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 .
Election/Restrictions
Applicant’s election without traverse of Group I: a provisional tibial prosthesis system and claims 1-15 pertaining to the elected invention. However, Group III: Claims 19,20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Note Group II and its claim were canceled in response to the requirement. Election was made without traverse in the reply filed on 3/4/2026.
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) 1-3,7-9,12,13,15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Claypool et al. (2012/0158152). Fig. 1 shows a provisional tibial prosthesis system 30A comprising: a tibial component 38A, a base component 34A, a shim 36A. Fig. 5 shows the tibial component having a rail (156A,170A,168A,172A) that defines a pocket 150A and a distal surface 152A configured to seat on a resected proximal surface of a tibia T (see for example Figs. 7,8); a base component configured to seat within the pocket of the tibial component when positioned thereon, see Figs. 1,6. Thus, when so positioned with the pocket, the base component has a substantially flat proximal surface 84A and a substantially flat distal surface 82A; see Fig. 3B. Fig. 4A shows a shim 36A having a feature 144A configured to couple with a second feature 96A of the base component 34A (see Fig. 3B for illustration) when disposed thereon, wherein the shim has a substantially flat proximal surface 124A. Regarding claim 2, it can be seen (Fig. 1) that neither the proximal surface of the base component 34A nor the proximal surface of the shim 36A is configured to articulate with a femoral prosthesis, since both are flat. Regarding claims 3,9 the feature (slot) of the shim is configured to mate with and be complementary to the second feature (elongate boss) of the base component, see for example Fig. 1 when the shim is placed atop the proximal surface of the base component. With respect to claim 7, Claypool et al. disclose (paragraph 73) the shim is one of a plurality of shims each having a different proximal-distal thickness from one another. Regarding claim 8, Claypool et al. additionally disclose (paragraphs 84,86,87) any one of the plurality of shims is stackable on the base component by sliding the feature of one of the plurality of shims anterior-posterior into the second feature of the base component. With respect to claim 12, Fig. 3B shows a periphery 108A of the base component 34A is configured to seat against an interior of the rail of the tibial component, see Figs.1,6. With respect to claim 13, Claypool et al. disclose (paragraph 8) the tibial component comprises one of a provisional component or a permanent implant (not having to remove a knee component and only use shims). Regarding claim 15, Fig. 1 shows the base component with the substantially flat distal surface 82A (see Fig. 3B) rests on a substantially flat proximal surface of the tibial component within the pocket 150A (see Fig. 5), and wherein the base component has no feature to couple with the tibial component when so seated on the substantially flat proximal surface of the tibial component but is held in position within the pocket atop the substantially flat proximal surface of the tibial component by gravity and/or a compressive force.
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) 4,6 are rejected under 35 U.S.C. 103 as being unpatentable over Claypool et al. (2012/0158152) in view of Green et al. (2022/0168111). Claypool et al. is explained as before. However, Claypool et al. did not explicitly disclose the distal surface of the base component and the proximal surface of the base component have a substantially same shape and size so as to be reversable in orientation between a right knee and a left knee of a patient. Green et al. teach (paragraphs 34,36) that the distal surface of an implant component and the proximal surface of the implant component have a substantially same shape and size so as to be reversable in orientation between a right knee and a left knee of a patient. It would have been obvious to one of ordinary skill in the art to provide reversible orientation components as taught by Green et al. with the provisional tibial prosthesis system of Claypool et al. and make the base component with reversible surfaces for left and right knee since such a modification only involves routine skill in the art to provide ability to provide more versatility to the orthopedic surgeon when placing the provisional tibial prosthesis in the site. With respect to claim 6, Claypool et al. show the feature of the shim 36A comprises a boss with a dovetail 136A (see Fig. 4B) and the corresponding feature of the joining prosthesis component 32A comprises a notch with a corresponding dovetail 66A (Fig. 2B). However, the Claypool did not explicitly show the dovetail coupling arrangement with the baseplate. It would have been obvious to one of ordinary skill in the art to alternatively arrange the coupling arrangements between the shim and baseplate along with the upper femoral component such that the shim has the boss with a dovetail to engage with a dovetail notch in the baseplate in the provisional tibial prosthesis system of Claypool such that it prevents a stronger interlock between shim and baseplate and such a modification only involves routine skill in the art.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Claypool et al. (2012/0158152) in view of Green et al. (2022/0168111) as applied to claim 4 above, and further in view of Steiner et al. (2008/0154379). Claypool et al. in view of Green et al. is explained supra. However, Claypool as modified by Green did not disclose a third feature of the base component having an identical configuration with the second feature of the base component, wherein the third feature is on a distal side of the base component and the second feature is on a proximal side of the base component. Please note that the base component of the claimed features of the tibial system is an intermediate element between the shim and tibial component. Steiner et al. teach (fig. 2) that a third feature 42 on a distal side of an intermediate component of a prosthesis and the second feature 40 is on a proximal side of an intermediate component of the prosthesis 10. It would have been obvious to one of ordinary skill in the art to provide double connection or as recited in the claim a third feature on a distal side of an intermediate component of a prosthesis and the second feature is on a proximal side of an intermediate component of the prosthesis as taught by Steiner et al. with the provisional tibial prosthesis system of Claypool et al. as modified by Green et al. such that it provides the ability to interlock the intermediate component or base component in either orientation in which it is placed by having the additional third feature or dovetail as seen in Steiner.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Claypool et al. (2012/0158152) in view of Biedermann (CN 1148798). Claypool et al. is explained as before. However, Claypool et al. did not explicitly disclose the feature comprises a male projection and the second feature comprises a complimentary female recess in the base component. Biedermann teaches (Fig. 3) that a shim element 22 include a feature that defines a male projection 32 to be received in a complimentary female recess 31 in a base component 30. It would have been obvious to one of ordinary skill in the art to alternatively reverse cooperating or complimentary male and female interlocking elements as taught by Biedermann with the provisional tibial prosthesis system of Claypool et al. since such a modification only involves routine skill in the art to provide ability to alternate what components are inserted first or different directions depending on access directions.
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Claypool et al. (2012/0158152) in view of Rogalski (2003/0144738). Claypool et al. is explained as before. However, Claypool et al. did not explicitly disclose each of the shim and the base component have a removal feature to aid in removing the shim and the base component from a knee joint. Rogalski teaches (Fig. 1a) a plate or shim or base element 100 that includes a removal feature 106, 108 which enables a tool 114 to remove or reposition the component, Fig. 3. It would have been obvious to one of ordinary skill in the art to incorporate a removal feature to aid in removing the shim and the base component from a knee joint as taught by Rogalski with the provisional tibial prosthesis system of Claypool et al. such additional sizes or dimension components can be placed therein a tibial site as needed.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Claypool et al. (2012/0158152) in view of Chana et al. (WO 2011/127477). Claypool et al. is explained as before. However, Claypool et al. did not explicitly disclose the system include a femoral cut guide configured to reference one of the proximal surface of the base component or the proximal surface of the shim when making a resection of a femur. Chana et al. teaches (Fig. 4H1) that a femoral cut guide 1400 configured to reference one of the proximal surface of the base component T1 or the proximal surface of the shim when making a resection of a femur DF. It would have been obvious to one of ordinary skill in the art to use a femoral cut guide as taught by Chana et al. with the provisional tibial prosthesis system of Claypool et al. such that the surgeon can provide proper orientation of the femoral cuts needed to prepare for a femoral component to correctly match articulation or corresponding cooperating components with the tibia.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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