DETAILED ACTION
The following is a non-final office action is response to communications received on 11/16/2023. Claims 21-39 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.
Claims 21-24, 36 & 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9 & 19 of U.S. Patent No. 11,857,423. 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 21 & 22, patent claims 1 & 9 recite the same limitations.
Regarding Claim 23, patent claim 3 recites the same limitations.
Regarding Claim 24, patent claim 4 recites the same limitations.
Regarding Claims 26 & 39, patent claim 19 recites the same limitations.
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) 21, 24-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lennox (US 5,507,824).
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Regarding Claim 21, Lennox teaches a liner (20) for an acetabular cup (16), comprising:
a proximal surface (shown), at least a portion of the proximal surface is configured to extend along a plane (P5) at an angle relative to an outer rim (shown) of the acetabular cup (16) when the liner is seated in the acetabular cup;
an outer convex surface (shown) configured to at least partially extend into (in cavity 32) an acetabular cup (16) when the liner is seated in the acetabular cup;
a concave bearing surface (socket 62) recessed relative to the proximal surface (shown) and configured to receive a head (68) of a femoral stem (14); and
one or more visual indicators (reference mark 57) on the liner (Fig 5) that is fully capable of identifying a location for applying an impaction force on the liner (as it identifies the center line of the liner).
Regarding Claim 24, Lennox teaches wherein the one or more visual indicators are fully capable of being virtual indicators applied or projected onto the concave bearing surface. An image projected onto the bearing would not structurally change the bearing, and as the device casting the projection is not positively claimed, the device of Lennox is fully capable of receiving a projected image.
Regarding Claim 25, Lennox teaches wherein the one or more visual indicators (57) comprise a visual indicator indicating a center location (Fig 5) of the acetabular cup that is fully capable of applying an impaction force square with the acetabular cup.
Regarding Claim 26, Lennox teaches wherein the one or more visual indicators comprise a visual indicator (57) indicating an offset location (as the socket 62 is offset relative to the liner) of a center of the acetabular cup when the liner is seated in the acetabular cup.
Regarding Claim 27, Lennox teaches wherein a second portion (shown) of the proximal surface is configured to extend along a plane (P4) parallel to the outer rim (P1) of the acetabular cup (16) when the liner (20) is seated in the acetabular cup.
Regarding Claim 28, Lennox teaches wherein an entirety of the proximal surface is configured to extend along the plane (P5) at the angle relative to the outer rim (P1) of the acetabular cup when the liner is seated in the acetabular cup (Figs 2, 4 & 6).
Claim(s) 36-39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryland et al. (US 5,169,399).
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Regarding Claim 36, Ryland teaches a method for implanting a liner in an acetabular cup, comprising:
identifying a size of an acetabular cup (112) for an acetabular hole;
identifying a liner (114) for use with the acetabular cup;
inserting the acetabular cup in the acetabular hole (Fig 2);
inserting the liner in the acetabular cup, the liner (114) having a concave bearing surface (shown) and a proximal surface (shown) that extends along a plane (shown in blue) at an angle relative to an outer rim (shown as red) of the acetabular cup when the liner is seated in the acetabular cup (Fig 2); and
impacting the liner into place in the acetabular cup (Col 6: lines 23-27) with an impactor (10) square with the acetabular cup to seat the liner in the acetabular cup, the impactor having an impaction surface (where impactor contacts the liner in Fig 2) corresponding to one or both of the proximal surface and the concave bearing surface of the liner.
Regarding Claim 37, Ryland teaches wherein impacting the liner with the impactor (10) includes applying an impaction force (Col 6: lines 23-27) on the liner so that the applied force is centered on a visual indicator (i.e., the liner opening) on the liner.
Regarding Claim 38, Ryland teaches wherein impacting the liner with the impactor (10) includes applying an impaction force (Col 6: lines 23-27) square on the liner (114) relative to the acetabular cup (112).
Regarding Claim 39, Ryland teaches wherein impacting the liner with the impactor (10) includes applying an impaction force (Col 6: lines 23-27) centered at an offset location (as the central axes of the liner and cup are offset from one another) of a center of the acetabular cup when the liner is seated in the acetabular cup.
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) 29 & 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lennox (US 5,507,824) in view of Ryland et al. (US 5,169,399). Please refer to the annotated figure(s) supra in consideration of the following rejections.
Regarding Claim 29, Lennox discloses the invention substantially as claimed. Lennox teaches a liner (20) for an acetabular cup, comprising:
a liner (20) comprising:
a proximal surface (shown) configured to extend along a plane (P5) at an angle relative to an outer rim (shown) of the acetabular cup (16) when the liner is seated in the acetabular cup;
an outer convex surface (shown) configured to at least partially extend into (in cavity 32) an acetabular cup (16) when the liner is seated in the acetabular cup;
a concave bearing surface (socket 62) recessed relative to the proximal surface (shown) and configured to receive a head (68) of a femoral stem (14); and
one or more visual indicators (reference mark 57) on the liner (Fig 5) that is fully capable of identifying a location for applying an impaction force on the liner (as it identifies the center line of the liner).
However, Lennox does not disclose an impactor having an impaction surface corresponding to one or both of the proximal surface and the concave bearing surface of the liner.
Ryland teaches an impactor (10) for impacting an acetabular liner (114) in the same field of endeavor. Said impactor comprising an impactor surface (any surface of impactor elements 36 & 38) corresponding to one or both of the proximal surface and the concave bearing surface of the liner (Fig 2) to aid the surgeon in assembling the acetabular cup during surgery (Col 6: lines 23-27).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize the impactor, as taught by Ryland, in the assembly of the acetabular cup of Lennox. As Lennox teaches that the liner (20) can be secured to the shell member with various mechanisms (Col 12: lines 21-23), utilizing Ryland’s impactor would have been an obvious tool/mechanism for the surgeon to assemble the device of Lennox during surgery.
Regarding Claim 32, the combination teaches wherein the one or more visual indicators are fully capable of being virtual indicators applied or projected onto the concave bearing surface. An image projected onto the bearing would not structurally change the bearing, and as the device casting the projection is not positively claimed, the device of Lennox is fully capable of receiving a projected image.
Regarding Claim 33, the combination teaches wherein the concave bearing surface (62) extends about an axis (shown in green) that is offset from an axis (shown in yellow) of the acetabular cup when the liner is seated in the acetabular cup.
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Regarding Claim 34, the combination teaches wherein the impactor (10) comprises a shaft (shown), wherein the impaction surface extends at an angle (shown) relative to a length of the shaft of the impactor (Fig 2).
Regarding Claim 35, the combination teaches wherein the impactor comprises a shaft (shown), wherein a first portion of the impaction surface extends at an angle (shown) relative to a length of the shaft of the impactor (as shown on Fig 1), wherein a second portion (shown) of the impaction surface extends perpendicular to the length of the shaft.
Allowable Subject Matter
Claims 22, 23 would be allowed if (1) if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and (2) a timely filed terminal disclaimer(s) in compliance with 37 CFR 1.321(c) or 1.321(d) is filed to overcome the nonstatutory double patenting rejection(s) set forth in this Office action.
Claims 30 & 31 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.
The following is a statement of reasons for the indication of allowable subject matter: Regarding Claims 22, 23, 30 & 31, Jackson, III (US 9,561,086), which is the most pertinent art found, fails to teach and/or fairly suggest the instant invention. Jackson III teaches an acetabular cup (10) comprising a plurality of guide lines, or visual markers (12-14 in Figs 2-4), to ensure the acetabular component is properly aligned (e.g., not anteverted or retroverted) during surgery (Col 4: lines 1-10). However, the prior art either individually or in combination, does not teach or render obvious wherein the one or more visual indicators include markings on the concave bearing surface of the acetabular liner, that identify a location for applying an impaction force on the liner.
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