DETAILED ACTION
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Regarding each of claims 1 and 11, “thirst” should be “third”.
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, 2, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2010/0016903 (Matityahu) in view of U.S. Patent Application Publication No. 2014/0379030 (Jackson) and U.S. Patent Application Publication No. 2019/0167326 (Greenhalgh).
Regarding claim 1, Matityahu discloses a pedicle nail system (see Figs. 9 and 18) comprising: a pedicle nail (332) having a shank (340) including a proximal end (336) comprising mounting threads (343) having a pitch (see Fig. 18) and a distal bone engagement end (342), the pedicle nail further including a nail head (102) disposable on the proximal end of the shank (see Figs. 2 and 18) and configured to threadably engage with the mounting threads (via mating threads 110, see paragraph [0087]), the nail head having external bone threads (112) configured to engage bone (50) to secure the nail head to bone (see paragraph [0065]); and a tulip (118) configured to be disposed on a proximal end (114) of the nail head of the pedicle nail (see paragraph [0068] and Figs. 9 and 18), wherein the nail head is a separate element from the shank and the tulip (nail head 102 is a separate component attachable and detachable from the shank 340 and tulip 118, see paragraphs [0068] and [0087] and Figs. 9, 18, 27, and 28), wherein the shank comprises fenestrated perforations (356) about the longitudinal axis thereof, wherein the number of fenestrated perforations can range from 2 to 100 (six fenestrations 356, see Fig. 18).
Matityahu is silent on whether the tulip comprises a pair of arms defining a recess, the recess configured to receive a surgical rod. However, Matityahu discloses a portion of tulip 118 that receives a transverse member 130, see paragraph [0068] and Figs. 9 and 18). Additionally, Jackson discloses a pedicle nail system (1) including a tulip (26) that comprises a pair of arms (72/73) defining a recess (76), the recess configured to receive a surgical rod (3). 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 tulip to comprise a pair of arms defining a recess configured to receive a surgical rod as suggested by Jackson to allow for easy top-loading and securement of the rod into the tulip (see paragraphs [0086] and [0090]) and because such a modification merely involves substituting one known tulip configuration for connecting a surgical rod to a pedicle anchor for another known tulip configuration for connecting a surgical rod to a pedicle anchor without any unpredictable results.
Matityahu is silent on a particular configuration wherein at least a first two fenestration perforations are grouped in a first set, a second set of at least two fenestration perforations are grouped together and spaced apart from the first set, a thirst set of at least two fenestration perforations are grouped together and spaced apart from the second set and a fourth set of at least two perforations are grouped together and spaced apart from the third set. However, Matityahu discloses that one or more apertures (356) may be positioned on the shank and spaced longitudinally or circumferentially as desired (see paragraph [0092] and Fig. 18). Additionally, Greenhalgh discloses a fenestrated pedicle fastener (see paragraph [0123]) comprising a shank (12), the shank comprises fenestrated perforations (74) about a longitudinal axis (8) thereof, wherein at least a first two fenestration perforations are grouped in a first set, a second set of at least two fenestration perforations are grouped together and spaced apart from the first set, a third set of at least two fenestration perforations are grouped together and spaced apart from the second set and a fourth set of at least two perforations are grouped together and spaced apart from the third set (perforations 74a on axis 112a, perforations 74b on axis 112b, perforations 74c on axis 112c, etc.; see paragraph [0216] and Figs. 12A-12C; alternatively, two or more perforations may be grouped by spaced apart sections 12SS1, 12SS2, 12SS3, 12SS4, etc.; see paragraph [0216] and Figs. 12A-12C). 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 pairs of perforations grouped in at least four spaced apart sets as Matityahu suggests one or more apertures may be positioned on the shank and spaced longitudinally or circumferentially as desired to allow for anchoring fluid to flow through the shank and help anchor the shank in bone (see paragraphs [0092] and [0102] and Fig. 18), and Greenhalgh suggests spacing apart at least four sets of perforations, each set including at least two perforations in order to control the flow of anchoring fluid to flow through the fastener and into surrounding bone to help anchor the fastener in bone (see Abstract, paragraphs [0138] and [0216] and Figs. 12A-12C).
Regarding claim 2, Matityahu discloses wherein the shank is a curved shank (portion 342 of shank 340 is arcuate, see Fig. 18 and paragraph [0086]), having a curvature angle theta (see Fig. 18; shank portion 342 has a curvature angle relative to a vertical axis defined by shank portion 336).
Regarding claim 10, Jackson suggests wherein the proximal end of the tulip (26) comprises an insertion assembly tool interface (grooves 86/87 or structure 82, see paragraphs [0090] and [0115]). 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 proximal end of the tulip to comprise an insertion assembly tool interface therein as suggested by Jackson in order to facilitate insertion of the pedicle nail system into bone, and securing of a surgical rod into the tulip (see Jackson, paragraphs [0090] and [0115]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Matityahu in view of Jackson and Greenhalgh, and further in view of U.S. Patent Application Publication No. 2015/0080972 (Chin) and U.S. Patent Application Publication No. 2014/0277162 (Kostuik).
Regarding claim 4, Matityahu fails to disclose wherein the shank comprises at least two protrusions configured along the longitudinal axis thereof, wherein the protrusions form channels along the longitudinal axis. However, Matityahu suggests the outer surface (350) of the shank may be roughened (see paragraph [0087]), and that roughening an implant surface induces bone in-growth (see paragraph [0081]). Additionally, Chin discloses a bone implant (100B) wherein the implant comprises at least two protrusions (166) configured along a longitudinal axis thereof (see Fig. 4A), wherein the protrusions form channels (between protrusions 166) along the longitudinal axis (see Fig. 4A), wherein the protrusions have exposed vertical edges (see Fig. 4A). 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 outer surface of the shank of Matityahu to provide at least two protrusions that form channels as suggested by Chin in order to increase the surface area of the shank, which helps promote bone growth and fusion (see Chin, paragraph [0042]).
Matityahu and Chin fails to disclose the vertical edge has at least two notches, wherein the notches are in vertical alignment with one another. However, Kostuik discloses a bone implant (10), wherein a shank (12) of the bone implant has exposed vertical edges (see Fig. 2), the vertical edges having a plurality of notches (17) that are in vertical alignment with one another (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 shank of Matityahu in view of Chin to have aligned notches in the vertical edges of the shank protrusions as suggested by Kostuik in order to further increase the surface area of the shank to further promote bone ingrowth (see Kostuik, paragraph [0034]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Matityahu in view of Jackson and Greenhalgh, and further in view of U.S. Patent Application Publication No. 2005/0055026 (Biedermann).
Regarding claim 8, Matityahu fails to explicitly disclose wherein the tulip is a monoaxial tulip. However, Biedermann discloses a bone anchoring element (see Fig. 8) that includes a pedicle fastener (13) and a tulip (90), wherein the tulip is a monoaxial tulip (see Fig. 8 and paragraph [0056]). 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 tulip be a monoaxial tulip in order to provide greater stability between the bone and a rod connected to the tulip via a rigid connection between the monoaxial tulip and pedicle fastener.
Claims 11, 12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Matityahu in view of U.S. Patent Application Publication No. 2015/0282843 (Spitler) and Greenhalgh.
Regarding claim 11, Matityahu discloses a pedicle nail system (see Figs. 9 and 18) comprising: a pedicle nail (332), wherein the pedicle nail comprises a shank (340), wherein the shank comprises a proximal end (336) and a distal bone engagement end (342), wherein the proximal end comprises mounting threads (343), the pedicle nail further including a nail head (102) disposable on the proximal end of the shank (see Figs. 2 and 18) and configured to threadably engage with the mounting threads (via mating threads 110, see paragraph [0087]), and a tulip (118) configured to be disposed on a proximal end (114) of the nail head of the pedicle nail (see paragraph [0068] and Figs. 9 and 18), wherein the shank comprises fenestrated perforations (356) about the longitudinal axis thereof, wherein the number of fenestrated perforations can range from 2 to 100 (six fenestrations 356, see Fig. 18).
Matityahu fails to explicitly disclose an insertion tool assembly, wherein the insertion tool assembly comprises a driver having a distal end, the distal end of the driver is configured to be removably connected to the nail head to mount the nail head to the shank and is configured to be removably connected to the tulip to mount the tulip to the nail head. However, Spitler discloses a pedicle nail system (see Figs 2, 10, and 11) including an insertion tool assembly (70), wherein the insertion tool assembly comprises a driver (72) having a distal end (76/82), the distal end of the driver is configured to be removably connected to a tulip (14) to mount the tulip to a nail head (24) (see paragraph [0034]). Regarding claim 20, Spitler discloses wherein the proximal end of the tulip comprises an insertion assembly tool interface (78 and interior portion of tulip 14, see paragraph [0032] and Fig. 11). 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 pedicle nail system of Matityahu to have use an insertion tool assembly to mount the tulip to the nail head as suggested by Spitler in order to facilitate secure connection of the tulip to a pedicle nail implanted in bone in a patient via a tool and rotational threading (see Spitler, paragraph [0034]). Additionally, Matityahu discloses that nail head is mounted to the shank via threaded rotation (see paragraphs [0066], [0082], and [0087]), and it would be obvious to also use the insertion tool assembly of Spitler to also mount the nail head to the shank in order to reduce the number of tools needed to assembly the pedicle nail system.
Matityahu is silent on a particular configuration wherein at least a first two fenestration perforations are grouped in a first set, a second set of at least two fenestration perforations are grouped together and spaced apart from the first set, a thirst set of at least two fenestration perforations are grouped together and spaced apart from the second set and a fourth set of at least two perforations are grouped together and spaced apart from the third set. However, Matityahu discloses that one or more apertures (356) may be positioned on the shank and spaced longitudinally or circumferentially as desired (see paragraph [0092] and Fig. 18). Additionally, Greenhalgh discloses a fenestrated pedicle fastener (see paragraph [0123]) comprising a shank (12), the shank comprises fenestrated perforations (74) about a longitudinal axis (8) thereof, wherein at least a first two fenestration perforations are grouped in a first set, a second set of at least two fenestration perforations are grouped together and spaced apart from the first set, a third set of at least two fenestration perforations are grouped together and spaced apart from the second set and a fourth set of at least two perforations are grouped together and spaced apart from the third set (perforations 74a on axis 112a, perforations 74b on axis 112b, perforations 74c on axis 112c, etc.; see paragraph [0216] and Figs. 12A-12C; alternatively, two or more perforations may be grouped by spaced apart sections 12SS1, 12SS2, 12SS3, 12SS4, etc.; see paragraph [0216] and Figs. 12A-12C). 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 pairs of perforations grouped in at least four spaced apart sets as Matityahu suggests one or more apertures may be positioned on the shank and spaced longitudinally or circumferentially as desired to allow for anchoring fluid to flow through the shank and help anchor the shank in bone (see paragraphs [0092] and [0102] and Fig. 18), and Greenhalgh suggests spacing apart at least four sets of perforations, each set including at least two perforations in order to control the flow of anchoring fluid to flow through the fastener and into surrounding bone to help anchor the fastener in bone (see Abstract, paragraphs [0138] and [0216] and Figs. 12A-12C).
Regarding claim 12, Matityahu discloses wherein the shank is a curved shank (portion 342 of shank 340 is arcuate, see Fig. 18 and paragraph [0086]), having a curvature angle theta (see Fig. 18; shank portion 342 has a curvature angle relative to a vertical axis defined by shank portion 336).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Matityahu in view of Spitler and Greenhalgh, and further in view of Chin and Kostuik.
Regarding claim 14, Matityahu fails to disclose wherein the shank comprises at least two protrusions configured along the longitudinal axis thereof, wherein the protrusions form channels along the longitudinal axis. However, Matityahu suggests the outer surface (350) of the shank may be roughened (see paragraph [0087]), and that roughening an implant surface induces bone in-growth (see paragraph [0081]). Additionally, Chin discloses a bone implant (100B) wherein the implant comprises at least two protrusions (166) configured along a longitudinal axis thereof (see Fig. 4A), wherein the protrusions form channels (between protrusions 166) along the longitudinal axis (see Fig. 4A), wherein the protrusions have exposed vertical edges (see Fig. 4A). 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 outer surface of the shank of Matityahu to provide at least two protrusions that form channels as suggested by Chin in order to increase the surface area of the shank, which helps promote bone growth and fusion (see Chin, paragraph [0042]).
Matityahu and Chin fails to disclose the vertical edge has at least two notches, wherein the notches are in vertical alignment with one another. However, Kostuik discloses a bone implant (10), wherein a shank (12) of the bone implant has exposed vertical edges (see Fig. 2), the vertical edges having a plurality of notches (17) that are in vertical alignment with one another (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 shank of Matityahu in view of Chin to have aligned notches in the vertical edges of the shank protrusions as suggested by Kostuik in order to further increase the surface area of the shank to further promote bone ingrowth (see Kostuik, paragraph [0034]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Matityahu in view of Spitler and Greenhalgh, and further in view of Biedermann.
Regarding claim 18, Matityahu fails to explicitly disclose wherein the tulip is a monoaxial tulip. However, Biedermann discloses a bone anchoring element (see Fig. 8) that includes a pedicle fastener (13) and a tulip (90), wherein the tulip is a monoaxial tulip (see Fig. 8 and paragraph [0056]). 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 tulip be a monoaxial tulip in order to provide greater stability between the bone and a rod connected to the tulip via a rigid connection between the monoaxial tulip and pedicle fastener.
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.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773