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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant’s arguments, filed 4/3/26, with respect to claim objection have been fully considered and are persuasive. The objections of 2, 4, 5 has been withdrawn.
Applicant’s arguments, filed 4/3/26, with respect to 35 USC 112(b) rejections have been fully considered and are persuasive. The rejection of claim 3 has been withdrawn.
Applicant’s arguments, filed 4/3/26, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a locking element configured for locking a direction and/or axial rotational angle of the ulnar stem portion” and “a fixing element configured for fixing the linking body to the remainder of the ulnar stem portion” in claim 4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 3 objected to because of the following informalities: “at least two of the plurality of linking bodies have” should read “at least two of the plurality of linking bodies having”. Appropriate correction is required.
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.
Claim(s) 1-2, 5, 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiss (US20030208277).
Regarding claim 1, Weiss discloses an elbow joint prosthetic implant (FIG 8) comprising: a humeral component (230) comprising a humeral stem portion (231) configured for placement within the humeral intramedullary canal of a subject ([0057]), an ulnar component (210) comprising an ulnar stem portion (211) configured for placement within the ulnar intramedullary canal of the subject ([0055]), the humeral component (230) and ulnar component (210) are connected by an implant elbow joint (where 260 is the proximal elbow joint and 236 is the distal elbow joint), wherein the ulnar component (210) further comprises an angulation joint (where 244 is the proximal angulation joint and 224 is the distal angulation joint) that is separate from the implant elbow joint (FIG 8), the angulation joint (244/224) has at least one degree of freedom of rotational movement ([0065]), and that angulation joint is configured to adjust and fix a varus-valgus direction of the ulnar stem portion (FIG 13, 14).
Regarding claim 2, Weiss discloses the elbow joint prosthetic implant according to claim 1, wherein the implant elbow joint (260/236) comprises a proximal part (260) configured to couple to a distal part (236) thereby forming the implant elbow joint; the angulation joint (244/224) comprises a proximal angulation coupling (244) configured to couple to a distal angulation coupling (224), thereby forming the angulation joint (244/224), the ulnar component (210) comprises a linking body (240) having a proximal end (right end in FIG 8) and a distal end (left end in FIG 8), the proximal end of the linking body is disposed with the distal part (236) of the elbow joint (FIG 8), the distal end of the linking body (left end in FIG 8) is disposed with the proximal angulation coupling (224) of the angulation joint (FIG 8), a position and/or orientation of the distal elbow coupling and the proximal angulation coupling is fixed (the positionings outside of axis of rotation of elbow and angulation are fixed), and the linking body (240) is dismountable from the ulnar component (FIG 8).
Regarding claim 5, Weiss discloses the elbow joint prosthetic implant according to claim 2, wherein the proximal angulation coupling (244) and distal angulation coupling (224) form the angulation joint having one degree of rotational freedom ([0065], FIG 13, 14), one of the proximal angulation coupling (244) or distal angulation (224) coupling comprises a protrusion (244, FIG 8), the other of the proximal angulation coupling (244) or distal angulation coupling (224) comprises a reciprocating tapered hole configured to engage the tapered member thereby forming the one degree of rotational freedom angulation joint (224, FIG 8, FIG 14).
Regarding claim 7, Weiss discloses the elbow joint prosthetic implant according to claim 1, wherein the ulnar stem portion (211) is a rigid monoblock (FIG 8 shows ulnar stem portion 211 as one piece).
Regarding claim 8, Weiss discloses the elbow joint prosthetic implant according to claim 1, wherein the ulnar stem portion (211) is least partially articulated, allowing the ulnar stem portion (211) to conform to the shape of the ulnar intramedullary canal ([0055], FIG 8).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3, 12-14 is rejected under 35 U.S.C. 103 as being unpatentable over Weiss (US20030208277), as applied to claim 2 above, and further in view of Deransart (11364127).
Regarding claim 3, Weiss discloses the invention of claim 2, but fails to disclose a plurality of linking bodies, at least two of the plurality of linking bodies having a different fixed position and/or different fixed orientation relation between the elbow joint distal part and the proximal angulation coupling.
Deransart also discloses a prosthetic implant (Col 2, Line 11). Deransart teaches the implant comprises a plurality of linking bodies (FIG 7F, #168), at least two of the plurality of linking bodies having a different fixed position and/or different fixed orientation relation between the joint distal part (FIG 7F, #163B) and the proximal angulation coupling (FIG 7F, #164).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Weiss’ elbow joint prosthesis to include a plurality of linking bodies, at least two all having a different fixed position and/or different fixed orientation relation between the elbow joint distal part and the proximal angulation coupling, as taught by Deransart, in order to allow for a clinician to make or change reconstruction decisions during surgery (Col. 10, line 30).
Regarding claim 12, Weiss as modified by Deransart discloses the invention of claim 3, wherein at least two of plurality of linking bodies (FIG 7F, #168) have a different fixed distance between the elbow joint distal part (FIG 7F, #163B) and the proximal angulation coupling (FIG 7F, #164) (Col. 10, Line 44, where having or eliminating the middle portion of the coupler is the same as the coupler having different fixed distances).
Regarding claim 13, Weiss as modified by Deransart discloses the invention of claim 3, wherein all of plurality of linking bodies (FIG 7F, #168) have a different fixed distance between the elbow joint distal part (FIG 7F, #163B) and the proximal angulation coupling (FIG 7F, #164) (Col. 10, Line 44, where having or eliminating the middle portion of the coupler is the same as the coupler having different fixed distances).
Regarding claim 14, Weiss as modified by Deransart discloses the invention of claim 3, wherein all of the plurality of linking bodies (FIG 7F, #168) have a different fixed position and/or different fixed orientation relation between the elbow joint distal part (FIG 7F, #163B) and the proximal angulation coupling (FIG 7F, #164) (Col. 10, Line 44, where having or eliminating the middle portion of the coupler is the same as the coupler having different fixed positions).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Weiss (US20030208277) as applied to claim 2 above, and further in view of Berelsman (US 20100179661) and Orbay (20200397591).
Regarding claim 4, Ball discloses the invention of claim 1 and the presence of a connecting mechanism (240), but does not disclose a locking element configured for locking a direction and/or axial rotational angle of the ulnar stem portion, a fixing element configured for fixing the linking body to the remainder of the ulnar stem portion, a combined locking and fixing element configured for both locking a direction and/or axial rotational angle of the ulnar stem portion and fixing the linking body to the remainder of the ulnar stem portion.
Berelsman also discloses an elbow joint prosthetic implant (10n; Figs. 16-18) comprising an ulnar component comprising an ulnar stem portion (14n). Berelsman teaches a locking element (FIG 20B, #800, 806; this element is interpreted under 112(f) as a fixation screw, see page 16, line 16 of the instant application, and equivalents thereof) configured for locking a direction and/or axial rotational angle of the ulnar stem portion (FIG 20B, #14p’. Paragraph 127: “prevent bearing insert from rotating relative to integrally attached cage portion”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Weiss’ elbow joint prosthesis to include a locking element configured for locking a direction and/or axial rotational angle of the ulnar stem portion as taught by Berelsman in order to minimize stress in the bearing components and more accurately mimic normal joint motion ([10]).
Orbay teaches a fixing element (208; this element is interpreted under 112(f) as a threaded member, see page 20, line 13 of the instant application, and equivalents thereof) configured for fixing the linking body to the remainder of the ulnar stem portion (Paragraph 44: “Thread 303 is adapted to engage the thread 208 on the inner surface of the entrance 207 of the ulnar head component 200.” Ulnar head component 200 is part of ulnar medullary stem 104).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified Weiss’ elbow joint prosthesis to include a fixing element configured for fixing the linking body to the remainder of the ulnar stem portion as taught by Orbay to provide joint stability ([0008]).
It would also be obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have combined the locking and fixing element configured for both locking a direction and/or axial rotational angle of the ulnar stem portion and fixing the linking body to the remainder of the ulnar stem portion, as taught by both Berelsman and Orbay, to increase the accuracy and stability of the joint (Berelsman [10]; Orbay [0008]).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Weiss (US20030208277) as applied to claim 5 above, and further in view of Stockmans (20220160514).
Regarding claim 6, Weiss discloses the invention of claim 5 but fails to disclose the proximal angulation coupling and distal angulation coupling form the angulation joint having two or three degrees of rotational freedom, one of the proximal angulation coupling or distal angulation coupling comprises a spherical member, the other of proximal angulation coupling or distal angulation coupling comprises a reciprocating socket configured to engage the spherical member, thereby forming the two or three degrees of rotational freedom angulation joint.
Stockmans also discloses a prosthetic implant (100) comprising proximal (FIG 5, #120) and distal angulation couplings (FIG 5, #110) for joints, such as an elbow ([0002]). Stockmans teaches that one of the proximal angulation coupling (FIG 5, #120) or distal angulation coupling (FIG 5, #100) comprises a spherical member (FIG 5, #121), the other of proximal angulation coupling (FIG 5, #120) or distal angulation coupling (FIG 5, #100) comprises a reciprocating socket configured to engage the spherical member (FIG 4, #103), thereby forming the two or three degrees of rotational freedom angulation joint, as it is understood in the art that ball and socket joints form two or three degrees of rotational freedom.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Weiss’ elbow joint prosthesis to include the proximal angulation coupling and distal angulation coupling form the angulation joint having two or three degrees of rotational freedom, one of the proximal angulation coupling or distal angulation coupling comprises a spherical member, the other of proximal angulation coupling or distal angulation coupling comprises a reciprocating socket configured to engage the spherical member, thereby forming the two or three degrees of rotational freedom angulation joint as taught by Stockman in order to provide an improved implant with controlled impingement and reduced wear [0006; 0008].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (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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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights