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 .
This Office action is in response to the amendment filed 08/12/2026. Claims 1-22 are pending. Claims 1 and 5 have been amended, and claims 12-22 have been added.
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 16-19 and 21 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 16 recites "the thread angle of the side wall threading." There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites that "the edge annular surface of the annular edge area extends between the annular outer area and the central inner area." Claim 1, from which claim 17 depends, requires the edge annular surface to annularly surround the second surface and the annular outer area and to be located between the annular outer area and the side wall threading. It is unclear how the edge annular surface can extend between the annular outer area and the central inner area while also being located radially outward of the annular outer area. Claim 17 further recites that "the side wall threading is flat." It is unclear what structure is required for threading to be flat, i.e., whether the crests, the flanks, or some other portion of the threading is flat.
Claim 18 recites "the radius change across at least the first surface and the second surface." There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites "the vertex of the ellipsoid." There is insufficient antecedent basis for this limitation in the claim, and an ellipsoid has more than one vertex. For purposes of examination, the limitation is interpreted as "a vertex of the ellipsoid."
Claim 21 recites that "a curvature of the first radius and the second radius is greater than a radius of the set screw." A radius is itself a measure of curvature, and it is unclear whether the claim requires each of the first radius and the second radius to be greater than the radius of the set screw, or something else. For purposes of examination, the limitation is interpreted as each of the first radius and the second radius being greater than a radius of the set screw.
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.
Claim(s) 1, 2, 4, 12-18, 20 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson (U.S. 7,789,896 B2).
Concerning claim 1, Jackson discloses a set screw (see Fig. 14, element 18) for threadable engagement with a head (10, i.e., receiver) of a pedicle screw for holding a spinal rod (21), the set screw having a spinal rod facing side (i.e., lower surface 156) and a set screw driver facing side (i.e., top of base 140), the set screw comprising: an opening (i.e., hex-shaped aperture 168) at the set screw driver facing side to engage with the set screw driver (i.e., Allen-type tool); and a convex surface (i.e., dome 158) at the spinal rod facing side, an apex (166) of the convex surface substantially corresponding with a rotational central axis (E) of the set screw, the convex surface comprising: a first surface (see Fig. 14 below) with a curvature having a first radius formed by a central inner area located at the rotational central axis of the set screw (i.e., the portion of dome 158 at apex 166); a second surface (see Fig. 14 below) annularly surrounding the first surface and having a second curvature with a second radius formed by an annular outer area of the set screw (i.e., the portion of dome 158 surrounding apex 166; the dome 158 is a partial sphere having a uniform radius of generation, or alternatively is radiused at the location of greatest projection and feathered along the periphery with a continually changing radius of generation, see col. 10, lines 12-25); and an edge annular surface (see Fig. 14 below) annularly surrounding the second surface and the annular outer area, the edge annular surface being formed by an annular edge area located between the annular outer area and a side wall threading (i.e., flange form 144 – which could be threads (see col. 9, line 59 – col. 10, line 4) of the set screw, wherein the central inner area, the annular outer area, and the annular edge area directly face the spinal rod when the set screw is threadedly rotated into the head of the pedicle screw (see Figs. 13 and 14), and each of the central inner area, the annular outer area, and the annular edge area form the convex surface and the annular edge area extends away from the annular outer area and the central inner area towards the set screw driver facing side and extends to the side wall threading to form a beveled edge with the side wall threading, the beveled edge extending fully circumferentially around the convex surface directly facing the spinal rod when the set screw is threadedly rotated into the head of the pedicle screw (see Fig. 13 and 14).
[AltContent: textbox (Edge Area)][AltContent: textbox (Axis)][AltContent: arrow][AltContent: textbox (First Surface)][AltContent: arrow][AltContent: textbox (Second surface)][AltContent: arrow][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector][AltContent: connector]
PNG
media_image1.png
630
592
media_image1.png
Greyscale
It is noted that claim 1 does not require the first radius and the second radius to differ. It is further noted that the flange form (144) is a helically wound guide and advancement structure that threadably mates with the guide and advancement structure (62) of the receiver arms, and is therefore considered side wall threading; Jackson further states that the flange form may alternatively be a buttress thread, square thread or reverse angle thread (see col. 9, line 59 – col. 10, line 4).
Concerning claim 2, wherein the convex surface (158) is an integral part of the set screw (i.e., formed on the lower surface 156 of the base 140), and the convex surface is configured to directly engage with a surface of the spinal rod (the dome 158 engages the rod 21 at the apex 166, see Figs. 13 and 14).
Concerning claim 4, wherein an entire surface of the spinal rod facing side of the set screw forms a convex volume (see Fig. 13).
Concerning claim 12, wherein each of the central inner area and the annular outer area form a spherical surface on the convex surface (the dome 158 is spherical in shape, i.e., a partial sphere, see col. 10, lines 5-11).
Concerning claim 13, wherein the spherical surface has a constant radius of curvature (the dome 158 has a uniform or constant radius of generation, see col. 10, lines 5-11).
Concerning claim 14, wherein each of the central inner area, the annular outer area, and the annular edge area form a spherical surface on the convex surface (see Fig. 14 above, wherein the partial sphere of dome 158 extends to the flange form 144).
Concerning claims 15-17, wherein the annular edge extends to form a distal crest of the side wall threading (see Fig. 14 and note that the annular edge meets the side wall flange or thread as desired and would therefore form a distal crest at the meeting point.) Applicant’s attention is directed to col. 9, line 53 – col. 10, line 4. The bottom surface of the set screw extends to the sidewall of the set screw which includes threads. The threads can have multiple shapes and forms as noted in the Specification.
Concerning claim 18, wherein the radius change across at least the first surface and the second surface is progressive to progressively change to a larger radius in a direction towards the side wall threading (the dome 158 may be radiused at the location of greatest projection and feathered along the periphery so as to have a continually changing radius of generation, i.e., the radius progressively increases toward the periphery adjacent the flange form 144, see col. 10, lines 12-25).
Concerning claim 20, wherein an entire surface of the convex surface forms a continuous convex or protruding bulge directly facing the spinal rod when the set screw is threadedly rotated into the head of the pedicle screw (the dome 158 is a smoothly curved, continuous surface that engages the rod 21, see Figs. 13 and 14).
Concerning claim 22, wherein the first radius of curvature of the convex surface is smaller at the rotational central axis of the set screw as compared to the second radius of curvature of the convex surface around the rotational central axis (the dome 158 is radiused at the location of greatest projection along axis E and feathered along the periphery with a continually changing radius of generation, see col. 10, lines 12-25).
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.
Claim(s) 3, 19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (U.S. 7,789,896 B2).
Jackson discloses the invention of claim 1 as set forth above, except for explicitly disclosing that the convex surface of the set screw is hardened relative to a body of the set screw.
Official notice is taken that hardening the contact surface of a metal fastener relative to its core, such as by nitriding, case hardening or coating, is old and well known in the art for increasing the wear resistance of the contact surface.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to harden the convex surface (158) of Jackson relative to the body of the set screw, as is well known in the art, in order to increase the wear resistance of the rod-engaging surface while maintaining the toughness of the body of the set screw.
Concerning claim 19, Jackson discloses the invention of claim 1 as set forth above, except for explicitly disclosing that the convex surface forms a shape of an ellipsoid, the vertex of the ellipsoid being located at the rotational central axis of the set screw. However, Jackson teaches that the dome (158) may have a shape that is only partly a spherical curved surface or some other shape, and may be radiused at the location of greatest projection along the axis E and feathered along the periphery with a continually changing radius of generation (see col. 10, lines 12-25).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the dome (158) of Jackson as an ellipsoid having its vertex at the rotational central axis (E), since Jackson expressly contemplates non-spherical dome shapes having a continually changing radius with greatest projection along the axis, and a change in shape is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed invention is significant.
Concerning claim 21, Jackson discloses the invention of claim 1 as set forth above, except for explicitly disclosing that the first radius and the second radius are greater than a radius of the set screw.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the dome (158) of Jackson with a radius of generation greater than the radius of the base (140), since such a modification would have involved a mere change in the size of a component, and the claimed set screw would not perform differently than the prior art set screw, the dome of Jackson engaging the rod (21) at the apex (166) in either case.
Allowable Subject Matter
Claims 5-11 are allowed. The prior art of record, taken alone or in combination, fails to disclose or render obvious a set screw for threadable engagement with a head of a pedicle screw for holding a spinal rod, the set screw comprising an opening at the set screw driver facing side entirely traversing the set screw from the spinal rod facing side to the set screw driver facing side, the opening having a torque-engaging mechanism, and an annular surface at the spinal rod facing side surrounding the opening, the annular surface being sloped outwards away from a central axis of the set screw and towards the set screw driver facing side and towards an outer edge of the set screw in a radial direction away from the central axis, in combination with the remaining limitations of claim 5.
Response to Arguments
Applicant’s arguments filed 08/12/2026 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
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 ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, at 571 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
