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 .
Response to Arguments
Applicant's arguments filed August 28th, 2025 have been fully considered but they are not persuasive. Applicant’s amendment to further define that the interconnecting system is connected to the distraction device and the other connection device with two respective lockable ball joints is not found persuasive to overcome the prior art/rejections of record. Myers et al. teaches two lockable ball joints (608, 610) in which 608, connects to both 1102 and 606 via 600 and 610 connects to 1104. As a result, Applicant’s arguments and remarks are not found persuasive to overcome the prior art/rejections of record.
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 57-61, 63-72 and 74-76 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.
Regarding claims 57 and 70, Applicant claims “wherein the interconnecting system is connected to the distraction device and the other connection device with two respective ball joints.” It is unclear which of the first connection device (see line 11 of claim 57 and line 5 of claim 70) and the second connection device (see line 13 of claim 57 and line 7 of claim 70) Applicant is attempting to further define.
Claims 58-61, 63-69, 71-72 and 74-76 are rejected under 35 U.S.C. 112(b) as they depend from a rejected base claim and do not rectify the issue(s) at hand.
Claim Rejections - 35 USC § 102
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 70-76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Myers et al. (US 2014/0066931). Regarding claim 70, Myers et al. disclose an external distractor capable of distracting a knee joint of a patient (figure 21), wherein the distractor is arranged to be connected between the tibia and the femur of said patient for gradually enlarging the distance between the tibia and the femur, the distractor comprising a first connection device (1104, figure 21) arranged to be connected to the tibia (if one so chooses) with at least one first bone pin (560/562); and a second connection device (1102, figure 21) arranged to be connected to the femur (if one so chooses) with at least one second bone pin (560/562), a distraction device (506) arranged in one of the first and second connection devices (figures 9, 21-22 and 27 as the claim 1134 extends around components 608, 610 of distraction device 506) having an adjustable length for adjusting the distance between the first and the second connection devices (¶125 “telescoping movement”) along an adjustment axis (see figure below), an interconnecting system (606, figures 7, 9 and 21) extending between the first and second connection devices (figures 7, 9, 21), wherein the interconnecting system is movable between an unlocked position, wherein the connection devices are movable with respect to each other (¶90-91, ¶125), and a locked position, wherein the mutual positions of the connection devices are fixed (¶90-91, ¶125), wherein the interconnecting system is connected to the distraction device and the other connection device with two respective lockable ball joints (608, which connects to both 1102 and 606 via 600 610, which connects to 1104).
Regarding claim 71, Myers et al. disclose the distraction device (506) is arranged integrally in one of the connection devices (figures 21, 27).
Regarding claim 72, Myers et al. disclose the interconnecting system comprises at least one lockable hinge (1134 is/acts as a living hinge).
Regarding claim 74, Myers et al. disclose at least one of the connection devices is provided with two substantially parallel openings (1142’s, figures 22-23) for receiving two parallel bone pins (560, 562) for connecting the connection device to the tibia or the femur (figure 21). Regarding claim 75, Myers et al. disclose the openings in the at least one connection device is arranged along an axis (A3) (see figure below) at a distance from a pivot point of a ball joint (figures 21-22, see figure below).
Regarding claim 76, Myers et al. disclose the first connection device is arranged to receive the at least one bone pin at a distance from the adjustment axis (figures 21-22), and the second connection device is arranged to receive the at least one second bone pin at a distance from the adjustment axis (figures 21-22).
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 57-69 are rejected under 35 U.S.C. 103 as being unpatentable over Myers et al. (US 2014/0066931) in view of Vaidya (US 2015/0209092). Regarding claim 57, Myers et al. disclose an external distractor system capable of use in distracting a knee joint of a patient, wherein the distractor system is arranged to be connected between the tibia and the femur f said patient for gradually enlarging the distance between the tibia and the femur, the system comprising a first external distractor (1100) arranged to be connected between the tibia and the femur at a first side of the knee; wherein each of the first external distractor comprises a first connection device (1104) arranged to be connected to the tibia with at least one first bone pin (560/562); and a second connection device (1102) arranged to be connected to the femur with at least one second bone pin (562), a distraction device (506) arranged in one of the first and second connection devices (figures 9, 21-22 and 27 as the claim 1134 extends around components 608, 610 of distraction device 506) having an adjustable length for adjusting the distance between the first and the second connection devices (¶125 “telescoping movement”) along an adjustment axis (A4) (see figure below), an interconnecting system (606, figure 7) extending between the distraction device and the other of the first and second connection devices (figures 7, 9, 21), wherein the interconnecting system is movable between an unlocked position, wherein the connection devices are movable with respect to each other (¶90-61, ¶125), and a locked position, wherein the mutual positions of the connection devices are fixed (¶90-91, ¶125), wherein the interconnecting system is connected to the distraction device and the other connection device with two respective lockable ball joints (608, which connects to both 1102 and 606 via 600 610, which connects to 1104).
Myers et al. fails to expressly teach or disclose a second external distractor for use in a bilateral distraction system which is arranged to be connected between the tibia and the femur at a second side opposite the first side of the knee and the first external distractor. Vaidya disclose a distractor system which comprises first and second distractors (left and right 15, 16 and 17’s) which are bilaterally spaced (figures 4-5) and arranged to be connected between a tibia (2) and a femur (1) on respective sides of the knee joint (figures 4-5). It would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the external distractor system of Myers to be a bilateral system with two distractors as taught by Vaidya as it would provide stabilization and support to both the medial and lateral sides of the knee joint. Regarding claim 58, the resultant device of Myers et al. in view of Vaidya yields the first and second external distractors are configured to be arranged substantially on a similar coronal plane on either side of the knee (see figures 4-5 of Vaidya).
Regarding claim 59, the resultant device of Myers et al. in view of Vaidya yields the second external distractor has a configuration which is mirror symmetrical to the first external distractor with respect to the sagittal plane of the knee. (see figures 4-5 of Vaidya).
Regarding claim 60, Myers et al. disclose the interconnecting system comprises at least one lockable hinge (1134 is/acts as a living hinge).
Regarding claim 61, Myers et al. disclose the first and/or second connection devices of the first and second external distractor are separate (figures 21-27 of Myers in view of Vaidya).
Regarding claim 63, Myers et al. disclose at least one of the connection devices is provided with two substantially parallel openings (1142’s) for receiving two parallel bone pins (560, 562) for connecting the at least one connection device to the tibia or the femur. Regarding claim 64, Myers et al. disclose the openings (1142’s) in the connection device, are arranged along an axis (A3) (see figure below) at a distance from a pivot point of a ball joint (see figure below). Regarding claim 65, Myers et al. disclose the openings in the at least one connection device is arranged along an axis (A3) (see figure below) substantially parallel to the adjustment axis (A4) (see figure below) and such that the two bone pins (560, 562) extend substantially perpendicularly to the adjustment axis (A4) (figures 21-22).
Regarding claim 66, Myers et al. disclose the openings (1142’s) in the at least one connection device is arranged along an axis (A3) at a distance from the adjustment axis (A4) (figure 22).
Regarding claim 67, Myers et al. disclose the distraction device (506) is arranged in one of the connection devices (figure 21), wherein the interconnecting system extends between the distraction device and the other connection device (figure 21).
Regarding claim 68, Myers et al. disclose the connection device is arranged to receive the bone pin at a distance from the adjustment axis (figures 21-22).
Regarding claim 69, Myers et al. disclose the first connection device is arranged to receive its bone pins at a distance from the adjustment axis in a first direction (figures 21-22), wherein the second connection device is arranged to receive its bone pins at a distance from the adjustment axis in a second direction being substantially opposite the first direction (if one so chooses by flipping the side it is located on the distraction device 506).
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
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