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.
Claim 11 is 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 11 recites the limitation "the first or second set screw" in line 1. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the first or second set screw” will be interpreted as “a first or second set screw”.
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, 2, 3 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pennig (U.S. Patent No.4,988,349).
Regarding claim 1, Pennig discloses a bone positioning device (Figure 1), comprising: a first fixation pin for attachment to a first bone (see annotated Figure 1 below); a second fixation pin for attachment to a second bone (see annotated Figure 1 below); a first block (support plate 1) having a first aperture for slidably receiving the first fixation pin (aperture within fastening support 9); a second block (support plate 2) having a second aperture for slidably receiving the second fixation pin (aperture within fastening support 8); and a multi-axis joint (double-ball hinge 3) connecting the first block and the second block (see annotated Figure 1 below), the multi-axis joint allowing the first block and the second block to move with respect to each other about more than one axis (see description of “double ball hinge” found in col.2, ll.19-32).
Regarding claim 2, Pennig further discloses wherein the multi-axis joint further includes a link (12) having a first end (15) rotatably connected to the first block and a second end (14) rotatably connected to the second block (see Figure 2, see also col.2, ll.19-32).
Regarding claim 3, Pennig further discloses wherein the first end (15) includes a first ball received within a first socket of the first block, and the second end (14) includes a second ball received within a second socket of the second block (see Figure 2, see also col.2, ll.19-32).
Regarding claim 8, Pennig further discloses a compression screw (10) operable to exert a compression force between the first and second fixation pins (see Figure 2, see also col.2, ll.16-18).
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Claims 1, 2, 4-13 and 15-20 (as best understood), are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orsak et al. (U.S. Publication No.2009/0118733 A1; hereinafter “Orsak”).
Regarding claim 1, Orsak discloses a bone positioning device (Figures 11A-F), comprising: a first fixation pin (fixation pin which extends through 142 as shown in Figures 11C-D, see also para.0111) for attachment to a first bone (see annotated Figure 11D below); a second fixation pin for attachment to a second bone (fixation pin which extends through 1143 as shown in Figures 11C-D, see also para.0111); a first block (1010A) having a first aperture for slidably receiving the first fixation pin (see annotated Figure 11D below); a second block (1010C) having a second aperture for slidably receiving the second fixation pin (see annotated Figure 11D below); and a multi-axis joint (3010) connecting the first block and the second block (see annotated Figure 11D below), the multi-axis joint allowing the first block and the second block to move with respect to each other about more than one axis (see description of 3010 found in para.0115).
Regarding claim 2, Orsak further discloses wherein the multi-axis joint (3010) further includes a link (“H-shaped body”, see para.0115) having a first end (see annotated Figure 11F below) rotatably connected to the first block and a second end (see annotated Figure 11F below) rotatably connected to the second block (para.0115).
Regarding claim 4, Orsak further discloses a first end set screw (3022) extending through the first block and positioned against the first end (Figure 11F).
Regarding claim 5, Orsak further discloses a second end set screw (3024) extending through the second block and positioned against the second end (Figure 11F).
Regarding claim 6, Orsak further discloses a first set screw (186) extending through the first block into the first aperture and positioned against the first fixation pin, and a second set screw (1186) extending through the second block into the second aperture and positioned against the second fixation pin (see Figure 11D).
Regarding claim 7, Orsak further discloses wherein the first and second set screws (186, 1186) are positioned perpendicular to first and second fixation pins, respectively (see Figure 11F, see also para.0111).
Regarding claim 8, Orsak further discloses a compression screw (155) operable to exert a compression force between the first and second fixation pins (see Figure 11C, see also para.0068).
Regarding claim 10, Orsak further discloses wherein the first or second block has a first portion (143) slidingly connected to second portion (1010A)(see Figure 11C-D), the first aperture extending through the first portion and the second portion (see annotated Figure 11 C below), the first aperture having a first cross-sectional area in the first portion and a second cross-sectional area in the second portion, the first cross-sectional area being smaller than the second cross-sectional area (see annotated Figure 11C below), and the compression screw (155) extending through the second portion (1010A)(see Figure 11C).
Regarding claim 11, Orsak further discloses wherein a first or second set screw (186) extends through the first portion (143)(see Figure 11F).
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In a second interpretation, regarding claim 1, Orsak discloses a bone positioning device (Figures 11A-F), comprising: a first fixation pin (pin is considered a combination of elements 143 and 5a, wherein 5a is shown in Figure 1A while 143 is shown in Figure 11C); a second fixation pin for attachment to a second bone (fixation pin which extends through 1143 as shown in Figures 11C-D, see also para.01111); a first block (1010A) having a first aperture for slidably receiving the first fixation pin (see annotated Figure 11C below for second interpretation of aperture); a second block (1010C and 1143) having a second aperture for slidably receiving the second fixation pin (Figure 11C); and a multi-axis joint (3010) connecting the first block and the second block (see Figure 11D), the multi-axis joint allowing the first block and the second block to move with respect to each other about more than one axis (see description of 3010 found in para.0115).
Regarding claim 8 (second interpretation), Orsak further discloses a compression screw (155) operable to exert a compression force between the first and second fixation pins (see Figure 11C, see also para.0068).
Regarding claim 9, (second interpretation), Orsak further discloses wherein the compression screw (155) is positioned against one of the first or second fixation pins (155 is against portion 143 of the first pin as shown in annotated Figure 11C below).
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Regarding claim 12, Orsak discloses a method of fixing the orientation of a first bone with respect to a second bone, comprising the steps of: attaching a first fixation pin (fixation pin which extends through 142 as shown in Figures 11C-D, see also para.0111) to a first bone; attaching a second fixation pin (fixation pin which extends through 1143 as shown in Figures 11C-D, see also para.0111) to a second bone; inserting the first fixation pin within a first aperture of a first block (1010A)(see annotated Figure 11D below); inserting the second fixation pin within a second aperture of a second block (1010C)(see annotated Figure 11D below); positioning the first block along and about the first fixation pin; actuating a first set screw (186) to fix a position of the first block (1010A) along and about the first fixation pin (para.0111-0112); positioning the second block (1010C) along and about the second fixation pin (para.0111-0112); actuating a second set screw (1186) to fix a position of the second block along and about the second fixation pin (para.0111-0112); adjusting the position of the first block with respect to the second block about at least a first axis (1505A) and a second axis (1505B) (para.0116-0117); actuating a third set screw (3021, 3022) to fix a position about the first axis (para.0116); and actuating a fourth set screw (3023, 3024) to fix a position about the second axis (para.0117).
Regarding claim 13, Orsak further discloses the step of actuating a compression screw (155) to apply a compression force between the first and second bones and facilitate a desired alignment between first and second bones (see Figure 11, see also para.0068).
Regarding claim 15, Orsak further discloses the step of positioning a cutting guide (pin-holder 1143) proximate a leading edge of the first or second bone, and cutting the bone with a cutting tool (pin that resides within the additional aperture in pin-holder 1143) guided by the cutting guide (Figure 11D).
Regarding claim 16, Orsak further discloses actuating a compression screw (155) to apply a compression force between the first and second bones after the cutting step and facilitate a desired alignment between first and second bones (para.0068).
Regarding claim 17, Orsak further discloses the step of removing the first fixation pin from the first bone and the second fixation pin from the second bone after attaching a bone connector to the first and second bones (see claim 1 of Orsak).
Regarding claim 18, Orsak further discloses wherein the first bone is a metatarsal and the second bone is a cuneiform (Figures 5A-5H).
Regarding claim 19, Orsak further discloses wherein the first bone is a first portion of a metatarsal and the second bone is a second portion of the metatarsal (Figures 5A-5H).
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Regarding claim 20, Orsak discloses a bone cutting guide (Figures 5A-H), comprising; a plate (external fixator device 5) defining a plane; a block (pin-holder 143) having a guiding surface integral with or coupled to the plate (Figures5A-H), the guiding surface being parallel to the plane and being spaced laterally therefrom (Figures 5A-H); and a handle (650) extending from the plate (Figure 5D).
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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.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Orsak in view of Pennig.
Regarding claim 14, Orsak discloses the claimed invention as disclosed in claim 12 above, but fails to disclose the step of imaging the first and second bones connected to the first and second blocks. However, Pennig discloses placing support plates to bone segments to be joined under an x-ray screen, in order to align the bone parts with respect to one another (col.1, ll.55-60). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Orsak’s method of fixing an orientation of bone segments to include the step of imaging the first and second bones in order to effectively place the bone segments in their desired orientations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pennig U.S. Patent No.5,304,177
Danieli U.S. Patent No.5,152,280
Fishbane U.S. Patent No.5,122,145
Asche et al. U.S. Patent No.5,122,140
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