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 foreign priority to 1058647, filed 10/22/2010.
Status of Claims
Claims 28, 30, 32, 33, 35, and 40 are pending.
Claims 1-27, 29, 31, 34, and 36-39 have been cancelled.
Examiner’s Comment
It is noted that in their current form many of the claims compare dimensions and aspects of the first and second glenoid components using the word different. While it is believed that the applicant intended for different to mean having a different value, the broadest reasonable interpretation of different according to Merriam Webster also includes “another”. As in they switched to a different channel. The channel may be showing the same movie, but it is a different channel just because it is another channel.
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.
Claim 28, 30, 32, 33, 35, and 40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tornier US 2005/0049709 A1 in view of Stone et al (Stone) US 2005/0107882 A1, Alepee FR 2923154 A1, Freeman et al (Freeman) USPN 3,992,726, and Bhatnagar et al (Bhatnagar) US 2008/0195108 A1.
Tornier discloses the invention substantially as claimed a glenoid component (2 Figure 2) for use in a shoulder joint comprising:
a first glenoid component (2 Figure 2):
a first body (2) having
a first joint surface (20) comprising a first radius of curvature configured to engage at least one of a first prosthetic humeral head or a first natural humeral head (Figure 1), and
a first bearing surface (18) disposed opposite the first joint surface configured to engage a surface of a first glenoid included in the first shoulder joint (Figure 1), comprising a second radius of curvature (12 lower surface radius is shown best in Figure 2)
a first keel (14) extending from the first body passed the first bearing surface (Figure 2).
However, Tornier does not disclose his invention comprises a plurality of different sized glenoid components, wherein there is a recess between the keel and the bearing surface, the bearing surfaces are planar, and the bearing surfaces include different radii of curvature.
It is old and extremely well known in the art of medical components to provide kits including a variety of components in different sizes and configurations enabling the surgeon to find the perfect fit for each patient. This includes varying a single dimension such as the thickness of a component or a radius of curvature while preserving most of or all other dimensions in order to provide additional spacing and filler to restore bone loss or accommodate expansion or loosing of joints. (For example, additional qualifying prior art includes EP 2135587, WO 97/25943, US 6,436,102, and US 2007/0142918).
Alepee teaches the use of kit comprising at least 2 bone joint components comprising substantially the same size and shape, specifically the radius of the upper articulating surfaces are the same (Abstract and Figure 1) but the thickness of the adjacent layer is varied (1a Figure 1) in the same field of endeavor for the purpose of restoring the natural height to the joint.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the component of Tornier as a kit with additional glenoid components having the shape and articulating radius of curvature but increasing the size of the some components by increasing thickness of the body of the component as taught by Alepee in order to allow the surgeon to match the component to each patients needed joint height.
Stone teaches the use of a variety of glenoid components with a variety of bearing surfaces which have recesses between the keel and the bearing surface (64 Figures 6-7 in the same field of endeavor for the purpose of providing space to mate with the component site and allow for ingrowth surrounding the keel.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide all of the glenoid components of the kit of Tornier with a recess positioned between the keel and bearing surface as taught by Stone in order to provide space to mate with the component site and allow for ingrowth.
Freeman teaches the use of articulating bone joint components wherein the bottom bearing surfaces are smooth (flat outer surfaces with anchors Figures 1-4) in the same field of endeavor for the purpose of allowing the surgeon to cut back the natural bone to a fresh healthy predetermined planar surface resulting in matching bearing and bone surfaces free from any disease or deformities for all components of the kit regardless of the size.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bearing surfaces all of the components of the kit of Tonier to be smooth in order to provide the provide the surgeon with matching bearing surfaces and a clean uniform bone surface free from any disease or deformities that will match any component of the kit regardless of the size.
Bhatnagar teaches the use of a kit of articulating bone joint components wherein the bottom bearing surfaces have different dimensions (Figure 5 shows the kit can include groups of components with the bone contacting surface having the same dimension as well as groups of components with the bone contacting surface having different dimension) in the same field of endeavor for the purpose of allowing the surgeon to select the component with most appropriately sized bone contacting surface for each patient from a large kit of varied dimensions
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the kit of Tonier to include additional components with the above modifications as well as adding additional components with bearing surfaces having varied radius of curvature in order to provide the provide the surgeon with a plurality of options for bearing surfaces to choose from such that the patient gets the optimal contact between the bearing surface and bone.
With regards to claim 30, it is noted that the claim still does not define the thicknesses be taken at the same location of the body. The glenoid components of tonier have a variety of portions with varied thicknesses because of the tapered rounded edges. Therefore one could compare the edge thickness of one component to a central thickness of another component. Additionally, in this case Alepee teaches that it is old and well known in the art of articulating components to provide the height between the upper curved surface and lower planar surface with varied thicknesses.
With regards to claims 32-33, Tonier discloses the glenoid components comprise anchors elements 2 extending from the bearing surfaces (Figures 2 and 3).
With regards to claim 35, Tonier as modified discloses the largest edge to edge expanse across the joint surface of the first body is different than that of the second body. In view of the broadest reasonable interpretation of different, explained above, the two components inherently have different expanses. Additionally, Bhatnagar teaches that it is old and well known to provide the kit with components with larger and smaller edge to edge expanses (Figure 5)
With regards to claim 40, as explained previously both the thickness and expanse requirements of the combination are met by the modified glenoid components of the prior art combination. Specifically, Alepee teaches changing the thickness of the component and Bhatnagar discloses changing the expanses.
Response to Arguments
Applicant's arguments filed 01/23/2026 have been fully considered but they are not persuasive.
The applicant argues that the bearing surfaces with varied radius of curvature is not taught by the prior art combination. This is not persuasive because the rejection has been modified to include the teaching of Bhatnagar who specifically discloses varying the inner bone contacting bearing surface dimensions for a variety of implants.
Additionally, this is not persuasive because it is old and extremely well know that kits can be provided with varied dimensions in order to find the optimal implant for each patient. For example the standard mechanics kits manufactured by Craftsman as far back as 1932 provided sockets in all sorts of sizes with varied dimensions. The include proximal surfaces with varied opening sizes for each socket size. They include bodies with varied lengths for each socket size. They provide distal surfaces with varied openings to receive different nut sizes within each of the above groups. The concept of providing components as a large kit having some dimensions varied and some dimensions maintained is old and extremely well known. According to Reu Gerhard (EP 2135587), in recent years the number of trial implants to be held for surgery has steadily increased and continues to increase. For example, in a trial implant system comprising rod ends having five different neck lengths (S, M, L, XL, XXL) and three different diameters (e.g. 28 mm, 32 mm and 36 mm), a total of 15 different probes are to be provided. The same applies to the sample journals and lateralized variants of sample journals. Overall, therefore, an increasingly number of trial implants are required in order to optimally determine the size, and position of the implant itself before implantation.
Therefore, the rejections are clearly articulated with proper motivations and have been maintained.
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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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/Christopher D. Prone/Primary Examiner, Art Unit 3774