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 .
Response to Amendment
This office action is in response to the amendment filed May 22, 2026. As directed by the amendment, claims 1, 20, 39 have been amended and claims 66-68 have been added. Claims 2, 7-17, 19, 21, 26-36, 38, 40-42, 44-62 were cancelled. As such, claims 1, 3-6, 18, 20, 22-25, 37, 39, 43, 63-68 remain under consideration in the instant application.
Claim Objections
Claim 6 is objected to because of the following informalities: claim 6 is missing a period at its end. Appropriate correction is required.
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)(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) 1, 3-6, 18, 20, 22-25, 37, 39, 43, 63-68 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lewis et al. (US 2022/0354654), hereinafter “Lewis”.
Regarding claim 1, Lewis discloses a bone screw (10) comprising: a screw shaft (19) having one or more threads (FIG. 2) and one or more bone collecting channels (13), wherein the one or more bone collecting channels include one or more cutting edges (12) extending from an outer diameter of the channel to an inner diameter of the channel (FIG. 2); a screw head (15) having a spheroidal shape (FIG. 2) and coaxially extending from a proximal end of the screw shaft (FIG. 2), the screw head comprising one or more second threads (16) disposed on an outer surface of the screw head: and wherein an outer diameter of the screw head is greater than an outer diameter of the screw shaft (FIG. 2).
Regarding claim 3, Lewis discloses the bone screw of claim 1 wherein the one or more bone collecting channels has a depth from a crest of the one or more threads to a radial distance less than a minor diameter of the one or more threads (FIG. 2).
Regarding claim 4, Lewis discloses the bone screw of claim 1 wherein the one or more bone collecting channels extends in a helical path (FIG. 2).
Regarding claim 5, Lewis discloses the bone screw of claim 1 wherein the one or more bone collecting channels (14) extends in a straight path.
Regarding claim 6, Lewis discloses the bone screw of claim 1 wherein the one or more bone collecting channels extends from a distal end of the bone screw towards a head of the bone screw (FIG. 2).
Regarding claim 20, Lewis discloses a cannulated (11C) bone screw (10) comprising: a screw shaft (19) having one or more threads and one or more bone collecting channels (13); a screw head (15) having a spheroidal shape (FIG. 2) and coaxially extending from a proximal end of the screw shaft, the screw head comprising one or more second threads (16) disposed on an outer surface of the screw head; and wherein said one or more bone collecting channels are separated from a central bore of said cannulated bone screw (FIG. 2); the one or more bone collecting channels include one or more cutting edges (12) extending from an outer diameter of the channel to an inner diameter of the channel; and an outer diameter of the screw head is greater than an outer diameter of the screw shaft (FIG. 2).
Regarding claim 22, Lewis discloses the cannulated bone screw of claim 20 wherein the one or more bone collecting channels has a depth from a crest of the one or more threads to a radial distance less than a minor diameter of the one or more thread (FIG. 2)s.
Regarding claim 23, Lewis discloses the cannulated bone screw of claim 20 wherein the one or more bone collecting channels extends in a helical path (FIG. 2).
Regarding claim 24, Lewis discloses the cannulated bone screw of claim 20 wherein the one or more bone collecting channels (14) extends in a straight path.
Regarding claim 25, Lewis discloses the cannulated bone screw of claim 20 wherein the one or more bone collecting channels extends from a distal end of the bone screw towards a head of the bone screw (FIG. 2).
Regarding claim 39, Lewis discloses a method of inserting a bone screw comprising the steps of: providing one or more bone screws (10) having one or more bone collecting channels (13) and a screw head (15) having a spheroidal shape and coaxially extending from a proximal end of the screw shaft, wherein the screw head comprises one or more second threads (16) disposed on an outer surface of the screw head, and an outer diameter of the screw head is greater than an outer diameter of the screw shaft (FIG. 2); inserting the one or more bone screws into a bone (FIG. 22); and cutting bone material with the one or more bone collecting channels, wherein the one or more bone collecting channels include one or more cutting edges (12) extending from an outer diameter of the channel to an inner diameter of the channel (FIG. 2).
Regarding claim 43, Lewis discloses the method of claim 39 further comprising the step of collecting bone material into the one or more bone collecting channels (¶47).
Regarding claim 63, Lewis discloses the bone screw of claim 1, wherein at least one of the cutting edges comprises one or more teeth radially extended outward from a surface of the corresponding bone collecting channel, wherein the one or more teeth are arranged to form an array along an outer circumference of the screw shaft.
Regarding claim 64, Lewis discloses the cannulated bone screw of claim 20, wherein at least one of the cutting edges comprises one or more teeth (crests of threads) radially extended outward from a surface of the corresponding bone collecting channel, wherein the one or more teeth are arranged to form an array along an outer circumference of the screw shaft (FIG. 2).
Regarding claim 65, Lewis discloses the method of claim 39, wherein at least one of the cutting edges comprises one or more teeth (crests of threads) radially extended outward from a surface of the corresponding bone collecting channel, wherein the one or more teeth are arranged to form an array along an outer circumference of the screw shaft (FIG. 2).
Regarding claim 66, Lewis discloses the bone screw of claim 1, wherein the screw head comprise a tool interface recess with a hexalobe feature (17).
Regarding claim 67, Lewis discloses the cannulated bone screw of claim 20, wherein the screw head comprise a tool interface recess with a hexalobe feature (17).
Regarding claim 68, Lewis discloses the method of claim 39, wherein the screw head comprise a tool interface recess with a hexalobe feature (17).
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.
Claim(s) 18, 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lewis.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to use an insertion torque in the range of about 1.5 in-lbs to about 12 in-lbs, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art.
Response to Arguments
Applicant’s arguments with respect to claims 1, 20, 39 have been considered but are moot because the arguments do not apply to any of the references being used in the current rejection. The newly presented rejection was necessitated by the amendments to the claims of May 22, 2026.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 OLIVIA C CHANG whose telephone number is (571) 270-5017. The examiner can normally be reached Monday-Friday, 7:30AM-5:00PM.
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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/OLIVIA C CHANG/Primary Examiner, Art Unit 3775
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