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 .
DETAILED ACTION
Election/Restrictions
Applicant timely traversed the restriction requirement in the reply filed on 03/23/2026 with the election of Claims 108-116 and Figs. 12A-12K and 16A. Therefore, claims 70-107 and 117-120 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 108-116 are presently pending in this application.
Applicant's election with traverse is acknowledged. The traversal is on the ground(s) that the tibial keel subspecies are distinct from the femoral component. This is found to be persuasive and the subspecies A-W directed to the tibial prosthesis are rejoined with Species 1-5 directed to the femoral prosthesis. Figs. 12A-12K are elected on the record and Fig. 16A is withdrawn.
Claim Rejections - 35 USC § 112
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.
Claim 108 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claim limitations, "may”, “can be”, “optionally” and cited within parentheses () render the claim indefinite. It is unclear if this indefinite language is positively reciting the claim limitations it precedes.
Regarding claims 112 and 113, they are prosthesis dependent claims depending from a method claim 107 and therefore lack proper antecedent basis. Furthermore, regarding claim 113, “the tangent linking” lacks proper antecedent basis.
Regarding claim 116, “typically” render the claim indefinite. It is unclear if this indefinite language is positively reciting the claim limitations it precedes.
Claims 109-111 and 114-115 are rejected as being dependent on a rejected claim.
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 108 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (2019/0117407) in view of Hafez (2015/0182342).
Regarding claim 8, as best understood, Yang discloses a femoral prosthesis 100 for implantation on a femur of a patient's knee (abstract and Fig. 9A), comprising: (a) two condylar portions 51/91 (Fig. 9A) comprising the medial and lateral condyles, having a bone- facing surface for abutting at least a portion of each condyle of the patient's knee (surface shown in Fig. 8) and an articular surface generally opposite each bone-facing surface (surface shown in Fig. 9A); each articular surface having a curvature (J-curve) generally disposed in a first plane (sagittal plane) (Fig. 8 discloses a J-curve) and ML curve generally disposed in a second and third plane (frontal plane for the distal condyles and transverse planes for the posterior condyles) (Figs. 9A and 12); each articular surfaces of the medial and lateral condyles may have a condylar offset in the third/transverse plane (Fig. 9A shows the transverse plane where the condyles 51/91 have an offset Dp), which is optionally equivalent; (b) a trochlear portion, comprising the trochlear depth as well as the lateral and medial trochlear elevations (as shown in Fig. 12), having a bone-facing surface for abutting at least a portion of the trochlea of the patient's knee and an articular surface generally opposite the bone-facing surface; each articular surface having a curvature (J-curve) generally disposed in a first plane (sagittal plane) (as shown in Fig. 8) and ML curve generally disposed in a second and third plane (frontal plane and transverse planes) (Figs. 9A and 12); each articular surfaces of the medial and lateral elevations optionally having an offset and a depth to the trochlea in the second and third plane (Fig. 9A discloses the transverse plane having an offset Da and Fig. 12 discloses the frontal plane having a taller lateral elevation than medial elevation), which can be equivalent or not; (c) the articular surface orientation of the trochlea portion to the distal and posterior condylar portions of the distal and posterior condyles are not dependent and are parallel or obliquely oriented (convergent or divergent) in at least one of the planes (as shown in Fig. 8); (d) an ML condylar offset is optionally integrated between the medial and lateral articular surfaces of the posterior (- posterior condylar offset) condylar portions of the distal and posterior condyles (offset Dp; Fig. 9A), this condylar offset being optionally equivalent between distal and posterior condylar portions; and (e) an ML trochlear offset is optionally integrated between the medial and lateral articular surfaces of the medial and lateral trochlear elevation, this trochlear offset optionally being the same as the condylar offset of the distal and posterior condyles (elevation offset of lateral and medial elevations shown in Fig. 12).
Yang is silent regarding each articular surfaces of the medial and lateral condyles may have a condylar offset in the second/frontal plane, which is optionally equivalent; an ML condylar offset is optionally integrated between the medial and lateral articular surfaces of the distal (= distal condylar offset). However, Hafez teaches similar femoral condyles 34/40 (Fig. 6) comprising each articular surfaces of the medial and lateral condyles may have a condylar offset in the second/frontal plane, which is optionally equivalent; an ML condylar offset is optionally integrated between the medial and lateral articular surfaces of the distal (= distal condylar offset) (offset lines 34a and 34b; Fig. 6). Therefore, 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 device in Yang to include each articular surfaces of the medial and lateral condyles may have a condylar offset in the second/frontal plane, which is optionally equivalent; an ML condylar offset is optionally integrated between the medial and lateral articular surfaces of the distal (= distal condylar offset), as taught and suggested by Hafez, for providing a patient specific prosthesis able to conform to a deformed joint (par. 0028 and abstract).
Regarding claim 109, Yang discloses wherein the sagittal J-curve of at least one of the joint-surface from the distal and posterior condyles (medial, lateral) or the trochlea (elevation, trochlea depth) is defined by a single, double or multi-radius or is fitting with a patient- specific J-curve (multi radius J-curve; Fig. 8).
Regarding claim 110, Yang discloses wherein the sagittal J-curve of at least one of the medial and lateral joint-surfaces from the distal and posterior condyles is optionally positioned at a fixed distance to the trochlea J-curves (medial and / or lateral elevation, trochlea depth), optionally symmetrically (fixed J-curve shown in Fig. 8).
Regarding claim 111, Yang discloses wherein the sagittal J-curve of at least one of the joint-surface from the distal and posterior condyles (medial, lateral narrowing angle) or the trochlea (medial and / or lateral elevation, trochlea depth == sulcus axis in frontal plane, Whiteside line in the axial plane) is optionally obliquely oriented in at least one of the planes, mainly the frontal and the axial planes (Fig. 8 discloses the J-curves of the condyles and the trochlea, where the J-curves are oblique shown by the circles).
Regarding claim 112, as best understood, Yang discloses wherein at least one of the joint facing-surface of the condylar portion and/ or of the trochlea portion has an articular geometry and dimensions corresponding (or close matching, or close fitting) to the patient's knee articular surface, in terms of sizing (comprising at least AP sizing), shape (comprising at least condylar and trochlear offset, J-curves and ML curves) and contour (comprising at least AP/ML, sizing, narrowing angle, trochlear height, posterior condyles height) (contoured articular surfaces; par. 0098).
Regarding claim 113, as best understood, Yang discloses wherein the tangent linking the medial and lateral most distal points of the bone-facing surfaces of the distal or the tangent linking the medial and lateral most posterior points of the bone-facing surfaces of the posterior condyles or the tangent linking the medial and lateral most anterior points of the bone-facing surfaces of trochlea portion are parallel or oblique with respect to one another (as shown in Fig. 8).
Regarding claim 114, Yang discloses wherein the bone-facing surfaces are defined with a single straight flat or oblique surface or with two staggered (offset) flat or oblique surfaces or with a staggered (offset) curved surface (Fig. 8 discloses straight and staggered surfaces).
Regarding claim 115, Yang discloses wherein the bone-facing surfaces are fixed to the bone with optionally with a cemented fixation (par. 0047).
Regarding claim 116, as best understood, Yang discloses wherein the prosthesis corresponds to different systems selected from one of the group of systems consisting of PS: Postero-Stabilized, UC: Ultra- Congruent, PCR: Posterior Cruciate Retaining, and BCR: Bi-Cruciate Retaining, and is adapted for mobile insert or fixed insert, for primary or revision knee (semi-constrained or constrained, hinged), optionally for cemented fixation, for monobloc or modular components, and for any material typically a material selected from one of the group of materials consisting of Ti, CrCo, and Ceramic (par. 0034 and 0094).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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