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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 2, 2026 has been entered.
Response to Amendment
This office action is in response to the amendment filed July 11, 2025. As directed by the amendment, claims 63-65 have been added. As such, claims 1, 3-6, 18, 20, 22-25, 37, 39, 43, 51, 53, 55, 63-65 remain under consideration in the instant application.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “one or more teeth” (claims 63-65), must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not disclose “one or more teeth” (claims 63-65).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 63-65 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not disclose “one or more teeth” (claims 63-65).
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 63-65 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. It is unclear to what the “one or more teeth” recited in claims 63-65 refers. Additionally, Applicant fails to provide where in the specification antecedence can be found in the Remarks dated September 30, 2025.
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.
Claim(s) 1-6, 20-25, 39, 41, 43, 51, 53, 55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mehl et al. (US 2019/0388131), hereinafter “Mehl”.
Regarding claim 1, Mehl discloses a bone screw (10) comprising: a screw shaft (30) having one or more threads (33) and one or more bone collecting channels (35a-c), wherein the one or more bone collecting channels include one or more cutting edges extending from an outer diameter of the channel to an inner diameter of the channel (“cutting flutes” 35a-c).
Regarding claim 3, Mehl 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. 4).
Regarding claim 4, Mehl discloses the bone screw of claim 1 wherein the one or more bone collecting channels extends in a helical path (¶48).
Regarding claim 5, Mehl discloses the bone screw of claim 1 wherein the one or more bone collecting channels extends in a straight path (FIG. 1).
Regarding claim 6, Mehl 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. 1).
Regarding claim 20, Mehl discloses a cannulated (34) bone screw (10) comprising: a screw shaft (30) having one or more threads (33) and one or more bone collecting channels (35a-c); wherein said one or more bone collecting channels are separated from a central bore of said cannulated bone screw (via wall at 35a, FIG. 1); and wherein the one or more bone collecting channels include one or more cutting edges extending from an outer diameter of the channel to an inner diameter of the channel (“cutting flutes” 35a-c).
Regarding claim 22, Mehl 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 threads (FIG. 4).
Regarding claim 23, Mehl discloses the cannulated bone screw of claim 20 wherein the one or more bone collecting channels extends in a helical path (¶48).
Regarding claim 24, Mehl discloses the cannulated bone screw of claim 20 wherein the one or more bone collecting channels extends in a straight path (FIG. 1).
Regarding claim 25, Mehl 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. 1).
Regarding claim 39, Mehl 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 (35a-c); inserting the one or more bone screws into a bone (¶12); and cutting material with the one or more bone collecting channels, wherein the one or more bone collecting channels include one or more cutting edges extending from an outer diameter of the channel to an inner diameter of the channel (“cutting flutes” 35a-c).
Regarding claim 43, Mehl discloses the method of claim 41 further comprising the step of collecting bone material into the one or more bone collecting channels (¶12).
Regarding claim 51, Mehl discloses a method of inserting a cannulated (34) bone screw (10) comprising the steps of: providing one or more cannulated bone screws (10) having one or more bone collecting channels (35a-c), wherein the one or more bone collecting channels include one or more cutting edges extending from an outer diameter of the channel to an inner diameter of the channel (“cutting flutes” 35a-c); and inserting the one or more cannulated bone screws into a bone (¶12).
Regarding claim 53, Mehl discloses the method of claim 51 further comprising the step of cutting bone material with the one or more bone collecting channels (¶12).
Regarding claim 55, Mehl discloses the method of claim 53 further comprising the step of collecting bone material into the one or more bone collecting channels (¶12).
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 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mehl.
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
In response to Applicant's argument that Mehl fails to disclose “wherein the one or more bone collecting channels include one or more cutting edges extending from an outer diameter of the channel to an inner diameter of the channel,” Examiner respectfully disagrees. The bone collecting channels 35a-c are described as “cutting flutes” (¶48) which are well known in the art as comprising cutting edges. These “flutes” extend from the outer diameter of the channel to the inner diameter of the channel as depicted in at least Figures 2-3. Therefore, the invention of Mehl meets the claim.
Conclusion
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