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 § 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 1, 3-6, 8, 10-13, 15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (2010/0160981; cited by Applicant) in view of in view of Jeon et al. (2007/0270839).
Regarding claim 1, Butler et al. disclose an extensible spinal support system (Figs. 16-18), comprising:
a base rod receptacle 230 configured to receive a base spinal support rod 250;
an extension subassembly 150, 156 including a base portion 156 and an extension rod receptacle 150, the extension rod receptacle configured to receive an extension spinal support rod 308 (Fig. 17); and
a pivot member 162 coupling the extension rod receptacle 150 to the base portion 156 (Fig. 16 and para. 0055), wherein the base portion 156 is configured to couple to the base rod receptacle 230 without disturbing the base spinal support rod 250 (the rod 250 is independently tightened by continued rotation of the pivot member 162 (id.).
Butler et al. disclose the claimed invention except wherein the base rod receptacle includes exterior threads, the base portion includes a skirt portion with interior threads, and the base portion is configured to couple to the base rod receptacle by engaging the interior threads of the skirt portion with the exterior threads of the base rod receptacle.
Jeon et al. disclose a spinal support system and teach that a rod receptacle 30 (Fig. 9) can be provided with exterior threads 44 (Fig. 3A; para. 0043), and a base portion 120 (Fig. 7d) can include a skirt portion 123 (Fig. 7c) with interior threads 122 (id.) configured to engage the exterior threads 44 (Figs. 2 and 9) of the rod receptacle 30 (id.). In addition, it is noted that in Jeon et al. the pedicle screw and rod are independently tightened, as in Butler et al (see Figs. 2 and 9; para. 0013). The skirt portion 123 secures the walls (i.e., branches; para. 0043; Figs. 2 and 9) of the rod receptacle 30 and reduces the likelihood of involuntary loosening of the components (para. 0013).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the base rod receptacle 230 of Butler et al. to include exterior threads, and the base portion 156 to include a skirt portion with interior threads, the base portion being configured to couple to the base rod receptacle by engaging the interior threads of the skirt portion with the exterior threads of the base rod receptacle, in view of Jeon et al., to secure the walls of the base rod receptacle and reduce the likelihood of involuntary loosening of the components.
Regarding claim 3, the pivot member 162 of the combination includes a head portion 161 (Fig. 16) and a threaded shaft portion (Fig. 16), the shaft portion extending through an opening (annotated Fig. 16, below) in the extension rod receptacle 150 and engaging a threaded center hole in the base portion 156 (id.).
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Regarding claim 4, the extension rod receptacle 150 of the combination includes an internal flange (annotated Fig. 16, supra) captured between the head portion 161 of the pivot member 162 and the base portion 156 (Fig. 16).
Regarding claim 5, the pivot member 156 of the combination is configured to allow monoaxial rotation of the extension rod receptacle 150 relative to the base portion 156 (monoaxial rotation is within the capability of the polyaxial connection; para. 0052).
Regarding claim 6, the extensible spinal support system of the combination further comprises a pedicle screw 220 coupled to a distal end of the base rod receptacle 230, wherein the pedicle screw 220 and the base rod receptacle 230 are configured for polyaxial rotation relative to each other (para. 0052).
Regarding claim 8, Butler et al. disclose a method of extending a spinal support system (Figs. 16-18), comprising:
providing a base rod receptacle 230 containing a base spinal support rod 250;
coupling a base portion 156 of an extension subassembly 150, 156 to the base rod receptacle 230 without removing the base spinal support rod 250 (para. 0055); and
pivotally attaching an extension rod receptacle 150 to the base portion 156, wherein the extension rod receptacle 150 is configured to receive an extension spinal support rod 308 (Fig. 17).
Butler et al. disclose the claimed invention except wherein coupling the base rod receptacle comprises threadedly engaging a skirt portion of the base portion with exterior threads of the base rod receptacle.
Jeon et al. disclose a spinal support system and teach that a rod receptacle 30 (Fig. 9) can be provided with exterior threads 44 (Fig. 3A; para. 0043), and a base portion 120 (Fig. 7d) can include a skirt portion 123 (Fig. 7c) with interior threads 122 (id.) configured to engage the exterior threads 44 (Figs. 2 and 9) of the rod receptacle 30 (id.). In addition, it is noted that in Jeon et al. the pedicle screw and rod are independently tightened, as in Butler et al (see Figs. 2 and 9; para. 0013). The skirt portion 123 secures the walls (i.e., branches; para. 0043; Figs. 2 and 9) of the rod receptacle 30 and reduces the likelihood of involuntary loosening of the components (para. 0013).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the base rod receptacle 230 of Butler et al. to include exterior threads, and the base portion 156 to include a skirt portion with interior threads configured to engage the exterior threads of the base rod receptacle, such that coupling the base rod receptacle comprises threadedly engaging a skirt portion of the base portion with exterior threads of the base rod receptacle, in view of Jeon et al., to secure the walls of the base rod receptacle and reduce the likelihood of involuntary loosening of the components.
Regarding claim 10, pivotally attaching the extension rod receptacle 150 of the combination comprises:
inserting a threaded shaft portion of a pivot member 162 through an opening (annotated Fig. 16, supra) in the extension rod receptacle 150 (Fig. 16); and
engaging the threaded shaft portion with a threaded center hole in the base portion 156 (Fig. 16).
Regarding claim 11, the extension rod receptacle 150 of the combination includes an internal flange (annotated Fig. 16, supra) captured between the head portion 161 of the pivot member 162 and the base portion 156 (Fig. 16).
Regarding claim 12, the pivot member 156 of the combination is configured to allow monoaxial rotation of the extension rod receptacle 150 relative to the base portion 156 (monoaxial rotation is within the capability of the polyaxial connection; para. 0052).
Regarding claim 13, the method of the combination further comprises coupling a pedicle screw 220 to a distal end of the base rod receptacle 230, and wherein the pedicle screw 220 and the base rod receptacle 230 are configured for polyaxial rotation relative to each other (Fig. 16 and para. 0052).
Regarding claim 15, Butler et al. disclose an extension subassembly for a spinal support system (Figs. 16-18), comprising:
a base portion 156 configured to couple to a base rod receptacle 230 containing a base spinal support rod 250;
an extension rod receptacle 150 configured to receive an extension spinal support rod 308 (Fig. 17); and
a pivot member 162 coupling the extension rod receptacle 150 to the base portion 156 (Fig. 16 and para. 0055), wherein the pivot member 162 enables at least monoaxial rotation (monoaxial rotation is within the capability of the polyaxial connection; para. 0052) of the extension rod receptacle 150 relative to the base portion 156.
Butler et al. disclose the claimed invention except wherein the base portion includes a skirt portion with interior threads configured to engage exterior threads on the base rod receptacle.
Jeon et al. disclose a spinal support system and teach that a rod receptacle 30 (Fig. 9) can be provided with exterior threads 44 (Fig. 3A; para. 0043), and a base portion 120 (Fig. 7d) can include a skirt portion 123 (Fig. 7c) with interior threads 122 (id.) configured to engage the exterior threads 44 (Figs. 2 and 9) of the rod receptacle 30 (id.). In addition, it is noted that in Jeon et al. the pedicle screw and rod are independently tightened, as in Butler et al (see Figs. 2 and 9; para. 0013). The skirt portion 123 secures the walls (i.e., branches; para. 0043; Figs. 2 and 9) of the rod receptacle 30 and reduces the likelihood of involuntary loosening of the components (para. 0013).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the base rod receptacle 230 of Butler et al. to include exterior threads, and the base portion 156 to include a skirt portion with interior threads configured to engage the exterior threads of the base rod receptacle, in view of Jeon et al., to secure the walls of the base rod receptacle and reduce the likelihood of involuntary loosening of the components.
Regarding claim 17, the pivot member 162 of the combination includes a head portion 161 (Fig. 16) and a threaded shaft portion (Fig. 16), the shaft portion extending through an opening (annotated Fig. 16, supra) in the extension rod receptacle 150 and engaging a threaded center hole in the base portion 156 (id.).
Regarding claim 18, the extension rod receptacle 150 of the combination includes an internal flange (annotated Fig. 16, supra) captured between the head portion 161 of the pivot member 162 and the base portion 156 (Fig. 16).
Regarding claim 19, the pivot member 162 of the combination is secured to the base portion 156 by a threaded engagement (Fig. 16).
Regarding claim 20, the base portion of the combination (supra) further (in addition to the skirt, as modified; supra) comprises an integral set screw portion, i.e., the base portion 156, configured (e.g., via the internal threads of the base portion 156; Fig. 16) to secure the base spinal support rod 250 within the base rod receptacle of the combination.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (2010/0160981; cited by Applicant) in view of Jeon et al. (2007/0270839), as applied to claims 1 and 6 above, and further in view of Barker et al. (2002/0026193).
The device of the combination of Butler et al. and Jeon et al. disclose the claimed invention except for a lock ring disposed between the base spinal support rod 250 and a head portion 238 of the pedicle screw 220, the lock ring including a malleable feature configured to conform to the base spinal support rod 250 when compressed.
Barker et al. disclose a spinal support system and teach that a lock ring 70 can be disposed between the spinal support rod R and a head portion 54 of the pedicle screw 50 (Fig. 7), the lock ring including a malleable feature configured to conform to the base spinal support rod 250 when compressed (para. 0049). This configuration provides a more secure locking of the implant (id.).
Therefore, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide the spinal support system of the combination of Butler et al. and Jeon et al., with a lock ring disposed between the base spinal support rod 250 and a head portion 238 of the pedicle screw 220, the lock ring including a malleable feature configured to conform to the base spinal support rod 250 when compressed, in view of Barker et al., to provide a more secure locking of the implant.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Butler et al. (2010/0160981; cited by Applicant) in view of Jeon et al. (2007/0270839), as applied to claims 8 and 13 above, and further in view of Barker et al. (2002/0026193).
The device of the combination of Butler et al. and Jeon et al. disclose the claimed invention except for disposing a lock ring between the base spinal support rod 250 and a head portion 238 of the pedicle screw 220, the lock ring including a malleable feature configured to conform to the base spinal support rod 250 when compressed.
Barker et al. disclose a spinal support system and teach that a lock ring 70 can be disposed between the spinal support rod R and a head portion 54 of the pedicle screw 50 (Fig. 7), the lock ring including a malleable feature configured to conform to the base spinal support rod 250 when compressed (para. 0049). This configuration provides a more secure locking of the implant (id.).
Therefore, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide the spinal support system of the combination of Butler et al. and Jeon et al., with a lock ring disposed between the base spinal support rod 250 and a head portion 238 of the pedicle screw 220, the lock ring including a malleable feature configured to conform to the base spinal support rod 250 when compressed, in view of Barker et al., to provide a more secure locking of the implant.
Response to Arguments
Applicant's arguments filed 31 July 2026 have been fully considered but they are not persuasive.
It is first noted that the rejection under 35 U.S.C. 102(a)(1) has been withdrawn in response to Applicant incorporating the limitations of now canceled claims 2, 9 and 16 into the independent claims. However, the independent claims remain rejected under the combination of Butler et al. (hereinafter “Butler”) and Jeon et al. (hereinafter “Jeon”), as previously applied to claims 2, 9 and 16.
Applicant’s argument (Remarks, page 8) that the combination would change Butler’s principle of operation and render its breakaway collar and set-screw attachment mechanism unsuitable for its intended purpose is not persuasive. Butler’s principle of operation is not affected by the location of the threads and the presence of the threaded interior surface of the base, as taught by Jeon.
With threads of base portion 156 of Butler (Fig. 16) placed on the interior surface of the skirt 123 (Fig. 7c of Jeon), as taught by Jeon (supra), the base portion 156 is still forced downward by the interior threads of the skirt portion. Therefore, when the torque limit is reached (from the abutment of the base portion 156 with the taper lock 246 and head 238 of the pedicle screw 220; Fig. 16 and para. 0055 of Butler) the breakaway action would still occur. The presence of the skirt and location of the threads neither changes the principle of operation nor renders it unsuitable for its intended purpose. This leads to Applicant’s second argument, which has also been found to be unpersuasive.
Applicant argues (Remarks, page 8) that there is no rational reason to import Jeon’s skirt and thread structure into Butler. Examiner respectfully disagrees. Jeon teaches that this configuration creates apposing forces that reduce the likelihood of involuntary loosening of the components (para. 0013 of Jeon).
Finally, Applicant argues that “without disturbing” or “without removing” (as found in amended independent claims 1 and 8; there is no such limitation in independent claim 15) involves the set screw that secures the base spinal rod to the base rod receptacle not having to be removed from the interior threads of the base rod receptacle (Remarks, page 9). However, this language is not found in the claims. Instead, the system and method of the combination involve the configuration of the combination as set forth above. That configuration does not require any set screw to be removed. In addition, with respect to claim 1, the base portion couples to the base rod receptacle without “disturbing” the base spinal rod because the rod is not tightened until a subsequent step after the base portion 156 is tightened and the torque limit is reached (para. 0055 of Butler). The coupling is complete prior to and independent of tightening or “disturbing” the rod. Likewise, with respect to claim 8, the base portion couples to the base rod receptacle without removing the base spinal support rod (id.).
Applicant did not separately argue the merits of the combination of Butler in view of Jeon, further in view of Barker et al., as applied to claims 7 and 14.
For the preceding reasons, the combination of Butler and Jeon, as applied to the claims, has been maintained. The claims stand rejected as set forth above.
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). It is noted that the same art has been applied with the same reasoning as was applied to previous claims 2, 9 and 16. The rejection merely addresses the limitations from these claims as now incorporated by Applicant into the independent claims. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
