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 .
The Amendment filed 10/13/2025 has been entered. Claims 21-40 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to the newly amended claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 securable to the tibial tray to engage the resilient element”, as recited in newly amended claim 21, the “retention system configured to engage the resilient element”, as recited in newly amended claim 31, and the , “the retention clip configured to at least partially cover the recess of the tibial stem and engage the resilient element to retain the resilient element within the recess”, as recited in newly amended claim 36, 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 § 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 21-40 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. The “retention clip securable to the tibial tray to engage the resilient element” (see claim 21), the “retention system configured to engage the resilient element” (see claim 31), and the “retention clip configured to at least partially cover the recess of the tibial stem and engage the resilient element to retain the resilient element within the recess” (see claim 36), are not properly described in the application as filed. According to page 8 of the specification, fig. 2 shows a resilient element (144) positioned within recess (142) and fig. 6 shows that the resilient element covers the proximal ends of grooves (146) provided in the recess (142) to prevent projections of the resilient element (144) from being removed, thereby retaining the resilient element (144) within the stem recess (142). However, the disclosure does not adequately describe any engagement between the resilient element and the retaining clip. It is unclear how covering the grooves in which the projections of the resilient element reside to prevent them from being removed requires engagement between the components, particularly since the term “engage” is defined as: to entangle in, to interlock with, to bind, etc., which is not the same as one element sitting on top of another.
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) 21-40 are rejected under 35 U.S.C. 103 as being unpatentable over GB 2517154 A to Dodd et al. (Dodd) in view of US Patent No. 4,944,757 to Martinez et al. (Martinez).
Regarding claim 21
Dodd teaches a ligament assembly comprising a resilient element connected to a bone anchor and a ligament (abstract).
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Dodd meets the limitations of a prosthetic assembly (tibial component; 4) comprising: a medial bearing (12) and a lateral bearing (13); a tibial tray (6) comprising: a substantially centrally located boss (defined by walls 29, 31); and a tibial stem (8) defining a recess (26); a resilient element (spiral spring; 20) positionable at least partially within the recess and connectable to an artificial ligament (18) (the spring 20 is mounted in the stem 8, as shown in fig. 3); and a retention clip (44) engageable with opposite sides (33, 35) of the boss, the retention clip (44) securable to the tibial tray to engage the resilient element (20) to retain the resilient element within the recess (page 8, lines 1-6 disclose that the U-shaped clip 44 is pushed in the slots 36, 38 to cover the grooves to prevent the projections 52, 54 of the spring/resilient element 20 being withdrawn fully from the bore 26 – see 112 rejection above).
Dodd also teaches that the bearing components may be fixed to the tray (page 6, lines 24-34). However, Dodd does not teach 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 or that the retention clip traps the medial bearing and the lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively.
[AltContent: rect]Martinez teaches a modular knee joint including a tibial platform with a top surface that engages a tibial inert by locking in place with a lock key (abstract).
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More specifically, Martinez teaches an upraised boss (33) primarily centered along the top surface (29) that is provided to operatively engage the tibial insert (11) and secure the components with the tibial key (clip; 19). Martinez also teaches a pair of peripheral lips (64; since the lips project from the upper surface and prevent movement of the insert, they are construed to be brackets, as claimed, particularly a medial retaining bracket located at a medial edge of a medial portion of the tibial tray 15 and a lateral retaining bracket located at a lateral edge of a lateral portion of the tibial tray 15; see annotated fig. 1 above) on the top surface (29) of the base plate (15), for the purpose of preventing anterior-posterior and medial-lateral movement of the tibial insert (11) upon assembly with the tibial base plate (col. 2, lines 35-53 and fig. 1), and thereby trapping the insert (medial and lateral bearings) against the lips (medial and lateral brackets; 64), respectively, when the components are locked together with the key (clip; 19).
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 tray of Dodd to include a pair of peripheral lips, particularly 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 such that the retention clip traps the medial bearing and the lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively, in order to fix the bearings/insert in place, as contemplated by Dodd, by preventing anterior-posterior and medial-lateral movement of the tibial bearings upon assembly with the tibial base plate, as taught by Martinez.
Regarding claim 22
Dodd in view of Martinez teaches the prosthetic assembly of claim 21. Dodd also teaches wherein the recess (26) includes a groove (56, for example) configured to receive at least a portion (52, for example) of the resilient element therein to allow the resilient element to expand and contract within the stem recess (page 8, lines 26-34 discloses that the resilient element/spring flexes under loading from the ligament within the stem recess).
Regarding claim 23
Dodd in view of Martinez teaches the prosthetic assembly of claim 21. Dodd also teaches wherein the recess includes a first groove and a second groove (56, 58) each configured to receive a portion (projections; 52, 54) of the resilient element (20) therein to allow the resilient element to expand and contract within the stem recess (page 8, lines 26-34 discloses that the resilient element/spring flexes under loading from the ligament within the stem recess).
Regarding claim 24
Dodd in view of Martinez teaches the prosthetic assembly of claim 23. Dodd also teaches wherein the retention clip (44) includes a first arm configured to cover the first groove and a second arm configured to cover the second groove when the retention clip is engaged with the boss (Figs. 2 and 3 show that the first and second arms cover the first and second grooves when the clip is engaged with the boss).
Regarding claim 25
Dodd in view of Martinez teaches the prosthetic assembly of claim 24. Dodd also teaches wherein each of the first arm and the second arm extend anteriorly-to-posteriorly to engage opposite sides of the boss (Figs. 2 and 3 show that each of the first and second arms extend anteriorly-to-posteriorly to engage opposite side of the boss).
Martinez also teaches a retention clip having a first arm and a second arm (fig. 1) that are each configured to engage and trap the insert against the lips (brackets; 64), such that the medial bearing is trapped against the medial retaining bracket, and the lateral bearing is trapped against the lateral retaining bracket (fig. 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the each of the first arm and the second arm of the retention clip are configured to engage and trap the insert against the brackets, such that the medial bearing is trapped against the medial retaining bracket, and the lateral bearing is trapped against the lateral retaining bracket, in order to fix the bearings/insert in place, as contemplated by Dodd, by preventing anterior-posterior and medial-lateral movement of the tibial bearings upon assembly with the tibial base plate, as taught by Martinez.
Regarding claim 26
Dodd in view of Martinez teaches the prosthetic assembly of claim 25. Martinez also teaches wherein the first arm is slidably insertable into a medial passage of the medial bearing and the second arm is slidably insertable into a lateral passage of the lateral bearing, for the purpose of securely retaining the insert to the base plate (col. 2, lines 43-61 discloses inserting the arms of the clip into paralleled grooves; 39 formed in the slot; 35 on the undersurface of the insert).
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 fixed insert of Dodd to include medial and lateral passages on the undersurface into which the first and second arms of the clip are inserted, in order to securely retain the insert to the base plate, as taught by Martinez.
Regarding claim 27
Dodd in view of Martinez teaches the prosthetic assembly of claim 21. Dodd also teaches wherein the resilient element includes a ligament anchor (bollard; 22) configured to connect the resilient element to the artificial ligament (page 7, lines 1-3 discloses that the bollard/anchor receives an end of the ligament 18).
Regarding claim 28
Dodd in view of Martinez teaches the prosthetic assembly of claim 21. Dodd also teaches wherein the resilient element is a spiral spring (page 6, lines 35-36 through page 7, line 1 discloses a spiral spring).
Regarding claim 29
Dodd in view of Martinez teaches the prosthetic assembly of claim 21. Dodd also teaches wherein the resilient element is configured to apply tension to the artificial ligament (page 6, lines 35-36 disclose that the spiral spring is a tensioning element).
Regarding claim 30
Dodd in view of Martinez teaches the prosthetic assembly of claim 29. Dodd 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 (page 8, lines 26-34 disclose that the spring flexes under loading from the ligament).
Regarding claim 31
Dodd meets the limitations of a prosthetic assembly (fig. 1) comprising: a medial bearing (12) and a lateral bearing (13); a tibial tray (14) comprising: a tibial tray (6) comprising: a central boss (defined by walls 29, 31); and a tibial stem (8) defining a recess (26); a resilient element (spiral spring; 20) located at least partially within the recess and connectable to an artificial ligament (18) (the spring 20 is mounted in the stem 8, as shown in fig. 3); and a retention system (44) engaged with opposite sides (33, 35) of the boss, the retention system (44) configured to engage the resilient element to retain the resilient element within the recess (page 8, lines 1-6 disclose that the U-shaped clip 44 is pushed in the slots 36, 38 to cover the grooves to prevent the projections 52, 54 of the spring/resilient element 20 being withdrawn fully from the bore 26 – see 112 rejection above).
Dodd also teaches that the bearing components may be fixed to the tray (page 6, lines 24-34). However, Dodd does not teach 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 or that the retention system secures the medial bearing and the lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively.
Martinez teaches a modular knee joint including a tibial platform with a top surface that engages a tibial inert by locking in place with a lock key (abstract). More specifically, Martinez teaches an upraised boss (33) primarily centered along the top surface (29) that is provided to operatively engage the tibial insert (11) and secure the components with the tibial key (clip; 19). Martinez also teaches a pair of peripheral lips (64; since the lips project from the upper surface and prevent movement of the insert, they are construed to be brackets, as claimed, particularly a medial retaining bracket located at a medial edge of a medial portion of the tibial tray 15 and a lateral retaining bracket located at a lateral edge of a lateral portion of the tibial tray 15; see annotated fig. 1 above) on the top surface (29) of the base plate (15), for the purpose of preventing anterior-posterior and medial-lateral movement of the tibial insert (11) upon assembly with the tibial base plate (col. 2, lines 35-53 and fig. 1), and thereby securing the insert (medial and lateral bearings) against the lips (medial and lateral retaining brackets; 64), respectively, when the components are locked together with the key (clip; 19).
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 tray of Dodd to include a pair of peripheral lips, particularly 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 such that the retention clip secures the medial bearing and the lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively, in order to fix the bearings/insert in place, as contemplated by Dodd, by preventing anterior-posterior and medial-lateral movement of the tibial bearings upon assembly with the tibial base plate, as taught by Martinez.
Regarding claim 32
Dodd in view of Martinez teaches the prosthetic assembly of claim 31. Dodd also teaches wherein the recess (26) includes a first groove (56) and a second groove (58) supporting portions (projections 52, 54) of the resilient element (20) therein to allow the resilient element to expand and contract within the stem recess (page 8, lines 26-34 disclose flexion of the spring within the recess).
Regarding claim 33
Dodd in view of Martinez teaches the prosthetic assembly of claim 32. Dodd also teaches wherein the retention system (44) includes a first arm covering the first groove and a second arm covering the second groove (fig. 3 shows that the arms of the clip cover the grooves).
Regarding claim 34
Dodd in view of Martinez teaches the prosthetic assembly of claim 33. Dodd also teaches wherein each of the first arm and the second arm extend anteriorly-to-posteriorly and engage opposite sides of the boss (figs. 2 and 3 show that the arms engage opposite sides 33, 35 of the boss defined by walls 29, 31).
Martinez also teaches a retention clip having a first arm and a second arm (fig. 1) that are each configured to engage and trap the insert against the lips (brackets; 64), such that the medial bearing is secured against the medial retaining bracket, and the lateral bearing is trapped against the lateral retaining bracket (fig. 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the each of the first arm and the second arm of the retention clip are configured to engage and secure the insert against the brackets, such that the medial bearing is secured against the medial retaining bracket, and the lateral bearing is secured against the lateral retaining bracket, in order to fix the bearings/insert in place, as contemplated by Dodd, by preventing anterior-posterior and medial-lateral movement of the tibial bearings upon assembly with the tibial base plate, as taught by Martinez.
Regarding claim 35
Dodd in view of Martinez teaches the prosthetic assembly of claim 34. Martinez also teaches wherein the first arm is slidably insertable into a medial passage of the medial bearing and the second arm is slidably insertable into a lateral passage of the lateral bearing, for the purpose of securely retaining the insert to the base plate (col. 2, lines 43-61 discloses inserting the arms of the clip into paralleled grooves; 39 formed in the slot; 35 on the undersurface of the insert).
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 fixed insert of Dodd to include medial and lateral passages on the undersurface into which the first and second arms of the clip are inserted, in order to securely retain the insert to the base plate, as taught by Martinez.
Regarding claim 36
Dodd meets the limitations of a prosthetic assembly (fig. 1) comprising: a medial bearing (12) and a lateral bearing (12); a tibial tray (4) comprising: a substantially centrally located boss (defined by walls 29, 31); and a tibial stem (8) defining a recess (26); a resilient element (20) positionable at least partially within the recess and connectable to an artificial ligament (18) (fig. 3 shows the spring 20 positioned in the recess 26); and a retention clip (44) including a pair of arms configured to engage opposite sides of the boss (figs. 2 and 3 show that the pair of arms of the clip 44 are configured to engage opposite sides 33, 35 of the boss), the retention clip configured to at least partially cover the recess of the tibial stem and engage the resilient element to retain the resilient element within the recess (page 8, lines 1-6 disclose that the U-shaped clip 44 is pushed in the slots 36, 38 to cover the grooves to prevent the projections 52, 54 of the spring/resilient element 20 being withdrawn fully from the bore 26 – see 112 rejection above).
Dodd also teaches that the bearing components may be fixed to the tray (page 6, lines 24-34). However, Dodd does not teach a medial retaining bracket located at a medial edge of a medial portion of the tibial tray, a lateral retaining bracket located at a lateral edge of a lateral portion of the tibial tray, or that the retention clip is configured to trap a medial bearing and a lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively.
Martinez teaches a modular knee joint including a tibial platform with a top surface that engages a tibial insert by locking in place with a lock key (abstract). More specifically, Martinez teaches an upraised boss (33) primarily centered along the top surface (29) that is provided to operatively engage the tibial insert (11) and secure the components with the tibial key (clip; 19). Martinez also teaches a pair of peripheral lips (64; since the lips project from the upper surface and prevent movement of the insert, they are construed to be brackets, as claimed, particularly a medial retaining bracket located at a medial edge of a medial portion of the tibial tray 15 and a lateral retaining bracket located at a lateral edge of a lateral portion of the tibial tray 15; see annotated fig. 1 above) on the top surface (29) of the base plate (15), for the purpose of preventing anterior-posterior and medial-lateral movement of the tibial insert (11) upon assembly with the tibial base plate (col. 2, lines 35-53 and fig. 1), and thereby trapping the insert (medial and lateral bearings) against the lips (medial and lateral brackets; 64), respectively, when the components are locked together with the key (clip; 19).
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 tray of Dodd to include a pair of peripheral lips, particularly 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 such that the retention clip traps the medial bearing and the lateral bearing against the medial retaining bracket and the lateral retaining bracket, respectively, in order to fix the bearings/insert in place, as contemplated by Dodd, by preventing anterior-posterior and medial-lateral movement of the tibial bearings upon assembly with the tibial base plate, as taught by Martinez.
Regarding claim 37
Dodd in view of Martinez teaches the prosthetic assembly of claim 36. Dodd also teaches wherein the pair of arms includes a first arm and a second arm extending anteriorly-to-posteriorly to engage opposite sides of the boss (Figs. 2 and 3 show that each of the first and second arms extend anteriorly-to-posteriorly to engage opposite side of the boss).
Martinez also teaches a retention clip having a first arm and a second arm (fig. 1) that are each configured to engage and trap the insert against the lips (brackets; 64), such that the medial bearing is trapped against the medial retaining bracket, and the lateral bearing is trapped against the lateral retaining bracket (fig. 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the each of the first arm and the second arm of the retention clip are configured to engage and trap the insert against the brackets, such that the medial bearing is trapped against the medial retaining bracket, and the lateral bearing is trapped against the lateral retaining bracket, in order to fix the bearings/insert in place, as contemplated by Dodd, by preventing anterior-posterior and medial-lateral movement of the tibial bearings upon assembly with the tibial base plate, as taught by Martinez.
Regarding claim 38
Dodd in view of Martinez teaches the prosthetic assembly of claim 37. Martinez also teaches wherein the first arm is slidably insertable into a medial passage of the medial bearing and the second arm is slidably insertable into a lateral passage of the lateral bearing, for the purpose of securely retaining the insert to the base plate (col. 2, lines 43-61 discloses inserting the arms of the clip into paralleled grooves; 39 formed in the slot; 35 on the undersurface of the insert).
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 fixed insert of Dodd to include medial and lateral passages on the undersurface into which the first and second arms of the clip are inserted, in order to securely retain the insert to the base plate, as taught by Martinez.
Regarding claim 39
Dodd in view of Martinez teaches the prosthetic assembly of claim 36. Dodd also teaches wherein the resilient element includes a ligament anchor (bollard; 22) configured to connect the resilient element to the artificial ligament (18) as shown in fig. 2.
Regarding claim 40
Dodd in view of Martinez teaches the prosthetic assembly of claim 39. Dodd also teaches wherein the resilient element is configured to expand and contract within the stem recess in response to load applied to the artificial ligament (page 8, lines 26-34 disclose flexion of the spring within the recess).
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, 29, 31, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 16 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 securable to the tibial tray to engage the resilient element to retain the resilient element within the recess (see patent claims 1, 14, and 16; the claim language has been interpreted such that the retention clip covering the recess meets the limitation that the retention clip engages the resilient element within the recess – see 112 rejection above).
Regarding claim 29, the patent claims also recite wherein the resilient element is configured to apply tension to the artificial ligament (see patent claims 14 and 16).
Regarding claim 31, 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; a lateral retaining bracket located at a lateral edge of a lateral portion of the tibial tray; a central boss; and a tibial stem defining a recess; a resilient element located at least partially within the recess and connectable to an artificial ligament; and a retention system 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, the retention system secured to the tibial tray proximate the recess of the tibial stem, the retention system configured to engage the resilient element to retain the resilient element within the recess (see patent claims 1, 14 and 16; the claim language has been interpreted such that the retention clip covering the recess meets the limitation that the retention clip engages the resilient element within the recess – see 112 rejection above).
Regarding claim 36, 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; 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 including a pair of arms 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, the retention clip configured to at least partially cover the recess of the tibial stem and engage the resilient element to retain the resilient element within the recess (see patent claims 1, 14 and 16; the claim language has been interpreted such that the retention clip covering the recess meets the limitation that the retention clip engages the resilient element within the recess – see 112 rejection above).
Claims 21, 22, 30, 31, and 36-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 4, and 13 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 securable to the tibial tray to engage the resilient element to retain the resilient element within the recess (see patent claims 1, 3, 9, and 13; the claim language has been interpreted such that the retention clip covering the recess meets the limitation that the retention clip engages the resilient element within the recess – see 112 rejection above).
Regarding claim 22, the patent claims also recite the prosthetic assembly of claim 21, wherein the recess includes 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 (see patent claim 4).
Regarding claim 30 corresponds with patent claim 4.
Regarding claim 31, 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; a lateral retaining bracket located at a lateral edge of a lateral portion of the tibial tray; a central boss; and a tibial stem defining a recess; a resilient element located at least partially within the recess and connectable to an artificial ligament; and a retention system 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, the retention system secured to the tibial tray proximate the recess of the tibial stem, the retention system configured to engage the resilient element to retain the resilient element within the recess (see patent claims 1, 3, 9, and 13; the claim language has been interpreted such that the retention clip covering the recess meets the limitation that the retention clip engages the resilient element within the recess – see 112 rejection above).
Regarding claim 36, the patent claims also recite the 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; 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 including a pair of arms 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, the retention clip configured to at least partially cover the recess of the tibial stem and engage the resilient element to retain the resilient element within the recess (see patent claims 1, 3, 9, and 13; the claim language has been interpreted such that the retention clip covering the recess meets the limitation that the retention clip engages the resilient element within the recess – see 112 rejection above).
Regarding claim 37, the patent claims also recite the prosthetic assembly of claim 36, wherein the pair of arms includes a first arm and a second arm extending anteriorly-to-posteriorly to engage opposite sides of the boss, the first arm configured to engage and trap the medial bearing against the medial retaining bracket, and the second arm configured to engage and trap the lateral bearing against the lateral retaining bracket (see patent claims 1, 3, 9, and 13).
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.
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/M.A.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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