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 responsive to the amendment filed on 18 March 2026. As directed by the amendment: Claims 1, 4, and 5 have been amended, and claims 2, 6-10, and 12 are cancelled. Claims 1, 3-5, and 11 currently stand pending in the application.
The claim amendments are sufficient to overcome the rejection under 35 U.S.C. 112(d) listed in the previous Office Action, which is correspondingly withdrawn.
Response to Arguments
Applicant's arguments filed 18 March 2026, with respect to the rejections under 35 U.S.C. 103, have been fully considered but they are not persuasive. Applicant contends that Dehnad (US 2018/0093013) discloses an antibacterial coating layer applied to a surface, and does not disclose the screw body within the antibacterial region has a modified material surface to impart an antibacterial property. Applicant contends that Dehnad does not disclose an antibacterial region defined by modification of the material surface of the screw body itself, but rather discloses an additional layer applied onto a surface of the screw body. Examiner respectfully submits that the coating disclosed by Dehnad on the hollow portion of the screw body results in an antibacterial region included as part of the screw body itself. Claim 1 requires an antibacterial region provided in the hollow portion of the screw body; the antibacterial region is interpreted as provided in and as part of the hollow portion of the screw body, i.e. as part of the screw body itself. When the coating is formed in Dehnad, the antibacterial region is provided. The screw body, which now includes this integral antibacterial coating/region, has a modified material surface in this region because the material surface comprising the coating is modified (by inclusion of ions) relative to the uncoated regions in order to impart the antibacterial property.
Dehnad contemplates surface modification processes to form the coating/region, including sputtering (par. [0089], [0171], [0180], [0187]), vacuum deposition (par. [0187]), physical vapor deposition (PVD) (par. [0068], [0180]), chemical vapor deposition (CVD) (par. [0068], [0180]), or plating (par. [0180]). As recited in the instant specification, these processes are all techniques for modifying the composition or structure of a surface of a base material, so the application of the coating in Dehnad by one of such processes contemplated by Dehnad would correspondingly modify the composition or structure of the surface of the screw body itself. The resulting antibacterial region in Dehnad thus appears as a coating or layer because it has a different composition and it has a thickness, just as is shown in the instant application, e.g. FIG. 3B. Just because the resulting antibacterial region appears as a coating or layer, does not mean that it was not formed by modifying the underlying surface.
Claim Objections
Claim 4 is objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 4 / lines 2-3: “antibacterial treatment on [[a]] the inner surface of the hollow portion.”
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.
Claims 1, 3-5, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2018/0093013 to Dehnad et al. (hereinafter, “Dehnad”).
As to claim 1, Dehnad discloses a bone screw (1701) (par. [0230]), FIGS. 17A-17C, comprising: a screw body configured to be inserted into biological tissue, the screw body having a shaft portion that extends along a longitudinal axis thereof, and a hollow portion that penetrates the screw body in a direction along the longitudinal axis, FIGS. 17A and 17C; and an antibacterial region (antibacterial member 1703) provided in the hollow portion of the screw body (par. [0010], [0023], [0230], [0253]), wherein the antibacterial region imparts an antibacterial property (par. [0253]); and the antibacterial region is provided only in the hollow portion.
As to claim 5, Dehnad discloses the bone screw according to claim 1, wherein the antibacterial region contains silver (at least partially silver, par. [0230]).
Dehnad is silent as to the screw body within the antibacterial region has a modified material surface to impart the antibacterial property; and the antibacterial region is provided on only an inner surface of the hollow portion (claim 1); wherein an outer surface of the screw body is not subjected to antibacterial treatment (claim 3); wherein the antibacterial region is formed by antibacterial treatment on a surface of the screw body (claim 4); wherein an outer surface of the screw body has an antibacterial activity value of less than 2.0 (claim 11).
Dehnad contemplates that the bone screw body in FIG. 17A may itself be coated with the antimicrobial ion releasing coating (par. [0230]) and that a bone screw may be not completely coated, but include differently coated regions, or regions that are both coated and uncoated (par. [0231]). Dehnad also contemplates that the hollow portion of a bone screw body creates a fluid flow path along which fluid such as oxygen carrying blood may flow to provide oxygen to create galvanic silver ion generation for the antimicrobial effect (par. [0259]). Dehnad also contemplates that the antibacterial region is formed by modifying a material surface of the screw body through a surface modification process selected from a group consisting of sputtering (par. [0089], [0171], [0180], [0187]), thermal spraying, vacuum deposition (par. [0187]), physical vapor deposition (PVD) (par. [0068], [0180]), chemical vapor deposition (CVD) (par. [0068], [0180]), plating (par. [0180]), and anodization.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Dehnad’s bone screw body with an antimicrobial ion releasing coating on an inner surface of the hollow portion, since Dehnad contemplates that the screw body may be coated with the antimicrobial ion releasing coating in only particular regions, and also contemplates that the hollow portion of the bone screw body is where such a coating would be most effective as that is where fluid flow along the coating would be able to create the galvanic silver ion for the antimicrobial effect. The coating on the hollow portion of the screw body results in an antibacterial region included as part of the screw body in the hollow portion, that imparts an antibacterial property to the hollow portion of the screw body. In other words, the antibacterial region is provided by the forming of the coating. The screw body within and including this antibacterial region has a modified material surface because the material surface comprising the coating is modified (by inclusion of ions) relative to the uncoated regions in order to impart the antibacterial property.
The antibacterial region is formed through a surface modification process such as sputtering, vacuum deposition, or plating, as contemplated by Dehnad, which results in the material surface of the screw body at the antibacterial region being modified as it comprises a coating of a partially silver material that releases antimicrobial ions. The antibacterial region is thus formed by antibacterial treatment (one of the surface modification processes that results in the antibacterial coating) on a surface of the hollow portion of the screw body on which the coating is formed. Examiner notes that the limitation reciting that the antibacterial region is formed by antibacterial treatment on a surface of the screw body is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found (in this case, an antibacterial layer), a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cover only the inner surface of the hollow portion with the antibacterial region/coating, since as above, Dehnad contemplates coating only particular regions, with the hollow portion coating providing most effective contact with fluid flow and release of silver ions, and therefore not subjecting the outer surface of the screw body to antibacterial treatment (e.g. by masking) such that the antibacterial activity value is less than 2.0, or approximately 0, would reduce the manufacturing cost of the screw as less silver would be required.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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