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 .
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.
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 2, 5, 14, 19 and 20 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.
Claim 2 is rejected under 35 U.S.C. § 112(b) as being indefinite. Claim 2 depends from claim 1 and recites that “the first degree is about 3 degrees of hyperextension.” The term “about” is a relative term that, while it may be interpreted by a person of ordinary skill in the art as permitting some range of variation around 3 degrees, does not in this instance provide an objective boundary for that range. The specification does not define the term “about” or otherwise identify the permissible tolerance associated with the recited angular position. Accordingly, although the Office may construe “about 3 degrees” consistent with the general meaning of approximation in the art, the metes and bounds of the limitation remain unclear because it is not reasonably certain what angular positions are encompassed, including whether the limitation overlaps with the “0 degrees or less” language of claim 1. For examination purposes, “about 3 degrees” will be construed broadly enough to reach values near full extension, including 0 degrees.
Claim 5 is rejected under 35 U.S.C. § 112(b) as being indefinite. Claim 5 depends from claim 1 and recites that “the first degree is about 3 degrees of hyperextension and the second degree is about 120 degrees of flexion.” The term “about” may be understood in the art to indicate a range of approximation around the stated values, but the claim and specification do not provide an objective basis for determining the extent of that range. In particular, the disclosure does not define the tolerance for “about 3 degrees of hyperextension” or “about 120 degrees of flexion,” nor does it clarify whether the first recited angular position includes or excludes positions at or near 0 degrees of flexion. As a result, even if the examiner were to construe “about” as a limited range consistent with its general meaning, the scope of the claim remains uncertain and not reasonably certain to a person of ordinary skill in the art. For examination purposes, “about 3 degrees” will be construed broadly enough to reach values near full extension, including 0 degrees.
Claim 14 is rejected under 35 U.S.C. § 112(b) as being indefinite. Claim 14 depends from claim 13 and recites that “the first degree is about 3 degrees of hyperextension and the second degree is about 120 degrees of flexion.” The modifier “about” is a relative term that may be construed by a skilled artisan as encompassing a range around the stated values; however, the claim and specification do not define the permissible variation or provide an objective standard for determining the boundaries of that range. Accordingly, while an examiner may interpret “about 3 degrees” in a manner consistent with the ordinary usage of approximation, the claim fails to particularly point out and distinctly claim the invention because the scope of the first and second degrees is not reasonably certain. For examination purposes, “about 3 degrees” will be construed broadly enough to reach values near full extension, including 0 degrees.
Claim 19 is rejected under 35 U.S.C. § 112(b) as being indefinite. Claim 19 recites that the femoral articular surface contacts the tibial articular surface at “about 3 degrees of hyperextension” and “about 120 degrees of flexion.” The term “about” may be treated by an examiner as denoting a range of values consistent with ordinary usage in the art; however, the claim and specification do not define the degree of permissible variation or otherwise provide an objective boundary for that range. As a result, even under a construction that gives “about” its general approximate meaning, the scope of the angular limitations remains uncertain, including the extent to which the limitation encompasses positions near 0 degrees of flexion. Therefore, the claim does not inform, with reasonable certainty, the scope of the invention. For examination purposes, “about 3 degrees” will be construed broadly enough to reach values near full extension, including 0 degrees.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8-10, 12-14, 16 as understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by White (Pub. No.: 2020/0352727 A1; cited by applicant).
With regard to claims 1 and 13, White discloses a hinged orthopaedic prosthesis system 100, comprising: a femoral component 106 configured to be coupled to a surgically-prepared distal end of a patient’s femur, the femoral component including a lateral condyle 304 and a medial condyle 302 spaced apart from each other and an intercondylar femoral box (310, 312, 314, 316) defined between the lateral and medial condyles, wherein at least one of the lateral and medial condyles includes a femoral articular surface 302, 304; a housing assembly 108 including an upper housing (122, 124, 132, 134) and a housing stem 120 extending inferiorly from the upper housing, wherein the upper housing is configured to be received into the intercondylar femoral box of the femoral component to couple the femoral component to the housing assembly (see paragraph [0051]), wherein the femoral component is rotatable relative to the housing assembly about a flexion-extension axis of rotation (604, 700); and a tibial component including (i) a platform (102, 104) having a superior surface (202, 204) including a tibial articular surface configured to articulate with the femoral articular surface of the femoral component and (ii) a tibial stem 116 extending downwardly from an inferior surface of the platform and including an internal passageway 118 having an opening 212 located on the superior surface of the platform and configured to receive the housing stem of the housing assembly (see paragraph [0046]); wherein the femoral articular surface contacts the tibial articular surface at a first contact point on the femoral articular surface at a first degree of flexion of 0 degrees or less and contacts the tibial articular surface at a second contact point on the femoral articular surface at a second degree of flexion greater than 90 degrees (see paragraphs [0054], [0055], [0057] - [0062]; and Figures 8, 10-15, 21 and 22), and wherein the femoral articular surface has a first curved surface section extending from the first contact point to the second contact point and wherein the first curved surface section has a constant radius of curvature when viewed in a sagittal plane and an origin of the constant radius of curvature of the first curved surface section is coincident with the flexion-extension axis of rotation 604 (see paragraphs [0054], [0055], [0057] - [0062]; and Figures 8, 10-15, 21, and 22, also see annotated Figures 6, 8, and 13 below).
With regard to claim 2, White further discloses the first degree is about 3 degrees of hyperextension, i.e. around zero degrees (see paragraph [0054]). As explained in the 112(b) rejection above, “ For examination purposes, “about 3 degrees” will be construed broadly enough to reach values near full extension, including 0 degrees”.
With regard to claim 3, White further discloses the second degree is greater than 100 degrees of flexion (see paragraph [0054]).
With regard to claim 4, White further discloses the second degree is about 120 degrees of flexion (see paragraph [0054]).
With regard to claims 5 and 14, White further discloses the first degree is about 3 degrees of hyperextension and the second degree is about 120 degrees of flexion (see paragraph [0054]).
With regard to claims 8 and 16, White further discloses a tibial stem axis (it is noted the tibial stem 116 inherently has a stem longitudinal axis, see annotated Figure 8 below) and wherein the flexion-extension axis of rotation (for example 604 in Figure 8) is posterior to the tibial stem axis.
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With regard to claims 9 and 10, White further discloses the tibial articular surface includes a dwell point that defines a distal-most point on the tibial articular surface (see annotated Figures 6, 8 and 13 below) and wherein the tibial articular surface includes a first tibial surface section posterior of the dwell point that has a constant radius of curvature (it is noted that the constant radius of curvature is coincident with, or otherwise lies on the constant radius of curvature of the first curved surface section).
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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 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over White in view of Williams, et al. (Pub. No.: US 2009/0326667 A1).
Whites discloses the claimed invention except for the tibial bearing 104 having a stem. Whites also discloses that the tibial bearing 104 is illustratively embodied as a “fixed” insert or bearing in which 104 is secured to the component 102. However, Whites further states that the bearing 104 may be embodied as a “mobile” or rotating tibial bearing or insert (see Paragraph [0047]).
Williams, et al. discloses a system comprising a femoral component 12, a tibial bearing 14 (i.e. a tibial insert) and a tibial tray 16. The tibial bearing 14 includes a steam 36. The tibial bearing 14 is configured to be couple to the tray 16 as a rotating or mobile tibial bearing, i.e. configured to rotate relative to the tray during use.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the system of White with the tibial bearing 14 having a stem in view of Williams, et at. in order to make the tibial bearing 14 rotatable or mobile.
Allowable Subject Matter
Claims 19 and 20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 6, 7, 11, 15 and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for prior art of interest.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eduardo C Robert whose telephone number is (571)272-4719. The examiner can normally be reached M-F: 8 AM-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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