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 .
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 1-19 and 22 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.
Regarding claim 1, from which claims 2-15 depend, and additionally claims 9 and 10, “the securing member” lacks antecedent basis. For the purpose of examination, it is assumed the stabilizing member is referred to.
Regarding claims 15 and 22, “BOA-like” is indefinite as it is unclear what group of fasteners is within the scope of being BOA-like.
Regarding claim 16, “the securing member” lacks antecedent basis. For the purpose of examination, it is assumed the stabilizing member is referred to.
Regarding claim 17, from which claims 18 and 19 depend, “the securing member” lacks antecedent basis. For the purpose of examination, it is assumed the stabilizing member is referred to.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 10, and 14-24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2005/0216017 (Fielding).
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 securing 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).
PNG
media_image1.png
576
655
media_image1.png
Greyscale
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-like, 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 securing 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).
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 securing 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).
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).
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-like 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]).
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 5-9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Fielding in view of U.S. Patent Application Publication No. 2006/0235387 (Peterman).
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 a 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 a transverse process of the second vertebra (claim 6). However, Peterman discloses a method of treating injured, degraded, or diseased spinal joints (see Abstract and paragraph [0001]) that involves securing elongate stabilizing members (70/72) around transverse processes (24/34) of the adjacent vertebrae (see Fig. 2). 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 to place an elongate stabilizing member around transverse processes 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).
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 securing 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 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 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 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 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 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 on thoracic vertebrae as Zucherman suggests thoracic vertebrae can be affected by spinal disease requiring treatment via a stabilizing member (see Zucherman, paragraph [0012]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alamin ‘872, Alamin ‘890 and Gandhi disclose methods of limiting flexion of the spine.
Mosnier discloses a method of inhibiting proximal junctional failure.
The Bess references disclose a spinal fixation construct that uses tethers.
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, 10:00 a.m. - 6:00 p.m. EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert, can be reached on 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773