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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/392,693, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application does not have figures 7 and 8 of the instant application. Accordingly, because claims 8 and 17-20 are directed to the embodiment of fig. 7, claims 8 and 17-20 have an effective filing date of the instant application, 7/27/2023. Claims 1-7 and 9-16 are supported by the provisional application and have an effective filing date of 7/27/2022.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8, 14-16, and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation "the first plane" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitations "the acetabular component" in lines 1-2, “the outer surface” in lines 3-4, “the head” in line 4, and “the femoral component” in line 4. There is insufficient antecedent basis for each of these limitations in the claim.
Claim 15 recites the limitations "the acetabular component" in lines 1-2, “the outer surface” in lines 3-4, “the head” in line 4, and “the femoral component” in line 4. There is insufficient antecedent basis for each of these limitations in the claim.
Claim 16 recites the limitations "the acetabular component" in lines 1-2, “the outer surface” in lines 3-4, “the head” in line 4, and “the femoral component” in line 4. There is insufficient antecedent basis for each of these limitations in the claim.
Claim 19 recites the limitation "the first plane" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claims 1, 2, 9-11, and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marlow US 5,989,294 (hereafter referred to as Marlow).
Regarding claim 1, Marlow discloses a dual mobility hip resurfacing implant (fig.1), comprising: an acetabular component 10, 11 having a first outer surface (outer convex surface of 10) and a first inner surface (inner concave surface of 11) defining a first cavity (fig.1); a liner 13 comprising: a second outer surface including a first convex surface portion 22 (figs.7-9), the second outer surface of the liner being configured to be received within the first cavity and articulable therein (figs.2-4); and a second inner surface including a first concave surface portion 23, the second inner surface defining a second cavity (figs. 1-4 and 7-9); and a femoral head component 15 comprising: a third outer surface including a second convex surface portion (considered the convex surface) configured to be received within the second cavity and articulable therein (figs. 2-6); and a third inner surface 16 including a second concave surface portion (fig.1), the third inner surface configured to be received on a femoral head of a femur bone (the third inner surface is capable of being received on a femoral head of a femur bone that has been shaped to receive the third inner surface; see US 2012/0221115 figs.43-44 for an example of such a use), wherein the first convex surface portion includes interruptions 24 such that when the first convex surface portion is interrupted, the first convex surface portion includes a first plurality of interruptions at a first plurality of locations on the second outer surface (figs. 7-9).
Regarding claim 2, see figs. 8 and 9 for a plurality of openings 24 extending completely through the liner 13.
Regarding claim 9, Marlow discloses a dual mobility hip implant system (fig.1) comprising an acetabular shell 10, 11 having a first outer surface (outer convex surface of 10) and a first inner surface (inner concave surface of 11) defining a first cavity (fig.1); and a liner 13 having a second outer surface 22, a second inner surface 23 defining a second cavity (figs. 1 and 7-9), and a plurality of openings 24 extending through the liner from the second outer surface to the second inner surface (figs.7-9), the second outer surface being configured to be received within the first cavity and being articulable relative to the inner surface of the acetabular component when disposed therein (figs. 2-6), wherein the liner is configured to be received on a femoral head implant 15 (claim 9 does not positively recite a femoral head implant but Marlow does disclose a femoral head implant).
Regarding claims 10 and 11, see the openings 24 in figs 1-9.
Regarding claim 13, see figs. 1-6 for femoral head implant 15 capable of articulation as claimed.
Regarding claims 14-16, fig.2 shows a difference in radius of curvature between the outer surface of the liner 13 and the inner surface of the shell 11. Claims 14-16 do not positively recite a femoral head implant/femoral component. Therefore, the implant system including the shell and liner of Marlow are capable of being used with a femoral head implant/femoral component wherein the difference in radius curvature between an outer surface of a head of a femoral component and an inner surface of the liner is greater than, less than, or equal to the difference in radius of curvature between the outer surface of the liner 13 and the inner surface of the shell 11 as shown in fig.2. In other words, a head size can be chosen to meet the claims.
Claims 9, 10, and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Woehler DE 4442424 (hereafter referred to as Woehler; refer to the attached translation for passages referenced herein).
Regarding claim 9, Woehler discloses a dual mobility hip implant system comprising: an acetabular shell 11 having a first outer surface and a first inner surface defining a first cavity (fig.1); and a liner 10 having a second outer surface, a second inner surface defining a second cavity, and a plurality of openings extending through the liner from the second outer surface to the second inner surface (fig.1 and pg. 3, par.8 discloses spaces between the windings of the liner for lubrication), the second outer surface being configured to be received within the first cavity and being articulable relative to the inner surface of the acetabular component when disposed therein (fig.1; pg.2, par.7 discloses the liner is a “double-sided sliding surface”), wherein the liner is configured to be received on a femoral head implant 12 (fig.1).
Regarding claim 10, see the upper right quadrant in fig.1 for equidistant openings.
Regarding claim 13, see fig.1 for femoral head implant 12.
Regarding claims 14-16, fig.1 shows a difference in radius of curvature between the outer surface of the liner 10 and the inner surface of the shell 11. Claims 14-16 do not positively recite a femoral head implant/femoral component. Therefore, the implant system including the shell and liner of Woehler are capable of being used with a femoral head implant/femoral component wherein the difference in radius of curvature between an outer surface of a head of a femoral component and the inner surface of the liner is greater than, less than, or equal to the difference in radius of curvature between the outer surface of the liner 10 and the inner surface of the shell 11 as shown in fig.1. In other words, a head size can be chosen to meet the claims.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muratoglu et al. US 2014/0128988 (hereafter referred to as Muratoglu; cited in IDS).
Regarding claim 1, Muratoglu discloses a dual mobility hip resurfacing implant, comprising: an acetabular component 378 having a first outer surface and a first inner surface 380 defining a first cavity (fig.48), a liner 346, 374 comprising: a second outer surface including a first convex surface portion (figs.44, 47), the second outer surface of the liner being configured to be received within the first cavity and articulable therein (par.251); and a second inner surface including a first concave surface portion 348, the second inner surface defining a second cavity (figs.44, 47); and a femoral head component 330, 332, 342 comprising: a third outer surface including a second convex surface portion configured to be received within the second cavity and articulable therein (figs.42A-B, 43; par.251); and a third inner surface including a second concave surface portion (see the concave inner surface of the heads in figs. 42A-B and 43), the third inner surface capable of being received on a femoral head of a femur bone, wherein at least one of the first convex surface portion and the second convex surface portion include interruptions such that when the first convex surface portion is interrupted, the first convex surface portion includes a first plurality of interruptions at a first plurality of locations on the second outer surface, and when the second convex surface portion is interrupted, the second convex surface portion includes a second plurality of interruptions at a second plurality of locations on the third outer surface (figs. 41A-48 discloses interruptions on each of the articulating surfaces; pars. 251-252 disclose contoured/textured surfaces to reduce contact area).
Regarding claim 3, see fig. 43 and 49A-E for grooves on the outer surface of the head.
Regarding claim 5, see at least figs. 43-44 for both the liner and head having interruptions.
Claims 17, 18, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Oak US 2024/0225846 (hereafter referred to as Oak; note that these claims have an effective filing date of 7/23/2023 which is after the provisional filing date of Oak).
Regarding claim 17, Oak discloses a dual mobility implant system 400, comprising: A liner 410 comprising: a convex outer surface configured to be received within an acetabular shell 418 (fig.4D); and a concave inner surface defining a first cavity, the concave inner surface including a first circumferential ledge 412 (figs.4B and 4D); and a femoral implant including a head 404 configured to be received within the first cavity (fig.4D), the head having a second circumferential ledge 408 (fig.4b shows the protrusion 408 has a circumference and fig.4D shows the protrusion forms a ledge), wherein the second circumferential ledge is in operative communication with the first circumferential ledge such that an extent of rotation of the femoral implant relative to the liner when the femoral implant is disposed in the liner is limited by the first circumferential ledge (figs. 4D-4F).
Regarding claim 18, the first circumferential ledge 412 is positioned in the middle of the liner and therefore between first and second planes as claimed.
Regarding claim 20, a width of the ledge 412 is about 50% of the maximum thickness of the liner which occurs at the combination of 410 and 414.
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 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Muratoglu as applied to claim 1 above, and further in view of Ebbitt US 2009/0192620 (hereafter referred to as Ebbitt). Muratoglu discloses the implant of claim 1 as discussed above but Muratoglu does not disclose that the femoral head further comprises a stem extending from the inner surface, the stem being configured to be received within an opening of the femoral head of the femoral bone, and does not disclose wherein the second outer surface and the second inner surface are separated by a liner end surface and the femoral head component further comprises an extension extending to an open end of the femoral head component such that the extension is remote from an apex of the femoral head component relative to other parts of the femoral head component, the extension having a blocking surface configured to prevent over rotation of the liner end surface by limiting an extent of rotation of the liner end surface.
Ebbitt teaches a hip implant, in the same field of endeavor, wherein a femoral head 5 comprises a stem 55 extending from an inner surface 60, the stem being configured to be received within an opening of the femoral head of the femoral bone (fig.7C) for the purpose of providing a femoral head implant for hip resurfacing which is less invasive and preserves more bone than conventional hip arthroplasty (par.8). Ebbitt further teaches a cup component 28 comprises an outer surface and an inner surface that are separated by an end surface 28e and the femoral head component further comprises an extension 70 extending to an open end of the femoral head component such that the extension is remote from an apex of the femoral head component relative to other parts of the femoral head component, the extension having a blocking surface configured to prevent over rotation of the end surface by limiting an extent of rotation of the liner end surface (fig.7C; par.61) for the purpose of reducing the potential for lever arm dislocation (par.61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the femoral implant of Ebbitt comprising a stem extending from the inner surface of the femoral head component for the femoral head component of Muratoglu in order to resurface the femoral head which is less invasive and preserves more bone than conventional hip arthroplasty. It would have been further obvious to modify Muratoglu and include the femoral head extension taught by Ebbitt for contacting the liner end in order to reduce the potential for lever arm dislocation.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Oak in view of Ebbitt (claim 8 has an effective filing date of 7/27/2023). Oak discloses a dual mobility hip resurfacing implant 400, comprising: an acetabular component 418 having a first outer surface and a first inner surface defining a first cavity (fig. 4D); a liner 410 comprising: a second outer surface including a first convex surface portion, the second outer surface of the liner being configured to be received within the first cavity and articulable therein (figs. 4D-4F); and a second inner surface including a first concave surface portion, the second inner surface defining a second cavity (figs. 4D-4F); and a femoral head component 404 comprising: a third outer surface including a second convex surface portion configured to be received within the second cavity and articulable therein (figs. 4D-4F), wherein the second inner surface of the liner includes a first circumferential ledge 412 complementary to a second circumferential ledge 408 on the third outer surface of the femoral head component, the first and second circumferential ledges being positioned between a plane through a center of rotation of the implant that is parallel to an end surface of the liner and a second plane parallel to the first plane and through an apex of the liner (fig.4D shows the ledge 412 located between the end of the liner and the apex of the liner). Oak discloses the invention substantially as claimed but does not disclose that the femoral head component comprises a third inner surface including a second concave surface portion, the third inner surface configured to be received on a femoral head of a femur bone or wherein at least one of the first convex surface portion and the second convex surface portion include interruptions such that when the first convex surface portion is interrupted, the first convex surface portion includes a first plurality of interruptions at a first plurality of locations on the second outer surface, and when the second convex surface portion is interrupted, the second convex surface portion includes a second plurality of interruptions at a second plurality of locations on the third outer surface.
Ebbitt teaches a hip implant, in the same field of endeavor, wherein femoral head component 5 comprises an inner surface 60 including a concave surface portion, the inner surface configured to be received on a femoral head of a femur bone (fig.7C) for the purpose of providing a femoral head implant for hip resurfacing which is less invasive and preserves more bone than conventional hip arthroplasty (par.8). Ebbitt further teaches interruptions 85 at a plurality of locations on the convex surface portion of the femoral head component (fig.8) for the purpose of collecting and distributing synovial fluid (par.55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the femoral implant of Ebbitt comprising a third inner surface including a second concave surface portion, the third inner surface configured to be received on a femoral head of a femur bone for the femoral head component of Oak in order to resurface the femoral head which is less invasive and preserves more bone than conventional hip arthroplasty. It would have been further obvious to modify Oak and include the femoral head interruptions taught by Ebbitt in order to collect and distribution synovial fluid.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Woehler as applied to claim 9 above, and further in view of Hanes US 2004/0193282 (hereafter referred to as Hanes; cited in IDS). Woehler discloses the dual mobility hip implant system of claim 9 and Woehler further discloses the liner is polyethylene (Woehler pg.4, par.1). However, Woehler does not specifically disclose that the polyethylene is cross-linked UHMWPE.
Hanes teaches dual mobility a hip implant system, in the same field of endeavor, wherein a liner 14 is made from cross-linked UHMWPE. Hanes teaches cross-linked UHMWPE is a suitable material well-known in the art for liners (par.33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select cross-linked UHMWPE as taught by Hanes for the polyethylene liner of Woehler since Hanes specifically teaches this is a well-known liner material and it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Oak. Oak discloses the system of claim 17 as discussed above. The first circumferential ledge 412 of Oak appears to be located at about a 20 degree angle from a plane parallel to the end surface of the liner based on figs. 4B-4C but Oak does not disclose that the first circumferential ledge is specifically at a 5 to 20 degree angle relative to a first plane. However, the optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal position of the ledge of Oak needed to achieve the desired range of motion. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the angle of the ledge, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the teachings of Oak. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality (In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426).
Allowable Subject Matter
Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: While grooves in articulating surfaces are generally known in the art as evidenced by Muratoglu and Ebbitt, the prior art does not disclose, teach, or suggest a hip implant comprising a femoral head component comprising a plurality of grooves including a plurality of angled ridges distributed along a least a portion of a length of the groove, each of the plurality of angled ridges extending transverse to a longitudinal direction of the groove.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Vio US 2010/0049329 discloses a dual mobility hip implant (par.48) comprising an acetabular component, a liner, and a femoral head, wherein the liner has interruptions (fig.1). Tornier et al. US 2009/0112328 discloses a dual mobility hip implant comprising an acetabular component, a liner with a ledge, and a femoral head limited by the ledge.
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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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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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