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 .
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.
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Claims 17-27 and 32-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 1223259B2, referred herein as Pat. ‘259. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 17-26 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Pat. ‘259. Pat. 259 recites A sterile kit for performing a joint implant surgery, the kit comprising: a reamer assembly; a grommet placer instrument; a sizing instrument; a wire guide; and a guide wire [claim 1 col. 12 lines 47-48,Col. 13 lines 8,14, Col. 14 lines 3-6]; wherein the guide wire comprises an elongated guide wire body and a needle head located on one end of the elongated guide wire body; wherein the wire guide comprises a wire guide body, a proximal guide located on a first end of the wire guide body, and a distal guide located on a second end of the wire guide body, and wherein the first end and the second end are opposite ends of the wire guide body [claim 1 Col. 13 lines 14-18]; wherein the reamer assembly comprises: a reamer; and a reamer depth stop having a body and at least two flexible tongs extending from the body, wherein the reamer comprises: a reamer shaft comprising a proximal end and a distal end; a cutting tip located at the distal end of the reamer shaft; a hollow channel within and extending through the cutting tip and the reamer shaft; and at least two grooves located on the reamer shaft, representing a proximal stop position and a distal stop position, wherein the at least two flexible tongs are shaped and configured to snap in place at the proximal stop position and then the distal stop position when the reamer depth stop is slid on to the reamer in a direction from the proximal end to the distal end, and wherein the reamer comprises an indent and a flattened portion located near the proximal end of the reamer, wherein the indent and the flattened portion are configured and shaped to facilitate quick connect attachment to a driving tool [claim 1 Col. 12 lines 49-67, Col. 13 lines 1-7]; wherein the grommet placer instrument comprises: a grommet placer shaft comprising a proximal end and a distal end; a grommet placer head located on the proximal end of the grommet placer shaft; at least two flexible split shafts located on the distal end of the grommet placer shaft;
a grommet stop extending from each of the at least two flexible split shafts; and a grommet clip extending from each of the at least two flexible split shafts [claim 1 Col. 13 lines 9-19]; and further comprising a broach [claim 1 col. 13 lines 19-Col. 14 lines 2].
Claims 27 and 33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3-5 of Pat. ‘259 for reciting substantially similar limitations.
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) 17-25 and 28-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirnmann (US Patent Pub. 20040092940A1) in view of Johnson et al (US Patent 6045572) and Knight et al (US Patent Pub. 20130213843A1).
Zwirnmann recites a sterile kit for performing a joint implant surgery. Specifically in regards to claims 17 and 21-22, the kit comprising: a reamer assembly comprises: a reamer (10); and a reamer depth stop (18) having a body and at least two flexible tongs (68, Fig. 6) extending from the body; a reamer shaft comprising a proximal end (30) and a distal end (13); a cutting tip (rip with 16) located at the distal end (13) of the reamer shaft; a hollow channel (channel created within 18/20) within and extending through the cutting tip (tip with 16) and the reamer shaft; and at least two grooves (24 shown in Fig. 2) located on the reamer shaft, representing a proximal stop position and a distal stop position (Zwirnmann recites that the tap 12 further comprises a plurality of circumferential grooves 24, indica 26, such as for example lines, for marking the effective length 28 of the exposed portion of the cutting threads 16) (Fig. 1-2; and Para. [0028],[0029],[0038]). In regards to claim 23, Zwirnmann recites wherein the at least two flexible tongs (68) are shaped and configured to snap in place at the proximal stop position and then the distal stop position when the reamer depth stop (18) is slid on to the reamer in a direction from the proximal end (30) to the distal end (13) (Zwirnmann recites the fingers 68 are configured and dimensioned to bear upon and slide along the shaft 22 of the self-drilling tap 12and are operably configured and dimensioned to selectively engage and disengage with the grooves 24 of the tap 12.) (Fig. 2-3 and 6-7; and Para. [0038],[0042]). In regards to claims 24-25, Zwirnmann recites wherein the reamer (10) comprises an indent and a flattened portion (31) located near the proximal end of the reamer, and wherein the indent and the flattened portion are configured and shaped to facilitate quick connect attachment to a driving tool (Fig. 2; and Para. [0029]). However, the reference is silent as to a grommet placer, sizing instrument, or wire guide.
Johnson recites a sterile kit for performing a joint implant surgery. Specifically in regards to claims 17, the kit comprising: a grommet placer instrument (28, Fig. 1) and a wire guide (34) (Fig. 1), and guide wire (30) (Fig. 1);. In regards to claims 18-20, Johnson recites the wire guide (34) comprises an elongated guide wire body (see Fig. 17) and a needle head (opening opposite end 84 of cap 38) located on one end of the elongated guide wire body; and wherein the wire guide (34, Fig. 17) comprises a wire guide body, a proximal guide (opening adjacent 84) located on a first end of the wire guide body, and a distal guide (opening close to arrow shown in Fig. 17) located on a second end of the wire guide body (Fig. 17; and Col. 4 lines 34-43 and Col. 5 lines 40-47); and wherein the first end and the second end are opposite ends of the wire guide body (Fig. 17). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the kit of Zwirnmann by adding a wire guide and grommet placer as taught in Johnson in order to be able to bring two sites together while minimizing damage to them and maintaining them while also allowing some flexibility and movement by the patient without disturbing the healing process (Col. 1 line 39-43).
However the references are still silent as to a sizing instrument.
Knight recites a sterile kit for performing a joint implant surgery. Specifically in regards to claims 17, the kit (Fig. 15) comprising a sizing instrument (400, Fig. 7). In regards to claims 28-31, Knight recites wherein the sizing instrument (400) comprises: a central body (circular portion of 400); and at least four size guides (410/411) extending from the central body (Fig. 7); wherein each size guide (410/411) comprises a size guide head (portion adjacent 410/411 that connects projections to central portion of 400) having a different size from each of the other size guide heads (Fig. 7); wherein each size guide head has a different thickness (415) from each of the other size guide heads (Fig. 7); and wherein the sizing instrument (400) is optionally provided in a sterile package separate from the sterile kit (Fig. 7; and Para. [0042]-[0043]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the kit of Zwirnmann by adding a sizing instrument as taught in Knight in order to be able properly determine the size of implant required in the surgical site (Para. [0043]).
In regards to claim 32, Zwirnmann recites a broach (Fig. 14; and Para. [0053]-[0054]).
In regards to claim 33, Zwirnmann in view of Johnson and Knight disclose a joint implant kit. However, the references are silent as to a grommet impactor. Johnson further recites a grommet impactor (Col. 7 lines 27-65). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the kit of Zwirnmann by adding a grommet impactor as taught in Johnson in order to ensure that the grommets are properly closed on the site.
In regards to claim 34-35, Zwirnmann in view of Johnson and Knight disclose a joint implant kit. However, the references are silent as to a joint implant in a sterile package. Knight further discloses a joint implant (205), and wherein the joint implant (205) is optionally provided in a sterile package separate from the sterile kit (Fig. 1a-3a). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the kit of Zwirnmann by adding a joint implant in a sterile package as taught in Knight in order to have a complete kit that allows the surgeon to have an all in one kit for a surgery without having to have multiple kits for one procedure.
Claim(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zwirnmann in view of Johnson and Knight, as applied to claim 17 above and further in view of Prince (US Patent 2961755).
Zwirnmann in view of Johnson and Knight disclose a joint implant kit comprising a reamer assembly, a wire guide and guide wire, a grommet placer instrument, and a sizing instrument as recited above. In regards to claim 26, Johnson recites wherein the grommet placer instrument (28) comprises: a grommet placer shaft (76) comprising a proximal end (end with 60) and a distal end (Fig. 10) ; a grommet placer head located on the proximal end of the grommet placer shaft; at least two flexible split shafts (69/70) located on the distal end of the grommet placer shaft (Fig. 10-12; and Col. 5 lines 21-40 and Col. 8 lines 36-40). However, the references are silent as to a grommet stop and clip.
Prince in regards to claims 26-27, recites a grommet placer instrument (Fig. 2) having a grommet stop (8, Fig. 3-4) extending from each of the at least two flexible split shafts (5); and a grommet clip (7) extending from each of the at least two flexible split shafts (5); and wherein the grommet stops (8) are shaped and configured to prevent a grommet placed on the grommet placer instrument from sliding proximally on the grommet placer shaft, and the grommet clips (7) are shaped and configured to prevent the grommet from falling off tips of the grommet placer (Fig. 1-5; and Col. 2 lines 16-55). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the kit of Zwirnmann by adding a grommet stop and clip as taught in Prince in order to have a means to keep the grommet in place on the inserter during insertion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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MARCELA . SHIRSAT
Primary Examiner
Art Unit 3775
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