DETAILED ACTION
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 29, 31, 32, 35, 40, 46, and 48-52 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2008/0140207 (Olmos) in view of U.S. Patent Application Publication No. 2010/0222884 (Greenhalgh ‘884).
Regarding claim 46, Olmos discloses an intervertebral device (10), comprising: a base (16), the base including a longitudinal axis (longitudinal axis of body portion 16, see paragraph [0079]), the base including a plurality of first engaging elements (102/106/110/114) arranged so that each engaging element is positioned at a different vertical level with respect to adjacently positioned engaging elements (see Fig. 10A and paragraphs [0115]-[0117]), a first body portion (34) slidably coupled to the base (see paragraphs [0082] and [0147] and Figs. 5 and 6) and configured to move in a first direction with respect to the base (movement along the longitudinal axis of the device, see paragraphs [0082] and [0147] and Figs. 5 and 6), the first body portion includes a plurality of second engaging elements (90/94), each engaging element positioned at a different vertical level with respect to adjacently positioned engaging elements (see Figs. 10A-11), the first body portion configured to be positioned at one of a plurality of positions along the longitudinal axis of the base (see paragraphs [0082] and [0147] and Figs. 5, 6, 12, and 13), and a second body portion (14) slidably coupled to the base (via rails 130 and 132, see Figs. 12 and 13) and configured to move in a second direction with respect to the base (in a vertical direction perpendicular to the longitudinal axis of the device, see Figs. 12 and 13), the second body portion configured to be positioned at one of a plurality of positions at least perpendicular to the longitudinal axis of the base (see Figs. 12 and 13), wherein movement of the first body portion in the first direction causing engagement of the adjacently positioned first engaging elements to the adjacently positioned second engaging elements causing dependent vertical movement of the second body portion in the second direction (see paragraphs [0090], [0105], [0113]-[0117] and Figs. 3-6, 12, and 13).
Further regarding claim 46, Olmos is silent regarding the first engaging elements and the second engaging elements constructed and arranged to interlock upon application of a vertical force applied to the second body portion to prevent movement of the first body portion with respect to the base. However, Greenhalgh ‘884 discloses an intervertebral device (2) including a base (10) and a first body portion (108), wherein first engaging elements (154) of the base and second engaging elements (152) of the first body portion are constructed and arranged to interlock upon application of a vertical force to prevent movement of the first body portion with respect to the base (see paragraph [0123] and Figs. 34 and 35). 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 device of Olmos to have the first and second engaging elements interlock upon an applied vertical force (such as from a second boy portion, e.g.) as suggested by Greenhalgh ‘884 in order to lock the first body portion from moving relative to the base and keep the device in a desired expanded position without having to use separate locking components (see Greenhalgh ‘884, paragraph [0123]).
Regarding claim 29, Olmos discloses wherein the second body portion is configured to be positioned at one of a plurality of positions (different vertical heights, see paragraphs [0090], [0105], [0113]-[0117] and Figs. 3-6, 12, and 13), each one of the plurality of positions corresponding to a respective engagement of one of a plurality of the first engaging elements to one of the second engaging elements creating different heights of the intervertebral device (see paragraphs [0090], [0105], [0113]-[0117] and Figs. 3-6, 12, and 13).
Regarding claim 32, Olmos suggests a device 200 similar to device 2 wherein a base (204), first body portion (206), and second body portion (202) are configured to define a void (via apertures 252) central to the device (see paragraph [0162]). 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 have the device 2 define a void central to the device in order to facilitate circulation and bone growth throughout the intervertebral space and through the device, and thereby allow bone growth through the device and integration of the device with the surrounding materials (see Olmos, paragraph [0162]).
Regarding claim 40, Olmos discloses wherein the second body portion is configured to be positioned at one of a plurality of positions (different heights, see paragraphs [0090], [0105], [0113]-[0117] and Figs. 3-6, 12, and 13), each one of the plurality of positions corresponding to a respective one of a plurality of heights of the intervertebral device (see paragraphs [0090], [0105], [0113]-[0117] and Figs. 3-6, 12, and 13), the first engaging element of the first body portion configured to couple to a respective one of the plurality of second engaging elements (100/104/108/112) of the second body portion for each respective one of the plurality of heights of the intervertebral device (see paragraphs [0090], [0105], [0113]-[0117] and Figs. 3-6, 12, and 13).
Regarding claim 48, Olmos discloses wherein the first engaging elements are positioned on a top surface of the base while the second engaging elements are positioned on a bottom surface of the first body portion (see Figs. 10A and 11; engaging elements 102/110 on top surface of base 16 and engaging elements 90/94 on bottom surface of first body portion 34).
Regarding claim 49, Olmos discloses wherein the first engaging elements and the second engaging elements have conjugate shapes with respect to each other (see paragraphs [0113]-[0117] and Figs. 10A-11).
Regarding claim 50, Olmos discloses wherein the first engaging elements and the second engaging elements are V-shaped teeth (see paragraphs [0113]-[0117] and Figs. 10A-11), wherein the teeth interlock when the point of one tooth of the first body portion is positioned between two opposing teeth of the base (see paragraphs [0113]-[0117] and Figs. 10A-11). Additionally, Greenhalgh ‘884 also discloses wherein the first engaging elements and the second engaging elements are V-shaped teeth (V-shaped teeth 154/142, see Figs. 34 and 35), wherein the teeth interlock when the point of one tooth of the first body portion is positioned between two opposing teeth of the base (see paragraph [0123] and Figs. 34 and 35), and 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 device of Olmos to have the first and second engaging elements be V-shaped teeth that interlock as suggested by Greenhalgh ‘884 in order to lock the first body portion from moving relative to the base and keep the device in a desired expanded position without having to use separate locking components (see Greenhalgh ‘884, paragraph [0123]).
Regarding claim 51, Olmos discloses wherein at least one end of the base includes an opening (opening defining surface 72 in end 76 of portion 16 for receiving tool 32, see Figs. 4 and 5) for connection with an insertion tool (32).
Regarding claim 52, Olmos discloses wherein the opening is sized to allow an expansion tool (80) to extend through the opening to move the second portion with respect to the base (see paragraph [0111]).
Regarding claim 31, Olmos discloses wherein the first body portion being positioned at an incremental position along the longitudinal axis of the base for each respective one of the plurality of conjugately engaged first and second engaging elements while the second body portion incrementally changes the height of the intervertebral device (see paragraphs [0090], [0105], [0113]-[0117] and Figs. 3-6, 12, and 13).
Regarding claim 35, Olmos discloses wherein the geometric shape of each of the first engaging elements includes a polygon (triangle-shaped elements 102/106/110/114, see Figs. 10A and 10B).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Olmos in view of Greenhalgh ‘884, and further in view of U.S. Patent Application Publication No. 2010/0292796 (Greenhalgh ‘796).
Alternatively regarding claim 32, Greenhalgh ‘796 discloses an intervertebral device (2), comprising: a base (6), a first body portion (8), and a second body portion (10), wherein the base, the first body portion, and the second body portion are configured to define a void (via ports 26/27/28) central to the device (see Fig. 1a, 4a, 4b and paragraph [0073]). 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 device to define a void central to the device in order to allow the device to be filled with cements, fillers, glues, and/or a therapeutic and/or diagnostic agent, including osteogenic and osteoinductive growth factors (see Greenhalgh ‘796, paragraph [0108]).
Response to Arguments
Applicant’s arguments with respect to the claims 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, 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.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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