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 § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 21, 25-37 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kolb et al. (2004/0186482; cited by Applicant).
Regarding claim 21, Kolb et al. disclose a vertebral stabilization system (Fig. 7; paras. 0001 and 0025) comprising:
a shaft 14 (Fig. 3) with a distal end 14b and a proximal end 14a, the distal end of the shaft comprising a first locking mechanism 28 (threads, para. 0031);
a guide assembly 10 (Fig. 1) comprising a channel 14a sized to accept at least a portion of the shaft 14 and an opening through barrel 20a (and/or 20b) sized to accept a screw (para. 0036); and
an implant 60 comprising a distal end and a proximal end, wherein the proximal end comprises an orifice with a second locking mechanism (threads, para. 0031) configured to engage with the first locking mechanism 28 (id.), wherein at least a portion of the shaft can be inserted through the channel 14a (Fig. 7) and into the orifice, and wherein engagement of the first locking mechanism 28 and the second locking mechanism (threads of the orifice; para. 0031) draws the implant toward the guide assembly and locks the implant in a fixed position relative to the opening (para. 0031 and cf. alignment features 34, 35; Fig. 6),
wherein the opening through barrel 20a (and/or 20b) and the channel 14a are positioned such that the screw (para. 0036) extending through the opening is non-parallel with the distal end of the shaft 14 when the first locking mechanism 28 is engaged with the second locking mechanism (threads of the orifice; para. 0031) (Figs. 1 and 7).
Regarding claim 25, the guide assembly 10 is configured to accept the screw (para. 0036) while the first locking mechanism 28 and the second locking mechanism (threads of the orifice; para. 0031) are engaged (paras. 0031 and 0036; Fig. 7).
Regarding claim 26, the proximal end 14a of the shaft 14 has a larger diameter than an inner diameter of the channel 14a (cf. Fig. 3 and Fig. 7).
Regarding claim 27, the implant 60 comprises an intervertebral cage (i.e., “prosthetic implant”; para. 0004).
Regarding claim 28, the implant further comprises the vertebral stabilization plate 60 (Fig. 7).
Regarding claim 29, the system includes the screw (para. 0036), wherein the screw is engageable with the implant 60 while the first locking mechanism 28 is engaged with the second locking mechanism (threads of the orifice; para. 0031) (paras. 0031 and 0036; Fig. 7).
Regarding claim 30, the first locking mechanism 28 is a male thread (Fig. 3), and the second locking mechanism (threads of the orifice; para. 0031) is a female thread (id.).
Regarding claim 31, Kolb et al. disclose a surgical system (Fig. 7; paras. 0001 and 0025) comprising:
a shaft 14 (Fig. 3) with a distal end 14b and a proximal end 14a, the distal end of the shaft comprising a first locking mechanism 28 (threads, para. 0031);
a screw (para. 0036);
a guide assembly 10 (Fig. 1) comprising a channel 14a sized to accept at least a portion of the shaft 14 and an opening through barrel 20a (and/or 20b) sized to accept the screw (para. 0036); and
an implant 60 comprising a distal end and a proximal end, wherein the proximal end comprises an orifice with a second locking mechanism (threads, para. 0031) configured to engage with the first locking mechanism 28 (id.), wherein at least a portion of the shaft can be inserted through the channel 14a (Fig. 7) and into the orifice, and wherein engagement of the first locking mechanism 28 and the second locking mechanism (threads of the orifice; para. 0031) draws the implant toward the guide assembly and locks the implant in a fixed position relative to the opening (para. 0031 and cf. alignment features 34, 35; Fig. 6),
wherein the screw (para. 0036) is engageable with the implant 60 while the first locking mechanism 28 is engaged with the second locking mechanism (threads of the orifice; para. 0031), and
wherein the guide assembly 10 is configured to accept the screw (para. 0036) through the opening of barrel 20a (and/or 20b) while the first locking mechanism 28 and the second locking mechanism (threads of the orifice; para. 0031) are engaged (para. 0036).
Regarding claim 32, distal portions of the opening of the barrel 20a (and/or 20b) and the channel 14a are positioned within the guide assembly 10 at non-parallel angles (Figs. 1 and 7).
Regarding claim 33, the proximal end 14a of the shaft 14 has a larger diameter than an inner diameter of the channel 14a (cf. Figs. 3 and 7).
Regarding claim 34, the implant 60 comprises an intervertebral cage (i.e., “prosthetic implant”; para. 0004).
Regarding claim 35, Kolb et al. disclose a surgical system (Fig. 7; paras. 0001 and 0025) comprising:
a guide assembly 10 (Fig. 1) comprising a channel 14a and a screw opening through barrel 20a (and/or 20b; para. 0036);
a shaft 14 sized to traverse the channel 14a (Fig. 7; para. 0036), a distal end 14b of the shaft 14 comprising a first threaded connection 28 (Fig. 3);
a screw (para. 0036); and
an implant 60 comprising an orifice with a second threaded connection (para. 0031), the first threaded connection 28 engageable with the second threaded connection (para. 0031),
wherein engagement of the first threaded connection 28 and the second threaded connection (para. 0031) directly or indirectly connects the implant 60 to the guide assembly 10 and locks the implant 60 in a fixed position relative to the screw opening (i.e., opening of barrel 20a (and/or 20b), and
wherein the guide assembly 10 is positioned whereby at least a portion of the shaft 14 can extend from a distal end of the guide assembly 10 concurrent with the screw (para. 0036) extending from the distal end of the guide assembly (paras. 0031, 0036 and Fig. 7).
Regarding claim 36, the channel 14a and the screw opening (supra; para. 0031) are positioned whereby the screw (id.) and the distal end 14b of the shaft 14 are configured to extend from the distal end of the guide assembly 10 at non-parallel angles (paras. 0031 and 0036; Figs. 1 and 7).
Regarding claim 37, the proximal end 14a of the shaft 14 has a larger diameter than an inner diameter of the channel 14a (cf. Fig. 3 and Fig. 7).
Regarding claim 40, the implant 60 comprises an intervertebral cage (i.e., “prosthetic implant”; para. 0004).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 22-24, 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Kolb et al. (2004/0186482; cited by Applicant) in view of Williams (2017/0095344) and Sears et al. (2004/0199252).
Regarding claims 22 and 38, Kolb et al. disclose the claimed invention as set forth above except for explicitly reciting a shearable fastener sized to extend at least partially through the orifice of the implant (supra).
Williams discloses providing a threaded fastener 550 sized to extend through an orifice in a plate implant 500 and an intervertebral implant (i.e., cage) 200 to secure the plate to the intervertebral implant (para. 0036).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the system of Kolb et al. with a threaded fastener sized to extend through an orifice in the plate 60 of the implant to secure the plate to the prosthetic implant (i.e., cage) thereof.
Sears et al. discloses configuring fasteners for orthopedic fixation systems as shearable fasteners 428 (Fig. 16; para. 0058) having shearable zones 474 which break when a shearing force is applied to a head 472 of the shearable fastener 428 (id.). This configuration ensures proper torque is achieved and not exceeded.
Thus, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to also configure the threaded fastener, as taught by Williams, as a shearable fastener having shearable zones which break when a shearing force is applied to a head of the shearable fastener, in view of Sears et al., to ensure proper torque is achieved and not exceeded.
Regarding claim 23, the shearable fastener of the combination (supra) comprises a third locking mechanism (i.e., the threads) configured to engage with the second locking mechanism 28; para. 0031 of Kolb et al.; cf. para. 0036 of Williams).
Regarding claim 24, the shearable fastener of the combination (supra) comprises a shearable zone 474 which breaks when a shearing force is applied to a head 472 of the shearable fastener (supra; Fig. 16 and para. 0058 of Sears et al.).
Regarding claim 39, the shearable fastener of the combination (supra) comprises a third locking mechanism (i.e., the threads) configured to engage with the second threaded connection 28 (of Kolb et al.), and the shearable fastener (supra) comprises a shearable zone 474 which breaks when a shearing force is applied to a head 472 of the shearable fastener (supra).
Response to Arguments
Applicant’s arguments with respect to claims 21-40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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