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 26-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, 8, and 13 of U.S. Patent No. 12,349,891 in view of Gustine (U.S. Patent No. 9,060,815).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, 4-6, 8, and 13 entirely anticipates the subject matter of claims 26-35 with regard to the support apparatus. The reference patent does not, however, anticipate the plurality of spinal access instruments described in claims 26 and 35.
However, Gustine (U.S. Patent No. 9,060,815) teaches a plurality of spinal access instruments, including: at least one retractor configured for insertion within the surgical field (see Gustine, Col. 10, line 57-Col. 11, line 24, also see retractor 10 in Figure 1 of Pimenta, U.S. Patent No. 7,905,840, which Gustine incorporates by reference as the procedure used to access the spine), the at least one retractor 10 configured to retract soft tissue and having a distal end positionable substantially adjacent to an anterior aspect of a spine of the patient at a target intervertebral space between a target vertebra and an adjacent vertebra (see Pimenta, Figure 49 and Gustine, Figure 31 and Col. 10, line 57-Col. 11, line 24); at least one tissue preparation device 52 and 54 configured for cutting soft tissue, for penetrating an annulus within the target vertebral space between the target vertebra and the adjacent vertebra, for distracting the target vertebral space between the target vertebra and the adjacent vertebra, or combinations thereof (see Pimenta, Figure 41 and Col. 15, lines 13-38); at least one interbody device 10 configured for insertion within the target vertebral space between the target vertebra and the adjacent vertebra (see Gustine Figures 1-4 and 10 and Col. 3, line 63-Col. 4, line 15); at least one insertion device 200 configured for inserting and positioning the at least one interbody device 10 within the target vertebral space between the target vertebra and the adjacent vertebra (see Gustine, Col. 10, line 57-Col. 11, line 24); and a stabilization system 18 configured to stabilize the target vertebral space between the target vertebra and the adjacent vertebra after placement of the interbody device 10, the stabilization system 18 selected from the group consisting of one or a plurality of bone screws, one or a plurality of plates, a plurality of pedicle screws and a plurality of rods, one or a plurality of tethers, and combinations thereof (Figures 22-23 and Col. 8, lines 18-43), wherein the system is configured for a generally laterally directed insertion of the at least one interbody device within the target vertebral space between the target vertebra and the adjacent vertebra (see Gustine, Col. 10, line 57-Col. 11, line 24, also see retractor 10 in Figure 1 of Pimenta), wherein the at least one retractor 10 among the plurality of instruments includes a generally curved profile along an elongate axis of the at least one retractor (see Pimenta, Col. 9, lines 1-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the reference patent with the spinal access instruments of Gustine. One of ordinary skill in the art would have been motivated to do so because the spinal access instruments of Gustine can be used in a minimally invasive spinal fusion procedure, which reduces recovery time in patients (Abstract and Col. 2, lines 12-43).
Claim Objections
Claim 36 is objected to because of the following informalities:
In claim 36, lines 40-41, “the at least one interbody device is inserted in a generally laterally directed insertion” should read “the at least one interbody device is inserted in a generally lateral direction”.
Appropriate correction is required.
Allowable Subject Matter
Claims 26-35 would be allowable if rewritten or amended to overcome the nonstatutory double patenting rejection, set forth in this Office action or upon the timely filing of a terminal disclaimer.
Regarding claim 26, Skripps (U.S. Publication No. 2006/0248650) discloses an apparatus 14 for positioning a patient during surgery, comprising: a surgical table frame 14 having a longitudinal dimension (defined by the dimension extending from the head end comprising cushion 64 and foot end comprising cushion 26, Figure 1), wherein the surgical table frame 14 includes two or more longitudinal rails 60 and 62 that are laterally spaced from a centerline between the longitudinal rails 60 and 62 (Figure 1), the two or more laterally spaced longitudinal rails 60 and 62 defining a generally planar surface of the surgical table frame (Figure 1); and at least one rotatable support 10 mounted on the surgical table frame 14 for supporting a portion of a body of the patient when resting thereon (Figure 1 and paragraph 0073), the at least one rotatable support 10 having a support surface 86 that is substantially planar and generally parallel to the generally planar surface of the surgical table frame 14 (Figures 1 and 5 and paragraph 0077), the at least one rotatable support 10 being rotatable around an axis that is perpendicular to the planar surface of the at least one rotatable support 10 (where, by adjusting the position of connectors 72 and 74 on the longitudinal rails, the support 10 rotates around an axis extending upward from the surgical table, Figures 1-2 and paragraphs 0078-0079), wherein the at least one rotatable support includes two or more engagement elements 72 and 74, each of the two or more engagement elements 72 and 74 engaging with the two or more longitudinal rails 60 and 62 to mount the at least one rotatable support 10 on the surgical table frame 14 (Figures 1-2 and paragraph 0075); wherein at least one bolster 80 and 78 positioned on the at least one rotatable support 10 at a lateral aspect relative to the centerline, the at least one bolster 80 and 78 positioned for contacting and supporting a contacted lateral aspect of the portion of the body of the patient 300 when resting on the at least one rotatable support 10 (Figure 9 and paragraph 0102) wherein the at least one rotatable support 10 enables positional adjustment of the portion of the body of the patient when resting thereon by rotational movement of the at least one rotatable support 10 to displace the supported body position in one of first and second directions of rotation (the first direction being defined by one of the couplers 72 or 74 being positioned closer to the head support 64 than the other of the couplers 72 or 74, the second direction being defined by the other of the couplers 72 or 74 being positioned closer to the head support than the other of couplers 72 or 74, Figure 1 and paragraph 0075) to thereby allow for manipulation of the patient's anatomy 300 to maximize access to a surgical site of interest (Figures 1-2 and paragraphs 0078-0079); and wherein the apparatus is adapted for receiving a body of the patient 300 positioned thereon in one of a prone and supine position (Figure 17 and paragraph 0074).
Additionally, Graham (U.S. Publication No. 2007/0293796) is cited as being of interest for teaching wherein the at least one support 160 includes one or more straps 166 for securing the portion of the body of the patient 12 when resting on the at least one support 160 (Figure 2B and paragraphs 0059 and 0072).
Finally, Gustine (U.S. Patent No. 9,060,815) teaches a plurality of spinal access instruments, including: at least one retractor configured for insertion within the surgical field (see Gustine, Col. 10, line 57-Col. 11, line 24, also see retractor 10 in Figure 1 of Pimenta, U.S. Patent No. 7,905,840, which Gustine incorporates by reference as the procedure used to access the spine), the at least one retractor 10 configured to retract soft tissue and having a distal end positionable substantially adjacent to an anterior aspect of a spine of the patient at a target intervertebral space between a target vertebra and an adjacent vertebra (see Pimenta, Figure 49 and Gustine, Figure 31 and Col. 10, line 57-Col. 11, line 24); at least one tissue preparation device 52 and 54 configured for cutting soft tissue, for penetrating an annulus within the target vertebral space between the target vertebra and the adjacent vertebra, for distracting the target vertebral space between the target vertebra and the adjacent vertebra, or combinations thereof (see Pimenta, Figure 41 and Col. 15, lines 13-38); at least one interbody device 10 configured for insertion within the target vertebral space between the target vertebra and the adjacent vertebra (see Gustine Figures 1-4 and 10 and Col. 3, line 63-Col. 4, line 15); at least one insertion device 200 configured for inserting and positioning the at least one interbody device 10 within the target vertebral space between the target vertebra and the adjacent vertebra (see Gustine, Col. 10, line 57-Col. 11, line 24); and a stabilization system 18 configured to stabilize the target vertebral space between the target vertebra and the adjacent vertebra after placement of the interbody device 10, the stabilization system 18 selected from the group consisting of one or a plurality of bone screws, one or a plurality of plates, a plurality of pedicle screws and a plurality of rods, one or a plurality of tethers, and combinations thereof (Figures 22-23 and Col. 8, lines 18-43), wherein the system is configured for a generally laterally directed insertion of the at least one interbody device within the target vertebral space between the target vertebra and the adjacent vertebra (see Gustine, Col. 10, line 57-Col. 11, line 24, also see retractor 10 in Figure 1 of Pimenta), wherein the at least one retractor 10 among the plurality of instruments includes a generally curved profile along an elongate axis of the at least one retractor (see Pimenta, Col. 9, lines 1-14).
Neither of the above cited prior art disclose the two or more engagement elements of the rotatable support being in fixed arrangement relative to one another. Clayman (U.S. Patent No. 5,613,254) is cited as being of interest for teaching two or more engagement elements 123 being in fixed arrangement relative to one another (Figures 1 and 6 and Col. 7, lines 41-44). However, there would be no motivation to combine the teachings of Clayman with the disclosure of the rotatable support of Skripps. Skripps relies on the engagement elements 72 and 74 to be able to pivot independently relative to each other and the cross member 76 in order to facilitate rotation of the rotatable support 10 such that the rotatable support may be positioned in an orientation suitable to support a patient (paragraph 0083-0084). Modifying Skripps such that the engagement elements are in a fixed arrangement relative to one another would make Skripps unsuitable for its intended purpose. As such, there is no disclosure, teaching, or suggestion in the prior art such that a reasonable rejection of any independent claim may be reasonably maintained.
Claims 36-45 are allowed.
Claim 36 is directed to a method for performing a spinal surgical procedure by a posterior-lateral approach, wherein the method comprises using a patient support apparatus with the same feature as the support apparatus of claim 26, including requiring the two or more engagement elements of the rotatable support to be in fixed arrangement relative to one another. Additionally, claim 36 requires the method step of inserting the at least one interbody device in a generally laterally direction within the target vertebral space between the target vertebra and the adjacent vertebra and subsequently the stabilization system is placed posteriorly directed by adjustment of the support apparatus without substantially repositioning the patient on the support apparatus. As noted above, Gustine discloses spinal access instruments and a method for performing spinal access surgery. However, Gustine does not disclose, teach, or suggest the stabilization system being placed posteriorly by adjustment of the support apparatus. Ammerman (U.S. Publication No. 2018/0271574) teaches the stabilization system being placed posteriorly by adjustment of the support apparatus (paragraph 0116).
However, in Gustine, the stabilization system 18 is positioned to be perpendicular to the lateral aspect of the spine, and Gustine notes that the design and anterior positioning of their interbody device 10 is intended to reduce risk of nerve injury, as nerves are generally located more posteriorly along the spine (Col. 4, lines 16-55). As such, there would be no motivation to modify the method of Gustine such that the stabilization system is placed posteriorly, as required by the method of claim 36. For this reason and for the same reason as discussed above with regard to the two or more engagement elements in claim 26, there is no disclosure, teaching, or suggestion in the prior art of record such that a rejection of claim 36 may be reasonably maintained. Claims 37-45 are additionally allowable by virtue of their dependence from claim 36.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Foley (U.S. Patent No. 5,792,044) which discloses devices and methods for spinal access surgical procedures.
Landry (U.S. Patent No. 6,447,512) which discloses an interbody fusion device and method for implanting said interbody device.
Buchanan (U.S. Patent No. 2,565,019) which discloses a patient support comprising adjustable bolsters.
Miller (U.S. Patent No. 3,420,229) which discloses an apparatus comprising rotatable patient supports.
Cantrell (U.S. Publication No. 2007/0123402) which discloses a support comprising rotatably adjustable bolsters.
Lee (U.S. Publication No. 2014/0100446) which discloses a patient support comprising adjustable bolsters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON N LABARGE whose telephone number is (571)272-6098. The examiner can normally be reached M-F 8-4:00.
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/ALISON N LABARGE/Examiner, Art Unit 3679
/Matthew Troutman/Supervisory Patent Examiner, Art Unit 3679
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