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 1/16/2026 have been fully considered but they are moot in view of the new grounds of rejection necessitated by the amendments.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wright et al. US 2014/0142714 (hereafter referred to as Wright) in view of Wellings et al. US 2018/0325685 (hereafter referred to as Wellings).
Regarding claim 1, Wright discloses a knee implant comprising a femoral component 12 arranged and configured to engage a patient's femur, the femoral component including an articular surface 60 arranged and configured to articulate relative to a tibial component or insert 14 (fig.1), wherein the articular surface includes a patella path 66 along which a patella 70 travels, the patella path including a constraint region 104, 106 (distal region of the anterior flange 50) and a reduced constraint region 102 (proximalmost region of the anterior flange 50), the reduced constraint region comprising a surface (proximal surface 68 as shown in figs. 4-5) being arranged and configured to provide increased freedom-of-movement of the patella as it travels over the surface of the reduced constraint region compared to freedom-of-movement of the patella as it travels over the constraint region (see figs. 4-5 compared to figs. 7-8 and 10-11; pars.88 and 92 disclose less medial-lateral movement of the patella at locations 104 and 106 compared to location 102). Wright discloses the invention substantially as claimed and fig.4 appears to show a somewhat flat surface near number 128. However, Wright does not specifically disclose that the reduced constraint region comprises a flat surface.
Wellings teaches a knee implant, in the same field of endeavor, wherein a femoral component comprises a “substantially flat surface 312” located proximal to a proximal-anterior location for the purpose of providing laxity during patellar articulation and guiding the patellar component into the trochlear groove during flexion (par.32; fig.1). Wellings fig.9 further shows a flat femoral surface in region 1 which allows for the maximum medial-lateral laxity at minimal flexion/extension.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, if necessary, the reduced constraint region of Wright to include a flat surface as taught by Wellings in order to allow for optimal medial-lateral laxity during extension and early flexion. While Wright doesn’t recite “a flat surface” and Wellings teaches a “substantially flat surface” as opposed to a “flat surface”, it would have been an obvious matter of design choice to a person of ordinary skill in the art to form the reduced constraint region of Wright as a flat surface because Applicant has not disclosed that a flat surface, as opposed to a substantially flat surface, provides an advantage, is used for a particular purpose, or solves a stated problem. In fact, the specification of the instant applicant discloses two embodiments/designs for the reduced constraint region including an embodiment with a curved reduced constraint region (see application fig.5A) and an embodiment with a flat reduced constraint region (see application fig.6) that both perform the function of providing a reduced constraint region. One of ordinary skill in the art, furthermore, would have expected the implant of Wright in view of Wellings, and applicant’s invention, to perform equally well with either the substantially flat surface taught by Wellings or the claimed flat surface because both designs would perform the same function of allowing for medial-lateral patellar movement equally well considering both allow for medial-lateral patellar movement in extension and early flexion. Therefore, it would have been prima facie obvious to modify Wright in view of Wellings to obtain the invention as specified in claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Wright in view of Wellings.
Regarding claim 2, see Wright fig. 5 and par.84.
Regarding claims 3-4, Wright figs. 5, and 8 and 10 show the different medial-lateral freedom of movement in the constraint region and the reduced constraint region. The claims do not positively recite a patella or patella implant. As such, the patella path of the femoral component of Wright in view of Wellings is capable of achieving the claimed percentages and differences since these values depend on both the claimed femoral component and a patella/patella implant which is not positively claimed. In other words, because the femoral component of Wright in view of Wellings has constraint and reduced constraint regions, wherein the reduced constraint region enables increased medial-lateral movement of the patella, a person could select or shape a patella/patellar implant to achieve increased medial-lateral movement of the patella/patella implant of about 105 percent to about 150 percent and about 1 mm to about 20 mm.
Regarding claim 5, see figs.5, and 8 and 10 of Wright for a patella capable of increased internal-external rotation in extension (fig.5) compared to flexion (figs. 8 and 10).
Regarding claim 6, Wright figs. 5, and 8 and 10 show the patella is capable of different internal-external rotation in the constraint region and the reduced constraint region. As discussed above, the claims do not positively recite a patella or patella implant. As such, the patella path of the femoral component of Wright in view of Wellings is capable of achieving the claimed percentages since the percentage depends on both the femoral component and a patella/patella implant which is not positively claimed. In other words, because the femoral component of Wright in view of Wellings has constraint and reduced constraint regions, wherein the reduced constraint region enables increased internal-external rotation of the patella, a person could select or shape a patella/patellar implant to achieve increased internal-external rotation of the patella/patella implant of about 105 percent to about 150 percent.
Regarding claims 7-9, see Wright fig.6-14 for a trochlear groove (the groove 66 at locations 104 and 106) located inferiorly to the reduced constraint region 102 (which is shown in figs. 3-5). Wright fig.3 shows the patella in the reduced constraint region 102 during extension (less than 10 degrees flexion) and Wright figs. 6, 9, and 12 show the patella within the trochlear groove during flexion.
Regarding claim 10, see Wellings par.32 and fig.1 for substantially flat surface 312 located proximal to a proximal-anterior location.
Regarding claim 11, a length of a distal anterior flange region is arbitrary, meaning a length can be defined for some arbitrary distal portion of the flange. A length of a reduced constraint region is also somewhat arbitrary. Because the path of Wright gradually gets flatter in the proximal direction any proximal part of the path can be considered reduced in constraint relative to a distal part of the path. As such, two arbitrary lengths can be selected to define the claimed percentage.
Regarding claim 12, because the path 66 gradually gets wider toward the proximal end (see the funnel shape described in par.89 of Wright), any proximal part of the path can be considered reduced in constraint relative to a distal part of the path. Therefore, one can arbitrarily define a reduced constraint region having a length of 1 mm to about 20 mm.
Regarding claims 13-15, see Wright fig.3 for a patella implant 70 including a raised portion 72 on at least a distal region of a posterior side of the patella implant. The raised portion is capable of engagement within the constraint region of the patella path as shown in at least figs. 6, 9, and 12 of Wright. At least fig.5 of Wright shows the raised portion of the patellar implant flaring out moving from an outer edge to a center of the posterior side of the patella implant.
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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