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 - 15 are pending and examined below. Claim Objections Regarding claims 5 and 6, the claims read “the trochlear bearing surface is comprised on a main portion”. Examiner suggests instead “the trochlear bearing surface is comprised configured on a main portion”. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. The claim limitations being interpreted under 35 U.S.C. 112(f) are as follows: “means for attaching it to a subject’s ulna bone and to the subject’s radius bone” in claim 1 3 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. Claim(s) 1 - 5 , 9 -13 , and 15 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by US 2010/0145465 ( Smirthwaite ) 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) Regarding claim 2, Smirthwaite further discloses wherein the olecranon aperture boundary bearing surface (Fig. 3, 26) is shaped to resurface at least a portion of the lateral boundary of the olecranon aperture of a subject (Fig. 3, wherein 26 is configured for this intended use because it is shaped to resurface the entire olecranon aperture) Regarding claim 3, Smirthwaite further discloses wherein the olecranon aperture boundary bearing surface comprises a lateral side wall upstanding from the humeral component (see annotated Fig. 14 below) 1062355 244475 0 0 Regarding claim 4, Smirthwaite further discloses wherein the olecranon aperture boundary bearing surface (Fig. 3, 26) comprises a base (see annotated Fig. 3) and a lateral side wall upstanding from the base (see annotated Fig. 3) , the olecranon aperture boundary bearing surface being configured such that the base blends into the lateral side wall (see annotated Fig. 3 , wherein the base blends into the lateral side wall) 824230 17780 Regarding claim 5, Smirthwaite further discloses wherein the trochlear bearing surface is comprised 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 ) center -1270 0 0 Regarding claim 9, Smirthwaite further disclose 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 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) 6 and 8 is /are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0145465 ( Smirthwaite ) in view of US 2005/0 0 43806 (Cook) 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) 857250 81280 0 0 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 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 the first embodiment of Cook to be stemless as taught by the second embodiment of Cook, in order to eliminate the need to drill and ream the medullary canal of the humerus (¶0025) Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0145465 ( Smirthwaite ) 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. 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) 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 Cook 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 2004/ 0 220675 (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 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 Cook with an augmentation plate, as taught by Lewis, in order to provide an additional anchor to stabilize the elbow replacement prosthesis. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MAXIMILIAN TOBIAS SPENCER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8382 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8am-5pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408.918.7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MAXIMILIAN TOBIAS SPENCER/ Examiner, Art Unit 3774 /JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774