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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/02/2026 has been entered.
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 1-6 and 9-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Truncale et al. (U.S. Publication No.2009/0319045 A1; hereinafter “Truncale”).
Regarding claim 1, Truncale discloses a femoral plug (see the embodiment shown in Figure 33C) for sealing a femoral opening drilled in a distal region of a femur forming part of a knee joint to receive an intramedullary rod of an intramedullary cutting guide therein (see the hole in the distal region of the femur in Figure 1), the femoral plug comprising: an elongated body (see construct 722c in Figure 33C) sized for insertion into the femoral opening in the distal region of the femur that forms part of the knee joint after removal of the intramedullary rod of the intramedullary cutting guide (para.0191-0199), the elongated body being free of a through hole (Figure 33C); and threads (728) extending around at least a portion of the elongated body to engage bone surrounding the femoral opening to form a seal with the bone to prevent blood loss from the femoral opening into the knee joint (para.0191).
Regarding claim 2, Truncale further discloses wherein the threads (728) comprise a helical thread structure (Figure 33C).
Regarding claim 3, Truncale further discloses wherein the helical thread structure (728) comprises a series of parallel ridges (Figure 33C).
Regarding claim 4, Truncale further discloses wherein the parallel ridges comprise a single helix (728) that spirals about a periphery of the elongated body (Figure 33C).
Regarding claim 5, Truncale further discloses wherein the parallel ridges comprise discrete parallel bands (728) around a periphery of the elongated body (Figure 33C).
Regarding claim 6, Truncale further discloses wherein the elongated body comprises a chamfered edge (base 726C is tapered) to facilitate entry of the femoral plug into the femoral opening (Figure 33C).
Regarding claim 9, Truncale further discloses wherein the femoral plug (722C) is made of a biodegradable material (para.0193-0194).
Regarding claim 10, Truncale further discloses wherein the elongated body is a substantially cylindrical body (Figure 33C).
Regarding claim 11, Truncale further discloses wherein the femoral plug (722C) has a femoral plug diameter that is selected based on a diameter of a drill bit used to drill the femoral opening in the distal region of the femur (para.0191-0199).
Regarding claim 12, Truncale discloses a femoral plug (see embodiment shown in Figure 33C) for sealing a femoral opening drilled in a distal region of a femur forming part of a knee joint to receive an intramedullary rod of an intramedullary cutting guide therein (see the hole in the distal region of the femur in Figure 1), the femoral plug comprising: a monolithic elongated body (see construct 722C) sized for insertion into the femoral opening in the distal region of the femur that forms part of the knee joint after removal of the intramedullary rod of the intramedullary cutting guide (para.0191-0199), the monolithic elongated body being configured to fill substantially an entire cross-sectional area of the femoral opening (para.0191-0199); and threads (728) extending around at least a portion of the monolithic elongated body to engage bone surrounding the femoral opening to form a seal with the bone (Figure 33C); wherein the femoral plug is configured to prevent blood loss from the femoral opening into the knee joint (para.0191-0199).
Regarding claim 13, Truncale further discloses wherein the threads (728) are integrally formed with the monolithic elongated body (Figure 33C).
Regarding claim 14, Truncale further discloses wherein the monolithic elongated body (722C) is a substantially cylindrical body (Figure 33C).
Regarding claim 15, Truncale further discloses wherein the threads (728) comprise a helical thread structure (Figure 33C).
Regarding claim 16, Truncale further discloses wherein the helical thread structure (728) comprises a series of parallel ridges (Figure 33C).
Regarding claim 17, Truncale further discloses wherein the parallel ridges comprise a single helix (728) that spirals about a periphery of the monolithic elongated body (Figure 33C).
Regarding claim 18, Truncale further discloses wherein the parallel ridges comprise discrete parallel bands (728) around a periphery of the monolithic elongated body (Figure 33C).
Regarding claim 19, Truncale further discloses wherein the monolithic elongated body comprises a chamfered edge (base 726C is tapered) to facilitate entry of the femoral plug into the femoral opening (Figure 33C).
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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.
Claims 7, 8 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Truncale as applied to independent claims 1 and 12 above, in view of Appenzeller et al. (U.S. Publication No.2009/0157123 A1’ hereinafter “Appenzeller”).
Truncale discloses the claimed invention, as disclosed in claims 1 and 12 above, except for wherein the femoral plug further comprises a socket/tool-engaging portion configured to be engaged by a tool for driving the femoral plug into the femoral opening. However, Appenzeller discloses a bone fixation element comprising a driving element 60 (Figure 1) to drive the bone fixation element into a desired location in the patient’s bone (para.0070). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Truncale’s construct to include a tool-engaging portion, as taught by Appenzeller, in order to drive the bone fixation element into a desired location in the patient’s bone (para.0070).
Response to Arguments
Applicant’s arguments, filed on 02/02/2026 with respect to claims 1-20, 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.
Sybert et al. U.S. Publication No.2010/0082072 A1
McLaren U.S. Patent No.5,100,405
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