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 § 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 1-10 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 1 recites “an outer surface of the fastener head” (lines 2-3 of the last paragraph) and then again recites “an outer surface of the fastener head” (lines 3-4 of the last paragraph). It is unclear whether the second recitation of an outer surface is intended to refer to the first recitation of an outer surface or an additional outer surface. For examination purposes, the Examiner is interpreting claim 1 as reciting “the outer surface of the fastener head” (lines 3-4 of the last paragraph) such that the second recitation refers to the first recitation of an outer surface. Claims 2-10 are rejected because they depend from claim 1.
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 continuously engage an outer surface (outer surface portion 33 including groove 34 – see Fig. 4a) of the fastener head to impart a continuous frictional force on an outer surface of the fastener head when the head assembly is pivoted relative to the fastener head to inhibit free movement of the head assembly on the fastener head, before the rod is secured to the head assembly (see Fig. 19, which shows that projections 68 each extend partially circumferentially around the interior surface of pressure member 6’’; see para. 0073, which states that projections 68 engage with a single groove 34; see Fig. 4a, which shows that a single groove 34 extends around the circumference of head 3’; thus, during pivoting movement of head 3’ relative to the head assembly, there would be a range of movement wherein projections 68 remain engaged with groove 34 and outer surface portion 33 such that projections 68 impart a continuous frictional force on outer surface portion 33) (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).
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).
Allowable Subject Matter
Claims 9 and 10 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and upon amending claim 1 consistent with the Examiner’s interpretation in order to overcome the 35 U.S.C. 112 rejection set forth above.
Claims 11-15 and 21-23 are allowed.
Response to Arguments
Applicant's arguments filed June 28, 2026 with respect to the rejection of claim 1 in view of Biedermann have been fully considered but they are not persuasive. The Examiner notes that Applicant’s arguments (see pgs. 7-9) are focused on an embodiment of Biedermann not used in the Non-Final Rejection mailed on September 23, 2025 or the rejection set forth above (Figs. 1-15b is an embodiment that includes flaps 63; the embodiment used in the rejection, which is the embodiment shown in Figs. 18a-19 includes wall sections 63’ having projections 68). The Examiner further notes that the rejection of claim 1 above includes an explanation as to how the embodiment of Biedermann shown in Figs. 18a-19 meets the limitations of claim 1 as amended.
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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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