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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
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: “fastening portion configured for releasable fastening to the resected femur" and "coupling portion configured for releasable force-fit and/or form-fit coupling to a tibial alignment instrument for aligning a tibial cutting block” in claims 2 and 5 respectively.
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 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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20070173854 A1 Berger et al, herein referred to as Berger.
Berger discloses: A femoral condyle trial implant for trial application to a resected femur in a knee joint replacement operation (¶ 0030; femoral prosthesis capable of being used as trial implant), the femoral condyle trial implant comprising: a front face comprising a medial condyle surface (Fig 13, proximal facing surface spacer 60) configured for articulation with a medial tibial plateau of a proximal tibia (¶ 0041), and comprising a lateral condyle surface configured (Figs 5 and 10, strategy for resection of condyle surface followed by fitting of implant that accommodates space; ¶0034) for articulation with a lateral tibial plateau of the proximal tibia (¶0030 & 0004; Fig 2); and a rear face (Fig 13 distal face surface of space 60); the rear face being planar and forming a flat bone contact surface configured for contacting a distal cut surface of the resected femur (Fig 10, cut surface 58).
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) 1-4 and 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axelson et al. US 20150045801 A1, herein referred to as Axelson.
RE. claim 1, Axelson discloses: A femoral condyle trial implant (Fig. 12, alignment system 200) for trial application to a resected femur ([0058], distal resected femur for alignment) in a knee joint replacement operation ([0061], realigning tibia and femur would be a knee joint replacement as described, removing distal femur and proximal tibia, “restored the tibial/femoral structure to a pre-arthritic state, the adjustable tibial resection guide 206 can be pinned to the anterior surface of the tibial bone.”),
Axelson fails to discloses the femoral condyle trial implant comprising: a front face comprising a medial condyle surface configured for articulation with a medial tibial plateau of a proximal tibia, and comprising a lateral condyle surface configured for articulation with a lateral tibial plateau of the proximal tibia; and a rear face; the rear face being planar and forming a flat bone contact surface configured for contacting a distal cut surface of the resected femur.
However, in another embodiment Axelson discloses a similar femoral condyle trail implant. Axelson teaches the femoral condyle trial implant comprising: a front face (Annotated Fig 20 below, femoral spacer elements 202) comprising a medial condyle surface (Annotated Fig. 12 below, distal surface 212 and proximal surface 213) configured for articulation with a medial tibial plateau of a proximal tibia (¶ 0058-0059, designed to allow articulation between femur and tibia as claimed), and comprising a lateral condyle surface (configured for articulation with a lateral tibial plateau of the proximal tibia (Abstract); and a rear face (Figure 12, proximal facing surface 207); the rear face being planar and forming a flat bone contact surface configured for contacting a distal cut surface of the resected femur ([0058], into contact with distal cut surface of resected femur as claimed).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date to modify the base invention of Axelson to incorporate femoral condyle trial implant comprising: a front face comprising a medial condyle surface configured for articulation with a medial tibial plateau of a proximal tibia, and comprising a lateral condyle surface configured for articulation with a lateral tibial plateau of the proximal tibia; and a rear face; the rear face being planar and forming a flat bone contact surface configured for contacting a distal cut surface of the resected femur, as taught and suggested by Axelson in another embodiment in order to allow joint articulation [0058]]
Annotated Figure 20 Axelson et al.
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RE. Claim 2, Axelson discloses the invention substantially as claimed and
as discussed above with respect to claim 1 and teaches a femoral condyle trial implant (200) further comprising at least one fastening portion (Fig 12, Elongate members 209; this element is interpreted under 112(f) as a “through-bore” or a “cylindrical fastening pin”, see lines 4-5 and 15-16 on page 11 of the instant application, and equivalents thereof) configured for releasable fastening to the resected femur ([0058] “The proximal surface 207 (Fig 12) contacts the distal surface of the prepared femoral bone and the elongate peg members 209 are received within previously prepared apertures in the prepared distal surface of the femur”).
RE. Claim 3, Axelson discloses the invention substantially as claimed and
as discussed above with respect to claim 1 but fails to disclose wherein the at least one fastening portion is a through-bore which extends in a proximodistal direction between the front face and the rear face and which is configured for receiving a cylindrical fastening pin.
However, in another embodiment Axelson discloses a similar femoral condyle trail implant. Axelson teaches a femoral condyle trial implant wherein the at least one fastening portion is a through-bore (Fig. 7, holes 53a and 53b, [0065]) which extends in a proximodistal direction between the front face and the rear face and which is configured for receiving a cylindrical fastening pin [50].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date to modify the combination of Axelson’s embodiments as discussed above to incorporate at least one fastening portion is a through-bore which extends in a proximodistal direction between the front face and the rear face and which is configured for receiving a cylindrical fastening pin as taught and suggested by Axelson in another embodiment in order to the resection guide [0052].
RE. Claim 4, Axelson as applied to claim 2 above, teaches wherein the at least one fastening portion is a cylindrical fastening pin (209) protruding from the rear face (207).
RE. Claim 5, Axelson as applied to claim 1 above, teaches: wherein the front face (Fig. 20, 202) (has at least one first coupling portion (Fig. 20, connection member 214; this element is interpreted under 112(f) as a “receiving bore, receiving cutout, receiving groove or the like” or a “plug-in, latching, clamping and/or snap-fit connection”, see lines 29-30 and 1-3 on pages 5-6 of the instant application, and equivalents thereof) configured for releasable force-fit and/or form-fit (Force-fit and/or form-it are known in the art to mean closely fit. The prior art meets the limitations as claimed.) coupling to a tibial alignment instrument (200) for aligning a tibial cutting block (Figure 1, cutting surface 15).
RE. Claim 10, Axelson as applied to claim 1 above, teaches: wherein the plurality of femoral condyle trial implants (200) are of different sizes and are configured for trial application to different sizes of femoral bones ([53], 11-16).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Axelson as applied to claim 5 above, in view of Wilkinson EP 3395269 A2, herein referred to as Wilkinson.
RE. claim 6, Axelson discloses the invention substantially as claimed and
as discussed above with respect to claim 5, but fails to disclose at least one first coupling portion is a receiving bore introduced into the front face and extending in an anteroposterior direction.
But Wilkson discloses a similar femoral condyle trial implant. Wilkinson teaches wherein the at least one first coupling portion (Fig 72-73, connector 188) is a receiving bore introduced into the front face (Annotated Fig 72 below, femoral trial implant 80) and extending in an anteroposterior direction ([0097], Fig. 72).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the base femoral condyle trial implant of Axelson to include at least one first coupling portion is a receiving bore introduced into the front face and extending in an anteroposterior direction, as taught and suggested by Wilkinson in order to allow posterior translation and flexion/extension of the tibial resection guide [0106].
RE. Claim 7, the combination of Axelson and Wilkinson as discussed above with respect to claim 6 discloses: wherein the front face (80) has at least one second coupling portion (Fig 70, stylus 160) configured for releasable force-fit and/or form-fit coupling (Force-fit and/or form-it are known in the art to mean closely fit. The prior art meets the limitations as claimed.) to a compensation element for dimensional compensation of a defect of a tibial plateau (Col 7, lines 18-38, Fig. 57).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the base femoral condyle trial implant of Wilkinson to include a front face that has at least one second coupling portion configured for releasable force-fit and/or form-fit coupling to a compensation element for dimensional compensation of a defect of a tibial plateau, as taught and suggested by Wilkinson in order to allow posterior translation and flexion/extension of the tibial resection guide [0106]].
RE. Claim 8, the combination of Axelson and Wilkinson as applied to claim 7 above teaches at least one compensation element (Fig. 12, 208) [58]).
RE. Claim 9, the combination of Axelson and Wilkinson as applied to claim 8 above teaches: further comprising a plurality (202 and 208, meets limitation of plurality of different compensation elements) of different compensation elements, wherein the different compensation elements have different proximodistal thicknesses for dimensional compensation of defects of different extents (202 and 208) [58].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799