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 10/1/2025 have been fully considered but they are not persuasive. Regarding the rejections under 35 U.S.C. 112(a) and (b), applicant argues the amendments overcome the rejections. This is not persuasive because the amendments add new issues as discussed in detail in the rejections below.
Regarding the rejection of claim 19 under 35 U.S.C. 102(a)(1) as being anticipated by Siebel, applicant discusses fig.1 of Siebel in detail, but the examiner relied upon the tibial implant of fig.3 which clearly discloses a tibial implant having a baseplate as claimed and a fixation member oriented at an acute angle as claimed. Regarding the new limitation “wherein the acute angle includes between 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment”, this limitation is directed to new matter and is unclear as discussed in detail below. Applicant argues Siebel’s focus on alignment to the mechanical axis addresses a different type of approach than the kinematic alignment approach claimed in the present application. This is not persuasive because as best understood, the new limitation is directed to an intended use of the tibial implant. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, Siebel has the same structure as the claimed invention, including a fixation member oriented at an acute angle relative to the distal surface of the medial portion. Therefore, since Siebel discloses the same structure as the instant application, the tibial implant of Siebel is capable of being used in the claimed manner, as best understood, to provide varus angles for kinematic and mechanical alignment.
Arguments regarding the rejection of claim 26 under 35 U.S.C. 103 as being anticipated by Metzger are persuasive in light of the amendments.
All other arguments are moot in view of the new grounds of rejection necessitated by the amendments.
Terminal Disclaimer
The terminal disclaimer filed on 10/1/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Pat. Nos. 10,136,997 and 10,631,991 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Specification
Amendments to the specification were received on 10/1/2025. The amendments are acceptable and have been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 8, 9, 18, 19, 21-24, and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 19, and 27 each require “wherein the acute angle includes between 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment” but these values are not disclosed in the specification. Applicant states the amendment is based on par.48 of the specification but par.48 of the specification does not discuss the limitation as claimed. Par.48 specifically states “it has generally been shown that an optimal distal femoral cut is typically 2-7° of valgus” and “With the kinematically aligned TKA it has generally been found that tibial component 116 placement of a few more degrees varus (e.g., about 0.1 degrees to about 5 degrees) and the femoral component 112 placed in a few more degrees valgus (e.g., about 0.1 degrees to about 5 degrees) than traditional mechanically aligned TKA results in improved patient outcomes”. Par.48 of the specification does not discuss the fixation member and does not discuss an acute angle of the fixation member as it relates to varus. Therefore, the limitation “wherein the acute angle includes between 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment” is directed to new matter.
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.
Claims 1-6, 8, 9, 18, 19, 21-24, 27, and 28 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.
Claims 1, 19, and 27 each recite “wherein the acute angle includes between 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment”. This limitation is unclear. How can an acute angle “include” additional varus? What does “additional” mean? It is unclear what “additional” is in reference to. As best understood, the limitation is interpreted to mean that the acute angle allows for 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment, wherein “additional” is in comparison to 0 degrees of varus.
Regarding claim 8, lines 2-3 recite “wherein the lateral portion has a greater surface area than the medial portion”. This is unclear because there is a medial portion and a lateral portion of the baseplate (see claim 1) as well as a medial portion and lateral portion of the fixation member (claim 8). Therefore, it is unclear which lines 2-3 of claim 8 are referring to. For examination, the claim is interpreted to mean --the lateral portion of the fixation member has a greater surface area than the medial portion of the fixation member--.
Regarding claim 19, line 9 recites “wherein the lateral portion has a greater surface area than the medial portion”. This is unclear because there is a medial portion and a lateral portion of the baseplate (see claim 19, line 3) as well as a medial portion and lateral portion of the fixation member (claim 19, line 8). Therefore, it is unclear which line 9 is referring to. For examination, the claim is interpreted to mean --the lateral portion of the fixation member has a greater surface area than the medial portion of the fixation member--.
Regarding claim 28, lines 2-3 recite “wherein the lateral portion has a greater surface area than the medial portion”. This is unclear because there is a medial portion and a lateral portion of the baseplate (see claim 26) as well as a medial portion and lateral portion of the fixation member (claim 28). Therefore, it is unclear which lines 2-3 of claim 28 is referring to. For examination, the claim is interpreted to mean --the lateral portion of the fixation member has a greater surface area than the medial portion of the fixation member--.
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.
Claims 1, 2, 8, 19, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siebel US 2004/0204766 (hereafter referred to as Siebel).
Regarding claim 1, Siebel discloses a tibial implant (fig.3) configured for attachment to a tibia in a knee arthroplasty, the tibial implant comprising a baseplate having a lateral portion 1 (left portion in fig.3; par.15) and a medial portion 2 (right portion in fig.3; par.16) oriented relative to an anteroposterior axis, each of the lateral portion and the medial portion having a distal surface (considered the underside) capable of interfacing with a resected proximal surface of the tibia, and a fixation member (stem in fig.3) coupled to and extending both distally and medially 2 from the baseplate such that the fixation member is oriented at an acute angle, alpha/3 (par.23 discloses 3 is an angle less than 90 degrees), relative to the distal surface of the medial portion (fig.3), wherein the acute angle is 87 degrees of varus as measured between the distal surface of the baseplate and an axis of symmetry of the fixation member such that the fixation member is capable of generally aligning with a central axis of a tibial diaphysis of the tibia when the tibia is coupled to the distal surface of the baseplate (this limitation is directed to the intended use and the structure of Siebel is the same as the invention and is therefore capable of performing the intended use). Siebel disclose an acute angle of 87 ± x degrees (par.5). As best understood in light of the 112b issues discussed above, since 87 degrees of varus is 3 degrees of “additional” varus (relative to 0 degrees in a perpendicular stem), the 87 degree angle of Siebel meets the claim. For example, the claim requires at a minimum 0.1 degrees of additional varus for kinematic alignment in addition to 2 degrees of varus for mechanical alignment, therefore the 3 degrees of varus provided by the 87 degree acute angle of the stem of Siebel provides at least 2.1 degrees of “additional varus” as compared to a neutral stem. Further, the limitation “wherein the acute angle includes between 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment” can be interpreted as an intended use. In which case, the tibial implant of Siebel having a stem forming an acute angle is capable of being implanted to provide between 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment.
Regarding claim 2, the fixation member comprises a stem as shown in fig.3.
Regarding claims 8 and 19, fig.3 shows the fixation member includes a lateral portion (portion on lateral side of the stem axis) and a medial portion (portion on the medial side of the stem axis). Since the lateral portion is slightly longer due to the acute angle, the lateral portion of the fixation member has a greater surface area than the medial portion of the fixation member.
Regarding claim 21, Siebel fig.3 shows the fixation member comprises a stem.
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.
Claims 3, 5, 6, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Siebel as applied to claims 2 and 21 above, and further in view of Justin et al. US 2003/0204263 (hereafter referred to as Justin). Regarding claims 3, 5, 6, and 22, Siebel discloses the tibial implant of claims 2 and 21 as discussed above. However, Siebel does not disclose that one or both of the keel and stem are configured to be removably attached to the baseplate, wherein the stem and keel are configured to couple together, and wherein the stem is configured to couple to the baseplate at the acute angle and coupling of the keel with the stem orients the keel at substantially a same acute angle relative to the distal surface of the medial portion as the acute angle, or wherein the stem and keel are configured to couple together, and wherein the keel is configured to couple to the baseplate at the acute angle and coupling of the stem with the keel orients the stem at substantially a same acute angle relative to the distal surface of the medial portion as the acute angle.
Justin teaches a tibial implant, in the same field of endeavor, wherein a fixation member comprises both of a keel 40 and stem 80 which are configured to be removably attached to a baseplate 10 (figs.1 and 3), wherein the stem 80 and keel 40 are configured to couple together, and wherein the stem is configured to couple to the baseplate at an angle (at least via bolt 92) and coupling of the keel with the stem orients the keel at substantially a same angle (fig.3 shows the keel and stem aligned), and wherein the keel is configured to couple to the baseplate at an angle (fig.3; coupled via at least bolt 92 and boss 18) and coupling of the stem with the keel orients the stem at substantially a same angle (fig.3 shows the keel and stem aligned), for the purpose of providing a modular tibial implant which allows for a low-profile tibial implant that can be implanted using a small incision while reducing trauma and aiding recovery (par.29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fixation member of Siebel to include a modular keel and stem that are configured to be coupled together and to the baseplate at the same angle as taught by Justin in order to provide a modular fixation member that allows for a minimal incision and reduced trauma to the knee joint. It would have been further obvious to maintain the acute angle of Siebel even when a modular fixation member as taught by Justin is used since Siebel discloses the acute angle better matches the anatomic knee joint.
Claims 1-4, 8, 9, and 18, are rejected under 35 U.S.C. 103 as being unpatentable over Metzger US 7,153,326 (hereafter referred to as Metzger) in view of Siebel.
Regarding claim 1, Metzger discloses a tibial implant 12 configured for attachment to a tibia in a knee arthroplasty, the tibial implant comprising a baseplate 22 having a lateral portion and a medial portion oriented relative to an anteroposterior axis, each of the lateral portion and the medial portion having a distal surface (undersurface) configured to interface with a resected proximal surface of the tibia (figs.1-2), and a fixation member 24 and 20 coupled to and extending both distally and medially from the baseplate such that the fixation member is oriented at an acute angle relative to the distal surface of the medial portion (figs.1-2), wherein the acute angle is measured between the distal surface of the baseplate and an axis of symmetry of the fixation member (specifically the long axis of symmetry of keel 24) such that the fixation member is capable of generally aligning with a central axis of a tibial diaphysis of the tibia when the tibia is coupled to the distal surface of the baseplate. While Metzger discloses an acute angle (see the angle between 24 and 22 on the medial side in figs. 1-2), Metzger does not specifically disclose an acute angle value in degrees.
Siebel teaches a tibial implant, in the same field of endeavor, wherein a fixation member forms an angle of 87 degrees ± x (par.5) for the purpose of matching an anatomical knee (par.5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an acute angle of 87 degrees for the fixation member of Metzger since Siebel teaches about 87 degrees and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A). As best understood in light of the 112b issues discussed above, since 87 degrees provides 3 degrees of “additional” varus (relative to a stem extending perpendicularly from the baseplate), the 87 degree angle taught Siebel teaches the limitation “wherein the acute angle includes between 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment”. For example, the claim requires at a minimum 0.1 degrees of additional varus for kinematic alignment in addition to 2 degrees of varus for mechanical alignment, therefore the 3 degrees of varus provided by the 87 degree acute angle of the stem of Siebel provides at least 2.1 degrees of “additional varus” (as compared to a perpendicular stem). Further, the limitation “wherein the acute angle includes between 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment” can be interpreted as an intended use. In which case, the tibial implant of Metzger in view of Siebel having a stem forming an acute angle is capable of being implanted to provide between 0.1 degrees to 5 degrees of additional varus for kinematic alignment in addition to between 2 degrees and 7 degrees of varus for mechanical alignment.
Regarding claims 2-4 and 9, see fig.1 of Metzger for the fixation member comprising keel 24 and stem 20 which are both removably attached to the baseplate and capable of being rotated 180 degrees as claimed.
Regarding claim 18, Metzger discloses the fixation member comprises both of a keel 24 and a stem 20 and further discloses a kit with a plurality of stems and trays to accommodate variations of prosthesis recipients (col.5, lines 57-60). While Metzger does not specifically state that all of the plurality of stems are configured to universally couple with a keel, it is standard in the art of prosthetic kits to have modular parts be capable of universally coupling together in order for the surgeon to be able to mix and match the components to best fit a particular patient. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to ensure that the plurality of stems of Metzger are configured to universally couple with a keel in order to allow for a surgeon to assemble the tibial prosthesis to best suit a particular patient.
Allowable Subject Matter
Claims 23 and 24 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 26 is allowed.
Claims 27-28 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774