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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 27, 2026 has been entered.
As directed by the amendment, claims 1 has been amended and claims 16-20 have been cancelled. Claim 15 was previously withdrawn and claims 21-22 have been added. As such, claims 1-14 and 21-22 remain under consideration in the instant application.
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, 3-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abbasi et al. (US 2020/0375750), hereinafter “Abbasi”.
Regarding claim 1, Abbasi discloses a fastener device (FIGS. 87-88), comprising: a proximal head (410); a shaft (414) extending from the proximal head and having external threads (415) on at least a portion of the shaft; and a chamber (1176) extending internally from the proximal head into the shaft, at least a portion of the chamber having internal threads (1147) along a substantial entirety of a length of the chamber (FIG. 88); wherein the external threads have a first handedness, and the internal threads have a second handedness different from the first handedness (¶283); wherein features of the first handedness of the external threads and the second handedness of the internal threads are governed by a relative torque relationship and wherein the relative torque relationship is determined based on one or more thread geometry parameters of one or both of the external threads and the internal threads (a relative torque relationship inherently exists between thread geometry parameters of the first handedness and the second handedness).
Regarding claim 3, Abbasi discloses the device of claim 1, wherein the fastener device is configured to be coupled or mated to an interlock driver tool including distal external threads cooperating with the internal threads of the chamber (FIGS. 101-105).
Regarding claim 4, Abbasi discloses the device of claim 3, wherein the fastener device and the interlock driver tool are configured to unscrew from each other while the fastener device is being screwed at least partially into a subject (¶283).
Regarding claim 5, Abbasi discloses the device of claim 3, wherein the fastener device and the interlock driver tool are configured to be seated together via the internal threads while the fastener device is being rotated for removal from a subject (FIGS. 101-105).
Regarding claim 6, Abbasi discloses the device of claim 1, wherein the fastener device is configured to be coupled or mated to a tool cooperating with the proximal head (FIGS. 101-105).
Regarding claim 7, Abbasi discloses the device of claim 6, wherein the proximal head includes a drive recess (416) and the tool cooperates with the proximal head via the drive recess (FIGS. 101-105).
Regarding claim 8, Abbasi discloses the device of claim 1, wherein the proximal head includes a drive recess that is one or more of the following shapes/types: slotted, cruciform, square, pentalobular, hexalobular, triangular, or tamper-resistant (FIG. 95).
Regarding claim 9, Abbasi discloses the device of claim 1, wherein the fastener device is made of non-ferrous material (¶212).
Regarding claim 10, Abbasi discloses the device of claim 1, wherein the fastener device includes a self-tapping tip or a self-drilling tip (419).
Regarding claim 11, Abbasi discloses the device of claim 1, wherein the external threads are of a cortical or cancellous thread type (FIG. 92).
Regarding claim 12, Abbasi discloses the device of claim 1, wherein the fastener device can be a part of a pedicle screw (intended use statement – there is no reason this fastener device cannot be a part of a pedicle screw).
Regarding claim 13, Abbasi discloses the device of claim 1, wherein the fastener device is a cannulated screw with a (partially) hollow core (FIG. 94).
Regarding claim 14, Abbasi discloses the device of claim 1, wherein the chamber is at least partly filled or covered with a hydrogel or soluble material (¶303).
Regarding claim 21, Abbasi discloses the device of claim 1, wherein the one or more thread geometry parameters include thread pitch, and/or thread profile dimensions (the threads inherently comprise thread pitch and thread profile dimensions).
Regarding claim 22, Abbasi discloses the device of claim 1, wherein the one or more thread geometry parameters include a plurality of thread geometry parameters, and wherein the plurality of thread geometry parameters includes thread pitch and thread profile dimensions (the threads inherently comprise thread pitch and thread profile dimensions).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abbasi.
Regarding claim 2, Abbasi discloses the device of claim 1, except does not specify wherein the first handedness is right-handed and the second handedness is left-handed. It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to form the threads this way, since right-handed external threads are standard and then it follows that the internal threads would be left-handed due to the “reverse threaded” (¶283) disclosure. In this case, the first handedness is right-handed and the second handedness is left-handed.
Response to Arguments
Regarding Applicant’s argument that Abbasi fails to disclose “wherein features of the first handedness of the external threads and the second handedness of the internal threads are governed by a relative torque relationship and wherein the relative torque relationship is determined based on one or more thread geometry parameters of one or both of the external threads and the internal threads,” Examiner respectfully disagrees. A relative torque relationship inherently exists between thread geometry parameters of the internal and external threads. Depending on the geometry of the internal thread relative to the external thread, a specific torque relationship occurs. The claim does not specify what the relative torque relationship is, therefore Abbasi 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