DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application claims priority from Provisional Application 61/436788, filed 01/27/2011.
Status of Claims
Claims 4-6, 11-14, 16, and 20-38 are pending.
Claims 1-3, 7-10, 15, 17, and 18 have been cancelled.
Election/Restrictions
Applicant elected group I and Species 1 (Fig. 8) without traverse on 05/15/2024.
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 “the medial equilibrium point of the medial bearing surface is located generally at the same anterior position as the lateral equilibrium point of the lateral bearing surface” (See 112 rejection of claims 25, 30, and 37 below for more details) 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 Objection
The applicant is advised to amend claim 25 such that the recent amendment starts in line 6 rather than at the end of the claim. This allows the for claim to read clearer and not jump around with what components are being described.
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.
Claims 25 and 30-38 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 25, 30, and 37, have been amended to require “the medial equilibrium point of the medial bearing surface is located generally at the same anterior position as the lateral equilibrium point of the lateral bearing surface”. This recitation renders the claim indefinite for several reasons. What does the applicant mean by anterior position? The scope of this phrase would not be readily understood by one of ordinary skill in the art. Does it require the point to be within an anterior section of the implant? Does the applicant mean to be referring to an anterior direction? If so, what other from what other component? Next, while the recitation does say anterior position, it is still defining them are being in the same general position. In its current form it does not allow for the two points to be medially/laterally offset. The term “generally”, allows for some movement but not to the extend shown in the figures. Second, a person of ordinary skill in the art would not be able to recognize what the scope of the term generally is with respect to the current claims. What degree of alignment would be required to meet the claims? Would 5 millimeters off qualify or would the spacing need to be within micrometers?
The applicant is advised to amend these recitations to better define how two points and then how they are spaced the same from all four edges. Or something similar.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4-5, 11-14, 16, 20-23, 25-30, and 32-38 are rejected under 35 U.S.C. 103 as being unpatentable over Hollister et al. (Hollister) USPN 5,133,758 in view of Otto et al (Otto) US 2004/0243244 A1.
4. Hollister discloses the invention substantially as claimed being a tibial insert (24 Figures 5-8a), comprising:
opposing top and bottom surfaces (top and bottom of 24 in Figure 7)
an anterior edge (bottom Figure 8);
a posterior edge (top Figure 8);
a medial bearing surface extending in a sagittal direction (right side Figure 8) and
a lateral bearing surface extending in the sagittal direction (left side Figure 8);
wherein the medial bearing surface has a concave shape 32 that extends over a majority of a length of the medial bearing surface in the sagittal direction;
wherein the lateral bearing surface has a concave shape 33 that extends over a majority of a length of the lateral bearing surface in the sagittal direction:
along a first sagittal line extending from the anterior edge to the posterior edge of the medial bearing surface (an imaginary line can be drawn splitting the medial bearing surface 32), a height of the medial bearing surface at the posterior edge as measured from the bottom surface to an upper most portion of the top surface at an intersection of the first sagittal line and the posterior edge (height is taken along front right edge of Figure 6) is different than a height of the medial bearing surface at the anterior edge measured from the bottom surface to an upper most portion of the top surface at an intersection of the first sagittal line and the anterior edge (height is taken along back right edge of Figure 6); or
along a second sagittal line extending from the anterior edge to the posterior edge of the lateral bearing surface (an imaginary line can be drawn splitting the lateral bearing surface 32), a height of the lateral bearing surface at the posterior edge as measured from the bottom surface to an upper most portion of the top surface at an intersection of the second sagittal line and the posterior edge (height is taken along back left edge of Figure 6) is different than a height of the lateral bearing surface at the anterior edge as measured from the bottom surface to an upper most portion of the top surface at an intersection of the second sagittal line and the anterior edge (height is taken along front left edge of Figure 6); and
wherein the concave shape of the medial bearing surface has a first radius of curvature (32 has a plethora of radius throughout its concave surface Figure 8) and the concave shape of the lateral bearing surface has a second radius of curvature (33 has a plethora of radius throughout its concave surface Figure 8), the second radius of curvature being larger than the first radius of curvature (there is inherently a largest lateral radius that is larger than the smallest medial radius).
However, Hollister does not disclose the whether heights are different or equal in value.
Otto teaches the use of knee prosthetics comprising a tibial platform (400 Figure 1C) with an upper surfaces comprising bearing surfaces extending to a chamfered edge (Figure 1C) [0020] and having different numerical values for the heights at the claims positions (see marked up figure 10 below) in the same field of endeavor for the purpose of helping to reduce wear on surrounding tissue.
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It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the edges of the tibial insert to have the chamfered edges and to have the bearing surfaces with the varied height locations as taught by Otto in order to help to reduce wear on surrounding tissue and to bias the joint to be more like the natural joint.
5. Hollister as modified discloses a slope of the concave shape of the medial bearing surface at a posterior end of such concave shape is steeper than a slope of the concave shape of the lateral bearing surface concave portion at a posterior end of such concave shape (the curved shape of every concave surface including at its edges is made up of a variety of identifiable slopes, the posterior portion of the concave bearing surfaces includes slopes that increase as you approach the posterior edge, therefore there is inherently an identifiable slope on the lateral bearing surfaces that is steeper/lager (closest to the posterior edge) than an identifiable slope on the medial bearing surface (a little further away from the posterior edge)).
11. Hollister as modified discloses the tibial insert is formed as a single-piece insert including the medial bearing surface and the lateral bearing surface (Figure 8 shows a single pieced uniform component ).
12. Hollister as modified discloses the bottom of the tibial insert includes with a planar portion (indicated by the flat line between 27 and 27a of Figure 7); and a posterior end portion of the medial bearing surface has a slope that is steeper relative to the planar portion than a slope of the posterior end portion of the lateral bearing surface (See explanation addressing the same limitation in claim 5).
13. Hollister as modified discloses the lateral bearing surface is configured to engage with a lateral condylar surface of a femoral component, with which the tibial insert is configured to engage (Figures 5 and 6);
and the medial bearing surface is configured to engage with a medial condylar surface of the femoral component (Figures 5 and 6).
14. Hollister as modified discloses differences between the medial and lateral bearing surface radius of curvatures are configured to cause asymmetrical translation, respectively, of the medial condylar surface and the lateral condylar surface of the femoral component (Figures 8a-10 3:63-4:21).
16. Hollister as modified discloses the medial bearing surface extends deeper toward an inferior end of the tibial insert, such that a base of the tibial insert is thinner at a bottom point of the medial bearing surface than at a bottom point of the lateral bearing surface (Hollister discloses the insert has a flat planar bottom shown in Figure 7 between 27 and 27a and that the medial bearing surface is larger and deeper so it inherently has a thinner bottom portion 7:60-62).
20. Hollister as modified discloses the differences between the medial and lateral bearing surface radius of curvatures are configured to promote tibiofemoral rotation (Figures 8a-10 3:63-4:21).
21. Hollister as modified discloses the concave shape of the lateral bearing surface is shaped such that a maximum depth of the lateral bearing surface is less than a maximum depth of the medial bearing surface, such that the medial bearing surface extends more inferior than the lateral bearing surface (Hollister discloses the insert has a flat planar bottom shown in Figure 7 between 27 and 27a and that the medial bearing surface is larger and deeper so it inherently has a greater maximum depth 7:60-62).
22. Hollister as modified discloses the anterior and posterior edges includes a chamfered surfaces (see modification in view of Otto explain in reference to claim 4 above);
the concave shape of the lateral bearing surface is a concave portion that extends entirely from the chamfer surface of the anterior edge to the chamfer surface of the posterior edge in the sagittal direction (see modification in view of Otto explain in reference to claim 4 above), and is generally centered in the tibial insert (Figure 8 shows 33 having portions being generally centered in the A-P direction of the insert);
the concave shape of the medial bearing surface defines a concave portion that extends entirely from the chamfer surface of the anterior edge to the chamfer surface of the posterior edge (see modification in view of Otto explain in reference to claim 4 above), which is offset from a center of the tibial insert in the sagittal direction, so that the concave portion of the medial bearing surface is located more toward an anterior of the tibial insert than the concave portion of the lateral bearing surface (both the lateral and medial bearing surfaces have numerous sub sections readable on the portions that can be identified within the bearing surfaces, one could identify a more anterior displaced portion of the medial bearing surface that doesn’t extend to the edge extending the most posterior to anticipate the claimed portions).
23. Hollister as modified discloses the medial bearing surface has a plateau or raised portion at a posterior portion of the medial bearing surface (Flat top right side of Figure 8);
the medial bearing surface has, adjacent to the posterior portion thereof, a sloped section (32 as explained above every portion of the curve of a concave surface has a slope); and
a slope of the sloped section of the medial bearing surface: is steeper than a slope of the lateral concave portion at a same anterior- posterior position on the tibial insert; and/or is steeper than a slope of adjacent portions of the medial concave portion; and/or is a steepest portion of the medial concave portion along the sagittal direction (the slope of every concave surface at the outer edge of the bowl is inherently steeper than the slope of adjacent portions of the concave surface at the bottom of the bowl).
25. and 32. Hollister as modified discloses
the lateral bearing surface includes a lateral equilibrium point corresponding to a lowest point of the concave shape of the lateral bearing surface (bottom of 33, it is noted that the terms corresponding/corresponds substantially broaden the claim because they broaden the location to just be near or around the actual lowest points);
the medial bearing surface includes a medial equilibrium point corresponding to a lowest point of the concave shape of the medial bearing surface (bottom of 32, it is noted that the terms corresponding/corresponds substantially broaden the claim because they broaden the location to just be near or around the actual lowest points); and
the medial equilibrium point of the medial bearing surface is located generally at the same anterior position as the lateral equilibrium point of the lateral bearing surface (in view of the broad interpretation of corresponds/corresponding as well as the broadening limitation of “generally” at the same position, the two equilibrium points of Hollister inherently read upon this requirement, furthermore the implant can be rotated about its longitudinal axis to achieve varied spacing anteriorly or posteriorly to further refine their alignment.)
the lateral bearing surface has a height at the lateral equilibrium point as measured from the bottom surface to the lateral equilibrium point that is greater than a height of the medial bearing surface at the medial equilibrium point as measured from the bottom surface to the medial equilibrium point (Hollister discloses that the medial bearing surface deeper so the lateral height will inherently greater than the medial height 7:60-62).
26. and 33. Hollister as modified discloses a total depth of the concave shape of the lateral bearing surface is less than a total depth of the concave shape of the medial bearing surface (Hollister discloses that the medial bearing surface deeper 7:60-62).
27. and 34. Hollister as modified discloses the medial bearing surface extends more inferior than the lateral bearing surface (Hollister discloses that the medial bearing surface deeper 7:60-62).
28. and 35. Hollister as modified discloses the lateral bearing surface is shallower in a posterior direction than the medial bearing surface (Hollister discloses that the medial bearing surface deeper 7:60-62).
29. and 36. Hollister as modified discloses the height of the medial bearing surface at the posterior edge is different/greater than the height of the medial bearing surface at the anterior edge; and the height of the lateral bearing surface at the posterior edge is greater than the height of the lateral bearing surface at the anterior edge (see modification in view of Otto outlined with respect to claim 4 above).
Claim 30 is identical to claim 4 except for now it is a system comprising a femoral component (20 Figure 6) and the previously described tibial component (shown in Figures 5-7 of Hollister).
With respect to the tibial insert limitations see the rejection of claim 4 above.
With respect to the equilibrium points see the rejection of claim 25 above.
37. Hollister discloses a tibial insert (24 Figures 5-8a), comprising:
opposing top and bottom surfaces (top and bottom of 24 in Figure 7)
an anterior edge (bottom Figure 8);
a posterior edge (top Figure 8);
a medial bearing surface extending in a sagittal direction (right side Figure 8), the medial bearing surface has a concave shape 32 that extends over a majority of a length of the medial bearing surface in the sagittal direction (Figure 8); and
a lateral bearing surface extending in the sagittal direction (left side Figure 8), the lateral bearing surface has a concave shape 33 that extends over a majority of a length of the lateral bearing surface in the sagittal direction (Figure 8);
wherein: along a first sagittal line extending from the anterior edge to the posterior edge of the medial bearing surface (an imaginary line can be drawn splitting the medial bearing surface 32), a height of the medial bearing surface at the posterior edge as measured from the bottom surface to an upper most portion of the top surface at an intersection of the first sagittal line and the posterior edge (see marked up figure above along with explanation addressing claim 4) is a different numerical value than (see modification in view of Otto above) a height of the medial bearing surface at the anterior edge measured from the bottom surface to an upper most portion of the top surface at an intersection of the first sagittal line and the anterior edge (see marked up figure above along with explanation addressing claim 4); or
along a second sagittal line extending from the anterior edge to the posterior edge of the lateral bearing surface (an imaginary line can be drawn splitting the lateral bearing surface 32), a height of the lateral bearing surface at the posterior edge as measured from the bottom surface to an upper most portion of the top surface at an intersection of the second sagittal line and the posterior edge (See marked up figure above along with explanation addressing claim 4) is a different numerical value than (see modification in view of Otto above) a height of the lateral bearing surface at the anterior edge as measured from the bottom surface to an upper most portion of the top surface at an intersection of the second sagittal line and the anterior edge (see marked up figure above along with explanation addressing claim 4); and
the lateral bearing surface includes a lateral equilibrium point corresponding to a lowest point of the concave shape of the lateral bearing surface (bottom of 33 Figure 8);
the medial bearing surface includes a medial equilibrium point corresponding to a lowest point of the concave shape of the medial bearing surface (bottom of 32 Figure 8);
the lateral bearing surface includes a first height as measured between the lateral equilibrium point and a highest point along the posterior edge of the lateral bearing surface;
the medial bearing surface includes a second height as measured between the medial equilibrium point and a highest point along the posterior edge of the medial bearing surface; and
the second height is different than the first height (Hollister discloses that the medial bearing surface deeper 7:60-62 so the heights will inherently be different); and
wherein the concave shape of the medial bearing surface has a first radius of curvature (32 has a plethora of radius throughout its concave surface Figure 8) and the concave shape of the lateral bearing surface has a second radius of curvature (33 has a plethora of radius throughout its concave surface Figure 8), the second radius of curvature being larger than the first radius of curvature (because the concave surfaces are not hemispherical shaped, and the radius is not required to be at a specific position or be the largest radius, there is inherently a largest lateral radius that is larger than the smallest medial radius)
wherein the medial equilibrium point of the medial bearing surface is located generally at the same anterior position as the lateral equilibrium point of the lateral bearing surface (in view of the broad interpretation of corresponds/corresponding as well as the broadening limitation of “generally” at the same position, the two equilibrium points of Hollister inherently read upon this requirement, furthermore the implant can be rotated about its longitudinal axis to achieve varied spacing anteriorly or posteriorly to further refine their alignment.
38. Hollister discloses the second height is greater than the first height (Hollister discloses that the medial bearing surface deeper 7:60-62 so the second height will inherently be greater than the first height).
Claims 6 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hollister and Otto (Combination 1) as applied to claims 4-5, 11-16, 20-23, 25-30, and 32-38 above, and further in view of Suguro et al. (Suguro) US 2005/0209701 A1.
Combination 1 discloses the claimed invention being described above. However, Hollister discloses an elongated ridge and not a post between the medial bearing surface and the lateral bearing surface having rotational offset in a superior-inferior aspect of the post.
Suguro teaches a similar tibial insert 2 (Fig. 6) comprising a post 13 between the medial bearing surface 10 and the lateral bearing surface 11, wherein the post comprises a rotational offset in a superior-inferior aspect of the post ([0030], [0034] and Fig. 6 disclose the post 13 is rotationally offset towards the lateral condyle, since the claims fail to limit the superior and inferior portions with respect to location, size, and shape the examiner has identified superior and inferior portions that are offset longitudinally and radially, which read upon the claimed portions.).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to replace the tibial insert ridge of Hollister to include an upright post between the medial bearing surface and the lateral bearing surface, wherein the post comprises a rotational offset in a superior-inferior aspect of the post, as taught by Suguro, for allowing the tibial insert to better mimic the flexion and extension of a natural knee joint (par. 0031 of Suguro).
18. Hollister discloses the lateral bearing surface has a shallower slope than the medial bearing surface (in view of the greater radius of curvature the lateral bearing surface inherently has a shallower slope, alternative see the explanation with respect to claim 5 above permitting the identification of multiple slopes to compare).
Allowable Subject Matter
Claim 24 is 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.
Claim 31 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.
Otto only discloses the height at the proximal edge of the medial bearing surface is greater than the height at the anterior edge. The lateral bearing surface fails to meet the greater height requirements of claims 24 and 31.
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
The applicant generally argues that the prior art of record fails to disclose the different medial and lateral radius and generally same equilibrium points. This is not persuasive because as explained above and noted in the previous interview the oblong concave structures of Hollister have a variety of radius there within. The claims failed to define the position of the radius or that it is the greatest radius. Therefore, there is inherently a largest lateral radius that is larger than the smallest medial radius. Furthermore, the applicant’s own disclosure merely describes the radius comparison limitation as showing that the medial concave surface is more concave/deeper than the lateral concave surface (see below), which Hollister also specifically discloses (7:61-62).
[0052] Differences between the medial bearing surface 316 and the lateral bearing surface 318 cause asymmetrical translation of the medial condylar surface 202 and the lateral condylar surface 204. For example, the medial bearing surface 316 is more concave (for example, extends deeper toward the inferior end of the tibial insert 300) than the lateral bearing surface 318. In other words, the lateral bearing surface 318 includes a larger radius of curvature than the medial bearing surface 316, and the generally shallower slope of the lateral bearing surface 318 facilitates greater travel of the lateral condylar portion 203 than that of the medial condylar portion 201.
Finally, Suguro (previously cited) teaches the use a tibial insert with concave medial and lateral bearing surfaces wherein the concave portion of the lateral bearing surface is shallower (Figure 1) and has a larger radius of curvature [0039] than the medial bearing surface in the same field of endeavor for the purpose of allowing the tibial insert to better mimic the flexion and extension of a natural knee joint.
With respect to the position of the two equilibrium points, as explained above the current wording creates 112 and drawing issues. Additionally, in view of the double broad recitations “corresponds”/”corresponding” as well as “generally” at the same position, the two equilibrium points of Hollister inherently read upon this requirement. Finally, the implant can be rotated about its longitudinal axis to achieve varied spacing. This would move the points anteriorly or posteriorly to further refine their alignment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/Primary Examiner, Art Unit 3774
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