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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-16) and the species of Figs. 10-26 in the reply filed on August 18, 2025 is acknowledged.
Claims 17 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 18, 2025.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann et al. (US 2021/0015521 A1).
Claim 1. Biedermann discloses a spinal pedicle screw having proximal and distal ends and an axis extending therebetween, the spinal pedicle screw comprising:
a fastener (bone anchoring element 1) comprising a shaft (shank 2 – see Fig. 1) and a fastener head (head 3’) disposed on the shaft, the fastener being configured to be anchored within a subject's bone; and
a head assembly (receiving part 5’, pressure member 6’’, and pin 59) coupled to the fastener head, the head assembly including a rod coupler (receiving part 5’) configured to secure a rod to the head assembly, and a collet (pressure member 6’’) received at least partially within the rod coupler,
wherein the fastener head is received in the collet (see Fig. 18a),
wherein the collet has an interior surface (surface of head receiving recess 62’) engaging the fastener head,
wherein the collet includes a friction rib (projection 68) on the interior surface and protruding inward therefrom, the friction rib configured to impart a frictional force on the fastener head to inhibit free movement of the head assembly on the fastener head (Figs. 18a-19; paras. 0071-0078).
Claim 2. Biedermann discloses wherein a distal portion (region 62d) of the interior surface of the collet engages the fastener head (see Fig. 18a), the friction rib being disposed proximal of the distal portion of the interior surface of the collet (see Fig. 19) (Figs. 18a-19; paras. 0071-0078).
Claim 3. Biedermann discloses wherein the distal portion of the interior surface of the collet is concave (see Fig. 18a) (Figs. 18a-19; paras. 0071-0078).
Claim 4. Biedermann discloses wherein the collet has proximal and distal open ends (see Fig. 18a), wherein the friction rib is disposed between the proximal and distal open ends (see Fig. 19) (Figs. 18a-19; paras. 0071-0078).
Claim 5. Biedermann discloses wherein the head assembly further includes at least one pin (pin 59) received in a pin opening (see Fig. 18a) defined by the rod coupler, wherein the collet defines at least one opening (recess 69) in which the at least one pin is received to inhibit rotation of the collet about the axis relative to the rod coupler (Figs. 18a-19; paras. 0071-0078).
Claim 6. Biedermann discloses wherein the head assembly further includes a saddle (recess 61’) received in the rod coupler and connected to the collet, wherein the collet defines a concave interior surface engaging the fastener head (see fig. 18a) (Figs. 18a-19; paras. 0071-0078).
Claims 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shluzas et al. (US 2013/0150852 A1).
Claim 11. Shluzas discloses a spinal pedicle screw having opposite proximal and distal ends and an axis extending therebetween, the spinal pedicle screw comprising:
a fastener (bone screw 14) comprising a shaft (shaft portion 16) and a fastener head (head portion 18) disposed on the shaft, the fastener being configured to be anchored within a subject's bone; and
a head assembly (housing 12, retainer 42, and spacer 50) including
a rod coupler (housing 12) configured to secure a rod to the head assembly,
a collet (retainer 42) received at least partially within the rod coupler, wherein the collet has an interior surface (surface of cavity 44) engaging the fastener head (see Fig. 1A) and at least one tongue (see Fig. 1A inset) extending radially inward from the interior surface, and
a saddle (spacer 50) received at least partially within the rod coupler, the saddle having a proximal surface (surface upon which rod 40 is seated as shown in Fig. 1A) for seating the rod thereon, wherein the saddle defines at least one exterior groove (see Fig. 1A inset),
wherein the at least one tongue of the collet is received the at least one groove of the saddle to couple the collet to the saddle (see Fig. 1A),
wherein the collet and the saddle are movable axially relative to one another along the axis of the spinal pedicle screw (prior to and during assembly of retainer 42 with spacer 50 as shown in Fig. 1A, retainer 42 is axially movable relative to spacer 50) (Figs. 1-1B; paras. 0038-0052).
Claim 12. Shluzas discloses wherein a distal portion of the saddle is received in a proximal portion of the collet (see Fig. 1A) (Figs. 1-1B; paras. 0038-0052).
Claim 13. Shluzas discloses wherein the collet is radially expandable (due to the presence of slots 48b) within the rod coupler to enable insertion of fastener head into the collet through an open distal end of the collet, and removal of the fastener head from the collet through the open distal end of the collet (see Fig. 1B) (Figs. 1-1B; paras. 0038-0052).
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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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Biedermann et al. (US 2021/0015521 A1) in view of Shluzas et al. (US 2013/0150852 A1).
Claim 8. Biedermann discloses wherein the collet is radially expandable within the rod coupler (due to the presence of slots 66) to enable insertion of fastener head into the collet, and removal of the fastener head from the collet (Figs. 18a-19; paras. 0071-0078).
Biedermann fails to disclose wherein the collet is axially movable relative to the saddle (claim 7).
Shluzas teaches a spinal pedicle screw comprising: a fastener (bone screw 14) having a fastener head (head portion 18); and a head assembly (housing 12, retainer 42, and spacer 50) including a rod coupler (housing 12), a collet (retainer 42), and a saddle (spacer 50), wherein the collet is axially movable relative to the saddle (prior to and during assembly of retainer 42 with spacer 50 as shown in Fig. 1A, retainer 42 is axially movable relative to spacer 50) (Figs. 1-1B; paras. 0038-0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal pedicle screw of Biedermann such that the collet is axially movable relative to the saddle (claim 7), as suggested by Shluzas, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179 (BPAI 1969).
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shluzas et al. (US 2013/0150852 A1) in view of Biedermann et al. (US 2021/0015521 A1).
Shluzas fails to disclose wherein the collet includes a friction rib on the interior surface and protruding inward therefrom, the friction rib configured to impart a frictional force on the fastener head to inhibit free movement of the head assembly on the fastener head (claim 15).
Biedermann teaches a spinal pedicle screw comprising: a fastener (bone anchoring element 1) having a fastener head (head 3’); and a head assembly (receiving part 5’ and pressure member 6’’), the head assembly including a rod coupler (receiving part 5’) and a collet (pressure member 6’’), wherein the collet includes a friction rib (projection 68) on an interior surface (surface of head receiving recess 62’) and protruding inward therefrom, wherein the friction rib is configured to impart a frictional force on the fastener head to inhibit free movement of the head assembly on the fastener head, and wherein the friction rib interacts with a respective groove (groove 34) in the fastener head to provide a position indication function (see paras. 0073 and 0077) (Figs. 18a-19; paras. 0071-0078).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal pedicle screw of Shluzas such that the collet includes a friction rib on the interior surface and protruding inward therefrom, the friction rib configured to impart a frictional force on the fastener head to inhibit free movement of the head assembly on the fastener head (claim 15) and the fastener head includes a respective groove, as suggested by Biedermann, as such a configuration can also provide a position indication function.
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shluzas et al. (US 2013/0150852 A1) in view of Rock et al. (US 2010/0114180 A1).
Shluzas fails to disclose wherein the head assembly further includes at least one pin received in a pin opening defined by the rod coupler, wherein the collet defines at least one opening in which the at least one pin is received to inhibit rotation of the collet about the axis relative to the rod coupler (claim 16).
Rock teaches a spinal pedicle screw comprising: a fastener (pedicle screw 10) including a fastener head (head 18); and a head assembly (coupling 50, collet 70, and pin 30) including a rod coupler (coupling 50), a collet (portion of collet 70 located below saddle 78 and including grooves 77 as shown in Fig. 2A), a saddle (portion of collet 70 located above grooves 77 and including saddle 78 as shown in Fig. 2A), and a pin (pin 30), wherein the pin is received in a pin opening (see opening in Fig. 1E that has a line extending to pin 30) defined by the rod coupler and at least one opening (elongated widened enlargement of one of grooves 77 as shown in Fig. 2A) defined by the collet to inhibit rotation of the collet about the axis relative to the rod coupler and maintain a fixed relationship between the collet and the rod coupler (see para. 0036) (Figs. 1A-2D; paras. 0035-0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal pedicle screw of Shluzas such that the head assembly further includes at least one pin received in a pin opening defined by the rod coupler, wherein the collet defines at least one opening in which the at least one pin is received to inhibit rotation of the collet about the axis relative to the rod coupler (claim 16), as suggested by Rock, in order to maintain a fixed relationship between the collet and the rod coupler.
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson et al. (US 2018/0168697 A1) in view of Shluzas et al. (US 2013/0150852 A1).
Claim 11. Jackson discloses a spinal pedicle screw having opposite proximal and distal ends and an axis extending therebetween, the spinal pedicle screw comprising:
a fastener (shank 120) comprising a shaft (body 122) and a fastener head (head 130) disposed on the shaft, the fastener being configured to be anchored within a subject's bone; and
a head assembly (receiver 140, half-ring collet members 220, and insert 170) including
a rod coupler (receiver 140) configured to secure a rod to the head assembly,
a collet (half-ring collet members 220) received at least partially within the rod coupler, wherein the collet has an interior surface (spherical portion 234 of inner surface 232) engaging the fastener head (see Figs. 46-47), and
a saddle (insert 170) received at least partially within the rod coupler, the saddle having a proximal surface (surface 173) for seating the rod thereon,
wherein the collet and the saddle are movable axially relative to one another along the axis of the spinal pedicle screw (see Figs. 48-51) (Figs. 23-53; paras. 0118-0162).
Claim 14. Jackson discloses wherein the collet includes ring portions (half-ring collet members 220) that are free from direct securement to one another (half-ring collet members 220 are secured to each other indirectly via lock sleeve 240) and are in generally opposing relationship to effectively form a split ring (see Figs. 42 and 43) (Figs. 23-53; paras. 0118-0162).
Jackson fails to disclose wherein the collet includes at least one tongue extending radially inward from the interior surface, wherein the saddle defines at least one exterior groove, and wherein the at least one tongue of the collet is received the at least one groove of the saddle to couple the collet to the saddle (claim 11).
Shluzas teaches a spinal pedicle screw comprising: a fastener (bone screw 14) having a fastener head (head portion 18); and a head assembly (housing 12, retainer 42, and spacer 50) including a rod coupler (housing 12), a collet (retainer 42), wherein the collet has an interior surface (surface of cavity 44) engaging the fastener head (see Fig. 1A) and at least one tongue (see Fig. 1A inset) extending radially inward from the interior surface, and a saddle (spacer 50), the saddle defining at least one exterior groove (see Fig. 1A inset), wherein the at least one tongue of the collet is received the at least one groove of the saddle to couple the collet to the saddle (see Fig. 1A), wherein the collet and the saddle are movable axially relative to one another along the axis of the spinal pedicle screw (prior to and during assembly of retainer 42 with spacer 50 as shown in Fig. 1A, retainer 42 is axially movable relative to spacer 50) (Figs. 1-1B; paras. 0038-0052).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spinal pedicle screw of Jackson such that the collet includes at least one tongue extending radially inward from the interior surface, the saddle defines at least one exterior groove, and the at least one tongue of the collet is received the at least one groove of the saddle to couple the collet to the saddle (claim 11), as suggested by Shluzas, in order to provide a more secure connection between the components of the spinal pedicle screw.
Allowable Subject Matter
Claims 9 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773