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 .
Response to Arguments
Applicant's arguments filed 5/26/2026 have been fully considered. Regarding the drawing objections, the amendments to the specification have corrected the issues and the drawing objections are withdrawn. Regarding the claim interpretation under 35 U.S.C. 112(f), the claims are no longer being interpreted under 35 U.S.C. 112(f) in light of the amendments to the claims which removed the term “means”.
Arguments regarding the rejection of claims 1-23 under 35 U.S.C. 102(a)(1) as being anticipated by Ferro have been fully considered but they are not persuasive. Applicant refers to fig.19 of Ferro and argues because Ferro relies on a single type of protrusion for performing all functions during implantation, Ferro does not teach at least “wherein the one or more guide projections, the one or more integration projections and the one or more securing projections are structurally distinct and perform different functions during implantation”. This is not persuasive because fig. 18 of Ferro has three structurally distinct projections capable of performing different functions during implantation. See the rejection below for further discussion.
Applicant also argues Ferro discloses a single-stage fixation approach relying on penetration of protrusions into bone and subsequent ingrowth. It is unclear what applicant means by “single-stage fixation approach” since applicant appears to describe at least two stages of Ferro namely penetration of protrusions into bone and subsequent ingrowth. Ferro does not use the term “single-stage”. Applicant argues Ferro does not disclose “a plurality of bone engaging projections extending from the bone facing surface and being adapted to extend into corresponding cavities formed in the prepared surface of the bone," as recited in amended claim 1 and states while the Office Action alleges that Ferro contemplates pre-punched holes, Ferro fundamentally teaches protrusions that are driven into bone to create fixation. This is not persuasive because Ferro explicitly disclose pre-punched holes, therefore the projections are capable of mating with "cavities formed in the prepared surface of the bone" of defined function and geometry. Further, the limitation “being adapted to extend into corresponding cavities formed in the prepared surface of the bone” is directed to an intended use of the device. The projections of Ferro are capable of extending into corresponding cavities formed in the prepared surface of the bone.
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.
Claims 1-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ferro et al. US 2017/0312084 (hereafter referred to as Ferro).
Regarding claim 1, Ferro discloses an orthopaedic implant 100 (fig.18) for use with or as part of an orthopaedic implant system, comprising: a body 102 having a bone facing surface 104 configured to mate with a prepared surface of a bone, and a plurality of bone engaging projections 106, 146, 148, 150 extending from the bone facing surface and being adapted to extend into corresponding cavities formed in the prepared surface of the bone when the body is mated with the bone (this is directed to the intended use/function of the projections; the projections of the implant of Ferro are capable of extending into cavities formed in the bone when the body is mated with the bone), wherein the plurality of bone engaging projections comprises: a guide projection 146 capable of guiding the implant into a fixated position with the bone (projection 146 can function to guide the implant into a fixated position within the bone and is therefore considered a guide projection); one or more integration projections 106 having a tapered/multi-faceted geometry and capable of promoting integration of the implant with the bone (projections 106 encourage surrounding bone growth as discussed in par.100); and one or more securing projections 148, 150 comprising ridges extending laterally relative to an insertion axis of the implant (see annotated fig.18 below) and capable of deforming the bone to secure the implant to the prepared surface of the bone (“configured to deform the bone” is directed to an intended use of the securing projections; the securing projections 148, 150 can be used to deform the bone at least during insertion), and wherein the guide projection 146, integration projection 106, and the securing projections 148, 150 are structurally distinct (at least because they are different structures having different shapes/designs) and are capable of performing different functions during implantation (because they have different structures they can perform different functions; for example they can at least be placed into different cavities of the bone and at different depths within the bone which means they can perform different functions).
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Regarding claim 2, see fig. 18 for guide projection 146 extending from the bone facing surface. The projection is capable of extending into a corresponding guide cavity formed in the prepared surface of the bone.
Regarding claim 3, see fig.18 for guide projection 146 which has a “substantially” uniform width (the guide projection tapers slightly and is therefore considered to have a substantially uniform width) as it extends outwardly from the bone facing surface.
Regarding claims 4 and 5, see guide projection 146 in fig.18 which has a tapered leading portion and therefore promotes insertion into a guide cavity.
Regarding claim 6, see the integration projections 106 in fig.18 which extend from the bone facing surfaces and are capable of extending into cavities formed in the prepared surface of the bone. Par.100 discloses the protrusions 106 provide a shallow seating into bone and encourage gone growth surrounding the tapered protrusions. While the cavities formed in the prepared surface of the bone are directed to an intended use, Ferro discloses pre-punched holes for the protrusions in par.135.
Regarding claims 7-8, see figs. 5-14 for the tapered, three dimensional geometric shape of the integration projections 106.
Regarding claim 9, see par.72 for increased surface area provided by the protrusions.
Regarding claim 10, see par.78 and figs. 7-8 for a rectangular pyramid shape.
Regarding claim 11, the elongated shape of the projections 106 inherently resists transverse movement in use.
Regarding claim 12, see the securing projections 148, 150 (fig.18) which extend from the bone facing surfaces and are capable of extending into securing cavities formed in the prepared surface of the bone. While the cavities formed in the prepared surface of the bone are directed to an intended use, Ferro discloses pre-punched undersized holes for the projections to form a tight press fit with the bone in par.135.
Regarding claim 13, see annotated fig.18 above which shows the lateral axis of the ridges (extending in a medial-lateral direction) being orthogonal to the vertical axis/axis of insertion.
Regarding claims 14-15, the claims are directed to an intended use of the implant since the claims discuss a substrate deforming joint between the ridges and the prepared surface of the bone (note: claims cannot positively recite such a joint since this would include positively claiming part of the body). The ridges of Ferro are capable of forming a substrate deforming joint with the prepared surface of the bone, wherein the substrate deforming joint results from a resilient deformation of the bone, since Ferro discloses in par.135 that the projections form a press-fit with pre-punched undersized holes.
Regarding claim 16, the tapered leading end of the ridges biases the implant onto the prepared surface of the bone (fig. 18).
Regarding claim 17, see fig.18 which shows tapered lateral sides of the ridges (the ridges become thinner as they extend outward from the center of the securing projection 148, 150), which provides diminished/lessened thickness of the ridges nearer lateral ends of the implant.
Regarding claim 18, securing projections 148, 150 are positioned adjacent/near guiding projection 146 (fig. 18).
Regarding claim 19, bone engaging projections 106, 146, 148, and 150 are capable of resisting rotational and translational forces on the implant when the body is mated with the bone as least because they are tightly seated within cavities of the bone as discussed in par.135.
Regarding claims 20-23, see par.72 for 20%, 50%, and double, which is 100%. Since 100% is less than 1000%, this is considered “up to”/less than and including 1000%. The examiner notes that the claims compare the surface area of an arbitrary “orthopaedic implant with only planar bone facing surfaces” that is not positively claimed. As such, the implant of Ferro having increased surface area due to the bone engaging projections is capable of having increased surface area of up to 20%, 50%, 100%, or 1000% of some arbitrary implant with planar surfaces.
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 1-16 and 18-24 are rejected under 35 U.S.C. 103 as being unpatentable over Chavane et al. FR 3019032 A1 (hereafter referred to as Chavane; refer to the attached translation for passages referenced herein) in view of Jurick et al. US 2017/0231770 (hereafter referred to as Jurick).
Regarding claim 1, Chavane discloses an orthopaedic implant (figs. 2-5) for use with or as part of an orthopaedic implant system, comprising: a body 1 having a bone facing surface 10 configured to mate with a prepared surface of a bone; and a plurality of bone engaging projections (figs. 2-5 show many bone engaging projections on the bone facing side of the implant) extending from the bone facing surface and being adapted to extend into corresponding cavities formed in the prepared surface of the bone when the body is mated with the bone (“adapted to extend into corresponding cavities” is directed to an intended use and the projections of the implant are capable of extending into corresponding cavities), wherein the plurality of bone engaging projections comprises one or more guide projections 15, 17 configured to guide the orthopaedic implant into a fixated position with the bone (translation pg.4, lines 35-37 discloses the “guiding pin 15” and “guide pin 17” are configured to guide the implant on the resected end of the femur during implantation), one or more integration projections 20 having a tapered or multi-faceted geometry (figs. 4 and 5) and configured to promote integration of the orthopaedic implant with the bone (translation pg.4 lines 37-40 refers to projections 20 as “anchors” and “anchoring pins” therefore they can function to promote integration of the implant with bone; translation pg. 3, par.1 discloses the anchors increase the area and promote attachment of bone); and one or more securing projections comprising ridges (see the ridges on the anterior and posterior faces 14.1, 14.2, 16.1, 16.2 in figs. 2 and 3 and see translation pg. 5, par.2 for “ridges”) configured to deform the bone to secure the orthopaedic implant to the prepared surface of the bone (this is directed to an intended use and the ridges on the anterior and posterior faces are capable of deforming the bone), wherein the one or more guide projections, the one or more integration projections and the one or more securing projections are structurally distinct and perform different functions during implantation (they each have different shapes and locations and can perform different functions at least because of their different shapes and locations). Chavane discloses the invention substantially as claimed but does not disclose that the ridges extend laterally relative to an insertion axis of the orthopaedic implant.
Jurick teaches an orthopedic implant, in the same field of endeavor, wherein anterior and posterior surfaces comprise ridges (considered the ridges formed on either side of grooves 906 in figs. 25-27 and ridges formed on either side of grooves 1006 in figs. 28-30). The ridges of the embodiment of figs. 28-30 extend in a substantially vertical direction while the ridges of the embodiment of figs. 25-27 extend laterally relative to an insertion axis of the implant. Jurick teaches the laterally extending ridges of figs. 25-27 are designed for the purpose of easing implantation and preventing movement after implantation (par.85).
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 substantially vertically extending ridges of Chavane to be laterally extending ridges as taught by Jurick in order to allow for easy insertion while preventing movement after implantation.
Regarding claims 2-5, the guide projections 15 and 17 of Chavane are capable of extending into guide cavities (“adapted to extend into corresponding guide cavities” is directed to an intended use), are substantially uniform in width as shown in figs. 2 and 3, and promote insertion due to their tapered leading ends as shown in figs. 2-3.
Regarding claims 6-11, the integration projections 20 of Chavane are capable of extending into integration cavities (“adapted to extend into corresponding integration cavities” is directed to an intended use), are tapered, three dimensional geometric shapes, specifically square or rectangular pyramids (figs. 4-5), maximize contact surface area between the implant and bone (see translation pg. 3, par.1 which discloses the anchors 20 increase the area), and are capable of resisting transverse movement of the implant due to their square/rectangular shape.
Regarding claims 12-16, the ridges taught by Jurick are capable of extending into securing cavities (“adapted to extend into corresponding securing cavities” is directed to the intended use), are orthogonal to the insertion axis (Jurick figs. 25-27), and are capable of forming a substrate deforming joint with the prepared surface of the bone which biases the implant onto the prepared surface of the bone due to the hook shape 916 (Jurick par.86).
Regarding claim 18, see Chavane figs.2-3 which show the securing projections (ridges) adjacent (interpreted as near) the guide projections 15, 17.
Regarding claim 19, the bone engaging projections of Chavane in view Jurick are capable of resisting rotation and translation forces due to their engagement with the bone once the implant is mated with the bone.
Regarding claims 20-23, see the Chavane translation pg.3 pars. 1-2 for the anchors increasing the effective area and covering a cumulative area of at least 7% of the area of the intercondylar surface. While Chavane does not specifically state that the bone facing surface or the plurality of bone engaging projections increase the surface area by up to 20%, 50%, 100% or 1000% relative to an orthopedic implant with only planar bone facing surfaces, 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 (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to increase the surface are to be up to 20%, 50%, 100% or 1000% relative to an orthopedic implant with only planar bone facing surfaces in order to optimize the effective area to optimize promotion of the attachment of bone tissue on the implant. The examiner notes that the claims compare the surface area of an arbitrary “orthopaedic implant with only planar bone facing surfaces” that is not positively claimed. As such, the implant of Chavane in view of Jurick having increased surface area due to the bone engaging projections is capable of having increased surface area of up to 20%, 50%, 100%, or 1000% of some arbitrary implant with planar surfaces.
Regarding claim 24, see figs. 2-3 of Chavane for a femoral implant capable of mating with the prepared surface of a femoral bone.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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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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