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 August 25, 2025. As directed by the amendment, claims 1, 12, 15, 17, 22 have been amended and claims 6-7 and 20 have been cancelled. Claims 8 and 21 were previously withdrawn. As such, claims 1-5, 9-19, 22-23 remain under consideration in the instant application.
Claim Objections
Claims 1-5, 9-19, 22-23 are objected to because of the following informalities: Claims 1, 12 and 17 comprise capital “A” at the start of each clause. Examiner recommends changing these to lower case “a” as they are part of the same claim sentence. 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 1-5, 9-11, 17-19, 22-23 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 1 recites the limitation “An open helical coil section integral and unitary with the tissue head section and projecting from a lower surface of the tissue head section with a proximal junction with a lower surface of the tissue head section”. There appears to be repetition in this limitation making it unclear. Examiner evaluated the claim as reciting “An open helical coil section (102) integral and unitary with the tissue head section and projecting from a lower surface (114) of the tissue head section
Claim 17 recites the limitation “a strain relief section at a proximal junction between the open helical coil section and the tissue head section”. It is unclear whether the proximal junction is of the coil section or the head section. Examiner evaluated the claim as reciting “a strain relief section
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) 1-4, 9-10, 12-13, 15-18, 22-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Erickson et al. (US 2008/0097444), hereinafter “Erickson”.
Regarding claim 1, Erickson discloses a monolithic tissue screw (100) consisting essentially of: a. A tissue head section (104) having a driver aperture (122) passing axially through the tissue head section, the driver aperture being configured to receive a driver therethrough co-axial with a central longitudinal axis of the monolithic tissue screw (¶68); and b. An open helical coil section (102) integral and unitary with the tissue head section and projecting from a lower surface (114) of the tissue head section, the open helical coil section defining a central opening in axial alignment with the driver aperture, the central opening capable to receive the driver therein and apply a rotational force to the tissue head section to rotate the tissue head section and the open helical section substantially without axial force applied by the driver to the monolithic tissue screw (¶68); and c. a strain relief section (see Figure A below) at the proximal junction between the open helical coil section and the tissue head section.
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Figure A: Tissue screw of Erickson.
Regarding claim 2, Erickson discloses the monolithic tissue screw according to Claim 1, wherein the driver aperture has a polygonal shape (can be polygonal, e.g., FIG. 2A, ¶68) defining driver aperture side walls.
Regarding claim 3, Erickson discloses the monolithic tissue screw according to Claim 2, wherein the driver aperture side walls engage with a driver and are configured to transfer torsional force applied by the driver to the tissue head section (¶68).
Regarding claim 4, Erickson discloses the monolithic tissue screw according to Claim 1, wherein the open helical coil section further has a tapered distal tip (at 108, FIG. 1B).
Regarding claim 9, Erickson discloses the monolithic tissue screw according to Claim 1, wherein the strain relief section further comprises a tapered opening (FIG. 1B; best seen in FIG. 9B).
Regarding claim 10, Erickson discloses the monolithic tissue screw according to Claim 1, wherein the helical coil section has a polygonal transverse cross-sectional shape (FIG. 1B).
Regarding claim 12, Erickson discloses a monolithic tissue screw (100), consisting essentially of: a. A tissue screw head section (104) having a polygonal driver aperture (can be polygonal, e.g., FIG. 2A, ¶68) passing axially through the tissue head section, the driver aperture being capable to receive a mating driver therethrough co-axial with a central longitudinal axis of the monolithic tissue screw; and b. An open helical coil section (102) unitary with the tissue head section and projecting from a lower surface (114) of the tissue head section, the open helical coil section having a tapered distal tip (FIG. 1B) and defining a central opening (122), wherein the tissue screw head section and the open helical coil are monolithic and integral with each other (FIG. 1B); and c. A strain relief opening (see Figure A above) between the tissue screw head and the open helical coil section.
Regarding claim 13, Erickson discloses the monolithic tissue screw according to Claim 12, wherein the open helical coil section is configured to rotate about its axis upon application of substantially only a rotational force applied by the mating driver to the polygonal driver aperture driver aperture has a polygonal shape defining driver aperture side walls (¶68).
Regarding claim 15, Erickson discloses the monolithic tissue screw according to Claim 12, wherein the strain relief section is positioned at a junction between a distal aspect (114) of the tissue screw head section and a proximal aspect (106) of the open helical coil section (FIG. 1B).
Regarding claim 16, Erickson discloses the monolithic tissue screw according to Claim 12, wherein the helical coil section has a polygonal transverse cross-sectional shape (FIG. 1B).
Regarding claim 17, Erickson discloses a monolithic tissue screw (100) comprising: a. A tissue head section (104) having a driver aperture (122) passing axially through the tissue head section (¶68), the driver aperture being capable to receive a driver therethrough co-axial with a central longitudinal axis of the monolithic tissue screw (¶68); and b. An open helical coil section (102) unitary with the tissue head section and projecting from a lower surface (114) of the tissue head section, the open helical coil section defining a central opening (122) in axial alignment with the driver aperture; and c. a strain relief section (see Figure A above) between the open helical coil section and the tissue head section (FIG. 1B).
Regarding claim 18, Erickson discloses the monolithic tissue screw according to Claim 17, wherein the driver aperture further comprises side walls (walls of 122) configured to engage with a driver and transfer torsional force applied by the driver to the tissue head section.
Regarding claim 22, Erickson discloses the monolithic tissue screw according to Claim 17, wherein the strain relief section further comprises a tapered opening (FIG. 1B).
Regarding claim 23, Erickson discloses the monolithic tissue screw according to Claim 17, wherein the helical coil section has a polygonal transverse cross-sectional shape (FIG. 1B).
Allowable Subject Matter
Claims 5, 11, 14, 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Erickson discloses a monolithic tissue screw (100) consisting essentially of: a. A tissue head section (104) having a driver aperture (122) passing axially through the tissue head section, the driver aperture being configured to receive a driver therethrough co-axial with a central longitudinal axis of the monolithic tissue screw (¶68); and b. An open helical coil section (102) integral and unitary with the tissue head section and projecting from a lower surface (114) of the tissue head section, the open helical coil section defining a central opening in axial alignment with the driver aperture, the central opening capable to receive the driver therein and apply a rotational force to the tissue head section to rotate the tissue head section and the open helical section substantially without axial force applied by the driver to the monolithic tissue screw (¶68); and c. a strain relief section (see Figure A above) at the proximal junction between the open helical coil section and the tissue head section.
However, the prior art, alone or in combination, fails to teach wherein the open helical coil section is comprised of plural helical windings having different pitches or wherein the tissue head section further comprises a substantially planar upper surface and a beveled side wall tapering diametrically toward the central longitudinal axis of the tissue screw and contiguous with a proximal end of the open helical coil section.
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