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 .
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 retention clip engageable/engaged with the recess of the tibial stem (see claims 21 and 31) 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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 21-24, 27-33, 36, 39, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2012/0239159 A1 to Metzger et al. (Metzger) in view of US Patent No. 8,470,048 B2 to Wolfson et al. (Wolfson).
Regarding at least claim 21
Metzger teaches a knee joint prosthesis assembly that includes a femoral component having a medial and lateral condyle portion and a tibial component having a medial and lateral portion (abstract).
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Metzger meets the limitations of a prosthetic assembly comprising: a medial bearing (416) and a lateral bearing (418); a tibial tray (414) comprising: a medial retaining bracket (440) located at a medial edge of a medial portion of the tibial tray and a lateral retaining bracket (440) located at a lateral edge of a lateral portion of the tibial tray (fig. 18 shows the positioning of the brackets at the medial and lateral edges, as claimed); a substantially centrally disposed boss (442); a tibial stem (516; fig. 21); and a retention clip (420) engageable with opposite sides of the boss (442) to trap the medial bearing (416) and the lateral bearing (418) against the medial retaining bracket and the lateral retaining bracket, respectively (paragraphs 0054-0055 disclose that the locking bar/retention clip extends through anterior channels of the bearing components such that a portion of the body 454 can locate along the posterior side of the bridge/boss 442 and a finger portion 456 locates around an anterior side of the bridge/boss 442).
Metzger also teaches that the knee prosthesis assembly can be used when it is desirable to retain or reconstruct an anterior cruciate ligament (ACL) and/or a posterior cruciate ligament (PCL) (paragraph 0034).
However, Metzger does not teach that the stem defines a recess or a resilient element positionable at least partially within the recess and connectable to an artificial ligament, or that the retention clip is engageable with the recess of the tibial stem to retain the resilient element within the recess.
Wolfson teaches a joint replacement prosthesis comprising a biasing element or a tensioning element housed in the stem of a tibial tray and operatively coupled to an artificial ligament (abstract). Wolfson further discloses a biasing and/or tensioning element can enable the tension of the ligament to be balanced with other soft tissues (col. 5, lines 59-67), such as a spring (1146) that assists in replicating the natural stiffness of the ligament that is to be replaced (col. 13, lines 1-4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tibial prosthesis stem of Metzger to include a recess and a resilient element configured to be located at least partially within the recess and configured to couple to an artificial ligament of the prosthetic assembly, in order to replicate the natural stiffness and balance the tension of the ligament, such as the reconstructed ACL and/or PCL of Metzger, as taught by Wolfson. The tibial prosthesis of Metzger with the tibial stem that defines a recess, as taught by Wolfson, would result in the retention clip being positioned across, and therefore engageable with, the recess of the tibial stem and would retain the resilient element within the recess, as claimed by applicant.
Regarding at least claim 22
Metzger in view of Wolfson teaches the prosthetic assembly of claim 21. Wolfson also teaches wherein the recess includes a groove configured to receive at least a portion of the resilient element (1146) therein to allow the resilient element to expand and contract within the stem recess (col. 12, lines 10-19 of Wolfson discloses an internal annular shoulder 1154 defined by the bore/recess of the stem - the portions defining this internal annular shoulder 1154 are each construed to be a groove in which the resilient element is received such that the resilient element is allowed to expand and contract; see annotated fig. 16 below).
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It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to modify the stem recess of Metzger in view of Wolfson to include a groove configured to receive at least a portion of the resilient element therein to allow the resilient element to expand and contract within the stem recess, in order to retain the resilient element, as implicitly taught by Wolfson.
Regarding at least claim 23
Metzger in view of Wolfson teaches the prosthetic assembly of claim 21. Wolfson also teaches wherein the recess includes a first groove and a second groove each configured to receive a portion of the resilient element therein to allow the resilient element to expand and contract within the stem recess (col. 12, lines 10-19 of Wolfson discloses an internal annular shoulder 1154 defined by the bore/recess of the stem - the portions defining this internal annular shoulder 1154 are each construed to be a groove in which the resilient element is received such that the resilient element is allowed to expand and contract; see annotated fig. 16 above).
It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to modify the stem recess of Metzger in view of Wolfson to include a first groove and a second groove each configured to receive a portion of the resilient element therein to allow the resilient element to expand and contract within the stem recess, in order to retain the resilient element, as implicitly taught by Wolfson.
Regarding at least claim 24
Metzger in view of Wolfson teaches the prosthetic assembly of claim 23, wherein the retention clip includes a first arm (454) and a second arm (456) and that the retention clip is engaged with the boss (fig. 17 shows the clip engaged with the boss).
However, Metzger in view of Wolfson does not explicitly teach that the first and second arms of the retention clip are configured to cover the first and second grooves, respectively, when the retention clip is engaged with the boss.
The retention clip of Metzger, which extends across the middle portion of the top surface of the tray and engages with the boss, combined with a stem having the recess that includes grooves of Wolfson, would result in a configuration in which the arms of the retention clip cover the grooves, at least to some extent, since the grooves are included in the stem recess and the arms lay above, and therefore cover, the recess.
Regarding at least claim 27
Metzger in view of Wolfson teaches the prosthetic assembly of claim 21. Wolfson also teaches wherein the resilient element includes a ligament anchor configured to connect the resilient element to the artificial ligament (col. 12, lines 32-47 discloses attaching the resilient/biasing element to the ligament with a bearing element/anchor 1144).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Metzger in view of Wolfson to include that the resilient element includes a ligament anchor configured to connect the resilient element to the artificial ligament, in order to attach the artificial ligament to the biasing/resilient element, as taught by Wolfson.
Regarding at least claim 28
Metzger in view of Wolfson teaches the prosthetic assembly of claim 21. However, Metzger in view of Wolfson does not teach wherein the resilient element is a spiral spring.
Wolfson also teaches that the resilient element is a spiral spring (col. 12, lines 48-54 disclose a coiled compression spring or any appropriate spring or springs, for the purpose of having characteristics similar to those of the natural ACL as disclosed in col. 13, lines 1-4).
It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to specify that the resilient element of Metzger in view of Wolfson is a spiral spring, in order to exhibit similar characteristics to those of the natural ACL, as taught by Wolfson.
Regarding at least claim 29
Metzger in view of Wolfson teaches the prosthetic assembly of claim 21. Wolfson also teaches wherein the resilient element is configured to apply tension to the artificial ligament (col. 5, lines 59-67 discloses a biasing and/or tensioning element that can enable the tension of the ligament to be balanced with other soft tissues, such as a spring, that assists in replicating the natural stiffness of the ligament that is to be replaced as disclosed in col. 13, lines 1-4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Metzger in view of Wolfson to specify that the resilient element is configured to apply tension to the artificial ligament, in order to replicate the natural stiffness and balance the tension of the ligament, such as the reconstructed ACL and/or PCL of Metzger, as taught by Wolfson.
Regarding at least claim 30
Metzger in view of Wolfson teaches the prosthetic assembly of claim 29. Wolfson also teaches wherein the resilient element is configured to expand and contract within the stem recess in response to a load applied to the artificial ligament (col. 12, lines 62-67 discloses that the resilient element is a spring that compresses when tensile forces are applied to the ligament, for the purpose of replicating the natural stiffness of the ligament as disclosed col. 13, lines 1-4).
It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to specify that the resilient element of Metzger in view of Wolfson is configured to expand and contract within the stem recess in response to a load applied to the artificial ligament, in order to allow the resilient element to compress when tensile forces are applied to the ligament for the purpose of replicating the natural stiffness of the ligament, as taught by Wolfson.
Regarding at least claim 31
Metzger meets the limitations of a prosthetic assembly comprising: a medial bearing (416) and a lateral bearing (418); a tibial tray (414) comprising: a medial retaining bracket (440) located at a medial edge of a medial portion of the tibial tray (fig. 18 shows the location of the medial retaining bracket); a lateral retaining bracket (440) located at a lateral edge of a lateral portion of the tibial tray (fig. 18 shows the location of the lateral retaining bracket); a central boss (442); and a tibial stem (516; fig. 21); and a retention system (442) engaged with opposite sides of the boss to secure the medial bearing and the lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively, (paragraphs 0054-0055 disclose that the locking bar/clip extends through anterior channels of the bearing components such that a portion of the body 454 can locate along the posterior side of the boss/bridge 442 and a finger portion 456 locates around an anterior side of the bridge/boss 442).
Metzger also teaches that the knee prosthesis assembly can be used when it is desirable to retain or reconstruct an anterior cruciate ligament (ACL) and/or a posterior cruciate ligament (PCL) (paragraph 0034).
However, Metzger does not teach that the stem defines a recess or a resilient element positionable at least partially within the recess and connectable to an artificial ligament, or that the retention system is engaged with the recess of the tibial stem to retain the resilient element within the recess.
Wolfson teaches a joint replacement prosthesis comprising a biasing element or a tensioning element housed in the stem of a tibial tray and operatively coupled to an artificial ligament (abstract). Wolfson further discloses a biasing and/or tensioning element can enable the tension of the ligament to be balanced with other soft tissues (col. 5, lines 59-67), such as a spring (1146) that assists in replicating the natural stiffness of the ligament that is to be replaced (col. 13, lines 1-4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tibial prosthesis stem of Metzger to include a recess and a resilient element configured to be located at least partially within the recess and configured to couple to an artificial ligament of the prosthetic assembly, in order to replicate the natural stiffness and balance the tension of the ligament, such as the reconstructed ACL and/or PCL of Metzger, as taught by Wolfson. The tibial prosthesis of Metzger with the tibial stem that defines a recess, as taught by Wolfson, would result in the retention system being positioned across, and therefore engaged with, the recess of the tibial stem and would retain the resilient element within the recess, as claimed by applicant.
Regarding at least claim 32
Metzger in view of Wolfson teaches the prosthetic assembly of claim 31. Wolfson also teaches wherein the recess includes a first groove and a second groove supporting portions of the resilient element therein to allow the resilient element to expand and contract within the stem recess (col. 12, lines 10-19 of Wolfson discloses an internal annular shoulder 1154 defined by the bore/recess of the stem - the portions defining this internal annular shoulder 1154 are each construed to be a groove in which the resilient element is received such that the resilient element is allowed to expand and contract; see annotated fig. 16 above).
It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to modify the stem recess of Metzger in view of Wolfson to include wherein the recess includes a first groove and a second groove supporting portions of the resilient element therein to allow the resilient element to expand and contract within the stem recess, in order to retain the resilient element, as implicitly taught by Wolfson.
Regarding at least claim 33
Metzger in view of Wolfson teaches the prosthetic assembly of claim 32, wherein the retention clip includes a first arm (454) and a second arm (456).
However, Metzger in view of Wolfson does not explicitly teach that the first and second arms of the retention clip cover the first and second grooves, respectively.
The retention clip of Metzger, which extends across the middle portion of the top surface of the tray and engages with the boss, combined with a stem having the recess that includes grooves of Wolfson, would result in a configuration in which the arms of the retention clip cover the grooves, at least to some extent, since the grooves are included in the stem recess and the arms lay above, and therefore cover, the recess.
Regarding at least claim 36
Metzger meets the limitations of a prosthetic assembly comprising: a medial bearing (416) and a lateral bearing (418); a tibial tray (414) comprising: a medial retaining bracket (440) located at a medial edge of a medial portion of the tibial tray (as shown in fig. 18); a lateral retaining bracket (440) located at a lateral edge of a lateral portion of the tibial tray (as shown in fig. 18); a substantially centrally located boss (442); and a tibial stem (516; fig. 21); and a retention clip (420) including a pair of arms (454 and 456) configured to engage opposite sides of the boss and trap a medial bearing and a lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively (paragraph 0055 discloses that the arms of the clip engage the boss on opposite sides to trap the medial and lateral bearings against their respective brackets).
Metzger also teaches that the knee prosthesis assembly can be used when it is desirable to retain or reconstruct an anterior cruciate ligament (ACL) and/or a posterior cruciate ligament (PCL) (paragraph 0034).
However, Metzger does not teach that the stem defines a recess, a resilient element positionable at least partially within the recess and connectable to an artificial ligament, or that the retention clip is configured to at least partially cover the recess of the tibial stem to retain the resilient element within the recess.
Wolfson teaches a joint replacement prosthesis comprising a biasing element or a tensioning element housed in the stem of a tibial tray and operatively coupled to an artificial ligament (abstract). Wolfson further discloses a biasing and/or tensioning element can enable the tension of the ligament to be balanced with other soft tissues (col. 5, lines 59-67), such as a spring (1146) that assists in replicating the natural stiffness of the ligament that is to be replaced (col. 13, lines 1-4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tibial prosthesis stem of Metzger to include a recess and a resilient element configured to be located at least partially within the recess and configured to couple to an artificial ligament of the prosthetic assembly, in order to replicate the natural stiffness and balance the tension of the ligament, such as the reconstructed ACL and/or PCL of Metzger, as taught by Wolfson. The tibial prosthesis of Metzger with the tibial stem that defines a recess, as taught by Wolfson, would result in the retention clip being positioned across, and therefore at least partially covering, the recess of the tibial stem and would retain the resilient element within the recess, as claimed by applicant.
Regarding at least claim 39
Metzger in view of Wolfson teaches the prosthetic assembly of claim 36. Wolfson also teaches wherein the resilient element includes a ligament anchor configured to connect the resilient element to the artificial ligament (col. 12, lines 32-47 discloses attaching the resilient/biasing element to the ligament with a bearing element/anchor 1144).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Metzger in view of Wolfson to include that the resilient element includes a ligament anchor configured to connect the resilient element to the artificial ligament, in order to attach the artificial ligament to the biasing/resilient element, as taught by Wolfson.
Regarding at least claim 40
Metzger in view of Wolfson teaches the prosthetic assembly of claim 39. Wolfson also teaches wherein the resilient element is configured to expand and contract within the stem recess in response to a load applied to the artificial ligament (col. 12, lines 62-67 discloses that the resilient element is a spring that compresses when tensile forces are applied to the ligament, for the purpose of replicating the natural stiffness of the ligament as disclosed col. 13, lines 1-4).
It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to specify that the resilient element of Metzger in view of Wolfson is configured to expand and contract within the stem recess in response to a load applied to the artificial ligament, in order to allow the resilient element to compress when tensile forces are applied to the ligament for the purpose of replicating the natural stiffness of the ligament, as taught by Wolfson.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 10,517,735 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 21, the patent claims also recite a prosthetic assembly comprising: a medial bearing and a lateral bearing; a tibial tray comprising: a medial retaining bracket located at a medial edge of a medial portion of the tibial tray and a lateral retaining bracket located at a lateral edge of a lateral portion of the tibial tray; a substantially centrally located boss; and a tibial stem defining a recess; a resilient element positionable at least partially within the recess and connectable to an artificial ligament; and a retention clip engageable with opposite sides of the boss to trap the medial bearing and the lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively, the retention clip engageable with the recess of the tibial stem to retain the resilient element within the recess (see patent claims 1 and 14)
Regarding claim 29, the patent claims also recite wherein the resilient element is configured to apply tension to the artificial ligament (see patent claim 14).
Claims 21 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,304,814 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 21, the patent claims also recite a prosthetic assembly comprising: a medial bearing and a lateral bearing; a tibial tray comprising: a medial retaining bracket located at a medial edge of a medial portion of the tibial tray and a lateral retaining bracket located at a lateral edge of a lateral portion of the tibial tray; a substantially centrally located boss; and a tibial stem defining a recess; a resilient element positionable at least partially within the recess and connectable to an artificial ligament; and a retention clip engageable with opposite sides of the boss to trap the medial bearing and the lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively, the retention clip engageable with the recess of the tibial stem to retain the resilient element within the recess (see patent claims 1 and 3)
Regarding claim 29, the patent claims also recite wherein the resilient element is configured to apply tension to the artificial ligament (see patent claim 2).
Allowable Subject Matter
Claims 25, 26, 34, 35, 37, and 38 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, and with a timely filed terminal disclaimer to overcome the double patenting rejection.
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach or fairly suggest the combination of elements claimed, particularly that the retention clip/system arms extend anteriorly-to-posteriorly to engage the opposite sides of the boss and also to engage and trap the medial bearing against the medial retaining bracket and the lateral bearing against the lateral retaining bracket.
The closest prior art to Metzger teaches a locking bar with arms extending medially-to-laterally to engage the boss as shown in fig. 18. It would not have been obvious to modify the direction of extension of the arms of Metzger because doing so would not allow the invention to be used as intended, particularly since anteriorly-to-posteriorly extending arms would block the central slot of the tray when needed for accommodating an ACL.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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/M.A.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774