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 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 2-20 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.
Claim 2 recites the limitation "the outer surface of the upper portion" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the outer surface of the upper portion” will be interpreted as “an outer surface of the upper portion”.
Claim 20 recites the limitation "the shape" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the shape” will be interpreted as “a shape”.
Claim 21 recites the limitation "the shape" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the shape” will be interpreted as “a shape”.
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 2, 5, 7-10 and 12-19, as best understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orbay et al. (U.S. Publication No.2005/0165395 A1; hereinafter “Orbay”).
Regarding claim 2, Orbay discloses a system capable of fixating bones or bone fragments (Figure 1) comprising: an orthopedic plate (12) having a first bore (a first post hole 36) therethrough and a top surface (see annotated Figure 2 below), the first bore residing at a first axis angle relative to the perpendicular of the top surface (see annotated Figure 2 below); a peg (post 14) extending along a longitudinal peg axis (see annotated Figure 2 below) and comprising a lower portion and an upper portion (see annotated Figure 2 below), an outer surface of the upper portion (head portion 46 with slots 48) configured to mate by interference fit with the first bore (slots 48 lock in particular rotational orientation relative to the locking structure 38 of the post hole 36, similar to a bayonet lock, see para.0032), the lower portion comprising a cross bore (transverse hole 50) transverse to the longitudinal peg axis (Figure 2); and a compression screw (cross peg 16) extending along a longitudinal screw axis (see annotated Figure 2 below), the compression screw configured to mate with the cross bore (Figure 2), wherein the lower portion is configured to be rotatably positioned about the longitudinal peg axis to align with the compression screw (each post 14 locks in particular rotational orientation relative to the post hole, thus configured to be rotatably positioned about the longitudinal axis of the post to align the cross peg 16, para.0032).
Regarding claim 5, Orbay further discloses wherein the orthopedic plate (12) and upper portion are configured for insertion of the peg (14) through the first bore (36) from the top surface (head portion 46 of post 14 resides within post hole 36 in such a way that it is locked and thus prevented from falling through, see para.0032) .
Regarding claim 7, Orbay further discloses wherein the orthopedic plate further comprises a second bore (32)(see annotated Figure 2 below).
Regarding claim 8, Orbay further discloses wherein the second bore (32) resides at a second axis angle relative to the perpendicular of the top surface (see annotated Figure 2 below).
Regarding claim 9, Orbay further discloses wherein the second bore is an elongated bore (screw holes 32 may be oblong as indicated by dotted line 32a in Figure 1).
Regarding claim 10, Orbay further discloses wherein the elongated bore (32a) is oriented in line with a longitudinal axis of the orthopedic plate (Figure 1).
Regarding claim 12, Orbay further discloses wherein the first bore (36) is configured to reside over a first bone or bone fragment and the second bore (32) configured to reside over a second bone or bone fragment (holes 36 and 32 are spaced apart such that they are configured to reside over separate parts of a bone, or multiple bones, see Figure 4).
Regarding claims 13-16, Orbay further discloses wherein the first axis angle is in the range of 0 degrees to 45 degrees, 0 degrees to 20 degrees, 0 degrees to 15 degrees, and 0 degrees to 10 degrees (the first axis angle as shown in annotated Figure 2 below shows that it is the same angle, thus 0 degrees, to the perpendicular of the top surface of the plate).
Regarding claim 17, Orbay further discloses wherein the peg upper portion comprises an upper aperture (axial bore 54) about the longitudinal peg axis (see Figure 3).
Regarding claim 18, Orbay further discloses wherein the upper aperture (54) of the upper portion is configured to allow a targeting guide (set screw 18) to pass therethrough and key onto the lower portion (set screw 18 extends through axial bore 54 from the upper portion towards the lower portion, see Figure 3 below).
Regaring claim 19, Orbay further discloses wherein the peg lower portion comprises a lower aperture (axial bore extends along the length of post 14, from the upper portion to the lower portion) about the longitudinal peg axis (Figure 3).
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Claim Rejections - 35 USC § 103
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 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 3-4, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over Orbay in view of Dahners (U.S. Publication No.2008/0234752 A1).
Regarding claims 3 and 4, Orbay discloses the claimed invention as disclosed in claim 2 above, except for wherein the first bore comprises threads, and wherein the upper portion comprises threads configured to mate with the threads of the first bore. However, Dahners discloses the use of threaded-head screws and threaded-aperture plates to prevent motion between bone fragments and the plate as well as premature loosening of the screws (see para.0004 of Dahners). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claim invention to modify Orbay’s orthopedic plate and peg such that the first bore comprises threads, and wherein the upper portion comprises threads configured to mate with the threads of the first bore, as taught by Dahners, in order to prevent motion between the bone fragment and the plate as well as toggling of the screws affixed to the plate (see para.0004 of Dahners).
Claim 6, as best understood, is rejected under 35 U.S.C. 103 as being unpatentable over Orbay in view of Foley et al. (U.S. Patent No.7,608,096 B2; hereinafter “Foley”).
Regarding claim 6, Orbay discloses the claimed inventios as disclosed in claim 2 above, except for wherein the orthopedic plate and upper portion are configured for insertion of the peg through the first bore from a bottom surface of the plate. However, Foley discloses a plate member 20 that is positioned over bone fixation member 22 and slot 30 that is bottom-loaded, since the fixation members are inserted prior installation of the plate (col.6, ll.46-col.7, ll.13). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claim invention to modify Orbay’s orthopedic plate and peg such that the orthopedic plate and upper portion are configured for insertion of the peg through the first bore from a bottom surface of the plate, as taught by Foley, in order to provide an alternate means of installation and allow the surgeon to place the plate over the pegs.
Claim 11, as best understood, is rejected under 35 U.S.C. 103 as being unpatentable over Orbay in view of Young et al. (U.S. Publication No.2005/0015089 A1; hereinafter “Young”).
Regarding claim 11, Orbay discloses the claimed invention, as disclosed in claim 2 above, except for wherein the elongated bore is oriented in an offset angle relative to a longitudinal axis of the orthopedic plate. However, Young discloses a bone plate having apertures that are angled from the plate’s longitudinal axis (see Figure 1a of Young) in order to provide different plate configurations depending on the physiology of the patient (see para.0033 of Young). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claim invention to modify Orbay’s orthopedic plate such that the elongated bore is oriented in an offset angle relative to a longitudinal axis of the plate, as taught by Yung, in order to provide different plate configurations depending on the physiology of the patient (see para.0033 of Young).
Claims 20 and 21, as best understood, is rejected under 35 U.S.C. 103 as being unpatentable over Orbay in view of Mitkovic (U.S. Publication No.2005/0101959 A1).
Regarding claims 20 and 21, Orbay discloses the claimed invention, as disclosed in claim 2 above, except for wherein the lower aperture of the peg or an exterior portion of the lower portion of the peg has a shape of at least one of a diamond, a square, an oval, an elongated circle, a star, or a combination thereof. Mitkovic discloses the use of various cross-sections (see Figure 20 of Mitkovic) in connecting rods in order provide a means of connection between two components that provides translation but prevents rotation of those components relative to each other (see para.0051 and 0055 of Mitkovic). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claim invention to modify Orbay’s peg such that the lower aperture of the peg or an exterior portion of the lower portion of the peg has a shape of at least one of a diamond, a square, an oval, an elongated circle, a star, or a combination thereof, as taught by Mitkovic, in order to provide a connection means between the upper and lower portions of the peg that allows for relative translation but prevents relative rotation (see para.0051 and 0055 of Mitkovic).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Powlan U.S. Patent No.8,262,709 B1
Kay et al. U.S. Patent No.7,799,061 B2
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