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 .
Claim Objections
Claims 16 and 20 are objected to because of the following informalities:
Claim 16, line 3 recites “first configuration a distal end” and should be amended to recite “a first configuration, a distal end”.
Claim 20 ends with two periods and should be amended to end with one period.
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 10, 12 and 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.
Claim 10 recites the limitation "the channel". There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, claim 9 will be interpreted to depend from claim 2.
Claim 12 recites the limitation "the seat". There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the seat” will be interpreted as “a seat within the first nail member”.
Claim 17 recites the limitations "the first configuration" and “the second configuration” in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, claim 17 will be interpreted to depend from claim 16.
Appropriate corrections are required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-4 and 14-19, as best understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doherty et al. (U.S. Publication No.2012/0136356 A1; hereinafter “Doherty”).
Regarding claim 1, Doherty discloses an intramedullary nail (1) that extends along a central axis (Figure 2), the intramedullary nail comprising: a first nail member (stem 7) configured to be positioned in a medullary canal of a bone, wherein the first nail member defines at least one first bone fixation hole (slot 2) configured to receive a respective at least one first bone fixation element (screw 5) so as to couple the first nail member to a first bone portion;
a second nail member (insert 30) configured to be at least partially inserted into the first nail member (Figures 3-4), wherein the second nail member defines at least one second bone fixation hole (32) configured to receive a respective at least one second bone fixation element (screw 4) so as to couple the second nail member to a second bone portion that is spaced from the first bone portion (Figure 2); a biasing element (washers 33) configured to apply a biasing force to at least one of the first and second nail members so as to apply compression between the first and second bone portions when the first nail member is coupled to the first bone portion and the second nail member is coupled to the second bone portion (para.0084).
Regarding claim 2, Doherty further discloses wherein the first nail member (7) includes a channel configured to receive at least a portion of the second nail member (Figures 3-4).
Regarding claim 3, Doherty further discloses wherein at least a portion of the second nail member (30) is disposed in the channel of the first nail member (Figure 4).
Regarding claim 4, Doherty further discloses wherein the second nail member (30) is disposed in the channel of the first nail member (Figure 4).
Regarding claim 14, Doherty further discloses wherein the first nail member (7) includes a first slot (slot 3) that is elongate along a longitudinal axis of the first nail member and the second bone fixation element (4) is positioned within the first slot such that the first nail member is movable relative to the second bone fixation element (para.0075).
Regarding claim 15, Doherty further discloses wherein the second nail member (30) includes a second slot (31) that is elongate along a longitudinal axis of the second nail member and the first bone fixation element (5) is positioned within the second slot such that the second nail member is movable relative to the first bone fixation element (para.0075).
Regarding claim 16, Doherty further discloses wherein the intramedullary nail is transitionable from a first configuration to a second configuration (Figures 13-14), wherein in the first configuration a distal end of the first nail member is spaced from a distal end of the second nail member by an initial distance, and wherein in the second configuration the distal end of the first nail member is spaced from the distal end of the second nail member by a compressed distance that is greater than the initial distance (para.0067, 0075, 0084).
Regarding claim 17, Doherty further discloses wherein a length of the intramedullary nail is the same in the first configuration and the second configuration (Figures 13-14), wherein the length is measured along the central axis from a first terminal end of the first nail member to a second terminal end of the second nail member opposite the first terminal end (para.0067, 0075, 0084).
Regarding claim 18, Doherty further discloses wherein the first nail member has a fixed length in the longitudinal direction (para.0067, 0075, 0084).
Regarding claim 19, Doherty discloses a method of coupling an intramedullary nail (1) that extends along a central axis to a first bone portion and a second bone portion (Figures 2, 13, and 14), the intramedullary nail including a first nail member (7) and a second nail member (30), the method comprising: positioning the first nail member in a medullary canal of at least one bone that defines the first and second bone portions (Figures 13-14), wherein the first nail member defines at least one first bone fixation hole (2);
inserting a respective at least one first bone fixation element (5) into the at least one first bone fixation hole so as to couple the first nail member to the first bone portion (Figures 13-14),
inserting a respective at least one second bone fixation element (4) into at least one second bone fixation hole (32) in the second nail member so as to couple the second nail member to the second bone portion (Figures 13-14); and applying a biasing force (via washers 33) to at least one of the first and second nail members so as to apply compression between the first and second bone portions (para.0084).
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Allowable Subject Matter
Claims 5-13 and 20, as best understood, 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, and once the rejections under 35 U.S.C. 112(b) discussed above have been corrected.
Claims 5-8 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 claim 5. In particular, none of the cited references teach or suggest wherein a first end of the biasing element is supported by a seat within the first nail member, a second end of the biasing element bears against the second nail member in a select direction, and the biasing force is applied to the second nail member in the select direction, as required by claim 5.
Claims 9-13 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 claim 9. In particular, none of the cited references teach or suggest wherein the second nail member includes a shaft and a receiver configured to couple to the shaft, the shaft having a shaft width in the lateral direction and the receiver having a receiver width that is greater than the shaft width, as required by claim 9.
Claim 20 in the instant application has 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 claim 20. In particular, none of the cited references teach or suggest wherein applying step is applied by a biasing element that is supported by a seat within the first nail member and bears against the second nail member in a select direction, and the biasing force is applied to the second nail member in the select direction, as required by claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and has been cited in the Notice of References Cited, PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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