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
Claim 18 is objected to because of the following informalities:
Claim 18, lines 10-11 recite “and the nail body the bone anchor so as to” and should be amended to recite “and the nail body so as to”.
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 1-20 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.
Independent claim 1 recites the limitation "the first nail member" in lines 6 and 10. There is insufficient antecedent basis for this limitation in the claim. Furthermore, dependent claims 5, 11, 12 and 14 recite the limitation “the first nail member”. For the purpose of examining the claim, “the first nail member” will be interpreted as “the nail body”.
Independent claim 18 recites the limitation "the first nail member" in line 8. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the first nail member” will be interpreted as “the nail body”.
Claim 14 recites the limitation "a bone fixation hole". It is unclear whether “a bone fixation hole” is referring to at least one first bone fixation hole disclosed in line 4 of claim 1, or if a new bone fixation hole is being claimed. For the purpose of examining the claim, “a bone fixation hole” will be interpreted as “a second bone fixation hole”.
Claim 15 recites the limitation "the second bone anchor". There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, claim 15 will be interpreted to depend from claim 14 where a second bone anchor has been positively recited.
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 1-5 and 16-20, as best understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kinmon et al. (U.S. Publication No.2012/0130370 A1; “Kinmon”).
Regarding claim 1, Kinmon discloses an intramedullary nail (10) that extends along a central axis, the intramedullary nail comprising: a nail body (11) configured to be positioned in a medullary canal of a bone, wherein the nail body defines a slot (30, 32) and at least one first bone fixation hole (20, 22), the at least one bone fixation hole configured to receive a respective at least one first bone fixation element (52, 53) so as to couple the nail body to a first bone portion (Figure 16), and the slot configured to receive a bone anchor (50, 51) that is configured to be coupled to a second bone portion (Figure 16); a biasing element (40, 44) configured to apply a biasing force to at least one of the bone anchor and the nail body (para.0065-0066), thereby creating compression between the first and second bone portions when the nail body is coupled to the first bone portion and the bone anchor is received in the slot and coupled to the second bone portion (para.0065-0066).
Regarding claims 2 and 3, Kinmon further discloses wherein the biasing element applies the biasing force to the nail body and to the bone anchor (para.0065-0066).
Regarding claim 4, Kinmon further discloses an actuator (elements 42, 46 as shown in Figure 11) coupled to the biasing element and the bone anchor such that the biasing element applies the biasing force to the actuator, thereby applying the biasing force to the bone anchor (para.0087).
Regarding claim 5, Kinmon further discloses wherein the nail body (11) includes a channel (14) configured to receive at least a portion of the actuator (Figure 11).
Regarding claim 16, Kinmon further discloses wherein the biasing element (40, 44) is a first biasing element and the intramedullary nail further comprises a second biasing element (see both elements 40 and 44 in Figure 11).
Regarding claim 17, Kinmon further discloses wherein the first and second biasing elements (40, 44) are positioned on opposite sides of the slot in a longitudinal direction (Figure 11), and the second biasing element is positioned between the slot of the nail body and the first bone fixation hole in the longitudinal direction (Figure 11).
Regarding claim 18, Kinmon discloses a method of applying compression between a first bone portion and a second bone portion (Figures 16-17), the method comprising: inserting an intramedullary nail (10) into a medullary canal of the bone (Figure 16); inserting a bone anchor (50) through a first slot (30) in a nail body (11) of the intramedullary nail into the first bone portion, such that the nail body is movable relative to the bone anchor along a central axis of the nail body (para.0065-0066); inserting a first bone fixation element (52) through the second bone portion into a first bone fixation hole (20) in the nail body so as to couple the nail body to the second bone portion (Figure 16); and causing an actuator (42) to bias against at least one of the bone anchor and the nail body so as to apply a compressive force between the bone anchor and the nail body (para.0087).
Regarding claim 19, Kinmon further discloses wherein the first bone fixation hole (20) is sized substantially equal to the first bone fixation element (Figure 11).
Regarding claim 20, Kinmon further discloses wherein the first bone fixation hole (20) is elongate along the central axis (Figure 11).
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Allowable Subject Matter
Claims 6-15 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.
Claims 6-15 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 6, and claims 1 and 4 from which claim 6 depends from. In particular, none of the cited references teach or suggest a pusher member configured to apply a second force to the bone anchor, as required by claim 6.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, and can be found 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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