DETAILED ACTION
This office action is responsive to the response to restriction requirement of June 18, 2026. By that response, claims 1-23, 25-28, and 30-50 were canceled; and claims 134-148 were newly presented. Claims 94-98, 103, 104, 108, 115, 117-126, and 134-148 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of Invention II, species 4, in the reply filed on June 17, 2026, is acknowledged. This election corresponds to claims 94-98, 103, 104, 115, 117-126, 134-140, and 146-148
Claims 108 and 141-145 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 17, 2026.
Specification
The disclosure is objected to because of the following informalities: [0065]-[0067] refer to figures 12A-C, which are not present in the figures. Figure 12 is present, and has no corresponding description. [0225] and [0296] also refer to fig. 12A; [0226] and [0299] refer to fig. 12B; [0232] refers to fig. 12C.
Appropriate correction is required.
Claim Interpretation
Applicant is permitted to be his own lexicographer. The claim term “tibia condyle receiver” is not a term that examiner knows. Studying the term in context of the disclosure makes clear that this is referring to the bony structures of the tibia which receive the femoral condyles, therein. Examiner generally understands these surfaces to be “tibial articular surfaces”, when standardized terminology is used.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 104 and 138-140 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 104 refers to releasing a stopper to allow “paddles of the first distractor to reposition away from one another until reaching an equilibrium”. Examiner is unclear as to what this means, and finds the metes and bounds of this limitation to be unclear, since examiner is not clear when the limitation is met or not met. Equilibrium in what way? What is causing this equilibrium (and what is it acting against)? Clarification is required. The disclosure has been studied and did not help examiner understand this term more clearly. Examiner requests citation for clarification of this teaching be provided.
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) 94, 103, 117-119, and 126 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rasmussen (US 2009/043310 A1).
Regarding claim 94, Rasmussen teaches a method of resecting a tibia as at fig. 13, the method comprising:
inserting a first distractor 13 between a distal femur condyle on bone 11 and a proximal tibia condyle receiver on bone 12 while a femur and a tibia are in mid-flexion as in the figures (fig. 5, fig. 7, fig. 9, etc., [0073]);
tensioning soft tissue proximate a joint of the tibia and the femur [0073] and using the first distractor to identify a gap between the distal femur condyle and the proximal tibia condyle receiver in mid-flexion when the soft tissue is tensioned (the arrangement of fig. 13 is considered to be the distractor 13 identifying the gap; gap further identified by placement of 52, supported by 47);
mounting a surgical pin (not shown) to the tibia 12 responsive to identifying the gap and establishing a necessary gap to accommodate an orthopedic implant (gap identified by location of 52, retained by 47; pins inserted through apertures 72);
positioning a cutting guide 52 with respect to the tibia 12 using the surgical pin passed through 72 [0083]; and,
resecting the tibia using the cutting guide (using slot 67, see fig. 18 [0084]).
Regarding claim 103, tensioning the soft tissue proximate the joint of the tibia 12 and the femur 11 includes monitoring rate of change in strain as a function of stress to tension the soft tissue, where tensioning is achieved when the rate of change in strain has markedly decreased, but the stress has not markedly decreased (e.g. visual indications of strain; torque wrench indicating stress; this will be achieved when the “adequate tension of the ligamentous structure is obtained” [0073]).
Regarding claim 117, Rasmussen teaches a method of resecting a tibia 12, the method comprising:
inserting a first distractor 13 between a distal femur condyle of 11 and a proximal tibia condyle receiver of 12 while a distal femur and a proximal tibia are in mid-flexion as seen in fig. 13;
using the first distractor 13 to identify a gap between the distal femur condyle of 11 and the proximal tibia condyle receiver of 12 in mid-flexion when soft tissue proximate the proximal tibia and distal femur are tensioned [0073];
calculating an implant gap necessary to accommodate an orthopedic implant inserted between the distal femur and the proximal tibia (e.g. raising and lowering 52 relative to 47);
mounting a surgical pin through hole 72 to the proximal tibia 12 responsive to calculating the implant gap (placement of 52 relative to 47);
positioning and orienting a cutting guide 52 with respect to the proximal tibia 12 by using the surgical pin through 72; and,
resecting the proximal tibia using the cutting guide 52 (using slot 67, [0084]), where an anterior-to-posterior slope of a proximal tibia resection is fixed by an anterior-to-posterior slope of the cutting guide 52.
Regarding claim 118, inserting the first distractor 13 between the distal femur condyle of 11 and the proximal tibia condyle receiver of 12 includes inserting the first distractor 13 between a distal femur medial condyle and a proximal tibia medial condyle receiver 11/12.
Regarding claim 119, inserting the first distractor 13 between the distal femur condyle and the proximal tibia condyle receiver 11/12 includes inserting the first distractor 13 between a distal femur lateral condyle and a proximal tibia lateral condyle receiver 11/12.
Regarding claim 126, the distal femur 12 includes at least a native femoral bone.
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) 95-98, and 134-137 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rasmussen in view of Trabish et al. (US 11,812,978 B2).
Regarding claims 95-98 and 134-137, Rasmussen teaches the limitations of claim 94, as above. However, Rasmussen fails to teach inserting the first distractor between the distal femur condyle of 11 and the proximal tibia condyle receiver of 12 includes inserting paddles of the first distractor between the distal femur condyle and the proximal tibia condyle receiver, where at least one of the paddles is repositionable with respect to a second of the paddles.
Trabish teaches a distractor 104 as at figs. 1A and 2A including paddles 130/128 for insertion into a flexed knee joint and capable of interacting with condyles and receivers, thereof.
Trabish’s distractor 104 is considered to be functionally equivalent to Rasmussen’s, essentially having different shaped components and a different actuation mechanism design.
It would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the Trabish distractor actuation mechanism/bone engagement designs for those of the Rasmussen design as a matter of a reduced profile tool with better ergonomics. Further, the paddle design of the Trabish distractor can be seen to distribute the load of the bones across a wider surface area, thereby reducing potential damage to the bones. The location where the modified device would be inserted is considered a centered location within a dwell location of the knee. Measurement components are visible on both Trabish and Rasmussen’s designs (portion 47 of Rasmussen functions as a measurement tool; structures shown in fig. 2B of Trabish, both of which can be considered a vertical support that limits motion to the vertical direction).
Allowable Subject Matter
Claims 104 and 138-140 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. No prior art rejection is presently made. The claims cannot be allowed until such time as the outstanding rejection under 35 USC 112(b) is overcome.
Claims 115, 120-125, and 146-148 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BATES/Primary Examiner, Art Unit 3799
