced knee flexion.
Furthermore, Kang is silent regarding the plurality of segments comprising an end front segment defining an angle of 90°-110° in relation to the planar middle segment, a successive second segment defining an angle of 130°-140° in relation to the planar middle segment, the planar middle segment, and a rear end segment defining an angle of 90°-110° in relation to the planar middle segment. However, Kang does disclose the segments are placed at angled with respect to each other along the surface of the anterior-posterior box (Figs. 1-2).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the plurality of segments comprising an end front segment defining an angle of 90°-110° in relation to the planar middle segment, a successive second segment defining an angle of 130°-140° in relation to the planar middle segment, the planar middle segment, and a rear end segment defining an angle of 90°-110° in relation to the planar middle segment, since these are result effective variables that contribute to the engagement of the femoral component to the bone, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Regarding claim 12, Heldreth discloses wherein the femoral element 12 cooperates with a tibial element 30, the tibial element having an upper surface configured to articulate with or engage the lower surface of the femoral element (Fig. 3).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Heldreth et al. (2012/0271428) “Heldreth” in view of Kang (2015/0257889) further in view of Steines et al. (2022/0273450) “Steines”.
Regarding claim 2, Heldreth in view of Kang discloses the claimed invention of claim 1; except for wherein the width of each lobe in the latero-lateral direction progressing in the direction opposite to a free end of the lobe remains constant. However, Steines teaches a similar femoral component 2400 (Fig. 24) comprising the width of each lobe in the latero-lateral direction progressing in the direction opposite to a free end of the lobe remains constant (par. 0465 and Fig. 24 disclose straight cut posterior condyles 2430). Therefore, 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 femoral component in Heldreth in view of Kang to include the width of each lobe in the latero-lateral direction progressing in the direction opposite to a free end of the lobe remains constant, as taught and suggested by Steines, for positively matching an articular bone surface (par. 0465 of Steines).
Claims 3 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Heldreth et al. (2012/0271428) “Heldreth” in view of Kang (2015/0257889) further in view of Servidio et al. (2019/0358044) “Servidio”.
Regarding claim 3, Heldreth in view of Kang discloses the claimed invention of claim 1; except for wherein the front portion comprises a front terminal portion, and wherein a part of the femoral element defined by the intermediate portion and the front portion has a progressively narrowing width in a direction toward the front terminal portion. However, Servidio teaches a similar femoral component 20 (Fig. 3A) comprising a part of the femoral element defined by the intermediate portion and the front portion has a progressively narrowing width in a direction toward the front terminal portion 21 (Fig. 3A discloses the width of front portion progressively narrows from where the intermediate portion 22 meets front portion 21). Therefore, 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 femoral component in Heldreth in view of Kang to include wherein the front portion comprises a front terminal portion, and wherein a part of the femoral element defined by the intermediate portion and the front portion has a progressively narrowing width in a direction toward the front terminal portion, as taught and suggested by Servidio, for better engagement at the bone contacting interface whilst allowing for enhanced knee flexion.
Regarding claims 7-11, Heldreth in view of Kang discloses the claimed invention of claim 1; except for a plurality of recesses defined in the upper surface, at least some of the upper recesses having a L-shaped configuration with ends open to an outer environment; wherein the ends of the L-shaped configuration comprise a first end open in the front or rear portion of the femoral element and a second open end open on a side of the femoral element; wherein the plurality of recesses store a filling material containing a pharmaceutical or medical substance releasable from the filling material; wherein the femoral element and the filling material are porous, with pores of a size sufficient to prevent bone regrowth inside the pores. However, Servidio teaches a similar femoral component 20 (Fig. 3D) comprising a plurality of recesses defined in the upper surface (porous patches 12 are formed as recesses within surrounding solid structure 14 to receive bone cement; Fig. 3D and par. 0037), at least some of the upper recesses having a L-shaped configuration with ends open to an outer environment (Fig. 3D discloses patch surface 32 having an L shape and being open to the environment to contact the bone); wherein the ends of the L-shaped configuration comprise a first end open in the front or rear portion of the femoral element and a second open end open on a side of the femoral element (L shaped patch surface 32 has a portion that extends to the rear and a portion that extends to the center 30; Fig. 3D); wherein the plurality of recesses store a filling material containing a pharmaceutical or medical substance releasable from the filling material (par. 0037 discloses the recessed patches 12 include bone cement); wherein the femoral element and the filling material are porous, with pores of a size sufficient to prevent bone regrowth inside the pores (par. 0037 discloses the porous patches allow for bone ingrowth).
Therefore, 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 femoral component in Heldreth in view of Kang to include a plurality of recesses defined in the upper surface, at least some of the upper recesses having a L-shaped configuration with ends open to an outer environment; wherein the ends of the L-shaped configuration comprise a first end open in the front or rear portion of the femoral element and a second open end open on a side of the femoral element; wherein the plurality of recesses store a filling material containing a pharmaceutical or medical substance releasable from the filling material; wherein the femoral element and the filling material are porous, with pores of a size sufficient to prevent bone regrowth inside the pores, as taught and suggested by Servidio, for better engagement at the bone contacting interface via bone ingrowth (par. 0037 of Servidio).
Furthermore, Heldreth in view of Kang and Servidio is silent regarding wherein the pores have a dimension of less than 100 microns. However, Servidio does disclose porous patches 12 which obviously have a certain dimension (par. 0037).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the pores have a dimension of less than 100 microns, since these are result effective variables that contribute to the amount of bone ingrowth, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05.
Furthermore, since applicants have not disclosed that these modifications solve any stated problem or are for any particular purpose and it appears that the device would perform equally well with either designs, these modifications are a matter of design choice. Absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. MPEP 2144.05.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Heldreth et al. (2012/0271428) “Heldreth” in view of Kang (2015/0257889) further in view of Angibaud et al. (2021/0386466) “Angibaud”.
Heldreth in view of Kang discloses the claimed invention of claims 1 and 12; except for wherein the upper surface of the tibial element is asymmetric by having a concave portion and a planar portion that are positioned asymmetrically in relation to an axis of symmetry of the upper surface of the tibial element. However, Angibaud teaches a similar tibial element 600 (Fig. 6) comprising an upper surface of the tibial element is asymmetric by having a concave portion and a planar portion that are positioned asymmetrically in relation to an axis of symmetry of the upper surface of the tibial element (par. 0055 discloses a fourth embodiment where the medial side is concave and the lateral side is flat). Therefore, 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 femoral component in Heldreth in view of Kang to include the upper surface of the tibial element is asymmetric by having a concave portion and a planar portion that are positioned asymmetrically in relation to an axis of symmetry of the upper surface of the tibial element, as taught and suggested by Angibaud, for allowing better medial and lateral contact points between the femoral and tibial components (par.0055 of Angibaud).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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