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 .
Response to Arguments
Applicant's arguments filed 06/15/2026 have been fully considered but they are not persuasive.
Applicant argues that Axelson fails to suggest that the curved distal surface 208 itself is properly shaped or configured to contact a tibial plateau surface. Applicant’s position is that the distal surface 208 is instead curved to allow the spacer elements 202 to slide along an arcuate path to “induce a varus of valgus angle to the cutting block until the jig and distal femoral resection are parallel.” However, as stated in the previous office action, Axelson teaches the femoral condyle trial implant comprises a front face (femoral spacer elements 202) comprising a medial condyle surface (see Annotated Fig. 12 below) 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 (see Annotated Fig. 12 below). It is the examiner’s position that the surfaces 212 of Axelson’s spacer elements 202 are fully capable of contacting a tibial plateau surface (see Annotated Fig. 12 below).
Applicant also argues on page 5 of remarks, that the mapped stylus 160 of Wilkinson is not secured to the trial implant front face forming a medial condyle surface, thereby fails to disclose or suggest “the front face has at least one second coupling portion configured for releasable force-fit and/or form-fit coupling to at least one compensation element for dimensional compensation of a defect of a tibial plateau.” Applicant’s position is that the stylus is instead secured to a restriction guide or other structures to check alignments and so on and the stylus 160 is not a compensation element for dimensional compensation of a defect of a tibial plateau. However, Examiner respectfully disagrees. In Fig 61a the stylus 160 can also be seen to extend past the resection guide where it can be seen interfacing with the medial condyle surface as it is sandwiched between the joint in Fig 62. Wilkinson also describes a pivot dimensional compensation in the claimed joint in Col 7, lines 18-38. This meets the claimed front face (80) having at least one second coupling portion (160) configured for releasable force-fit and/or form-fit coupling to at least one compensation element for dimensional compensation of a defect of a tibial plateau (Col 7, lines 18-38, Fig. 57) as claimed.
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 § 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) 1-6 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, in view of Wilkinson EP 3395269 A2, herein referred to as Wilkinson.
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; wherein the front face has at least one second coupling portion configured for releasable force-fit and/or form-fit coupling to at least one compensation element for dimensional compensation of a defect of a tibial plateau.
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 12 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 (Annotated Fig. 12 below); 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).
PNG
media_image1.png
547
660
media_image1.png
Greyscale
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].
However, Axelson fails to explicitly disclose wherein the front face has at least one second coupling portion configured for releasable force-fit and/or form-fit coupling to at least one compensation element for dimensional compensation of a defect of a tibial plateau.
Yet, in the same field of endeavor, 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); 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 2, Axelson as modified by Wilkson discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally 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 as modified by Wilkson 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 modified by Wilkson discloses the invention substantially as claimed and as discussed above with respect claim 2 above, and additionally 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 modified by Wilkson discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally 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 6, Axelson as modified by Wilkson discloses the invention substantially as claimed and as discussed above with respect to claim 5, and additionally teaches at least one first coupling portion is a receiving bore introduced into the front face and extending in an anteroposterior direction.
PNG
media_image2.png
571
397
media_image2.png
Greyscale
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 8, Axelson as modified by Wilkson discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches at least one compensation element (Fig. 12, 208) [58]).
RE. Claim 9, Axelson as modified by Wilkson discloses the invention substantially as claimed and as discussed above with respect to claim 8, and additionally 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].
RE. Claim 10, Axelson as modified by Wilkson discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally 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).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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.
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 at (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.
/A.F./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights