DETAILED ACTION
Claim Objections
Claims 5 and 6 are objected to because of the following informalities:
Regarding each of claims 5 and 6, “process” should be “processes”.
Appropriate correction is required.
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.
Claims 1-4, 10, and 14-24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2005/0216017 (Fielding) in view of U.S. Patent Application Publication No. 2005/0192581 (Molz).
Regarding claim 1, Fielding discloses a method (see paragraphs [0032]-[0035]) of increasing stability between at least two adjacent vertebrae (pair of adjacent vertebrae 2, see Figs. 1B and 2) in a spine of a subject, comprising: securing an elongate stabilizing member (20) about a first bony structure (10) of a first vertebra (2) (see Figs. 2 and 4A-4D and paragraph [0032]); securing the elongate stabilizing member about a first bony structure (10) of a second vertebra (2) (see Figs. 2 and 4A-4D and paragraph [0032]), the second vertebra inferior to the first vertebra (see Figs. 2 and 4A-4D; adjacent vertebrae include a superior vertebra and an inferior vertebra), the stabilizing member further extending across a midline of the spine (see marked-up Figs. 3D and 4D below); and securing a first portion (24a) of the stabilizing member relative to a second adjacent portion (24b) of the stabilizing member with one or more fastening elements (26) associated with one or more of the first portion or the second portion to prevent the first portion from being dissociated from or moved relative to the second portion (see paragraphs [0024] and [0027]), wherein the elongate stabilizing member is not secured directly to a pedicle screw or a stabilizing rod (see paragraph [0033] and Figs. 2, 3D, and 4A-4D; band 20 not secured directly to pedicle screws or stabilizing rod).
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Further regarding claim 1, Fielding is silent regarding the stabilizing member extending across a midline of the spine between the bony structures of the vertebrae. However, Molz discloses a spinal treatment method (see Abstract and Fig. 4) wherein a stabilizing member (100) is extended across a midline of the spine between bony structures (108) of adjacent vertebrae (102/104) (see Fig. 4 and paragraph [0058]). It would have been prima facie obvious matter of design choice to a person of ordinary skill in the art before the effective filing date of the invention to have the stabilizing member extend across a midline between the bony structures of the vertebrae as Molz discloses that an elongate stabilizing member may be secured to a plurality of vertebrae by a variety of methods in order to treat the spine, including by having the member extend across a midline of the spine between bony structure of adjacent vertebrae (see Fig. 4 and paragraph [0058]).
Regarding claim 2, Fielding discloses wherein securing the elongate stabilizing member about a first bony structure of a first vertebra comprises at least one of securing the elongate stabilizing member about a spinous process of the first vertebra or securing the elongate stabilizing member within a spinous process of the first vertebra (about a spinous process 10, see Figs. 2 and 4A-4D and paragraph [0032]).
Regarding claim 3, Fielding discloses wherein securing the elongate stabilizing member about a first bony structure of a second vertebra comprises at least one of securing the elongate stabilizing member about a spinous process of the second vertebra or securing the elongate stabilizing member within a spinous process of the second vertebra (about a spinous process 10, see Figs. 2 and 4A-4D and paragraph [0032]). .
Regarding claim 4, Fielding discloses wherein securing the elongate stabilizing member about a first bony structure of a second vertebra comprises securing the elongate stabilizing member about or within a spinous process of the second vertebra (about a spinous process 10, see Figs. 2 and 4A-4D and paragraph [0032]).
Regarding claim 10, Fielding discloses wherein the stabilizing member does not extend within a vertebral foramen of the spine (see paragraphs [0032]-[0035] and Figs. 2 and 4A-4D; stabilizing member extends around spinous processes; no disclosure of extending within a vertebral foramen).
Regarding claim 14, Fielding discloses wherein the method is part of one or more of ligament reconstruction, proximal junctional kyphosis (PJK) reduction, or a sublaminar band implantation (ligament reconstruction, see paragraphs [0022] and [0023]).
Regarding claim 15, Fielding discloses wherein the one or more fastening elements comprise one or more of: a zip-tie, a cam lock, a come-along, ratchet, rack & pinion, Velcro, BOA fastener, a knot in the elongate member, a set screw compression, a turnbuckle, or finger trap (see paragraphs [0027] and [0038]; zip-tie, ratchet, knot, set screw, and turnbuckle elements disclosed).
Regarding claim 16, Fielding discloses a method (see paragraphs [0032]-[0035] and Abstract) of limiting flexion between at least two adjacent vertebrae (pair of adjacent vertebrae 2, see Figs. 1B and 2) in a spine of a subject, comprising: securing an elongate stabilizing member (20) about a first bony structure (10) of a first vertebra (2) (see Figs. 2 and 4A-4D and paragraph [0032]); securing the elongate stabilizing member about a first bony structure (10) of a second vertebra (2) (see Figs. 2 and 4A-4D and paragraph [0032]), the second vertebra inferior to the first vertebra (see Figs. 2 and 4A-4D; adjacent vertebrae include a superior vertebra and an inferior vertebra), the stabilizing member further extending across a midline of the spine (see marked-up Figs. 3D and 4D above); and securing a first portion (24a) of the stabilizing member to a second portion (24b) of the stabilizing member with one or more fastening elements (26) associated with one or more of the first portion or the second portion to prevent the first portion from being dissociated from or moved relative to the second portion (see paragraphs [0024] and [0027]), wherein the elongate stabilizing member is not secured directly to a pedicle screw or a stabilizing rod (see paragraph [0033] and Figs. 2, 3D, and 4A-4D; band 20 not secured directly to pedicle screws or stabilizing rod).
Further regarding claim 16, Fielding is silent regarding the stabilizing member extending across a midline of the spine between the bony structures of the vertebrae. However, Molz discloses a spinal treatment method (see Abstract and Fig. 4) wherein a stabilizing member (100) is extended across a midline of the spine between bony structures (108) of adjacent vertebrae (102/104) (see Fig. 4 and paragraph [0058]). It would have been prima facie obvious matter of design choice to a person of ordinary skill in the art before the effective filing date of the invention to have the stabilizing member extend across a midline between the bony structures of the vertebrae as Molz discloses that an elongate stabilizing member may be secured to a plurality of vertebrae by a variety of methods in order to treat the spine, including by having the member extend across a midline of the spine between bony structure of adjacent vertebrae (see Fig. 4 and paragraph [0058]).
Regarding claim 17, Fielding discloses a method (see paragraphs [0032]-[0035] and Abstract) of limiting flexion between at least two adjacent vertebrae (pair of adjacent vertebrae 2, see Figs. 1B and 2) in a spine of a subject, comprising: securing an elongate stabilizing member (20) about a first bony structure (10) of a first vertebra (2) (see Figs. 2 and 4A-4D and paragraph [0032]); securing the elongate stabilizing member about a first bony structure (10) of a second vertebra (2) (see Figs. 2 and 4A-4D and paragraph [0032]), the second vertebra inferior to the first vertebra (see Figs. 2 and 4A-4D; adjacent vertebrae include a superior vertebra and an inferior vertebra), the stabilizing member positioned to be extending across a midline of the spine (see marked-up Figs. 3D and 4D above); and wherein the elongate stabilizing member is not secured directly to a pedicle screw or a stabilizing rod (see paragraph [0033] and Figs. 2, 3D, and 4A-4D; band 20 not secured directly to pedicle screws or stabilizing rod).
Further regarding claim 17, Fielding is silent regarding the stabilizing member extending across a midline of the spine between the bony structures of the vertebrae. However, Molz discloses a spinal treatment method (see Abstract and Fig. 4) wherein a stabilizing member (100) is extended across a midline of the spine between bony structures (108) of adjacent vertebrae (102/104) (see Fig. 4 and paragraph [0058]). It would have been prima facie obvious matter of design choice to a person of ordinary skill in the art before the effective filing date of the invention to have the stabilizing member extend across a midline between the bony structures of the vertebrae as Molz discloses that an elongate stabilizing member may be secured to a plurality of vertebrae by a variety of methods in order to treat the spine, including by having the member extend across a midline of the spine between bony structure of adjacent vertebrae (see Fig. 4 and paragraph [0058]).
Regarding claim 18, Fielding discloses wherein the elongate stabilizing member comprises a spring (see paragraph [0030]).
Regarding claim 19, Fielding discloses further comprising adjusting a tension in the spring to further limit flexion between the least two adjacent vertebrae in the spine of the subject (see Abstract and paragraphs [0026]-[0038]).
Regarding claim 20, Fielding discloses an implantable spine stabilizing device, comprising: an elongate stabilizing member (20) that is sized, configured and adapted to be secured about a first bony structure (10) of a first vertebra (2) (see Figs. 2 and 4A-4D and paragraph [0032]), is sized, configured and adapted to be secured about a first bony structure (10) of a second vertebra (2) (see Figs. 2 and 4A-4D and paragraph [0032]), the second vertebra inferior to the first vertebra (see Figs. 2 and 4A-4D; adjacent vertebrae include a superior vertebra and an inferior vertebra), is sized, configured, and adapted to be disposed across a midline of the spine (see marked-up Figs. 3D and 4D above), and is sized, configured, and adapted such that when implanted, the elongate stabilizing member limits flexion between the first and second vertebrae (see paragraphs [0032]-[0035] and Abstract) without being secured to a pedicle screw or a stabilizing rod (see paragraph [0033] and Figs. 2, 3D, and 4A-4D; band 20 not secured directly to pedicle screws or stabilizing rod).
Further regarding claim 20, Fielding is silent regarding the stabilizing member being configured and adapted to be disposed across a midline of the spine between the bony structures of the vertebrae. However, Molz discloses a spinal treatment method (see Abstract and Fig. 4) wherein a stabilizing member (100) is extended across a midline of the spine between bony structures (108) of adjacent vertebrae (102/104) (see Fig. 4 and paragraph [0058]). It would have been prima facie obvious matter of design choice to a person of ordinary skill in the art before the effective filing date of the invention to have the stabilizing member extend across a midline between the bony structures of the vertebrae as Molz discloses that an elongate stabilizing member may be secured to a plurality of vertebrae by a variety of methods in order to treat the spine, including by having the member extend across a midline of the spine between bony structure of adjacent vertebrae (see Fig. 4 and paragraph [0058]).
Regarding claim 21, further comprising one or more fastening elements (26) associated with one or more of a first portion (24a) or a second portion (24b) of the stabilizing element to prevent the first portion from being dissociated from or moved relative to the second portion (see paragraphs [0024] and [0027]).
Regarding claim 22, Fielding discloses wherein the one or more fastening elements comprise one or more of a zip-tie, a cam lock, a come-along, a ratchet, a rack & pinion, velcro, a BOA fastener, a knot in the elongate member, a set screw compression, a turnbuckle, or a finger trap (see paragraphs [0027] and [0038]; zip-tie, ratchet, knot, set screw, and turnbuckle elements disclosed).
Regarding claim 23, Fielding discloses further comprising a tension adjuster configured to adjust tension in the elongate stabilizing member (see Abstract and paragraphs [0026]-[0038]).
Regarding claim 24, Fielding discloses wherein the stabilizing member includes or consists of a spring (see paragraph [0030]).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Fielding in view of Molz, and further in view of U.S. Patent Application Publication No. 2012/0109200 (Cahill).
Regarding claims 5 and 6, Fielding is silent regarding wherein securing the elongate stabilizing member about a first bony structure of a first vertebra comprises securing the elongate stabilizing member about first and second transverse process of the first vertebra (claim 5); and wherein securing the elongate stabilizing member about a first bony structure of a second vertebra comprises securing the elongate stabilizing member about first and second transverse process of the second vertebra (claim 6). However, Cahill discloses a method of treating a vertebra (see Abstract and paragraph [0019]) that involves securing an elongate stabilizing member (1/2/25/26/6e, see Fig. 6C) around bony features of adjacent vertebrae, wherein Cahill discloses that its members may capture any combination of bony features of the vertebrae, including transverse processes (see paragraphs [0019] and [0086]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Fielding in view of Molz to place an elongate stabilizing member around first and second transverse processes of each adjacent vertebra as suggested by Cahill in order to facilitate stabilization and treatment of an spinal joint when spinous processes are not present or are incompetent, and/or to allow for restricting of additional spinal motions (lateral bending, e.g.) on both sides of a midline of the spine.
Claims 7-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fielding in view of Molz, and further in view of U.S. Patent Application Publication No. 2006/0235387 (Peterman).
Regarding claims 7-9 and 14, Fielding is silent regarding wherein securing the elongate stabilizing member about a first bony structure of a first vertebra comprises securing the elongate stabilizing member about a lamina of the first vertebra (claim 7); wherein securing the elongate stabilizing member about a first bony structure of a second vertebra comprises securing the elongate stabilizing member about a lamina of the second vertebra (claim 8); wherein the stabilizing member extends across a midline of the spine and within a vertebral foramen of the spine (claim 9); and wherein the method is part of one or more of ligament reconstruction, proximal junctional kyphosis (PJK) reduction, or a sublaminar band implantation (claim 14). However, Peterman discloses a method of treating injured, degraded, or diseased spinal joints (see Abstract and paragraph [0001]) that involves securing a cabling system (72) around lamina (18/20) and within a vertebral foramen of the adjacent vertebrae as part of a sublaminar band implantation (see paragraph [0032]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Fielding in view of Molz to place an elongate stabilizing member around the laminae and through the vertebral foramen of adjacent vertebrae as suggested by Peterman in order to facilitate stabilization and treatment of an injured, degraded, or diseased spinal joint (see Peterman, Abstract and paragraph [0001] and Fig. 2)
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Fielding in view of Molz, and further in view of U.S. Patent Application Publication No. 2014/0012326 (Alamin).
Regarding claim 11, Fielding is silent regarding wherein the method is performed in a subject in which a laminectomy has been performed. However, Alamin discloses a method of spinal treatment that includes extending a stabilizing member (304/406) around spinal processes of adjacent vertebrae (see Figs. and 3A-4A), wherein the method is performed in a subject in which a laminectomy may be performed (see paragraph [0051]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to perform the method of Fielding in view of Molz on a patient in which a laminectomy has been performed as Alamin suggests a laminectomy may be used in conjunction with a facet joint implant and spinous process stabilizing member to help treat the spine (see Alamin, paragraph [0051] and Fig. 3B).
Regarding claim 13, Fielding is silent regarding wherein the subject has an implanted construct rod or is in the process of having a construct rod implanted. However, Alamin discloses a method of spinal treatment that includes extending a stabilizing member (304/406) around spinal processes of adjacent vertebrae of a subject (see Figs. and 3A-4A), wherein the subject also has an implanted construct rod (404) (see Fig. 4A and paragraph [0053]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to perform the method of Fielding in view of Molz on a patient who also has an implanted construct rod as Alamin suggests, in a patient who has spinal fusion, a stabilizing member may help more evenly distribute and possibly lessen loading applied to the fusion instrumentation (including a construct rod) as well as adjacent tissue, particularly the adjacent intervertebral disc (see Alamin, paragraph [0053] and Fig. 4A).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fielding in view of Molz, and further in view of U.S. Patent Application Publication No. 2007/0276500 (Zucherman).
Regarding claim 12, Fielding is silent regarding wherein the first and second vertebrae are thoracic vertebrae. However, Zucherman discloses a method of treating spinal disease (see paragraphs [0018] and [0019] and Abstract) that involves extending a stabilizing member (330) around spinal processes of adjacent vertebrae (see Fig. 4A, e.g.), wherein disease can affect all regions of the spine, including thoracic vertebrae (see paragraph [0012]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to perform the method of Fielding in view of Molz on thoracic vertebrae as Zucherman suggests thoracic vertebrae can be affected by spinal disease requiring treatment via a stabilizing member (see Zucherman, paragraph [0012]).
Response to Arguments
Applicant’s arguments with respect to claims 1-24 have been considered but are moot in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. - 5:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
