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 Species I and claims 21 – 27 in the reply filed on 06/22/2026 is acknowledged.
Claims 45 – 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/22/2026.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the leaf spring included in the slot of claim 26 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 32 is objected to because of the following informalities:
In claim 32, the recitation of “through on of three” should read as “through one of three”, for clarity. Appropriate correction is required.
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 32 is 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.
In claims 32 and 36, the recitation of “through one of three posterior most throughbores in the distal portion” makes the claim unclear and vague for not specifying the correlation between the three throughbores and the first and second through bores, clarification is requested.
For the sake of examination, the three throughbores are interpreted as including the first and second throughbores.
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) 21 – 25, 27 – 29 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeager et al. (US Pub. 2022/0287724 A1) in view of Miles et al. (US Pub. 2021/0267607 A1).
Claim 21, Yeager discloses a method of preparing a condyle of a femur of a patient to receive a femoral condylar implant using a femoral preparation guide having a distal portion and a posterior portion [abstract, Figs. 1 – 5, guide 100 has a distal portion by #110 and a portion by #118 defines the posterior portion], the posterior portion have a femoral bone-facing surface and an opposing tibial bone-facing surface [at least a portion of 118 defines a surface portion facing towards femur “F” and a surface portion facing towards tibia “T”], the method comprising:
attaching to a shim to the opposing tibial bone-facing surface of the posterior portion of the femoral preparation guide [attaching shim 300 to 118, Figs. 4], the shim having an outer surface [defined by a surface of 300 facing the tibia];
positioning the femoral preparation guide such that (i) the distal portion of the femoral preparation guide is adjacent to a resected distal region of the condyle of the femur [adjacent to drilled hole 235, and/or the resected portion by blade 240, and/or the resected access hole 200, Figs. 3 - 4], (ii) the femoral bone-facing surface of the posterior portion of the femoral preparation guide is adjacent to a posterior region of the condyle of the femur [Figs. 4], and (iii) the outer surface of the shim is adjacent to a resected tibial plateau of a tibia of the patient [Figs. 4]; and
inserting at least a portion of a first pin through a first throughbore in the distal portion of the femoral preparation guide to aid in securing the femoral preparation guide to the femur [¶29, ¶69 and ¶72, inserting a pin through at least one of holes 114, 115, 117 and 120].
Yeager does not explicitly disclose wherein the outer surface of the shim being curved / convex.
Miles teaches an analogous surgical method [abstract, ¶28, and Figs. 1 – 8] comprising surgical instrument having a shim [102] with outer surface being curved / convex designed to interface with tibial plateau [¶63 - ¶65].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Yeager and Miles and construct the shim of Yeager having curved / convex outer surface in view of Miles. A PHOSITA would have been motivated to do so in order to improve tibiofemoral articulation, reduce point loading, and enhance joint balance during femoral preparation [Miles, ¶63 - ¶65].
The combination of Yeager and Miles discloses the limitations of claim 21, as above, and further, Yeager discloses:
Claim 22, positioning the femoral preparation guide such that (i) the distal portion of the femoral preparation guide contacts a resected distal region of the condyle of the femur [contact drilled hole 235, and/or the resected portion by blade 240, Figs. 4], (ii) the femoral bone-facing surface of the posterior portion of the femoral preparation guide contacts a posterior region of the condyle of the femur [Figs. 4], and (iii) the outer surface of the shim [modified in view of Miles to be curved / convex] contacts a resected tibial plateau of a tibia of the patient [Figs. 4].
Claim 23, selecting the femoral preparation guide from a plurality of femoral preparation guides of different sizes based at least in part on a size of the resected distal region of the condyle of the femur [¶4].
Claim 24, wherein the distal portion and the femoral bone-facing surface of the posterior portion intersect along a line [a portion by 110 defining the distal portion intersects with the femoral facing surface of 118 along an imaginary line extending along the femoral facing surface of 118], wherein the opposing tibial bone-facing surface of the posterior portion has a slot oriented to be parallel to the line [the dovetail or keyed arrangement defines a slot in the tibial facing surface of 118 parallel to the line, Figs. 44, ¶71], and wherein the shim includes a flat surface opposite the outer/curved surface and a protrusion extending from the flat surface [Fig. 4B], wherein a cross-section of the outer/curved surface is disposed parallel to the cross-section of the protrusion [Fig. 4B], and further comprising attaching the shim to the opposing tibial bone-facing surface of the posterior portion by sliding the protrusion into the slot [¶84].
Claim 25, wherein the slot has a dovetail cross-section, and the protrusion has the dovetail cross-section [Fig. 4B].
Claim 27, wherein the slot includes an internal bayonet recess and the protrusion includes a bayonet-key connector that slides into the slot and locks into the internal bayonet recess via a rotating motion [Fig. 4B].
Claim 28, selecting the shim from a plurality of differently sized shims [¶84, one or more spacers or shims 300].
Claim 29, wherein the shim is sized to provide a measure of a flexion space between the posterior portion of the femoral preparation guide and the resected tibial plateau for sizing of the femoral condylar implant, such that when the shim is attached to the posterior portion of the femoral preparation guide, the curved surface of the shim accommodates movement of the tibia in flexion relative to the femur [¶84, shims 300 used for determining distance, with the outer surface being modified to be curved in view of Miles].
Claim 37, wherein the positioning of the femoral preparation guide further includes positioning the femoral preparation guide such that the femoral preparation guide is in medial-lateral alignment relative to the condyle of the femur [Figs.4].
Claim(s) 31 - 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeager et al. (US Pub. 2022/0287724 A1) in view of Miles et al. (US Pub. 2021/0267607 A1) as above, and further in view of Freiberg et al. (US Pub. 2017/0007273 A1).
The combination of Yeager and Miles discloses the limitations of claim 21, as above, and further, Yeager discloses claim 31, wherein the first throughbore is an anterior most throughbore in the distal portion [¶72, hole 115, Fig.1], and inserting at least a portion of a second pin through a second throughbore in the distal portion of the femoral preparation guide [¶72, inserting pin into hole 117], the throughbore posterior to the anterior most throughbore [Fig.1, hoe 117 is posterior to hole 115].
The combination of Yeager and Miles does not disclose the second throughbore being oblique, the second pin disposed at a different angle relative to the distal portion than the first pin.
Freiberg teaches an analogous surgical method [¶72, hole 115, Fig.1] comprising a surgical instrument [100] having anterior through bore [116A], and inserting at least a portion of a second pin through a second oblique throughbore in the distal portion of the femoral preparation guide [116C], the oblique throughbore posterior to the anterior most throughbore [Fig.6A], the second pin disposed at a different angle relative to the distal portion than the first pin [¶66, 116C is angled relative to 116A].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teaching of Yeager, Miles and Freiberg, construct the guide of the combination of Yeager and Miles to include a second throughbore at different angle than the first bore in view of Freiberg. A PHOSITA would have been motivated to do so in order to enhance securing the guide to the bone and allow the surgeon perform desired cuts to the bone.
The combination of Yeager, Miles and Freiberg discloses the limitations of claim 31, as above, and further, Yeager discloses:
Claim 32, inserting at least a portion of the of a third pin through one of three posterior most throughbores in the distal portion of the femoral preparation guide [¶69 - ¶72, inserting pin through one of holes 115 and 120, Fig.1].
Claim 33, drilling a peg-hole into the condyle of the femur via a drill applied through a peg-hole drill template in the femoral preparation guide [¶80 - ¶81, drilling hole 235 via drill 230 through template 114].
Claim 34, wherein the peg-hole drill template is positioned near a junction of the distal portion and the posterior portion [Fig. 1, template 114 is positioned near a junction of the distal and posterior portions].
Claim 35, wherein the distal portion has a first resection slot for receiving a first cutting tool [¶80, slot 116 and cutting tool 240], and further comprising, resecting the posterior region of the condyle via the first cutting tool inserted through the first resection slot to create a flat posterior surface [Fig.4D].
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yeager et al. (US Pub. 2022/0287724 A1) in view of Miles et al. (US Pub. 2021/0267607 A1) as above, and further in view of Aranyi (US Pat. 5116349).
The combination of Yeager and Miles discloses the limitations of claim 24, as above, except for disclosing wherein the slot includes a leaf spring to provide an interference fit with the protrusion.
Aranyi teaches an analogous surgical instrument [Abstract, Fig.16] comprising a dovetail arrangement wherein a slot [423] includes a leaf spring [390, col.7 /lines 52 - 64].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Yeager, Miles and Aranyi, and construct the slot of the dovetail arrangement of the combination of Yeager and Miles including a leaf spring in view of Aranyi. A PHOSITA would have been motivated to do so in order to provide biasing stability to the dovetail arrangement.
Allowable Subject Matter
Claims 30 and 36 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 SAMUEL S. HANNA whose telephone number is (571)270-3248. The examiner can normally be reached 8-5 M-F.
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/SAMUEL S HANNA/Primary Examiner, Art Unit 3775
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