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 .
Status of Claims
This office action is responsive to the amendment filed on 03/12/2026. As directed by the amendment: claims 1, 123, 127, 143 and 147 have been amended, no additional claims have been cancelled and new claim 148 has been added. Thus, claims 1, 6, 9, 25, 123, 127, 132, 133, 135, 136, 140, 1471, 143 and 146-148 are presently pending in this application, and currently examined in the Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 6, 25, 123, 132, 135, 136, 140, 141, 146 and 147 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, lines 13-14 set forth the parameter of “the subchondral surface portion comprises a pocket surrounding a base of the at least one peg, the pocket comprising a flat surface” (emphasis added); however, this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure does not mention or clearly illustrate that the pocket, in the subchondral surface portion surrounding a base of the at least one peg, comprises a “flat surface.
Regarding claim 123, which depends from independent claim 143 which sets forth the parameters of i) the concave bearing surface portion overlapping with the porous titanium lattice structure of the intermediate portion, ii)a layer of solid titanium adjacent to the intermediate portion, and iii) a subchondral surface portion adjacent to the layer of solid titanium; and claim 123 further sets forth the parameter of the concave bearing surface portion being “compression molded onto the subchondral surface portion”, however this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed disclosure never mentions or suggests a tibial implant comprising a concave bearing surface portion overlapping with a porous titanium lattice structure of an intermediate portion, a layer of solid titanium adjacent to the intermediate portion, a subchondral surface portion adjacent to the layer of solid titanium, and also having the concave bearing surface portion being compression molded onto the subchondral surface portion.
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 123 and 148 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.
Regarding claim 123, which depends from independent claim 143 which sets forth the parameters of i) the concave bearing surface portion overlapping with the porous titanium lattice structure of the intermediate portion, ii)a layer of solid titanium adjacent to the intermediate portion, and iii) a subchondral surface portion adjacent to the layer of solid titanium; and claim 123 further sets forth the parameter of the concave bearing surface portion being “compression molded onto the subchondral surface portion”, however this parameter is found to be confusing. Specifically, it is not clear how the concave bearing surface portion, which is fused/bind, in an overlapping area/portion, with the porous titanium lattice structure of the intermediate portion, and having a layer of solid titanium adjacent to the intermediate portion and then the subchondral surface portion adjacent to the layer of solid titanium, can be “compression molded onto the subchondral surface portion”; firstly, there are multiple layers, i.e. the intermediate portion and the layer of solid titanium, between the concave bearing surface portion and the subchondral surface portion, i.e. the concave bearing surface portion and the subchondral surface portion aren’t next to one another, so therefore how could they be compression molded to one another, and secondly, it is clearly stated in independent claim 143 that the concave bearing surface portion is fused/bound within an overlap portion of the porous titanium lattice structure of the intermediate portion, thus further making it unclear/confusing how the concave bearing surface portion could be compression molded to the subchondral surface portion Thus, on having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 148, which recites the limitation(s) “the solid titanium of the proximal portion” on the last two lines of the claim; there is insufficient antecedent basis for this limitation(s) in the claim. Furthermore, claim 148 depends from independent claim 143 which sets forth the parameter of “the subchondral surface portion comprises a porous titanium lattice”, and claim 148 further sets forth the parameter of “the anti-rotation spike is continuous with the solid titanium of the proximal portion of the subchondral surface portion”; however, this parameter is found to be confusing since it is not clear how a solid titanium anti-rotation spike can be continuous with a porous titanium lattice structure of the subchondral surface portion, and/or how the subchondral surface portion can comprise a porous titanium lattice and solid titanium. Thus, on having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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, 6, 25, 132, 141, 146 and 147 are rejected under 35 U.S.C. 103 as being unpatentable over Rhodes (US PG Pub. 2007/0100460), as previously disclosed, in view of Wagner et al. (US Patent No. 8,317,870), hereinafter Wagner, in view of Wright et al. (US PG Pub. 2019/0298525), as previously disclosed, hereinafter Wright, and Blaylock et al. (US Patent No. 7,892,288), as previously disclosed, hereinafter Blaylock.
Regarding claim 1, Rhodes discloses a unicompartmental knee arthroplasty resurfacing implant (50), illustrated in Figures 5-17 and 29-33, configured to be implanted on a distal end of a femur (10), illustrated in Figures 5 and 6, the implant comprising a convex bearing surface portion, comprising a convex bearing surface (56) on a distal side, configured to interface with a complementary articulating surface of a proximal end of a tibia, wherein the convex bearing surface portion comprises a solid titanium; a subchondral surface portion comprising a flat subchondral surface (58), the subchondral surface portion being proximal to the convex bearing surface portion, the subchondral surface configured to interface with a surgically prepared bone surface on the distal end of the femur (10), wherein the subchondral surface portion comprises a porous titanium lattice; at least one elongate peg (54), extending away from the subchondral surface portion, and comprising a titanium structure throughout a length of the at least one elongate peg; and a plurality of barbs (76) on the at least one elongate peg (54), wherein the plurality of barbs include a solid titanium, wherein the convex bearing surface portion, the subchondral surface portion, the at least one elongate peg, and the plurality of barbs comprise a same titanium material forming a monolithic unit, illustrated in Figures 5-17 and 29-33 ([0056]; [0061]; [0065]; [0070], Lines 1-3; [0071], Lines 1-7 & [0072]); but does not specifically disclose the subchondral surface portion comprising a pocket, comprising a flat surface, surrounding a base of the at least one peg, the at least one elongate peg having a porous structure throughout its length, and that the implant comprises one or more notches configured to receive a removal tool.
However, Wagner teaches an orthopedic implant, in the same field of endeavor, comprising a bone facing surface (124) having at least one peg (128) and a pocket (126), comprising a flat surface, surrounding a base of the peg, illustrated in Figures 9-11; the pocket allows for a preload of bone cement, reduces incidences of cement plowing and forces excess bone cement out the anterior side such that it can be easily and readily removed/wiped away (Column 9, Lines 30-43 & Column 10, Lines 12-23). Furthermore, Wright teaches an orthopedic implant, in the same field of endeavor, comprising at least one elongate peg (410) comprising a porous titanium structure (420) throughout its length, and a plurality of solid titanium barbs (430) on/extending from the at least one elongate peg (410), illustrated in Figure 4; the porous structure allowing for bone in-growth while the solid barbs allow for reduced bone abrasion and increased hoop stresses in the bone ([0104]; [0107] & [0110]). Additionally, Blaylock teaches that it is known in the art for orthopedic implants, specifically femoral implants for the knee, to comprise one or more notches/grooves (86), illustrated in Figure 1, such as to cooperate with a removal tool in order to aid in the removal of the implant from the implantation site (Column 10, Lines 13-20).
In view of the teachings of Wagner, Wright and Blaylock, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the subchondral surface portion, of the implant of Rhodes, to comprise a pocket, comprising a flat surface, surrounding a base of the at least one peg, in order to allow for a preload of bone cement, reduce incidences of cement plowing and force excess bone cement out an anterior side such that it can easily and readily be removed/wiped away, as taught by Wagner; it also would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the at least one elongate peg, of the implant of Rhodes, to have a porous titanium structure throughout its length with solid barbs on/extending from the at least one elongate peg, in order to allow for bone in-growth while also reducing bone abrasion and increasing hoop stresses in the bone, as taught by Wright; and further would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the implant of Rhodes to comprise one or more notches/grooves, such as to cooperate with/receive a removal tool, in order to aid in the removal of the implant from the implantation site, as taught by Blaylock.
Regarding claims 6 and 132, Rhodes in view of Wagner, Wright and Blaylock disclose the unicompartmental knee arthroplasty resurfacing implant according to claim 1, wherein Rhodes further teaches the implant further comprises at least one anti-rotation spike (54E), comprising a solid metal material, extending away from the subchondral surface (58), illustrated in Figures 29-33 (Rhodes: [0072]).
Regarding claim 25, Rhodes in view of Wagner, Wright and Blaylock disclose the unicompartmental knee arthroplasty resurfacing implant according to claim 1, wherein Rhodes further teaches the convex bearing surface (56) portion comprises a round profile, illustrated in Figures 13-17 (Rhodes: [0057], 5th – 3rd to last Lines).
Regarding claim 141, Rhodes in view of Wagner, Wright and Blaylock disclose the unicompartmental knee arthroplasty resurfacing implant according to claim 1, wherein Rhodes further teaches the at least one elongate peg (56) comprises three elongate pegs (56), illustrated in Figures 29-33.
Regarding claim 146, Rhodes in view of Wagner, Wright and Blaylock disclose the unicompartmental knee arthroplasty resurfacing implant according to claim 1, wherein Rhodes further teaches the at least one elongate peg (56) comprises a plurality of longitudinal channels/longitudinal surface features/grooves configured to receive cement flow (Rhodes: [0068] – it is to be noted that though it is not specifically disclosed that the longitudinal channels/grooves are “configured to receive cement flow”, this limitation is considered a functional/intended use parameter, and in device/apparatus claims, only the claimed structural limitations of the final device hold patentable weight; intended use/functional limitations are considered to the extent that they further limit the structure of the final device. Thus, in the instant case, Rhodes teaches all the structural limitations set forth in the claim, and the implant/structure would be capable, i.e. has the physical/structural ability, of meeting the intended use/function of being “configured to receive cement flow”, and therefore reads on the claim).
Regarding claim 147, Rhodes in view of Wagner, Wright and Blaylock disclose the unicompartmental knee arthroplasty resurfacing implant according to claim 146, wherein Wagner further teaches the pocket (126) is configured to receive cement flow, illustrated in Figures 9-11 (Wagner: Column 9, Lines 30-43 & Column 10, Lines 12-23).
Claims 135 and 136 are rejected under 35 U.S.C. 103 as being unpatentable over Rhodes in view of Wagner, Wright and Blaylock as applied to claim 1 above, and further in view of Ryd et al. (US PG Pub. 2018/0243096), as previously disclosed, hereinafter Ryd.
Regarding claims 135 and 136, Rhodes in view of Wagner, Wright and Blaylock disclose the unicompartmental knee arthroplasty resurfacing implant according to claim 1, but do not teach the convex bearing surface further comprising a titanium nitride coating.
However, Ryd teaches that it is known in the art of articulating orthopedic devices, to have a titanium nitride coating on an articulating surface, due to titanium nitride being wear-resistant to provide a more durable surface, having a lower friction coefficient and better adherence than other wear-resistant coatings, thereby making it an optimal coating for articulating surfaces ([0020]).
In view of the teachings of Ryd, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the convex bearing surface, of the implant of Rhodes in view of Wagner, Wright and Blaylock, to further comprise a titanium nitride coating, based on its optimal properties of being wear-resistant to provide a more durable surface, having a lower friction coefficient and better adherence than other wear-resistant coatings, as taught by Ryd.
Claim 140 is rejected under 35 U.S.C. 103 as being unpatentable over Rhodes in view of Wagner, Wright and Blaylock as applied to claim 1 above, and further in view of Gordon et al. (US PG Pub. 2011/0257753), as previously disclosed, hereinafter Gordon.
Regarding claim 140, Rhodes in view of Wagner, Wright and Blaylock disclose the unicompartmental knee arthroplasty resurfacing implant according to claim 1, wherein Rhodes teaches the least one elongate peg comprises a titanium structure (Rhodes: [0071], Lines 1-7) and Wright teach the at least one elongate peg comprises a porous titanium structure (Wright: [0104] & [0107]); but do not specifically disclose the porous structure of the at least one elongate peg is a trabecular porous structure.
However, Gordon teaches that it is known in the art for porous regions, of orthopedic devices, to comprise trabecular porous structure in order to promote skeletal fixation by bone ingrowth ([0100], Lines 6-9).
In view of the teachings of Gordon, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the porous titanium structure of the at least one elongate peg, of the implant of Rhodes in view of Wagner, Wright and Blaylock, to comprise a trabecular porous structure, in order to promote skeletal fixation by bone ingrowth, as taught by Gordon.
Claims 9, 123, 127, 133 and 143 are rejected under 35 U.S.C. 103 as being unpatentable over Webb et al. (US PG Pub. 2021/0177614), hereinafter Webb, in view of Fitz et al. (US PG Pub. 2009/0226068), as previously disclosed, hereinafter Fitz, Rhodes and Wagner.
Regarding claims 123, 127, 133 and 143, Webb discloses a unicompartmental knee arthroplasty resurfacing implant (10), illustrated in Figures 1-4, configured to be implanted on a proximal end of a tibia (it is to be noted that even though it is not specifically disclosed that the implant of Webb is implanted on a proximal end of a tibia, the implant has the physical/structural ability/capability to meet this intended use/functional language of being implanted on a proximal end of a tibia, thereby reading on the parameter), the implant (10) comprising a bearing surface portion (12), configured to interface with a complementary articulating surface of a distal end of a femur, and having a bearing surface (16), wherein the bearing surface portion (12) comprises ultra-high molecular weight polyethylene; an intermediate portion (IP) comprises a porous lattice structure (30) serving as a binding site for a distal portion of the concave bearing surface portion (12) which overlaps with the porous lattice structure (30) of the intermediate portion along a longitudinal direction of the implant to form an overlap area so as to reduce a thickness of the implant; a layer of solid meal (14/SM) adjacent to the intermediate portion (IP); a subchondral surface portion (SSP), adjacent to the layer of solid meal (14/SM), and configured to interface with a surgically prepared bone surface on the proximal end of the tibia, wherein the subchondral surface portion (SSP) comprises a porous titanium irregular lattice (62), wherein the bearing surface portion (12) of the implant is compression molded onto the proximal side of the subchondral surface portion (SSP); and at least one elongate peg (24), comprising a porous titanium structure throughout its length, extending away from the subchondral surface portion (SSP), illustrated in Figures 1-4 and modified figure 4, below ([0037] – [0040]; [0045]; [0047] & [0048]); but does not specifically disclose the bearing surface portion/concave bearing surface is concave, the intermediate portion and the layer of solid metal comprise titanium, the at least one elongate peg comprises one or more longitudinally extending channels and a plurality of barbs, comprising solid titanium, and the subchondral surface comprising a pocket surrounding a base of the at least one peg.
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However, Fitz teaches that it is well-known in the art for the bearing surface (202), of a unicompartmental tibial implant (200), to be concave, in order to receive and mate with a femoral surface, illustrated in Figures 2A and 2G (Fitz: [0108] & [0109]). Furthermore, Rhodes teaches an orthopedic implant (50), in the same field of endeavor, comprising titanium and having at least one elongate peg (54), which comprises one or more longitudinally extending channels and a plurality of barbs (76), illustrated in Figures 5-33, in order to enhance fixation of the implant ([0056]; [0065]; [0068] & [0071]). Additionally, Wagner teaches an orthopedic implant, in the same field of endeavor, comprising a bone facing surface (124) having at least one peg (128) and a pocket (126), comprising a flat surface, surrounding a base of the peg, illustrated in Figures 9-11; the pocket allows for a preload of bone cement, reduces incidences of cement plowing and forces excess bone cement out the anterior side such that it can be easily and readily removed/wiped away (Column 9, Lines 30-43 & Column 10, Lines 12-23).
In view of the teachings of Fitz, Rhodes and Wagner, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the bearing surface portion/bearing surface, of the implant of Webb, to be concave, since this a known shape in the art for a tibial bearing surface, in order to receive and mate with a femoral surface, as taught by Fitz, and a change in form/shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). It also would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the at least one elongate peg, of the implant of Webb, to comprise one or more longitudinally extending channels and a plurality of barbs, in order to enhance fixation of the implant, as taught by Rhodes, and for the intermediate portion and the layer of solid metal to comprise titanium such that the intermediate portion, the layer of solid metal, the subchondral surface portion, the at least one elongate peg, and the plurality of barbs all comprise the same titanium material, as taught by Rhodes and Webb, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (see MPEP 2144.07). And it would have further been obvious to one having ordinary skill in the art before the effective filing date of the invention for the subchondral surface, of the implant of Webb, to comprise a pocket, in fluid communication with the one or more channels to receive a flow of cement, surrounding a base of the at least one peg, in order to allow for a preload of bone cement, reduce incidences of cement plowing and force excess bone cement out an anterior side such that it can easily and readily be removed/wiped away, as taught by Wagner.
Regarding claim 9, Webb in view of Fitz, Rhodes and Wagner disclose the unicompartmental knee arthroplasty resurfacing implant according to claim 143, wherein Fitz teaches the concave bearing surface portion has a rim that defines a proximal plane, illustrated in Figure 2G; and Webb teaches the subchondral surface portion (SSP) defines a distal plane (22), and the at least one elongate peg (24) defines an axis that is perpendicular to the distal plane (22), illustrated in Figures 1-4 and modified figure 4, above, and the axis being non-perpendicular to the proximal plane, due to its concave shape as taught by Fitz.
Claim 148 is rejected under 35 U.S.C. 103 as being unpatentable over Webb in view of Fitz, Rhodes and Wagner as applied to claim 143 above, and further in view of Whiteside (US PG Pub. 2003/0014122).
Regarding claim 148, Webb in view of Fitz, Rhodes and Wagner disclose the unicompartmental knee arthroplasty resurfacing implant according to claim 143, but do not specifically teach at least one anti-rotation spike continuous with the subchondral surface portion.
However, Whiteside teaches an orthopedic implant, in the same field of endeavor, comprising at least one anti-rotation spike (19), made of solid titanium, and continuous with a solid titanium of a proximal portion (13) of a subchondral surface portion (3), illustrated in Figures 1-3, the anti-rotation spike (19) aids in resisting movement of the subchondral surface portion/implant once implanted ([0034], Lines 1-4 & [0036], Lines 1-5).
In view of the teachings of Whiteside, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the implant, of Webb in view of Fitz, Rhodes and Wagner, to further comprise at least one anti-rotation spike, made of solid titanium, and continuous with the titanium of the subchondral surface portion, in order to aid in resisting movement of the subchondral surface portion/implant once implanted, as taught by Whiteside.
Response to Arguments
Applicant’s arguments with respect to the claim have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendment, Examiner now cites the prior art of Wagner and Webb, in addition to previous prior art; rejecting independent claim 1 as being unpatentable over Rhodes in view of Wagner, Wright and Blaylock, and independent claim 143 as being unpatentable over Webb in view of Fitz, Rhodes and Wagner.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 04/16/2026