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 1-4 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2016/0151171 (Mozeleski) in view of U.S. Patent Application Publication No. 2010/0106249 (Tyber), U.S. Patent Application Publication No. 2007/0266832 (Polick), and U.S. Patent Application Publication No. 2012/0078373 (Gamache ‘373).
Regarding claim 1, Mozeleski discloses a method for implanting an implant (100) between a superior vertebral body (first vertebra, see paragraph [0024]) and an inferior vertebral body (second vertebra, see paragraph [0024]), comprising: providing a spacer (200/300) having an upper surface (202) and a lower surface (204), and first (240/340) and second (230/343) fixation holes, wherein the upper surface is configured to engage the superior vertebral body and the lower surface is configured to engage the inferior vertebral body (see paragraphs [0024] and [0060]; surface texture configured to engage adjacent vertebrae); inserting the spacer between the superior vertebral body and the inferior vertebral body (see paragraphs [0024] and [0058]); extending a first fixation member (400/420) through the first fixation hole (see paragraph [0024]), the first fixation member having a threaded shaft and a head extending from the threaded shaft (see Figs. 1, 6A, and 6B; fixation member 420 is a bone screw with a head extending from a threaded shaft); and extending a second fixation member (400/410) through the second fixation hole (see paragraph [0024]).
Further regarding claim 1, Mozeleski fails to disclose the first fixation member being a polyaxial member. However, Tyber discloses an intervertebral implant (100) that comprises fixation members in the form of bone screws (182/184) each have a head (182a/184a) extending from a threaded shaft (182b/184b), wherein the fixation members are polyaxial members (see paragraph [0024]). 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 first fixation member of Mozeleski to be a polyaxial member as suggested by Tyber in order to prevent stress-shielding during implant subsidence (see paragraphs [0020], [0021], [0024] and [0026]).
Further regarding claim 1 and regarding claim 2, Mozeleski fails to disclose the head defining a spherical trough, and the step of inserting a spherical driver head into the spherical trough so as to allow driving of the first fixation member into a bone at a selected polyaxial angle (claim 1); wherein the head of the first fixation member includes a pair of slots disposed perpendicularly to the threaded shaft; and inserting a spherical driver head includes mating corresponding projections on the spherical driver head with the slots of the head of the first fixation member so as to define a universal joint (claim 2). However, Polick discloses a driver (106) for driving a fastener (104) having a head and threaded shaft, such as a screw (see paragraph [0002]), the head of the screw defining a spherical trough (see marked-up Fig. 4 below), and the step of inserting a spherical driver head into the spherical trough so as to allow driving of the first fixation member at a selected polyaxial angle (see marked-up Fig. 4 below and paragraphs [0001]-[0008]); wherein the head of the first fixation member includes a pair of slots disposed perpendicularly to the threaded shaft (see marked-up Fig. 4 below); and inserting a spherical driver head includes mating corresponding projections on the spherical driver head with the slots of the head of the first fixation member so as to define a universal joint (see marked-up Fig. 4 below and paragraphs [0001]-[0008]). 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 Mozeleski in view of Tyber to utilize a spherical driver head that mates with a spherical trough in the first fixation member head to drive the fixation member at a selected polyaxial angle, as Polick suggests such a driver/fastener configuration is one of numerous possible configurations for allowing an increased angle of deflection between the fastener and driver, thus allowing the fastener to be driven at various angles as needed by the user when a coaxial, straight-on approach between the fastener and driver is not available (see Polick, paragraphs [0001]-[0008]).
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Further regarding claim 1, Mozeleski is silent regarding wherein the first and second fixation holes each define a first portion and a second portion and wherein the second portion extends at an angle from the first portion. However, Gamache ‘373 discloses a spinal implant (8) with first and second fixation holes (22/24) that each define first (26) and seconds (28) portions that are angled relative to each other (see paragraphs [0071] and [0072] and Fig. 1D). 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 first and second fixation holes define first and second angled portions for receiving compatible fixation members (jointed or flexible) as suggested by Gamache ‘373 in order to allow for in-line insertion of the fixation members, which allows for a smaller incision and access site for the spinal implant, and also allows the surgeon to avoid having to insert the fixation members with the inserter disposed at a sharp angle (see Gamache ‘373, paragraph [0028])
Regarding claim 3, Mozeleski discloses wherein the spacer is formed of PEEK (see paragraph [0016]).
Regarding claim 4, Mozeleski discloses wherein the spacer comprises: a body (200) and an end member (300) attached to the body; a female recess (220), the end member including a male projection (320) insertable into the female recess to attach the body to the end member.
Regarding claim 6, Mozeleski discloses wherein the second fixation member (400) comprises a straight shim (410) (see paragraph [0074]; shim 410 can be straight).
Regarding claim 7, Mozeleski discloses wherein the second fixation member (400) comprise a curved shim (410) (see paragraph [0074]; shim 410 can be curved).
Regarding claim 8, Mozeleski discloses wherein a head portion of the second fixation member includes an opening (413) for receiving an insertion instrument.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable Mozeleski in in view of Tyber, Polick, and Gamache ‘373, and further in view of U.S. Patent Application Publication No. 2010/0305704 (Messerli).
Regarding claim 5, Mozeleski discloses wherein the spacer includes a body (200) and an end member (300) attached to the body. Mozeleski fails to disclose wherein a dovetail assembly is formed between the spacer body and the end member. However, Messerli discloses a spinal implant (see Figs. 7A-10B) including a spacer (1200) and end member (1100), wherein a dovetail assembly is formed between the spacer and end member (see paragraphs [0060]-[0061]). 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 implant of Mozeleski to have a dovetail assembly between the spacer body and end member as suggested by Messerli as such a modification merely involves simply substituting one known spacer/end member coupling assembly from a known spinal implant for another known spacer/end member coupling assembly from another known spinal implant without any unpredictable results.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable Mozeleski in in view of Tyber, Polick, and Gamache ‘373, and further in view of U.S. Patent Application Publication No. 2012/0078371 (Gamache ‘371).
Regarding claim 9, Mozeleski fails to disclose wherein the second fixation member continuously tapers from a head portion to a distal end. However, Gamache ‘371 discloses a spinal implant (1) including a non-threaded first fixation member (25/27/61), wherein the first fixation member comprises a head and a distal end (see Figs. 1A-2), and wherein the first fixation member continuously tapers from the head to the distal end (see Figs. 1A-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 second fixation member of Mozeleski to be shaped as suggested by Gamache ‘371 in order to facilitate a tapered interference fit between the bone and inserted fixation member; to facilitate insertion of the fixation member into bone; and because Gamache ‘371 suggests such a shape is one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a shim fixation member in a spinal implant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable Mozeleski in in view of Tyber, Polick, and Gamache ‘373 and further in view of U.S. Patent Application Publication No. 2014/0180417 (Bergey).
Regarding claim 10, Mozeleski discloses wherein second fixation member includes multiple splines (416/418). Alternatively, Bergey discloses a spinal implant (100) that includes a fixation member (150), wherein the fixation member may comprise more than two splines (160) (see paragraph [0037]). 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 second fixation member of Mozeleski to have multiple additional splines as suggested by Bergey in order to facilitate guided anchoring of fixation member in bone (see paragraph [0012]). Additionally, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claims 11-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mozeleski in view of Tyber, Polick, and U.S. Patent Application Publication No. 2014/0214167 (Theofilos).
Regarding claim 11, Mozeleski discloses a method for implanting an implant (100) between a superior vertebral body (first vertebra, see paragraph [0024]) and an inferior vertebral body (second vertebra, see paragraph [0024]), said method comprising: providing a spacer body (200) comprising an upper surface (202) and a lower surface (204), wherein the upper surface includes one or more protrusions and the lower surface comprises one or more protrusions (see paragraphs [0024] and [0060]; see paragraph [0060]; upper and lower surfaces have surface texture, including peaks or bumps) and wherein the spacer body includes a first opening and a second opening (230/240); attaching an end member (300) to the spacer body (see paragraph [0058] and Figs. 1-3), wherein the end member includes a first opening and a second opening (340 and 330), wherein the first opening on the end member aligns with the first opening on the spacer body and the third opening on the end member aligns with the second opening on the spacer body (see Figs. 1-4 and paragraphs [0063] and [0068]); inserting the spacer and the attached end member between the superior vertebral body and the inferior vertebral body (see paragraphs [0024] and [0058]); extending a first fixation member (400/420) through the first opening (see paragraph [0024]), the first fixation member having a head portion and a distal end (see Figs. 1, 6A, and 6B; fixation member 420 is a bone screw with a head and a threaded shaft that extends to a distal end); extending a third fixation member (400/410) through the third opening (see paragraph [0024]); and blocking the first fixation member and the third fixation member to prevent backout (see paragraph [0024]; via retention member 500),
Further regarding claim 11, Mozeleski fails to disclose the first fixation member being a polyaxial member. However, Tyber discloses an intervertebral implant (100) that comprises fixation members in the form of bone screws (182/184) each have a head (182a/184a) extending from a threaded shaft (182b/184b), wherein the fixation members are polyaxial members (see paragraph [0024]). 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 first fixation member of Mozeleski to be a polyaxial member as suggested by Tyber in order to prevent stress-shielding during implant subsidence (see paragraphs [0020], [0021], [0024] and [0026]).
Further regarding claim 11 and regarding claim 12, Mozeleski fails to disclose the first fixation member head defining a spherical trough, and the step of inserting a spherical driver head into the spherical trough so as to allow driving of the first fixation member into a bone at a selected polyaxial angle (claim 11); wherein the head of the first fixation member includes a pair of slots disposed perpendicularly to the threaded shaft; and inserting a spherical driver head includes mating corresponding projections on the spherical driver head with the slots of the head of the first fixation member so as to define a universal joint (claim 12). However, Polick discloses a driver (106) for driving a fastener (104) having a head and threaded shaft, such as a screw (see paragraph [0002]), the head of the screw defining a spherical trough (see marked-up Fig. 4 above), and the step of inserting a spherical driver head into the spherical trough so as to allow driving of the first fixation member at a selected polyaxial angle (see marked-up Fig. 4 above and paragraphs [0001]-[0008]); wherein the head of the first fixation member includes a pair of slots disposed perpendicularly to the threaded shaft (see marked-up Fig. 4 above); and inserting a spherical driver head includes mating corresponding projections on the spherical driver head with the slots of the head of the first fixation member so as to define a universal joint (see marked-up Fig. 4 above and paragraphs [0001]-[0008]). 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 Mozeleski in view of Tyber to utilize a spherical driver head that mates with a spherical trough in the first fixation member head to drive the fixation member at a selected polyaxial angle, as Polick suggests such a driver/fastener configuration is one of numerous possible configurations for allowing an increased angle of deflection between the fastener and driver, thus allowing the fastener to be driven at various angles as needed by the user when a coaxial, straight-on approach between the fastener and driver is not available (see Polick, paragraphs [0001]-[0008]).
Further regarding claim 11, Mozeleski fails to disclose the end member including a second opening and the step of extending a second fixation member through the second opening, the second opening on the end member does not align with an opening on the spacer body; and blocking the third fixation member. However, Mozeleski discloses that a plurality of bone fixation members may be used, and does not explicitly state that the implant is limited to only two bone fixation members (see paragraph [0068]). Additionally, Theofilos discloses a spinal implant (100) including a spacer (140) and end member (210), wherein the end member includes a first opening (one of 224), a second opening (226), and a third opening (another of 224), the first, second, and third openings adapted to receive fixation members (170); the fixation members blocked in their respective openings (see paragraph [0075]); and the second opening (226) not aligning with an opening on a spacer body (openings 224 of end member align with openings 156 of the spacer, but opening 226 does not align with an opening of the spacer, see Figs. 6A-7). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the implant of Mozeleski to include an additional end member opening through which an additional, blockable fixation member extends without extending through an opening in the spacer as suggested by Theofilos in order to provide additional securing of the spinal implant to a vertebra, and because it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 13, Mozeleski discloses wherein the spacer is formed of PEEK (see paragraph [0016]).
Regarding claim 14, Mozeleski discloses further comprising a female recess (220), the end member including a male projection (320) insertable into the female recess to attach the spacer body to the end member.
Regarding claim 16, Mozeleski discloses wherein the second fixation member (400) comprises a straight shim (410) (see paragraph [0074]; shim 410 can be straight).
Regarding claim 17, Mozeleski discloses wherein the second fixation member (400) comprise a curved shim (410) (see paragraph [0074]; shim 410 can be curved).
Regarding claim 18, Mozeleski discloses wherein a head portion of the second fixation member includes an opening (413) for receiving an insertion instrument.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable Mozeleski in in view of Tyber, Polick, and Theofilos and further in view of Messerli.
Regarding claim 15, Mozeleski fails to disclose wherein a dovetail assembly is formed between the spacer body and the end member. However, Messerli discloses a spinal implant (see Figs. 7A-10B) including a spacer (1200) and end member (1100), wherein a dovetail assembly is formed between the spacer and end member (see paragraphs [0060]-[0061]). 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 implant of Mozeleski to have a dovetail assembly between the spacer body and end member as suggested by Messerli as such a modification merely involves simply substituting one known spacer/end member coupling assembly from a known spinal implant for another known spacer/end member coupling assembly from another known spinal implant without any unpredictable results.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable Mozeleski in in view of Tyber, Polick, and Theofilos, and further in view of Gamache ‘371.
Regarding claim 19, Mozeleski fails to disclose wherein the second fixation member continuously tapers from a head portion to a distal end. However, Gamache ‘371 discloses a spinal implant (1) including a non-threaded first fixation member (25/27/61), wherein the first fixation member comprises a head and a distal end (see Figs. 1A-2), and wherein the first fixation member continuously tapers from the head to the distal end (see Figs. 1A-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 second fixation member of Mozeleski to be shaped as suggested by Gamache ‘371 in order to facilitate a tapered interference fit between the bone and inserted fixation member; to facilitate insertion of the fixation member into bone; and because Gamache ‘371 suggests such a shape is one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a shim fixation member in a spinal implant. See In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 20 is rejected under 35 U.S.C. 103 as being Mozeleski in in view of Tyber, Polick, and Theofilos, and further in view of Bergey.
Regarding claim 20, Mozeleski discloses wherein second fixation member includes multiple splines (416/418). Alternatively, Bergey discloses a spinal implant (100) that includes a fixation member (150), wherein the fixation member may comprise more than two splines (160) (see paragraph [0037]). 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 second fixation member of Mozeleski to have multiple additional splines as suggested by Bergey in order to facilitate guided anchoring of fixation member in bone (see paragraph [0012]). Additionally, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 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
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