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 .
EXAMINER’S COMMENT
There does not appear to be any overlapping subject matter requiring a Double Patenting rejection with regard to US Patents 12310637, 11759241, 10828074 and 9974581 at this time.
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, 2, 6-9, 11-14 and 17-20 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Bramlet (US 20020156473).
With respect to claim 1, Bramlet discloses a method for stabilizing a long bone (see abstract, fig. 25a, 26-28 below), the method comprising: providing a trochanteric nail (1), the trochanteric nail including: an elongate nail body (1, see para. 78) having a proximal portion and a distal portion (e.g., see fig. 25 below), wherein the proximal portion includes an opening (33, see para. 80), and the distal portion includes a plurality of openings (40, see fig. 25a below and para. 95); a plurality of corresponding expandable spikes (21) disposed below an outer surface of the distal portion in a contracted position (see para. 28 below), inserting the trochanteric nail through an intramedullary canal of the long bone (see fig. 25); inserting a femur neck nail (4) through the opening at the proximal portion (see para. 80, 94); deploying the expandable spikes to an expanded position by mechanical actuation of the expandable intramedullary nail such that the expandable spikes radially extend from the trochanteric nail to securely anchor the distal portion of intramedullary nail in the intramedullary canal (see fig. 26-27 below, para. 95-96).
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As for claim 2, Bramlet further teaches method of claim 1, wherein the trochanteric nail further includes an elongate adjustment rod (51) extending through the nail body, and coupled to the plurality of expandable spikes such that a longitudinal movement of the adjustment rod radially moves the expandable spikes (see fig. 26-27 above and also para. 97).
As for claim 6, Bramlet further discloses the system of claim 1, wherein the femur neck nail is expandable (see fig. 25 and para. 79).
As for claim 7, Bramlet further discloses the method of claim 1, wherein: the femur neck nail includes a femur neck body (4) and expandable femur neck spikes (12, see para. 79); and the femur neck spikes are disposed in the femur neck body in a contracted position, wherein, upon mechanical actuation, the femur neck spikes radially extend from the femur neck body to an expanded position to securely anchor the proximal portion of the trochanteric nail (see para. 79).
As for claim 8, Bramlet further discloses the method of claim 6, wherein the expandable femur neck nail includes a cannulated elongate body (3), an actuation mechanism (30) extending longitudinally through the elongate body, and a plurality of expandable femur neck spikes (12, see fig. 25 above) engaged with the actuation mechanism, the actuation mechanism configured to deploy the expandable femur neck spikes from the cannulated elongate body upon linear movement (via 29) of the actuation mechanism (see para. 79).
As for claim 9, Bramlet further discloses the method of claim 8, wherein the actuation mechanism includes an adjustment member (6) connected to a deployment member (23’), and the expandable femur neck spikes are configured to deploy into the expanded position when an axial force is applied to the adjustment member (see para. 79).
As for claim 11, Bramlet further discloses the method of claim 1, wherein the plurality of expandable spikes includes a first set of spikes (note that there are four openings 40, thus, also four elements 21, see para. 95) that expand in a first radial direction (e.g., two spikes expand to the left of the longitudinal axis of 1) and a second set of spikes that expand in a second radial direction opposite the first radial direction (e.g., the other two spikes 21 expand to the right of the longitudinal axis of 1).
As for claim 12, Bramlet further discloses the method of claim 11, wherein the first set of spikes are interleaved with the second set of spikes in a longitudinal direction see fig. 28 and note that all four tangs are interleaved with the interior of 1).
With respect to claim 13, Bramlet discloses a method for stabilizing a long bone (see abstract, fig. 25a, 26-28 above), the method comprising: providing a trochanteric nail (1), the trochanteric nail including: an elongate nail body (1, see para. 78) having a proximal portion and a distal portion (e.g., see fig. 25 below), wherein the proximal portion includes an opening (33), and the distal portion includes a plurality of openings (40, see fig. 25a above, para. 95); a plurality of corresponding expandable spikes (21) coupled to an adjustment rod (51) and disposed below an outer surface of the distal portion in a contracted position (see fig. 25a, 26-28 above), inserting the trochanteric nail through an intramedullary canal of the long bone (see fig. 25); inserting a femur neck nail (4) through the opening at the proximal portion (see fig. 25); deploying the expandable spikes to an expanded position by mechanical actuation of the adjustment rod such that the expandable spikes radially extend from the trochanteric nail to securely anchor the distal portion of intramedullary nail in the intramedullary canal (see fig. 25a, 26 above, para. 97).
As for claim 14, Bramlet further discloses the method of claim 13, wherein the expandable spikes are adapted to radially move upon a longitudinal movement of the adjustment rod (see fig. 26 above).
As for claim 17, Bramlet further discloses the method of claim 13, wherein the femur neck nail is expandable (see fig. 25 and para. 79).
As for claim 18, Bramlet further discloses the method of claim 13, wherein: the femur neck nail includes a femur neck body (4) and expandable femur neck spikes (12, see para. 79); and the femur neck spikes are disposed in the femur neck body in a contracted position, wherein, upon mechanical actuation, the femur neck spikes radially extend from the femur neck body to an expanded position to securely anchor the proximal portion of the trochanteric nail (see para. 79).
As for claim 19, Bramlet further discloses the method of claim 13, wherein the plurality of expandable spikes includes a first set of spikes (note that there are four openings 40, thus, also four elements 21, see para. 95) that expand in a first radial direction (e.g., two spikes expand to the left of the longitudinal axis of 1) and a second set of spikes that expand in a second radial direction opposite the first radial direction (e.g., the other two spikes 21 expand to the right of the longitudinal axis of 1).
As for claim 20, Bramlet further discloses the method of claim 19, wherein the first set of spikes are interleaved with the second set of spikes in a longitudinal direction see fig. 28 and note that all four tangs are interleaved with the interior of 1).
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in dependent claim 3. In particular, none of the cited references teach or suggest the method wherein the trochanteric nail further comprises an end cap threadingly coupled to a proximal end of the adjustment rod such that rotation of the end cap linearly translates the adjustment rod, as required by claim 3.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in dependent claims 4-5. In particular, none of the cited references teach or suggest the method wherein a distal portion of the adjustment rod is arranged with a plurality of angled tongues or grooves configured to engage with corresponding angled grooves or tongues on the plurality of spikes such that translational movement of the adjustment rod causes the plurality of spikes to deploy to the expanded position, as required by claim 4.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in dependent claim 10. In particular, none of the cited references teach or suggest the method wherein the deployment member is arranged with at least one angled tongue or groove configured to engage with a corresponding angled groove or tongue on the corresponding femur neck spike such that translational movement of the deployment member causes the corresponding femur neck spike to deploy to the expanded position, as required by claim 10.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in dependent claim 15. In particular, none of the cited references teach or suggest the method wherein the trochanteric nail further comprises an end cap threadingly coupled to a proximal end of the adjustment rod such that rotation of the end cap linearly translates the adjustment rod, as required by claim 15.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in dependent claim 16. In particular, none of the cited references teach or suggest the method wherein a distal portion of the adjustment rod is arranged with a plurality of angled tongues configured to engage with corresponding angled grooves on the plurality of spikes such that translational movement of the adjustment rod causes the plurality of spikes to deploy to the expanded position, as required by claim 16.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Allowable Subject Matter
Claims 3-5, 10, 15 and 16 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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