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 .
Election/Restrictions
Applicant’s election without traverse of Group I (device claims) and Species D (Figs. 8A-8B) in the reply filed on November 14, 2025 is acknowledged.
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 14-17 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.
Claims 14-17 recite “the expansion portion” which was previously introduced as “an expandable portion” and therefore lacks antecedent basis in the claims.
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) 12, 14-15, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bramlet (US 5976139).
Claim 12, Bramlet discloses a fixation device (Fig. 2) capable of stabilizing fractured bone portions (Fig. 2) comprising: a housing (30) having a proximal end (near where 38 points), a distal end (near where 30 points) opposite the proximal end (Fig. 2) and a bore (bore that screw 22 sits in) extending between the proximal and distal ends (Fig. 2), the housing defining a longitudinal axis (long axis running through the center of the housing); an actuator (22) being at least partially disposed within the bore of the housing and selectively moveable through the bore (Fig. 2), the actuator having an expandable portion (Figs. 5-6; one of the pins 60); and a first anchoring member (other pin 60) coupled to the actuator (Fig. 2; all the parts are coupled to each other) and configured to transition between a first condition (Fig. 5; closed) in which a portion of the first anchoring member has a first distance from the longitudinal axis (Fig. 5) and a second condition (Fig. 6; open) in which the portion of the first anchoring member has a second distance from the longitudinal axis (Fig. 6), the second distance being greater than the first distance (Figs. 5-6), wherein the expandable portion is configured to prevent the actuator from backing out of the housing upon expansion (Fig. 2).
Claim 14, Bramlet discloses the fixation device of claim 12, further comprising a wedge (Figs. 5-6; 110; one definition of wedge is something causing separation, furthermore, the threads are wedge shaped; Figs. 26-27 show a better view of the end 114) configured to be inserted into the housing to expand the expansion portion (Figs. 2 and 5-6).
Claim 15, Bramlet discloses the fixation device of claim 14, wherein the housing includes a stopper (Fig. 2; distal end of the housing that would contact the pin if it were slid up) configured to engage the expansion portion to prevent the proximal movement of the actuator (Fig. 2).
Claim 17, Bramlet discloses the fixation device of claim 12, further comprising a wedge (Figs. 5-6; 110; one definition of wedge is something causing separation, furthermore, the threads are wedge shaped; Figs. 26-27 show a better view of the end 114) configured to actuate the expansion portion (Figs. 5 and 6).
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bramlet (US 5976139), in view of Griffiths et al. (US 2010/0222827; “Griffiths”).
Claim 18, Bramlet discloses the fixation device of claim 17, as noted above.
However, Bramlet does not disclose the wedge being conical in shape having a diameter which tapers in the axial direction.
Griffiths teaches a screw (Fig. 2A) that has a tapered wedge distal end (132) that is conical in shape (Fig. 2A) having a diameter which tapers in the axial direction (Fig. 2A).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tip of the screw of Bramlet, to have a tapered wedge shaped tip, as taught by Griffiths, in order to make it easier to insert (paragraph [0041]) into whatever it may be inserted into whether it be a hole in a bone or a hole in another device.
Allowable Subject Matter
Claims 2-6 and 9-11 are allowed.
Claim 2 requires the actuator to have expanding legs best shown in Fig. 8B as 418. This is the stopping mechanism that stops the screw from backing out. It also requires an anchoring member, which correlates to legs 438, which help to anchor the device into the bone. Most of the prior art teaches the anchoring device that helps anchor the screw into the bone. However, the prior art does not teach both the anchoring legs and the stopping legs to help for stopping back out. Claims 3-6 and 9-11 are dependent from claim 2.
Claims 16 and 19-20 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.
Claim 16 requires the stopper to be a ledge extending radially inward form the inner surface of the housing, best shown in Fig. 8B as 415. The rejection above is just relying on the end faces of the housing to be the stopper, so Bramlet is lacking the ledges extending inward which help to stop the actuator from backing out.
Claim 19 requires a second anchoring member. The rejection above calls one leg the expandable portion and the other leg is the first anchoring member. Once the second anchoring member is brought in there is no longer enough expanding legs to meet the claim limitations.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached 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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/Zade Coley/Primary Examiner, Art Unit 3775