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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/28/2025 has been entered. It is further noted that the Advisory Action mailed 11/20/2025 in response to an inadvertent Notice of Improper Request for RCE is withdrawn. Claims 12 and 14-30 are currently pending in this application.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
With regard to applicant’s argument on page 6 that Smith does not disclose or suggest an acetabular support having a distal surface specifically shaped with respect to the morphology of the acetabular cavity of the coxal bone, the examiner disagrees. Paragraph 0027, lines 12-16, discloses that the cup portion of the implant may also be customized using the deforming fixture, wherein certain areas of the cup portion may be shaped or deformed.
With regard to applicant’s argument on page 7 that Smith does not disclose a joint portion with a concave surface having a different geometry from the acetabular support of the fastening portion, the examiner disagrees. The geometry of the customized cup portion/acetabular support as disclosed by Smith in lines 12-16 of paragraph 0027 is different from the concave surface (16) of the liner (52) which accepts the head (56) of the femur (50), as disclosed in paragraph 0042. The examiner suggests amending the claim to specify which surface of the acetabular support has the different geometry and to structurally define how it differs.
In response to applicant's argument on page 8 that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., dual-cavity structure) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
Claim(s) 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2013/0199259 A1 to Smith (Smith).
Smith meets the limitations of a coxal anchor component for a joint hip prosthesis of a patient having compromised anatomy (paragraph 0023 discloses making a custom shaped acetabular prosthesis by using data for the specific patient, including the patient’s pelvic anatomy and any damaged areas or areas that may need restructuring), said coxal anchor component comprising: a fastening portion configured for contact with a coxal bone and comprising a porous trabecular three-dimensional structure for promoting primary fixation and integration with the coxal bone (paragraph 0031 discloses the acetabular cup 12 including a substantially convex outer surface 18 that may be roughened with a porous surface layer or may be coated with a layer of porous plasma spray or other known material that serves to increase or support bone ingrowth, thereby promoting primary fixation and integration with the coxal bone; the layer of Smith is construed to be trabecular since it relates to trabeculae in that it is a supporting structure that forms a meshwork for interaction with bone and is therefore construed to be a porous trabecular three-dimensional structure), said fastening portion comprising: an acetabular support (cup; 12) configured for contact with an acetabular cavity (fig. 6), said acetabular support comprising a customized portion specifically shaped with respect to the morphology of the acetabular cavity of said coxal bone (paragraph 0027 discloses the cup portion being customized using a deforming fixture, wherein certain areas of the cup portion may be shaped or deformed such that the final shaped acetabular prosthesis will be able to substantially match the patient’s pelvic anatomy relative to the patient’s acetabulum), one or more additional components (flange members 32, 34, 36, and/or 35) being customized and shaped corresponding to said coxal bone (paragraphs 0036, 0038, and 0039 discloses that each of the flanges has a curvature profile that may be modified to meet any anatomical requirements based on the tomography data from the patient), said one or more additional components (flange members) being configured for respective fixation to one or more anatomical sites that delimit the acetabular cavity (paragraph 0034 discloses that the flange members/additional components attach the prosthesis to various surfaces/anatomical sites of the acetabular cavity); a joint portion opposite said fastening portion and having a concave surface configured for receiving and coupling with a conjugate femoral component of said joint hip prosthesis (paragraph 0031 discloses a concave inner surface 16 of the cup 12, which may be fitted with a liner 52 that accepts the head 56 of the femur 50, as disclosed in paragraph 0042); wherein the concave surface of the joint portion has a different geometry from the acetabular support of the fastening portion (the geometry of the customized cup portion/acetabular support as disclosed in lines 12-16 of paragraph 0027 is different from the concave surface 16 of the liner 52 which accepts the head 56 of the femur 50, as disclosed in paragraph 0042).
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.
Claim(s) 12, 14-18, 20, and 23-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of US Patent Application Publication No. 2017/0143495 A1 to Dunn et al. (Dunn).
Regarding at least claim 12
Smith teaches a method of making a custom acetabular implant for a patient that includes acquiring and analyzing tomography data of the patient and obtaining geometry and measurement parameters of the patient’s pelvic anatomy (abstract). Further, Smith teaches that the method includes shaping a blank acetabular prosthesis using a custom deforming fixture such that the shaped acetabular prosthesis has a final shaped geometry and measurement parameters to substantially match the patient’s pelvic anatomy relative to the patient’s acetabulum (abstract).
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Smith meets the limitations of a coxal anchor component for a joint hip prosthesis of a patient having compromised anatomy (paragraph 0023 discloses making a custom shaped acetabular prosthesis by using data for the specific patient, including the patient’s pelvic anatomy and any damaged areas or areas that may need restructuring), said coxal anchor component comprising: a fastening portion configured for contact with a coxal bone and comprising a porous trabecular three-dimensional structure for contact with the coxal bone, for promoting primary fixation and integration with the coxal bone (paragraph 0031 discloses the acetabular cup 12 including a substantially convex outer surface 18 that may be roughened with a porous surface layer or may be coated with a layer of porous plasma spray or other known material that serves to increase or support bone ingrowth; the layer of Smith is construed to be trabecular since it relates to trabeculae in that it is a supporting structure that forms a meshwork for interaction with bone and is therefore construed to be a porous trabecular three-dimensional structure), said fastening portion comprising: an acetabular support (cup; 12) comprising a distal surface (convex outer surface; 18) having the porous trabecular three-dimensional structure and configured for contact with an acetabular cavity, said acetabular support comprising a customized portion specifically shaped with respect to the morphology of the acetabular cavity of said coxal bone (paragraph 0027 discloses the cup portion being customized using a deforming fixture, wherein certain areas of the cup portion may be shaped or deformed such that the final shaped acetabular prosthesis will be able to substantially match the patient’s pelvic anatomy relative to the patient’s acetabulum), one or more additional components (flange members 32, 34, 36, and/or 35) being customized and shaped corresponding to said coxal bone (paragraphs 0036, 0038, and 0039 disclose that each of the flanges has a curvature profile that may be modified to meet any anatomical requirements based on the tomography data from the patient), said one or more additional components (flange members) being configured for respective fixation to one or more anatomical sites that delimit the acetabular cavity (paragraph 0034 discloses that the flange members/additional components attach the prosthesis to various surfaces/anatomical sites of the acetabular cavity), wherein said one or more additional components are projections of said distal surface (it can be seen from fig. 2B, for example, that the flanges/projections extend away from the distal surface of the support/cup), wherein said one or more additional components are configured to occupy one or more bone gaps extending within a pubis and/or ileum and/or ischium of said coxal bone (paragraph 0034 discloses that the flange members/additional components attach the prosthesis to various surfaces of the ilium, pubis, and/or the ischium bone structures and paragraph 0023 discloses that the prosthesis is created based on patient specific data including the location of gaps); a joint portion opposite said fastening portion and having a concave surface configured for receiving and coupling with a conjugate femoral component of said joint hip prosthesis (paragraph 0031 discloses a concave inner surface 16 of the cup 12, which may be fitted with a liner 52 that accepts the head 56 of the femur 50, as disclosed in paragraph 0042), wherein the concave surface of the joint portion has a different geometry from the acetabular support of the fastening portion (the geometry of the customized cup portion/acetabular support as disclosed in lines 12-16 of paragraph 0027 is different from the concave surface 16 of the liner 52 which accepts the head 56 of the femur 50, as disclosed in paragraph 0042).
However, Smith does not explicitly teach that the porous trabecular three-dimensional structure consists of a plurality of interconnected thin struts or rods with a hollow space therebetween to define a trabecular portion, wherein said trabecular portion is porous and configured for ingrowth of bone and soft tissue within said hollow space.
Dunn teaches a similar tri-flange acetabular implant that includes a three dimensional scaffold formed on the bone apposition surfaces of the cup portion (abstract).
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More specifically, Dunn teaches a cup portion (110) and three flanges extending from the rim of the cup that are designed to enable fixation of the implant to the surrounding patient bone and are typically classified as the ilium flange (120), ischium flange (130), and pubic ramus flange (140) (paragraph 0187). The three dimensional scaffold forms a continuous surface over the underside of the cup and flanges, for the purpose of allowing for maximum osseointegration of bone with the implant surface (paragraph 1089 and fig. 1). The scaffold further includes a range of different shaped scaffold members that are connected to form a structure sound lattice formed from “unit cells”, each unit cell being a void (hollow space) defined by scaffold members on all sides (paragraph 0195). The unit cells of Dunn may also have an irregular three dimensional shape wherein the cells are formed by an arrangement of plate and rod like structures that create a lattice similar to that found in trabecular bone tissue within human bone (paragraph 0195).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porous trabecular three-dimensional structure of Smith, which is intended to facilitate bone tissue in-growth, such that it consists of a plurality of interconnected thin struts or rods with a hollow space in therebetween to define a trabecular portion, wherein said trabecular portion is porous and configured for ingrowth of bone and soft tissue within said hollow space, in order to allow for maximum osseointegration of bone with the implant surface, as taught by Dunn.
Regarding at least claim 14
Smith in view of Dunn teaches the coxal anchor component of claim 12. Smith also teaches wherein said one or more additional components are made integral with the acetabular support (paragraph 0034 discloses that the flange members are integrally formed with the cup/support 12).
Regarding at least claim 15
Smith in view of Dunn teaches the coxal anchor component of claim 12. Smith also teaches wherein said one or more additional components are modular and fixed to the acetabular support by cement or fasteners (paragraph 0026 discloses that the flange members may instead be separate elements that are joined together by known means, such as by welding).
Regarding at least claim 16
Smith in view of Dunn teaches the coxal anchor component of claim 12. Smith also teaches wherein said one or more additional components comprise at least one iliac support shaped as a stem and configured for insertion in an ileum of said coxal bone (paragraph 0038 discloses that flange member 34 is secured via fastening members/iliac support such as a surgical screw/stem to at least a portion of a surface of the ilium).
Regarding at least claim 17
Smith in view of Dunn teaches the coxal anchor component of claim 16. Smith also teaches wherein said at least one iliac support is modular (the iliac support screw/stem is modular since it is disclosed as being able to pass through the bore 42 of the flange, as disclosed in paragraph 0038; it is noted that the term modular is interpreted in accordance with applicant’s specification which states, “the stem may be monolithic or modular” and since the term “module” is defined as: one of a set of separate parts that, when combined, form a complete whole).
Regarding at least claim 18
Smith in view of Dunn teaches the coxal anchor component of claim 16. Smith also teaches wherein said at least one iliac support is made integral with the acetabular support (paragraph 0038 discloses that the flange member 34 has a first portion 34A originating from and contiguous with the inner surface of the acetabular cup and a second portion 34B extending out from the first portion 34A, as well as fastening members that pass through bores 42 of the flange member 34 in order to allow the member to be secured to at least a portion of a surface of the ilium; the fastening member/support is construed as being made integral with the support/cup in use since it forms an essential part of the support/cup that is needed to make the prosthesis complete).
Regarding at least claim 20
Smith in view of Dunn teaches the coxal anchor component of claim 16. Smith also teaches wherein said at least one iliac support comprises at least one portion of said porous trabecular three-dimensional structure (paragraph 0042 discloses a porous material fastener/support that can be used to promote bone growth).
Regarding at least claim 23
Smith in view of Dunn teaches the coxal anchor component of claim 16. Smith also teaches wherein said one or more additional components further comprise at least one ischial support (32) adapted to abut at an ischium of said coxal bone (paragraph 0037 discloses flange member 32 being secured to the ischium).
Regarding at least claim 24
Smith in view of Dunn teaches the coxal anchor component of claim 23. Smith also teaches wherein said one or more additional components further comprises at least one pubic support (36) adapted to abut at a pubis of said coxal bone (paragraph 0034 discloses that the flange member 36 may be used for attachment to various surfaces of the pubis).
Regarding at least claim 25
Smith in view of Dunn teaches the coxal anchor component of claim 12. Smith also teaches wherein said one or more additional components comprise at least one stem configured for insertion in bone elements of said coxal bone (at least one of the bone screws used to screw the flange members meet the limitation of an additional component comprising at least one stem that is inserted into the bone elements of the coxal bone as claimed).
Regarding at least claim 26
Smith in view of Dunn teaches the coxal anchor component of claim 12. Smith also teaches wherein said fastening portion further comprises at least one suture hole (any of the throughbores 26 are holes that may be used for suturing).
Regarding at least claim 27
Smith in view of Dunn teaches the coxal anchor component of claim 12. Smith also teaches wherein said acetabular support and said one or more additional components are customized considering at least one of two variables including: component morphology and bone processing (paragraph 0027 discloses deforming the flange and/or the cup portion to achieve and match the desired patient-specific configuration; the flange and cup components are morphed into a desired configuration and therefore meet the limitation of customization considering component morphology at least to the same extent as applicant’s).
Regarding at least claim 28
Smith in view of Dunn teaches the coxal anchor component of claim 12. Smith also teaches wherein said one or more additional components further comprise at least one ischial support adapted to abut at an ischium of said coxal bone (flange member 32 is an ischial support since it is secured to the ischium as disclosed in paragraph 0037).
Regarding at least claim 29
Smith in view of Dunn teaches the coxal anchor component of claim 12. Smith also teaches wherein said one or more additional components further comprises at least one pubic support adapted to abut at a pubis of said coxal bone (flange member 36 is a pubic support since it is secured to the pubis as disclosed in paragraph 0034).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Dunn, as applied to claim 16 above, and further in view of US Patent Application Publication No. 2011/0313472 A1 to Yap et al. (Yap).
Smith in view of Dunn teaches the coxal anchor component of claim 16. Smith also teaches at least one iliac support (fastening member/surgical screw for the ilium flange member 34). However, Smith does not teach wherein said at least one iliac support comprises longitudinal fins.
Yap teaches an orthopedic screw system for bone fixation that includes anti-backout features which prevent unintentional withdrawal of the screw (paragraph 0010). In one embodiment, Yap teaches a screw (100) combined with an auxiliary fixation feature (130) that includes a rod (132) and fins (134) that are longitudinally aligned with the rod when in an insertion configuration and deployed to a rotated position, for the purpose of providing resistance to screw removal (Fig. 15-16; paragraphs 0056 and 0061).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coxal anchor component of Smith in view of Dunn, which includes at least one iliac support formed as a fastening member/surgical screw that is intended to secure the prosthesis to the bone, to include longitudinal fins, in order to provide resistance to screw removal from the bone, as taught by Yap. It is also noted that there is a lack of any disclosed criticality of the claimed limitation (page 14 of applicant’s specification states that the stem may have or not longitudinal fins).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Dunn, as applied to claim 16 above, and further in view of US patent Application Publication No. 2008/0183220 A1 to Glazer et al. (Glazer).
Smith in view of Dunn teaches the coxal anchor component of claim 16. Smith also teaches at least one iliac support (fastening member/surgical screw for the ilium flange member 34), as well as the use of porous material to promote bone growth (paragraph 0042). However, Smith does not teach wherein said at least one iliac support (fastening member/surgical screw for the ilium flange member 34) is coated with hydroxyapatite for fixing to said coxal bone.
Glazer teaches a system for increasing the anchoring strength of bone screws in defective bone tissue or compromised bores (paragraph 0008). The system of Glazer includes an insert that is used to increase anchoring strength of orthopedic screws in a variety of different applications, including acetabular cups (paragraph 0015). The insert is made from biocompatible materials and possibly includes a coating to reduce or prevent turning of an orthopedic screw once in place within the insert, or on outer peripheral surface, for the purpose of facilitating fixation. Glazer further teaches that those skilled in the art will appreciate that other surface treatments that can be used to promote fixation of the insert in bone, including plasma treatment, hydroxyapatite coatings, bead blasting, or any other suitable surface treatment (paragraph 0047).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the coxal anchor or Smith in view of Dunn, which includes an iliac support that is formed as a fastening member/surgical screw for attaching the prosthesis to the bone, as well as the use of porous material to promote bone growth, to include that the at least one iliac support (fastening member/surgical screw) is coated with hydroxyapatite for fixing to said coxal bone, in order to facilitate fixation with the bone, as taught by Glazer.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Dunn, as applied to claim 16 above, and further in view of WO 2004/100809 A1 to Bickley (Bickley).
Smith in view of Dunn teaches the coxal anchor component of claim 16. Smith also teaches at least one iliac support (fastening member/surgical screw for the ilium flange member 34) for fixing to said coxal bone. However, Smith does not teach wherein said at least one iliac support comprises a first flange configured for placement at a medial surface of the ileum and a second flange configured for placement at a side surface of the ileum.
Bickley teaches a fixation augmentation device that includes a tubular body or sleeve (1372) that receives a bone screw. In at least one embodiment, Bickley discloses securing a replacement hip socket to a pelvic bone with the device that includes flanges (1380) which expand upon insertion of the screw, for the purpose of providing a secure fixation to the bone (page 16, lines 3-14).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the iliac support (fastening member/surgical screw) of Smith in view of Dunn, which is used to securely fix the prosthetic acetabular cup to the coxal bone, to include a fixation device that receives the iliac support/screw and includes flanges that expand upon insertion, in order to provide secure fixation to the bone, as taught by Bickley. When secured to the ilium, the modified iliac support of Smith in view of Dunn and further in view of Bickley would include a first flange configured for placement at a medial surface of the ileum and a second flange configured for placement at a side surface of the ileum, as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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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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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774