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 Objections
Claims 19 and 20 are duplicates of claims 6 and 11, respectively. Applicant is advised that should claims 6 and/or 11 be found allowable, claims 19 and/or 20 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15 and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15, line 2, “the head of the pedicle screw” lacks antecedent basis.
Claim 16 is also rejected because it depends from and includes the limitations of rejected claim 15.
Appropriate correction is required.
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 1, 6, 7, 9, 11, 14, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann (DE-4307576-C1; see machine translation).
Regarding claim 1, Biedermann discloses a pedicle screw assembly (Figs. 1-3; page 4, para. 2, describing a third embodiment with a thrust washer 18 in addition to a head fixing screw 12; claim 1) comprising:
a tulip 5 having first and second openings 8, 7 and an inner surface having an internal threading 10;
a saddle (i.e., thrust washer 18; Figs. 1-3; page 4, para. 2, describing a third embodiment with a thrust washer 18 in addition to a head fixing screw 12; claim 1) movably disposed within the tulip 5 between the first and second openings, the saddle 18 having a first end (top) and a second end (bottom) including a cavity 15 configured to receive a pedicle screw 1;
a first locking screw 12 configured to be disposed over the saddle 18 and configured to be threaded into the internal threading 10 of the tulip 5 for locking a polyaxial motion (Fig. 2) of the pedicle screw 1 to the tulip 5;
a second locking screw 13 configured to be disposed over a rod 16 positioned over the first locking screw 12 for locking the rod 16 to the tulip 5.
Regarding claim 6, the internal threading of the tulip are angled, e.g., as by the angle of the helical internal threading 10, or as by the shape thereof in cross-section (Figs. 1 and 2).
Regarding claim 7, the threads of the second locking cap 13 are angled e.g., as by the angle of the helical threads, or as by their shape in cross-section (Figs. 1 and 2).
Regarding claim 9, an outer surface of the tulip 5 comprises opposing reduction pockets (e.g., the space defined between the bottom surface of lock nut 14 and the upper surface of the outer ledge on the tulip 5 (Fig. 2) capable of receiving a mating tool, if desired.
Regarding claim 11, corners of the internal threading 10 of the tulip include radii (see detail view of Fig. 2, below).
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Regarding claim 14, Biedermann discloses a pedicle screw assembly (Figs. 1-3; page 4, para. 2, describing a third embodiment with a thrust washer 18 in addition to a head fixing screw 12; claim 1) comprising:
a tulip 5 having a base (bottom), and first and second extensions (Fig. 1) extending upwardly from the base and defining a first opening 8, the base defining a second opening 7, the tulip including an inner surface having an internal threading 10;
a saddle (i.e., thrust washer 18; Figs. 1-3; page 4, para. 2, describing a third embodiment with a thrust washer 18 in addition to a head fixing screw 12; claim 1) movably disposed within the tulip 5 between the first and second openings 8, 7, the saddle having a first end (top) and a second end (bottom) including a cavity 15 configured to receive a pedicle screw 1 through the second opening 7;
a first locking screw 12 configured to be disposed over the saddle 18 and configured to be threaded into the internal threading 10 of the tulip 5 for locking a polyaxial motion (Fig. 2) of the pedicle screw 1 to the tulip 5;
a second locking screw 13 configured to be disposed over a rod 16 positioned over the first locking screw 12 for locking the rod 16 to the tulip 5.
Regarding claim 19, the internal threading 10 of the tulip 5 are angled, e.g., as by the angle of the helical internal threading 10, or as by the shape thereof in cross-section (Figs. 1 and 2).
Regarding claim 20, corners of the internal threading 10 of the tulip 5 include radii (see detail view of Fig. 2, above).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann (DE-4307576-C1; see machine translation), as applied to claim 1 above, in view of Barker et al. (2002/0026193).
Regarding claims 2 and 3 (treated together because of a complimentary design) Biedermann discloses the claimed invention except for a retainer positioned to abut the head of the pedicle screw (claim 2), wherein the retainer includes a circumferential ring received in a circumferential groove in the tulip (claim 3).
Barker et al. teach that a retainer 90 (Fig. 7) may be positioned to abut the head 54 (Fig. 4A) of a pedicle screw 50, wherein the retainer 90 includes a circumferential ring (Fig. 6A) received in a circumferential groove 41 (Fig. 7) in a tulip 30 (id.). This configuration facilitates assembly by allowing bottom-loading of the pedicle screw into the tulip (paras. 0040-0044).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the pedicle screw assembly of Biedermann with a retainer positioned to abut the head of the pedicle screw, wherein the retainer includes a circumferential ring received in a circumferential groove in the tulip, in view of Barker et al., to facilitate assembly by allowing bottom-loading of the pedicle screw into the tulip.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann (DE-4307576-C1; see machine translation), as applied to claim 1 above, in view of Jackson (2004/0039383).
Regarding claim 4, Biedermann discloses the claimed invention except for wherein the second locking screw includes a break-off locking cap a portion of which is configured to break off at a desired torque.
Jackson discloses a pedicle screw assembly (Figs. 1 and 2) and teaches that a locking screw 2 can include a break-off locking cap 3 a portion 10 (also 9) of which is configured to break off at a desired torque (paras. 0026 and 0028). This configuration ensures that proper torque is achieved and not exceeded.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the second locking screw of Biedermann with a break-off locking cap a portion of which is configured to break off at a desired torque, in view of Jackson, to ensure that proper torque is achieved and not exceeded.
Regarding claim 5, the break-off locking cap of the combination of Biedermann and Jackson is a threaded locking cap or a set screw (supra).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Biedermann (DE-4307576-C1; see machine translation) in view of Harper (2013/0018428).
Biedermann discloses the claimed invention except for an outer surface of the tulip 5 comprising chevron slots to receive a mating tool.
Harper disclose providing an outer surface of a tulip 10 with chevron slots 82 to provide a tool engagement groove to receive a mating tool and facilitate holding the tulip element (para. 0039).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to provide the outer surface of the tulip of Biedermann et al. with chevron slots, in view of Harper et al., to provide a tool engagement groove to receive a mating tool and facilitate holding the tulip element.
Claims 10, 12 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann (DE-4307576-C1; see machine translation), as applied to claim 1 above, in view of Jackson (2013/0131730).
Regarding claim 10, Biedermann discloses the claimed invention except for the corners of the threads of the second locking cap include chamfers.
Jackson et al. teach that corners of the threads of a locking cap can include chamfers (i.e., tapered lower edge of thread start structure 47; Fig. 2 and para. 0006) to facilitate introduction and starting of the threads.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the corners of the threads of the second locking cap of Biedermann to include chamfers, in view of Jackson et al., to facilitate introduction and starting of the threads.
Regarding claim 12, Biedermann discloses the claimed invention except for the internal threading 10 of the tulip 5 being square shaped.
Jackson teaches that threads of closures and arms of a pedicle screw assembly can have any desired shape, including square shaped (para. 0005) to prevent splaying of the receiver (i.e., tulip) arms (id.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the internal threading of the tulip to be square shaped, in view of Jackson et al., to prevent splaying of the tulip arms.
Regarding claim 13, Biedermann discloses the claimed invention except for the threads of the second locking screw being square shaped.
Jackson teaches that threads of closures and arms of a pedicle screw assembly can have any desired shape, including square shaped (para. 0005) to prevent splaying of the receiver (i.e., tulip) arms (id.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the threads of the second locking screw of Biedermann to be square shaped, in view of Jackson et al., to prevent splaying of the tulip arms.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann (DE-4307576-C1; see machine translation), as applied to claim 14 above, in view of Barker et al. (2002/0026193).
Regarding claims 15 and 16 (treated together because of a complimentary design), Biedermann discloses the claimed invention except for a retainer positioned to abut the head of the pedicle screw (claim 15), wherein the retainer includes a circumferential ring received in a circumferential groove in the tulip (claim 16).
Barker et al. teach that a retainer 90 (Fig. 7) may be positioned to abut the head 54 (Fig. 4A) of a pedicle screw 50, wherein the retainer 90 includes a circumferential ring (Fig. 6A) received in a circumferential groove 41 (Fig. 7) in a tulip 30 (id.). This configuration facilitates assembly by allowing bottom-loading of the pedicle screw into the tulip (paras. 0040-0044).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the pedicle screw assembly of Biedermann with a retainer positioned to abut the head of the pedicle screw, wherein the retainer includes a circumferential ring received in a circumferential groove in the tulip, in view of Barker et al., to facilitate assembly by allowing bottom-loading of the pedicle screw into the tulip.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann (DE-4307576-C1; see machine translation), as applied to claim 14 above, in view of Jackson (2004/0039383).
Regarding claim 17, Biedermann discloses the claimed invention except for wherein the second locking screw includes a break-off locking cap a portion of which is configured to break off at a desired torque.
Jackson discloses a pedicle screw assembly (Figs. 1 and 2) and teaches that a locking screw 2 can include a break-off locking cap 3 a portion 10 (also 9) of which is configured to break off at a desired torque (paras. 0026 and 0028). This configuration ensures that proper torque is achieved and not exceeded.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the second locking screw of Biedermann with a break-off locking cap a portion of which is configured to break off at a desired torque, in view of Jackson, to ensure that proper torque is achieved and not exceeded.
Regarding claim 18, the break-off locking cap of the combination of Biedermann and Jackson is a threaded locking cap or a set screw (supra).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
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