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 .
Status of Claims
Claims 1 and 5-15 are pending and examined below
Response to Arguments
The remarks of 07/14/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art doesn't explicitly teach or disclose all of the elements of amended claim 1. Specifically, applicant argues the following claim language:
“the radioulnar component being C-shaped in cross-section in the sagittal plane and sized so that the humeral component snap fits to the radioulnar component”
“the olecranon aperture boundary bearing surface comprising a concavely curved base and a lateral side wall upstanding from the base for resurfacing at least a portion of the lateral side of the boundary of the olecranon aperture of the subject, the olecranon aperture boundary bearing surface being configured such that the base blends curvedly into the lateral side wall”
These arguments are moot in light of the new 103 rejection below.
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.
Claim(s) 1, 5, 6, 8-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0145465 (Smirthwaite) in view of US 2005/0043806 (Cook) in view of EP 0006314 (Wadsworth)
Regarding claim 1, Smirthwaite discloses a total elbow replacement prosthesis (Fig. 3) comprising:
a radioulnar component (Fig. 3, 12) having an ulnar bearing surface (see annotated Fig. 3) and an anconeal process bearing surface (see annotated Fig. 3 below)
a humeral component (Fig. 3, 10) having a trochlear bearing surface (Fig. 1, 15, ¶0046), the trochlear bearing surface being configured for bearing against the ulnar bearing surface (annotated Fig. 3, ¶0042)
the humeral component further comprising an olecranon aperture boundary bearing surface (Fig. 3, 26), the anconeal process bearing surface being configured for bearing against the olecranon aperture boundary bearing surface (annotated Fig. 3, wherein the annotated anconeal process bearing surface is configured to bear against 26)
Smirthwaite discloses a radioulnar component (Fig. 3, 12) with a C shaped cross section in the sagittal plane (see Fig. 3) but doesn't explicitly teach or disclose that it is configured to snap-fit with the humeral component
Cook discloses wherein the radioulnar component is configured to snap fit with the humeral component (¶0004, “snap-fit”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the radioulnar component of Smirthwaite to be snap fit with the humeral component, as taught by Cook, in order to produce normal, pain-free joint function (¶0003)
Smirthwaite doesn't explicitly teach or disclose the olecranon aperture boundary bearing surface comprising a concavely curved base and a lateral side wall upstanding from the base for resurfacing at least a portion of the lateral side of the boundary of the olecranon aperture of the subject, the olecranon aperture boundary bearing surface being configured such that the base blends curvedly into the lateral side wall. Cook doesn't explicitly teach or disclose the olecranon aperture boundary bearing surface comprising a concavely curved base and a lateral side wall upstanding from the base for resurfacing at least a portion of the lateral side of the boundary of the olecranon aperture of the subject, the olecranon aperture boundary bearing surface being configured such that the base blends curvedly into the lateral side wall.
Wadsworth discloses the olecranon aperture boundary bearing surface comprising a concavely curved base (see annotated Fig. 4 below) and a lateral side wall upstanding from the base for resurfacing at least a portion of the lateral side of the boundary of the olecranon aperture of the subject, the olecranon aperture boundary bearing surface being configured such that the base blends curvedly into the lateral side wall (see annotated Fig. 4 below, wherein the base blends into the lateral side wall)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the humeral component of Smirthwaite in view of Cook with concavely curved base and a lateral side wall upstanding from the base, as taught by Wadsworth, in order to form a more secure articular surface.
Regarding claim 5, Smirthwaite further discloses wherein the trochlear bearing surface is configured on a main portion of the humeral component (see annotated Fig. 3), the main portion comprising an elongate member with an outer surface of substantially C-shaped cross-section (Fig. 3, wherein the main portion is both elongate and has an outer surface 15 with a substantially C-shaped cross-section), the radius of the outer surface of the main portion varying along the elongate axis of the trochlear bearing surface (see Fig. 3, wherien the radius of outer surface varies along the elongate axis)
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Regarding claim 6, Smirthwaite discloses wherein the trochlear bearing surface is comprised on a main portion of the humeral component (see annotated Fig. 3) the main portion being an elongate member with an outer surface (see Fig. 3, wherein main portion is elongate and has outer surface 15)
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Smirthwaite doesn't explicitly teach or disclose the outer surface of the main portion being substantially bobbin shaped.
Cook discloses a humeral component (Fig. 3) wherein the outer surface of the main portion is substantially bobbin shaped (Fig. 3, 40, ¶0004, wherein “spool” corresponds to substantially bobbin shaped)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the main portion of the humeral component of Smirthwaite to be substantially bobbin shaped, as taught by Cook, in order to restore anatomical articulation at the joint
Regarding claim 8, Smirthwaite discloses a humeral portion (see rejection of claim 1) but doesn't explicitly teach or disclose that it is stemless.
Cook discloses a humeral component that is stemless (Fig. 12, 110, ¶0025, “stemless”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the humeral component of Smirthwaite to be stemless as taught by Cook, in order to eliminate the need to drill and ream the medullary canal of the humerus (¶0025)
Regarding claim 9, Smirthwaite further discloses wherein the humeral component has an outer surface which is generally convex in the sagittal plane (Fig. 3, wherein 10 is generally convex in the sagittal plane)
Regarding claim 10, Smirthwaite further discloses wherein the olecranon aperture boundary bearing surface of the humeral component (Fig. 3, 26) has an outer surface which is generally concave in the coronal plane (Fig. 3, wherein 26 is generally concave in the coronal plane)
Regarding claim 11, Smirthwaite further discloses wherein the radioulnar component (Fig. 3, 12) has an outer surface which is generally concave in the sagittal plane (Fig. 3, wherein 12 has a generally concave outer surface in the sagittal plane)
Regarding claim 12, Smirthwaite further discloses wherein the ulnar bearing surface (Fig. 3, 15) blends into the anconeal process bearing surface (See Fig. 3, wherein 15 blends into 26)
Regarding claim 13, Smirthwaite further discloses wherein the radioulnar component (Fig. 3, 12) comprises means for attaching it to a subject's ulna bone and to the subject's radius bone (Fig. 3, 14, ¶0042, “attached to radius and ulna using bone screws 14”)
Regarding claim 15, Smirthwaite discloses a method of manufacturing a total elbow replacement prosthesis according to any preceding claim 1 (see rejection of claim 1), the method comprising:
making a radioulnar component having an ulnar bearing surface and an anconeal process bearing surface (see rejection of claim 1)
making a humeral component having a trochlear bearing surface (see rejection of claim 1), the trochlear bearing surface being configured for bearing against the ulnar bearing surface (see rejection of claim 1)
the humeral component further comprising an olecranon aperture boundary bearing surface (see rejection of claim 1), the anconeal process bearing surface being configured for bearing against the olecranon aperture boundary bearing surface (see rejection of claim 1)
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0145465 (Smirthwaite) in view of US 2005/0043806 (Cook) in view of EP 0006314 (Wadsworth), as applied to claims above, and further in view of US 4,242,758 (Amis)
Regarding claim 7, Smirthwaite discloses a trochlear bearing surface (see rejection of claim 1) but doesn't explicitly teach or disclose a medial condylar bearing surface and a lateral condylar bearing surface each for bearing against a corresponding depression in the ulnar bearing surface. Cook doesn't explicitly teach or disclose a medial condylar bearing surface and a lateral condylar bearing surface each for bearing against a corresponding depression in the ulnar bearing surface. Wadsworth doesn't explicitly teach or disclose a medial condylar bearing surface and a lateral condylar bearing surface each for bearing against a corresponding depression in the ulnar bearing surface.
Amis discloses an elbow prosthesis (Fig. 1) wherein the trochlear bearing surface comprises a medial condylar bearing surface (Fig. 9, 41) and a lateral condylar bearing surface (Fig. 9 ,39), each for bearing against a corresponding depression in the ulnar bearing surface (Fig. 9, wherein ulnar depressions 69 and 71 correspond to 41 and 39 respectively)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the trochlear bearing surface of Smirthwaite in view of Cook in view of Wadsworth with a medial condylar bearing surface and a lateral condylar bearing surface, as taught by Amis, in order to emulate the motion of the natural joint.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0145465 (Smirthwaite) in view of US 2005/0043806 (Cook) in view of EP 0006314 (Wadsworth), as applied to claims above, and further in view of US 2004/0220675 (Lewis)
Regarding claim 14, Smirthwaite discloses a total elbow replacement prosthesis (see rejection of claim 1) but doesn't explicitly teach or disclose an augmentation plate for attachment to a subject's radius and ulna. Cook doesn't explicitly teach or disclose an augmentation plate for attachment to a subject's radius and ulna. Wadsworth doesn't explicitly teach or disclose an augmentation plate for attachment to a subject's radius and ulna
Lewis discloses a total elbow replacement prosthesis (Fig. 3) comprising an augmentation plate (Fig. 2, 27) for attachment to a subject's radius and ulna (¶0028, wherein 27 is attached to radius and ulna)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the total elbow replacement prosthesis of Smirthwaite in view of Cook in view of Wadsworth with an augmentation plate, as taught by Lewis, in order to provide an additional anchor to stabilize the elbow replacement prosthesis.
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 extension fee 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
