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 .
Election/Restrictions
Applicant’s election of Species B in the reply filed on 2/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 2-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species embodiment, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/26/2026. The requirement is deemed proper and is therefore made FINAL.
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.
Claim(s) 1, 8, 10-11, 13-14, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (CN 111449808 A; hereinafter “Yang”).
Yang discloses the following regarding claim 1: an orthopaedic implant comprising: a securing element (2) configured to engage an articulating joint component (domed portion of element 1); and a lattice structure (porous structure) (Figs. 1-8; pg. 3 of the attached translation) connected to the securing element (e.g., Fig. 2) and having an engaging surface (outer surfaces of the lattice) configured, in use, to engage a bone surface (the engaging surface is fully capable of engaging bone upon the implantation of the device in a patient) (pg. 7), wherein the securing element provides a load path between the articulating joint component and the lattice structure (as the lattice structure and securing element are integrally connected) (Figs. 1-4), and wherein the lattice structure has an elastic modulus of between 0.1 gigapascals (GPa) and 20 GPa (pg. 5), such that the engaging surface is configured to deform by between 5 microstrain and 6000 microstrain upon application of a load by the articulating joint component (pgs. 5, 7; where the engaging surface is fully capable of deforming within the claimed microstrain range upon a particular load, as it has the claimed elastic modulus), and wherein the lattice structure has a second surface (inner surfaces of the lattice) arranged, in use, to abut the articulating joint component (e.g., Fig. 2).
Yang discloses the following regarding claim 8: an orthopaedic implant according to claim 1, wherein the securing member comprises a band arranged around a portion of the lattice structure (Figs. 1, 3, 4).
Yang discloses the following regarding claim 10: an orthopaedic implant comprising: a securing element (2) connected to an articulating joint component (domed portion of element 1), and a lattice structure (porous structure) (Figs. 1-8; pg. 3) connected to the securing element (e.g., Fig. 2) and having an engaging surface (outer surfaces of the lattice) configured, in use, to engage a bone surface (the engaging surface is fully capable of engaging bone upon the implantation of the device) (pg. 7), wherein the securing element provides a load path between the articulating joint component and the lattice structure (as the lattice structure and securing element are integrally connected) (Figs. 1-4), and wherein the lattice structure has an elastic modulus of between 0.1 gigapascals (GPa) and 20 GPa (pg. 5), such that the engaging surface is configured to deform by between 5 microstrain and 6000 microstrain upon application of a load by the articulating joint component (pgs. 5, 7; where the engaging surface is fully capable of deforming within the claimed microstrain range upon a particular load, as it has the claimed elastic modulus) and wherein the lattice structure has a second surface (inner surfaces of the lattice) arranged, in use, to abut the articulating joint component (e.g., Fig. 2).
Yang discloses the following regarding claim 11: an orthopaedic implant according to claim 1, wherein the lattice structure has an elastic modulus between 3 GPa and 20 GPa (pg. 5).
Yang discloses the following regarding claim 13: an orthopaedic implant according to claim 1, wherein the orthopaedic implant is any of a modular knee implant or a modular hip implant (pgs. 5, 7).
Yang discloses the following regarding claim 14: an orthopaedic implant according to claim 1, configured as any of a tibial component, a femoral component or an acetabular cup (pgs. 5, 7).
Yang discloses the following regarding claim 19: an orthopaedic implant according to claim 1, wherein the lattice structure makes up at least 5% of the implant by volume (Figs. 1-8).
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) 6, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of JP 2009516544 A (hereinafter “the ‘544 reference).
Yang discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite the elastic modulus of the lattice structure adjacent the engaging surface being less than the elastic modulus of a proximal portion of the lattice structure spaced from the engaging surface; the elastic modulus of the peripheral portion being less than the elastic modulus of the central portion; and the elastic modulus of the securing member being greater than the elastic modulus of the lattice structure. The ‘544 reference teaches that it is well known in the art that the elastic modulus of different parts of the implant are modified by adjusting the porous lattice structures and providing for solid, non-porous implant structures (pgs. 6-9 of the provided translation), as would be needed to provide the implant with the desired load bearing capacities needed to best suit its implantation site. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the device of Yang to have the claimed elastic moduli, according to the teachings of the ‘544 reference, in order to provide the implant with the desired load bearing capacities needed to best suit its implantation site. Such a modification would be made with a reasonable expectation of success.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Rolfe et al. (WO 2005/009729 A2; hereinafter “Rolfe”).
Yang discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the articulating joint component is a polymer articulating joint component. Rolfe teaches that it is well known in the art that lattice implants comprise a variety of different types of materials, including metals and polymers (para. 0180), for the purpose of providing the implant with the desired structural characteristics best suited for its implantation site. It would have been obvious to one having ordinary skill in the art to modify the device of Yang to comprise a polymer, as taught by Rolfe, in order to provide the implant with the desired structural characteristics best suited for its implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, substituting one type of implant material for another, is generally considered to be within the level of ordinary skill in the art.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Higgs et al. (WO 2021/257449 A1; hereinafter “Higgs”).
Yang discloses the limitations of the claimed invention, as described above. Yang further recites that the lattice structure comprises a plurality of interconnected struts (Figs. 1-4); and that the lattice structure comprises a plurality of nodes, wherein each node is connected to at least one another node by a respective strut (Fig. 4). However, it does not explicitly recite each strut having a cross-sectional dimension of between 0.1mm and 0.5mm; a strut density of between 3.0 per mm3 and 5.0 struts per mm3; and the average number of connections between the plurality of nodes being between 4.5 and 6.0. Higgs teaches that it is well known in the art that the properties of an orthopedic implant are controlled by the orientation, cross-sectional dimensions, and the densities of the struts making up the porous portions of the implants (paras. 0037-0046), for the purpose of providing the implant with the desired structural characteristics needed for its implantation site. It would have been obvious to one having ordinary skill in the art to modify the device of Yang to comprise the claimed lattice dimensions, according to the teachings of Higgs, in order to provide the implant with the desired structural characteristics needed for its implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that 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 strut cross-sectional dimensions, strut densities, and the average number of connections needed to achieve the desired results and ensure that the implant has the optimal structural characteristics. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of strut cross-sectional dimensions, strut densities, and the average number of connections, would have been obvious at the time of applicant's invention in view of the teachings of Yang and Higgs. 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.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Ma et al. (CN 110946678 A; hereinafter “Ma”).
Yang discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the lattice structure has an anisotropic elastic modulus. Ma teaches that it is well known in the art that the lattice structure has an anisotropic elastic modulus (pgs. 2-3 of the provided translation), for the purpose of designing the implant to better match and simulate the mechanical properties of bone. It would have been obvious to one having ordinary skill in the art to modify the device of Yang to have an anisotropic elastic modulus, as taught by Ma, in order to design the implant to better match and simulate the mechanical properties of bone. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
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/ANN HU/Primary Examiner, Art Unit 3774