DETAILED ACTION
The following is a non-final office action is response to communications received on 07/19/2024. Claims 1-17 are currently pending and addressed below.
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 .
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.
Claim 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 & 15-17 of U.S. Patent No. 10,278,826. The elements of the instant application are to be found in the Patent and therefore are anticipated. Although the conflicting claims are not identical, they are not patentably distinct from each other because the Patent and the instant application all recite the same basic structure with a permutation of similar elements throughout.
Regarding Claims 1-17, patent claims 1-17 (respectively) recite the same limitations.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the spherical shell section" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the tapered shell section" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the spherical shell section" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the tapered shell section" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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) 10-13 & 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hutton et al. (US 10,307,255).
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Regarding Claim 10, as best understood (see 112 rejection supra), Hutton teaches an acetabular implant for hip arthroplasty comprising:
an acetabular shell (100) configured to be attached to an acetabulum of a patient, the acetabular shell having a proximal end (shown) and a distal end (shown), the acetabular shell including an inner surface defining a shell cavity (inside shell), the inner surface having a shell section (shown) tapering inward toward a central axis (shown) of the acetabular shell as the shell section extends distally toward the distal end, the acetabular shell including at least one shell interlocking structure (shown); and
an acetabular liner (200) sized and shaped to be disposed in the shell cavity of the acetabular shell (Fig 6), the acetabular liner including an outer surface having a liner section (shown) corresponding to the shell section, a transition liner (shown) section disposed distally of the tapered liner section and a spherical liner section (shown) disposed distally of the transition liner section and corresponding to the spherical shell section (shown), the liner section configured to engage the shell section to inhibit movement of the acetabular liner (200) relative to the acetabular shell (100) when the acetabular liner is disposed in the shell cavity of the acetabular shell, the acetabular liner (200) including at least one liner interlocking structure configured to mate with the at least one shell interlocking structure (230) to inhibit rotation of the acetabular liner relative to the acetabular shell about the central axis when the acetabular liner is disposed in the shell cavity of the acetabular shell (Col 5: lines 36-39), the acetabular liner defining a liner cavity (shown),
wherein the transition liner section is generally conical (Figs 3, 5 & 6).
Regarding Claim 11, Hutton teaches wherein the at least one shell interlocking structure includes a plurality of shell interlocking structures (shown) circumferentially spaced apart from one another (Fig 1) and the at least one liner interlocking structure (230) includes a plurality of liner interlocking structures circumferentially spaced apart from one another (Fig 1), each shell interlocking structure configured to mate with one of the liner interlocking structures.
Regarding Claim 12, Hutton teaches wherein the at least one shell interlocking structure (shown) comprises an interlocking recess and the at least one liner interlocking (230) structure comprises an interlocking projection (Fig 1).
Regarding Claim 13, as best understood (see 112 rejection supra), Hutton teaches wherein the tapered shell section and the tapered liner section (shown) each taper at about 19 degrees relative to the central axis (Col 3: lines 52-56).
Regarding Claim 17, the combination teaches wherein the acetabular liner (200) is constructed using a cobalt-chrome alloy or a ceramic (Col 3: lines 16-19).
Claim Rejections - 35 USC § 103
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) 1-5 & 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutton et al. (US 10,307,255) in view of Davenport et al. (US 9,763,806).
Regarding Claim 1, as best understood (see 112 rejection supra), Hutton discloses the invention substantially as claimed. Hutton teaches an acetabular implant (Fig 6) for hip arthroplasty comprising:
an acetabular shell (100) configured to be attached to an acetabulum of a patient, the acetabular shell having a proximal end (shown) and a distal end (shown), the acetabular shell including an inner surface defining a shell cavity (inside shell), the inner surface having a shell section (shown) tapering inward toward a central axis (shown) of the acetabular shell as the shell section extends distally toward the distal end, the acetabular shell including a snap-fit receiver (shown as 150); and
an acetabular liner (200) sized and shaped to be disposed in the shell cavity of the acetabular shell (Fig 6), the acetabular liner including an outer surface having a liner section (shown) corresponding to the shell section, a transition liner (shown) section disposed distally of the liner section, and a spherical liner section (shown) disposed distally of the transition liner section and corresponding to the spherical shell section (shown), the liner section configured to engage the shell section to inhibit movement of the acetabular liner relative to the acetabular shell when the acetabular liner (200) is disposed in the shell cavity of the acetabular shell (100), the acetabular liner including a snap-fit retainer (250) sized and shaped to be received by the snap-fit receiver (150) of the acetabular shell to form a snap-fit connection (Col 5: lines 48-52) between the acetabular liner and the acetabular shell when the acetabular liner is inserted into the shell cavity of the acetabular shell,
wherein the transition liner section (shown) is generally conical (Figs 3, 5 & 6).
However, Hutton does not disclose wherein the acetabular shell (100) includes a tool interlocking structure configured to mate with a shell insertion tool to inhibit the acetabular shell from rotating.
Davenport teaches an acetabular inserter instrument (20) in the same field of endeavor. Said instrument comprising a rotational/keyed locking portion (76) configured to mate with a rotational control portion (78) of an acetabular cup in order to rotationally fix the two components (Col 5: lines 7-13) to provide control of the prosthesis during implantation (Col 5: lines 27-33).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize both the tool interlocking structure and shell insertion tool, as taught by Davenport, as a means to implant the shell (100) as taught by Hutton. Providing Davenport’s tool interlocking structure (78) on the shell of the Hutton, as well as the complimentary-shaped shell insertion tool, would allow the surgeon to rotationally fix the shell and instrument together thus provide increased control of the prosthesis during implantation
Regarding Claim 2, the combination teaches wherein the tool interlocking structure comprises an insertion tool recess sized and shaped to receive a corresponding projection of the shell insertion tool (Col 4: line 62 – Col 5: line 13).
Regarding Claim 3, the combination teaches wherein the insertion tool recess is aligned with the central axis, the insertion tool recess including a rotation inhibiting section sized and shaped to receive a rotation inhibiting structure of the shell projection of the shell insertion tool to inhibit the acetabular shell from rotating about the central axis when the acetabular shell and shell insertion tool are coupled together (Col 4: line 62 – Col 5: line 13).
Regarding Claim 4, the combination teaches wherein the snap-fit receiver (150) comprises a circumferential recess and the snap-fit retainer (250) comprises a circumferential lip (Figs 1 & 6).
Regarding Claim 5, the combination teaches wherein the acetabular shell (100) includes an alignment recess (shown as shell interlocking structure) and the acetabular liner (200) includes an alignment projection (230) configured to be inserted into the alignment recess to align the acetabular shell and the acetabular liner (Figs 1 & 6).
Regarding Claim 9, the combination teaches wherein the acetabular shell (100) includes a shell interlocking structure (shown) and wherein the acetabular liner (200) includes a liner interlocking structure (230) configured to mate with the shell interlocking structure to inhibit rotation of the acetabular liner relative to the acetabular shell about the central axis when the acetabular liner is disposed in the shell cavity of the acetabular shell
Claim(s) 6 & 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutton et al. (US 10,307,255) in view of Davenport et al. (US 9,763,806) and in further view of Rister et al. (US 11,013,604). Please refer to the annotated figure below in consideration of the following rejection:
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Regarding Claim 6, as set for the supra, the combination discloses the invention substantially as claimed. However, the combination does not disclose wherein the implant further comprises a mobile insert, the mobile insert sized and shaped to be received in the liner cavity, the mobile insert defining a mobile insert cavity sized and shaped to receive the femoral head, the mobile insert having a spherical outer surface forming the majority of a sphere.
Rister teaches an acetabular cup system with comprising a mobile insert (220) in the same field of endeavor. Said mobile insert sized and shaped to be received in a liner cavity (Fig 5), the mobile insert defining a mobile insert cavity sized and shaped to receive the femoral head (210), the mobile insert having a spherical outer surface forming the majority of a sphere (Figs 1 & 5). Rister further teaches that these dual-mobility systems (i.e., with a mobile insert) reduce the rate of dislocation of the implant (Col 1: lines 30-44) by allowing for varying head size.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the device of the combination with the mobile insert, as taught by Rister, in order to construct a dual-mobility system and therefore reduce the rate of dislocation of the implant.
Regarding Claim 7, the combination teaches wherein the mobile insert (220) defines a stem relief recess (shown) at a proximal end of the mobile insert cavity, the stem relief recess configured to receive a stem of a femoral implant when the femoral implant rotates relative to the mobile insert (Fig 1).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutton et al. (US 10,307,255) in view of Davenport et al. (US 9,763,806) and in further view of Nevins et al. (US 2012/0179270). Please refer to the annotated figure below in consideration of the following rejection:
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Regarding Claim 8, as set forth supra, the combination discloses the invention substantially as claimed. However, the combination does not specifically disclose wherein the acetabular shell defines at least five fastener openings, each fastener opening sized and shaped to receive a fastener to secure the acetabular shell to the acetabulum.
Nevins teaches an acetabular shell system (Fig 18) in the same field of endeavor. Said shell comprises at least five fastener openings (Fig 18), sized and shaped to receive a fastener and secure the shell to the acetabulum. The number of fasteners aids in the stability and fixation in the acetabular shell when there is less than optimal amount of bone to secure the shell to the acetabulum [0052].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the device of the combination with at least five fastener openings in order to aid in the stability and fixation of the acetabular shell when there is less than optimal amount of bone to secure the shell to the acetabulum.
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutton et al. (US 10,307,255) in view of Rister et al. (US 11,013,604). Please refer to the annotated figure below in consideration of the following rejection:
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Regarding Claim 14, as set forth supra, Hutton discloses the invention substantially as claimed. However, Hutton does not disclose wherein the acetabular shell includes an alignment recess and the acetabular liner includes an alignment projection configured to be inserted into the alignment recess to align the acetabular shell and the acetabular liner.
Rister teaches an acetabular cup system (Fig 5) in the same field of endeavor. Said system comprising an acetabular shell (120) including an alignment recess (135) and the acetabular liner (230) includes an alignment projection (238) configured to be inserted into the alignment recess to align the acetabular shell and the acetabular liner (Col 5: lines 44-51).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to add the alignment recess and projection, as taught by Rister to the acetabular shell and liner, as taught by Hutton, in order to align the shell and liner during implantation.
Regarding Claim 15, as set forth supra, Hutton discloses the invention substantially as claimed. However, Hutton does not disclose wherein the implant further comprises a mobile insert, the mobile insert sized and shaped to be received in the liner cavity, the mobile insert defining a mobile insert cavity sized and shaped to receive the femoral head, the mobile insert having a spherical outer surface forming the majority of a sphere.
Rister teaches an acetabular cup system with comprising a mobile insert (220) in the same field of endeavor. Said mobile insert sized and shaped to be received in a liner cavity (Fig 5), the mobile insert defining a mobile insert cavity sized and shaped to receive the femoral head (210), the mobile insert having a spherical outer surface forming the majority of a sphere (Figs 1 & 5). Rister further teaches that these dual-mobility systems (i.e., with a mobile insert) reduce the rate of dislocation of the implant (Col 1: lines 30-44) by allowing for varying head size.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the acetabular cup system, as taught by Hutton, with the mobile insert, as taught by Rister, in order to construct a dual-mobility system and therefore reduce the rate of dislocation of the implant.
Regarding Claim 16, the combination teaches wherein the mobile insert (220) defines a stem relief recess (shown) at a proximal end of the mobile insert cavity, the stem relief recess configured to receive a stem of a femoral implant when the femoral implant rotates relative to the mobile insert (Fig 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
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