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 with respect to the currently pending claims 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.
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 5 and 9 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 claim 5, Applicant recites “the sheath has a tapered end, and the tapered end is configured to reduce resistance as the sheath is pulled through the core channel”. It is unclear how the sheath can be pulled through the core channel as the sheath is comprised of the core channel (see claim 1, lines 1-2).
Claim 9 recites the limitation "the at least one relief area" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 5, 7-12, 15 and 17-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kobayashi (US 2018/0161083).
Regarding claim 1, Kobayashi discloses a sheath (102) comprising, a core channel (126) extending along a first dimension (“L”, figure 2A), the core channel configured to receive a tensioning element (e.g. 10) so that the tensioning element extends along the core channel in the first dimension (figures 1, 4), a plurality of buckles (118, 120) configured to assist in guiding placement of the tensioning element in the core channel, the plurality of buckles extending perpendicularly to the first dimension to connect a first portion of the sheath to a second portion of the sheath (“left” and “right” halves bisected by the longitudinal axis “L” figures 1-4), wherein the tensioning element is configured to circumscribe a bone (figure 1), the sheath is configured to be placed around a bone when the tensioning element received in the core channel circumscribes the bone (figure 1), and the sheath is configured to prevent direct contact between the tensioning element and the bone as the tensioning element is tensioned (figures 1, 4).
Regarding claim 2, Kobayashi discloses the sheath is configured to completely envelop the core channel (figures 2A, 2B, 2D).
Regarding claim 3, Kobayashi discloses the sheath is configured to only partially envelop a portion of the core channel so that the core channel is partially exposed (figures 1-4).
Regarding claim 5, Kobayashi discloses the sheath has a tapered end (see figure below), wherein and the tapered end is configured to reduce resistance as the sheath is pulled through the body core channel (the reduced profile eases insertion).
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Regarding claim 7, Kobayashi discloses the sheath has at least one relief area (130) having less material as compared to a remaining portion of the sheath (figures 2B, 2D), and the at least one relief area is configured to increase ease of bending the sheath (¶24).
Regarding claim 8, Kobayashi discloses the sheath contains at least one of a honeycomb pattern, a square grid pattern, round weepholes, or an asymmetrical pattern (figures 2A-2E). Regarding claim 9, the at least one relief area is configured to increase ease of trimming the sheath to a desired length (capable as it reduces the thickness making it easier to cut than areas with greater thickness).
Regarding claim 10, Kobayashi discloses the sheath has a non-uniform cross section (figures 2A-2E), the sheath has at least one relief area (130) having less material as compared to a remaining portion of the sheath (figures 2B, 2D), wherein and the at least one relief area is configured to permit free passage of blood and other biologic fluids to pass through to reach a fracture site on the bone and contribute to biological healing (capable as the relief areas are through openings which can permit passage).
Regarding claim 11, Kobayashi discloses the sheath includes malleable material, and wherein the sheath is configured to conform to a contour of the bone when the sheath circumscribes the bone (figure 1).
Regarding claim 12, Kobayashi discloses a sheath assembly comprising, a tensioning element (10), a sheath (102) comprising a core channel (126) extending along a first dimension (“L”, figure 2A), the core channel configured to receive the tensioning element so that the tensioning element extends along the core channel in the first dimension (figures 1, 4); and a plurality of buckles (118, 120) configured to assist in guiding placement of the tensioning element in the core channel, the plurality of buckles extending perpendicularly to the first dimension to connect a first portion of the sheath to a second portion of the sheath (“left” and “right” halves bisected by the longitudinal axis “L” figure 1-4), wherein the sheath is configured to be placed around and positioned against a bone (figure 1), the sheath is configured to reduce direct contact between the tensioning element and the bone (figure 1).
Regarding claim 15, Kobayashi discloses the sheath includes malleable material (¶25), and the sheath is configured to conform to the contour of the bone when the sheath circumscribes the bone (figure 1).
Regarding claim 17, Kobayashi discloses the sheath has at least one relief area (130) having less material as compared to a remaining portion of the sheath (figures 2 B, 2D), wherein and the at least one relief area is configured to increase ease of bending the sheath (¶24).
Regarding claim 18, Kobayashi discloses the sheath has a non-uniform cross section (figures 2A-2E), the sheath has at least one relief area (130) having less material as compared to a remaining portion of the sheath (figures 2B, 2D), and the at least one relief area is configured to permit free passage of blood and other biologic fluids to pass through to reach a fracture site on the bone and contribute to biological healing (capable as the relief areas are through openings which can permit passage).
Regarding claim 19, Kobayashi discloses a method for applying a sheath assembly comprising providing a tensioning element (10); providing a sheath (120) having a core channel (126) extending along a first dimension (“L”, figure 2A), the sheath also comprising a plurality of buckles (118, 120) extending perpendicularly to the first dimension to connect a first portion of the sheath to a second portion of the sheath (“left” and “right” halves bisected by the longitudinal axis “L” figures 1-4); receiving the tensioning element in the core channel of the sheath so that the tensioning element extends along the core channel in the first dimension, wherein the plurality of buckles assist in guiding placement of the tensioning element in the core channel (figures 1, 4); positioning the tensioning element and the sheath around a bone (figure 1); and securing the tensioning element and the sheath relative to the bone (¶26).
Regarding claim 20, Kobayashi discloses the sheath comprises one or more spikes (132), and securing the tensioning element and the sheath relative to the bone includes applying the one or more spikes to the bone (figure 1, ¶30).
Regarding claim 21, Kobayashi discloses the sheath comprises the first portion and the second portion, the first portion and the second portion are connected via a bottom wall (110), the first portion and the second portion extend along the first dimension along an entire length of the sheath (figure 2C), the core channel is positioned between the first portion and the second portion (figure 2A-2B), and the plurality of buckles extend in a second dimension perpendicular to the first dimension to connect the first portion of the sheath to the second portion of the sheath (figure 2A-2E).
Regarding claim 22, Kobayashi discloses the sheath completely envelopes the tensioning element at each cross-section along the first dimension where a buckle of the plurality of buckles is present to prevent inadvertent disengagement of the tensioning element from the sheath (figure 1-4).
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi in view of Beyersdorf et al. (US 10,716,608).
Regarding claim 13, Kobayashi discloses the claimed invention except for the tensioning element comprises at least one bead, the at least one bead has an increased thickness compared to a remainder of the tensioning element, and the at least one bead is configured to restrain movement of the tensioning element relative to the sheath.
Beyersdorf et al. disclose the use of a tensioning element (12) having at least one bead (32, figure 8), the at least one bead has an increased thickness compared to a remainder of the tensioning element (figure 8), and the at least one bead is configured to restrain movement of the tensioning element relative to the sheath (column 7, lines 32-36) as they provide a mechanism to avoid displacement of the sheath on the tensioning element (column 7, lines 32-36).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the tensioning element to have at least one bead as taught by Beyersdorf et al. as the at least one bead provides a mechanism to avoid displacement of the sheath on the tensioning element.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi (US 2018/0161083) in view of Vadewalle (US 5,993,452).
Kobayashi discloses the tensioning element is a wire (¶2, ¶24), the tensioning element includes two free ends (figure 1, ends that get crimped by 134), wherein the tensioning element is configured to be tensioned by twisting the two free ends of the tensioning element together (capable or being crimped to one another), and the tensioning element is configured to compress the sheath against the bone when the tensioning element is tensioned (figure 1, 4, ¶26).
However, Kobayashi is silent to the tensioning element is a metal wire.
Vandewalle teaches the use of a metal wire as a tensioning element (column 5, lines 45-52) as it is a known material for forming a cable/tensioning element for the fastening and securement of bone fragments.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the tensioning element of Kobayashi to be a metal wire as taught by Vandewalle as metal is a known material for forming a cable/tensioning element for the fastening and securement of bone fragments.
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.
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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