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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered.
The previous objection of the claims is withdrawn in light of applicant’s amendments. The previous objection to the drawings is withdrawn in light of applicant’s amendments. The previous rejection under 35 USC 112 is withdrawn in light of applicant’s amendments. Claims 49-70 are currently pending in this application. Claims 64-68 are withdrawn.
It is noted that the examiner attempted to contact applicant to discuss an examiner’s amendment in the interest of compact prosecution. However, no response was received.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 70 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 2006/0229730 A1 to Railey et al. (Railey).
Railey teaches a prosthesis suited for orthopedic implantation that possesses a multi-piece stem component that supports an artificial joint surface that can articulate with another artificial joint surface in various ways (abstract).
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Railey meets the limitations of a method of implanting an intermediate implant (22) of an ankle prosthesis (fig. 13), the method comprising: providing a talar implant (24) and a tibial implant (12), the tibial implant comprising an upper surface (see annotated fig. 13 above), a lower surface (see annotated fig. 13 above), and a slot formed between the upper surface and the lower surface (groove; 92); inserting the intermediate implant between the tibial implant and the talar implant (figs. 13 and 15A-C show the intermediate implant; 22 being inserted between the tibial and talar implants); and inserting an implant lock (detent; 98) at least partially within the slot (92) to fix the position of the intermediate implant relative to the tibial implant (fig. 15C shows the detent/lock inserted within the slot to fix the intermediate implant 22 to the tibial implant 12), the implant lock applying a force that is substantially perpendicular to an axis of rotation of the intermediate implant (22) (the intermediate implant, and therefore the lock/detent, applies a force that is substantially perpendicular to an axis of rotation of the intermediate implant, at least when the intermediate implant slides into snap-fit engagement with the tibial implant, as shown in fig. 15A).
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 49-63 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-13, and 17-20 of U.S. Patent No. 11,103,353 B2 in view of US Patent Application Publication No. 2008/0103603 A1 to Hintermann (Hintermann). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 49, the patent claims also recite a method of adjustably implanting an intermediate implant of an ankle prosthesis comprising a tibial implant the method comprising: implanting an intermediate implant, the intermediate implant comprising a projecting member defining an axis of rotation; rotating the intermediate implant about the axis of rotation of the projecting member and relative to the tibial implant while the tibial implant and the intermediate implant are implanted in the ankle; and fixing the position of the intermediate implant relative to the tibial implant by inserting an implant lock between the tibial implant, the implant lock applying a force that is substantially perpendicular to the axis of rotation of the projecting member (see patent claims 1, 17, 19, and 20).
It would have been obvious to one having ordinary skill in the art to specify that the ankle prosthesis of the patent is used in a method of adjustably implanting an intermediate implant of an ankle prosthesis comprising a tibial implant and a talar implant, in order to configure the intermediate implant between the tibial implant and the talar implant to allow the ankle to move, as taught by Hintermann (paragraph 0004 of Hintermann)
Regarding claim 50, the patent claims also recite the method of claim 49, the fixing step comprising the implant lock traversing linearly in a direction substantially perpendicular to the axis of rotation to engage the projecting member thereby resisting the rotation of the projecting member (see patent claims 1 and 20).
Regarding claim 51, the patent claims also recite the method of claim 49, the fixing step comprising the implant lock moving in the anterior-posterior direction relative to the projection member, thereby resisting the rotation of the projecting member (see patent claims 1 and 19).
Regarding claim 52, the patent claims also recite the method of claim 49, wherein the intermediate implant further comprises a first surface and a second, curved surface opposite the first surface, the projecting member extending outwardly from the first surface, wherein the tibial implant further comprises a recess, and the implanting step comprises inserting the projecting member into the recess of the tibial implant (see patent claims 1, 17, 19, and 20).
Regarding claim 53, the patent claims also recite the method of claim 52, wherein during the rotating step, the projecting member can rotate at least one of 70 degrees, at least 180 degrees, or 360 degrees relative to the tibial implant when disposed in the recess (see patent claim 2).
Regarding claim 54, the patent claims also recite the method of claim 49, where the projecting member comprises a substantially circular transverse cross-section and a cross section of the projecting member perpendicular to the transverse cross-section is a quadrilateral (see patent claim 3).
Regarding claim 55, the patent claims also recite the method of claim 49, wherein the projecting member comprises a lateral surface that is substantially parallel to the axis of rotation of the projecting member and comprises one or more interlocking surface features, and the fixing step further comprising engaging the implant lock with the one or more interlocking surface features (see patent claim 4).
Regarding claim 56, the patent claims also recite the method of claim 49, wherein the projecting member comprises a lateral surface comprising one or more interlocking surface features, wherein the implant lock comprises a first end and a second end opposite the first end, the first end comprising one or more interlocking surface features, and the fixing step further comprising engaging the interlocking surface features of the implant lock with the one or more interlocking surface features of the lateral surface of the projecting member to resist rotation of the projecting member relative to the tibial implant (see patent claims 5, 18, and 19).
Regarding claim 57, the patent claims also recite the method of claim 52, wherein the tibial implant comprises a slot that is in communication with the recess, and during the fixing step, the inserting of the implant lock comprises inserting the implant lock into the slot along a direction that is within 10° of an axis perpendicular to the axis of rotation (see patent claims 6 and 17).
Regarding claim 58, the patent claims also recite the method of claim 57, the fixing step further comprising releasably interlocking the implant lock with a portion of the tibial implant (see patent claim 7).
Regarding claim 59, the patent claims also recite the method of claim 58, wherein the implant lock comprises a protrusion and the slot further comprises a sidewall and a notch in the sidewall, and the fixing step further comprises engaging the protrusion with the notch of the slot such that the implant lock is releasably interlocked with the slot (see patent claim 8).
Regarding claim 60, the patent claims also recite the method of claim 59, wherein the slot comprises a width and the implant lock comprises a width that is less than the width of the slot (see patent claim 10).
Regarding claim 61, the patent claims also recite the method of claim 49, wherein the implant lock comprises an insert, the insert comprising a first portion and a second portion, and the fixing step further comprising moving the first portion relative to the second portion (see patent claim 11).
Regarding claim 62, the patent claims also recite the method of claim 61, wherein the first portion of the implant lock comprises a screw, and wherein the insert comprises a bore, the fixing step further comprising tightening the screw in the bore (see patent claim 12).
Regarding claim 63, the patent claims also recite the method of claim 62, wherein the first portion and the second portion of the insert of the implant lock are configured to move away from each other as the screw is rotated in a first direction and toward each other as the screw is rotated in a second direction (see patent claim 13).
Regarding claim 69, the patent claims also recite the method of claim 49, wherein the projecting member comprises a lateral surface that is substantially perpendicular to the axis of rotation, the lateral surface configured to engage the implant lock (see patent claim 4 – see also drawing objection and 112 rejection above).
Allowable Subject Matter
Claims 49-63 and 69 would be allowable if rewritten or amended to overcome the Double Patenting rejection(s), set forth in this Office action.
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 a method of adjustably implanting an ankle prosthesis made up of an intermediate implant, a tibial implant, and a talar implant, that includes rotating the intermediate implant relative to the tibial implant about a rotational axis defined by a projecting member on the intermediate implant while the tibial implant, talar implant, and intermediate implant are implanted in the ankle and also fixing the position of the intermediate implant relative to the tibial implant by inserting an implant lock between the tibial and talar implants such that the implant lock applies a force that is substantially perpendicular to the axis of rotation of the projecting member of the intermediate implant.
The closest prior art to Railey teaches an ankle prosthesis similar to the claimed invention, including tibial (30), intermediate (combination of 12 and 22), and talar (24) components. However, Railey does not teach rotating the intermediate implant about the axis of rotation of the projecting member relative to the tibial implant while the tibial (30), talar (24), and intermediate implants (combination of 12 and 22) are implanted in the ankle. It would not have been obvious to modify Railey to be rotatable in this manner because the tibial implant is fixedly secured to the intermediate implant such that the joint surface (22) of the intermediate implant is positioned for stable articulation with the talar joint surface (24), as disclosed in paragraph 0136. Railey also teaches an implant lock (312) applying a substantially perpendicular force during connection of the two pieces (12 and 22) of the intermediate component. However, Railey does not teach that the lock is used to fix the position of the intermediate implant relative to the tibial implant. It would not have been obvious to modify Reiley such that the lock fixes the intermediate implant (combination of 12 and 22) relative to the tibial implant (30) since the lock is removed prior to fixation of the intermediate implant relative to the tibial implant, as disclosed in paragraph 0135.
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
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774