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 .
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 1-3, 8, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al., US 2011/0054626 A1, in view of Carson et al., US 2003/0014120 A1. Figures 1-3 of Thomas et al. depict a knee prosthesis 10 comprising load bearing component 12 including a first connection mechanism 22 having a female member 32, a stem 16 for insertion into an intramedullary canal of a patient’s bone (paragraphs 0003-0004, 0028) and including a second connection mechanism having a male member 43, and a coupler 14 including a first end portion having a male member 28 defining a first central longitudinal axis 46 and a second end portion 40 having a female member 44 defining a second central longitudinal axis 48, male member 28 engaging female member 32 and female member 44 engaging male member 43 (paragraphs 0030, 0032). Axes 46 and 48 are non-intersecting (Figures 1 and 2), non-parallel (Figure 2), and offset from each other by a distance 50 (Figure 1); rotation of coupler 14 thus innately adjusts the varus/valgus angle of stem 16 relative to load bearing component 12 and facilitates reception of stem 16 in a bowed intramedullary canal (Figures 1-2; paragraphs 0005, 0033-0035). In the embodiments of Figures 1-8, coupler 14 is monolithically formed so that axes 46 and 48 are in a predetermined, non-adjustable configuration [paragraphs 0027, 0043, 0048 (contrasted with multiple piece coupler embodiments)]. Offset 50 (Thomas et al.: Figure 1) is capable (MPEP § 2114) of being oriented so as to lie along a medial/lateral plane, an anterior/posterior plane, or a plane angled from these planes but likewise extending along a superior/inferior dimension (paragraphs 0010, 0033, 0036) so as to define non-parallel axes components in both the coronal and the sagittal planes (similar to what is shown in Figure 2).
Thomas et al. lack explicit mention of providing the surgeon with a kit from which is selected an appropriately sized and dimensioned coupler 14 from among a plurality of couplers having varying configurations. However, such was quite common in the art at the effective filing date of the instant application, as seen from Carson et al. (paragraphs 0039-0050; page 7, claims 55-58). The Thomas et al. system being presented in kit form would thus have been immediately obvious to the ordinary practitioner, with Thomas et al. teaching “various sizes and configurations to ensure proper matching of the implant with the anatomy of the patient” (paragraphs 0004, 0034-0035, 0042, 0046) and with further motivation (to combine) provided by the structural and functional similarities of Carson et al. [drawings; abstract; paragraphs 0004, 0051-0053 (advantages), 0070 (male and female tapers may be reversed), 0071 (Morse tapers of generally circular cross-section to facilitate rotation and adjustment), 0073-0076 (angles and offsets)].
Regarding claim 11, couplers 14 with different offsets and/or angles would have been obvious from the ranges specified in either document (Thomas et al.: paragraphs 0004, 0010, 0034; Carson et al.: paragraph 0075) in order to provide adaptability to situations or indications encountered by a surgeon. Regarding claims 12-13, the features of a chosen coupler from a kit are unaffected by the particular method of selection; in a product or kit claim, “determination of patentability is based on the product itself” (MPEP § 2113). The further limitations of other claims are adequately addressed above (MPEP § 707).
Response to Arguments
In Thomas et al., Figures 1-2 are different views of the same embodiment (paragraphs 0013-0014), so even though axes 46 and 48 appear to intersect when viewed in the anterior-posterior plane (Figure 2), said axes are in fact offset from one another by a distance 50 (Figure 1) in addition to being angled 52 relative to one another (Figure 2; abstract; paragraphs 0033-0034). The capability of relative swiveling about tapered or frustoconical engagements (Figures 1, 5; MPEP § 2125) thus allows for independent adjustments on varus-valgus angles and flexion-extension angles (paragraphs 0035-0036).
Applicant’s argument that the axes (in Thomas et al.) are parallel to each other in the medial/lateral plane (Applicant’s reply of August 28, 2026: page 6, first paragraph) omits “when the axes 46, 48 are viewed in the medial/lateral plane” (Thomas et al.: paragraph 0033; emphasis added), so the axes only appear to be parallel from the perspective of Figure 1. Axes 46 and 48 are skewed, as explained above, and the rotational degrees of freedom at the frustoconical ends of coupler 14 enable angles between load bearing component 12 and stem 16 along orthogonal directions to be adjusted independently of one another.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114 (MPEP § 706.07(b)). 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 David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Melanie Tyson can be reached at telephone number 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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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774
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