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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 31 July 2026 has been entered.
Election/Restriction
Applicant’s election of group II, claims 16-22, in the Non-Final rejection mailed 12/17/2025 is acknowledged. Because applicant has not distinctly and specifically pointed out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group I, there being no allowable generic or linking claim.
Claim Objections
Claims 16, 18 and 19 are objected to because of the following informalities:
Claim 16, line 4: --of a bone plate-- should be added between “aperture” and “,”.
Claim 16, line 12: “a” (before “shank”) should be changed to --the--.
Claim 18, line 2: “a” (between “within” and “slanted”) should be changed to --the--.
Claim 18, line 2: “a” (between “of” and “bone”) should be changed to --the--.
Claim 19, line 1: “a” (between “wherein” and “maximal”) should be changed to --the--.
Appropriate correction is required.
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 16-22 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 limitation "the shank" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the bone" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 17 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 recites “wherein the shaped opening is substantially concentric with a longitudinal axis of the shank and comprises a multi-lobe shape suitable to receive the tool.” However, claim 16 recites “a shaped opening disposed within the superior end that is concentric with a longitudinal axis of the shank and configured to engagedly receive a tool for driving the bone screw into a hole drilled across the fusion site; the shaped opening is comprised of a hexalobe shape,” wherein the limitations of claim 16 appear to be narrower than the limitations of claim 17. Therefore, claim 17 fails to further limit the subject matter of claim 16. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-20 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Rezach, U.S. PG-Pub 2014/0236247 (previously cited in PTO-892 dated 12/17/2025).
Regarding claims 16 and 17, Rezach discloses a bone screw fully capable of compressing adjacent bones across a bone fusion site, comprising: a head portion (84) comprising a superior end and an inferior end; wherein the inferior end is configured to be received within a slanted aperture of a bone plate, such that a majority of the head portion countersinks within the slanted aperture, wherein a maximal circumference of the head portion is disposed between the superior and inferior ends midway between the superior and inferior ends, so as to maximize protrusion of the head portion during use (examiner annotated Fig. 6 below and paragraph [0036] discloses head portion 84 being spherical, wherein it is understood that the maximal circumference of a sphere is at its midway point);
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a shaped opening (90) disposed within the superior end that is concentric with a longitudinal axis (L2-L2) of a shank (82, 76, 78) and configured to engagedly receive a tool for driving the bone screw into a hole drilled across the fusion site; the shaped opening is comprised of a hexalobe shape (six lobes 92) (Figs. 7-8 and paragraph [0039]);
the shank (82, 76, 78) extending from the inferior end, the shank comprising distal threads (via 76, 78) and a proximal smooth portion (82); and a distal end (80) configured to be advanced within the hole (examiner annotated Fig. 6 above and paragraphs [0034]-[0035]).
Regarding claims 18-20, Rezach discloses wherein the inferior end is configured to be receiving within the slanted aperture of the bone plate, such that the head portion (84) countersinks within the slanted aperture and presses the bone plate against a surface of the adjacent bones; wherein the maximal circumference of the head portion is disposed between the superior end and the inferior end so as to minimize protrusion of the head portion above an upper surface of the bone plate; and wherein the distal threads (via 76, 78) are configured to rotatably engage within the hole, and wherein the proximal smooth portion (82) is configured to pass through the bone with relatively little resistance, the smooth portion being configured to allow the bone fusion site to close as the adjacent bones are compressed together (examiner annotated Fig. 6 above and paragraph [0035]).
Claim Rejections - 35 USC § 103
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) 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rezach, U.S. PG-Pub 2014/0236247 in view of Mobasser, U.S. PG-Pub 2012/0136398.
Regarding claims 21 and 22, Rezach discloses the invention essentially as claimed except for wherein the distal end includes one or more shapes/flutes that spiral along a portion of the distal threads and are configured to minimize resistance to forward movement of the bone screw within the hole drilled in the adjacent bones and are configured to clean an interior of the hole and remove bone debris therefrom.
Mobasser discloses a bone screw having threads (200) with one or more flutes (180) that spiral along a portion of the threads (Fig. 3) for conveying bone material away from the tip of the screw during insertion of the screw into bone and for removing bone material (paragraph [0014]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of Rezach to includes one or more shapes/flutes that spiral along a portion of the distal threads and are configured to minimize resistance to forward movement of the bone screw within the hole drilled in the adjacent bones and are configured to clean an interior of the hole and remove bone debris therefrom in view of Mobasser to permit conveying bone material away from the distal end of the screw during insertion of the screw into the bones and to permit removal of bone material.
Response to Arguments
Applicant’s arguments with respect to claim(s) 16 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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