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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on November 10th, 2025 is acknowledged.
Claims 16-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 11th, 2025.
Claim Objections
Claim 13 is objected to because of the following informalities: Applicant uses the phrase “wherein the second fixation element is loaded on the flexible strand such and/or”. This should read “wherein the second fixation element is loaded on the flexible strand Appropriate correction is required.
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 3, 5, 6, 8 and 10-11 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 2, 5, 6 and 8 Applicant recites “in particular…”. It is unclear if the claim is required to have the “in particular” if it is optional. The metes and bounds of this statement is unclear. For the purpose of examination, the “in particular” limitations are being treated as purely optional and not required to satisfy all limitations of the respective claims.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation “equal to or smaller than 4 mm”, and the claim also recites “preferably lies between 3 mm and 4 mm” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Additionally, claim 10 recites “preferably” it is unclear if the claim is required to have the preferred limitation or if it is optional. The Examiner suggests removing the entire preferably limitation and introducing the limitation without the word “preferably” in a dependent claim if they wish for the limitation to be further limiting.
Regarding claim 11, Applicant recites “in particular also for rotating” and “preferably wherein...”. It is unclear if the claim is required to have the “in particular” as well as the “preferably” limitation or if they are optional. The metes and bounds of these two statements is unclear. For the purpose of examination, both the “in particular” and “preferably” limitations are being treated as purely optional and not required to satisfy all limitations of the claims.
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 1-2 and 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bonutti et al. (US 2019/0133655), hereinafter Bonutti ‘19.
Regarding claim 1, Bonutti ’19, discloses a bone fixation device for fixation of a first bone (362, figure 30 or alternatively 364) and a second bone (364 or alternatively 362) to each other in a bone fracture and/or a joint dislocation, including a first fixation element (366, figure 30 or alternatively 372) configured for passing through a hole of the first bone (362, figure 30 or alternatively 364) and a hole of the second bone (364, figure 30 or alternatively 362) and for engaging the second bone (figure 30), a flexible strand (360), and a second fixation element (372, figures 30-31 or alternatively 366) configured for engaging the first bone and for securing the flexible strand (figures 26, 30), wherein the first fixation element includes a hollow cylinder (366 has a hollow cylinder as it is cylindrical in shape and has hollow portions in the holes through which 360 passes therethrough or alternatively see figure below), wherein the hollow cylinder extends in a direction of a longitudinal axis from a first end (see figure below) to a second end (see figure below) and has a wall defining a cylinder hollow space (wall forming one of the holes that 360 passes through or alternatively the portion of body which surrounds and forms openings 374/376) and, is configured for receiving the flexible strand (figure 30).
Regarding claim 2, Bonutti ’19 discloses, the first fixation element further includes at least one opening (see figure below, the hollow cylinder is the opening/forms the opening) that is configured for receiving the flexible strand, in particular formed in and/or on the wall of the hollow cylinder (Figure 30).
Regarding claim 10, Bonutti ’19 discloses an outer diameter of the hollow cylinder is equal to or smaller than 4 mm, preferably lies between 3 mm and 4 mm, and/or wherein a length of the hollow cylinder lies between 12 mm to 17 mm and/or wherein a thickness of the wall of the hollow cylinder lies between 0.5 mm and 1 mm and/or wherein an outer edge of a distal end face of the first fixation element is rounded (outer distal edge of 366 is rounded due to it the lobed cylindrical portions which form openings 374/376).
Regarding claim 11, Bonutti ’19 discloses the first fixation element includes at least one mating element (outer periphery of 372, figure 31) for mating with at least one mating element (334/336) of a pusher (208) for pushing and in particular also for rotating the first fixation element through the first bone and the second bone, preferably wherein the at least one mating element of the first fixation element includes a projection and/or a groove (372’s periphery has both projections and grooves figure 30, ¶112-113).
Regarding claim 12, Bonutti ’19 discloses the flexible strand is received by the first fixation element (figure 30).
Regarding claim 13, Bonutti ’19 discloses the second fixation element is formed as a plate-shaped element and/or includes at least one hole (374/376, figure 31) for receiving the flexible strand (figure 30) and/or wherein the second fixation element is loaded on the flexible strand such and/or the flexible strand is configured such that pulling the flexible strand when received by the first fixation element and the second fixation element causes the second fixation element to move in a direction opposite to the pulling direction for engaging the first bone (¶112-113).
Regarding claim 14, Bonutti ’19 discloses the device is configured for bone fixation in a lesser trochanteric fracture, in which a lesser trochanteric fragment is detached from the femur bone (if one so chooses to have the bone, 360 be one of these two), wherein the first bone is the femur bone (if one so chooses to have the bone, 360 be the femur), and the second bone is the lesser trochanteric fragment (if one so chooses to have the bone be the lesser trochanteric fragment), and/or being configured for bone fixation in an acromioclavicular joint dislocation, wherein the first bone is the clavicle and the second bone is the coracoid process (if one so chooses to have the bone, 360 be one of these two).
Regarding claim 15, Bonutti ’19 discloses an arrangement, including a bone fixation device (figure 26) for fixation of a first bone (364, figure 30) and a second bone (362, figure 30) to each other in a bone fracture and/or a joint dislocation (figure 30), including a first fixation element (372, figures 30-31) configured for passing through a hole of the first bone and a hole of the second bone (figure 31, if passes through in a left-to-right manner) and for engaging the second bone, a flexible strand (360), and a second fixation element (366) configured for engaging the first bone (364) and for securing the flexible strand (360), wherein the first fixation element includes a hollow cylinder (see figure below), wherein the hollow cylinder extends in a direction of a longitudinal axis from a first end (see figure below) to a second end (see figure below) and has a wall defining a cylinder hollow space (374, figure 31) and, is configured for receiving the flexible strand (360); and, a pusher (208, figure 28) for pushing the first fixation element of the bone fixation device through the hole of the first bone and the hole of the second bone, wherein the pusher includes at least one mating element (334/336, figure 28) that is configured to mate with at least one mating element (outer periphery of 372m, ¶112-113) of the first fixation element (¶112-113) and/or wherein the pusher has a pusher hollow space for passing through the flexible strand (¶112).
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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 3-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (US 2019/0133655) in view of Bonutti (US 5,403,348) hereinafter Bonutti ‘348.
Regarding claim 3, Bonutti ’19 discloses the claimed invention except for the at least one opening includes a wall hole formed in the wall of the hollow cylinder, in particular wherein the wall hole extends in a direction that is perpendicular or oblique to an outer circumferential surface and/or to an inner circumferential surface of the hollow cylinder.
Bonutti ‘348 discloses a fixation element (180, figure 20) having a hollow cylinder (body is a hollow cylinder) wherein an at least one opening (central bore of the hollow cylinder) includes a wall hole (any of 184-186/190/192) formed in the wall of the hollow cylinder (figure 20), in particular wherein the wall hole extends in a direction that is perpendicular or oblique to an outer circumferential surface and/or to an inner circumferential surface of the hollow cylinder (figure 2). The wall hole formed in the wall of the hollow cylinder allows for the suture to be able to cock or rotate the anchor to change its orientation between its insertion/installation condition and final or blocking condition (column 7, lines 43-47).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the first fixation element of Bonutti ’19 to have a wall hole formed in the wall of the hollow cylinder, in particular wherein the wall hole extends in a direction that is perpendicular or oblique to an outer circumferential surface and/or to an inner circumferential surface of the hollow cylinder as taught by Bonutti ‘348 as the wall hole(s) allows for the suture to be able to cock or rotate the anchor to change its orientation between its insertion/installation condition and final or blocking condition.
Regarding claim 4, Bonutti ’19 in view of Bonutti ‘348 disclose the wall hole is a through hole (184/186/190/192, figure 20) and communicates with the cylinder hollow space (figure 20 of Bonutti ‘348).
Regarding claim 5, Bonutti ’19 in view of Bonutti ‘348 disclose the at least one opening includes a further wall hole(186 is the wall hole with 190 being the further wall hole or alternatively 184 is the wall hole and 192 is the further wall hole of Bonutti ‘348), wherein the wall holes are arranged in a row in a direction from the first end to the second end, in particular parallel to the longitudinal axis, and/or arranged symmetrically to a central transverse axis of the hollow cylinder (figure 2 of Bonutti ‘348).
Regarding claim 7, Bonutti ’19 in view of Bonutti ‘348 disclose the at least one opening includes a channel (the channel is the main through bore which forms the hollow cylinder) formed inside the wall, the channel extending form the first end to the second end of the hollow cylinder (figure 2).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (US 2019/0133655) in view of Bonutti et al. (US 2006/0200199) hereinafter Bonutti ‘06.
Regarding claim 6, Bonutti ’19 discloses the claimed invention except for the at least one opening includes a slit in the wall, the slit extending from the first end in the direction from the first end to the second end, in particular wherein the at least one opening includes a further slit in the wall, the further slit extending from the second end of the hollow cylinder in the direction from the second end to the first end.
Bonutti ’06 discloses the use of a slit (“top” 16, figure 5B) extending from the first end (“top” end) in the direction from the first end to the second end (“bottom” end), in particular wherein the at least one opening includes a further slit in the wall (“bottom” 16, figure 5B), the further slit extending from the second end of the hollow cylinder in the direction from the second end to the first end (figure 5B, ¶51). The slits allow for a multiple of positions/variations in location of the passing suture (¶49).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have provided the device of Bonutti ’19 with at least one opening includes a slit in the wall, the slit extending from the first end in the direction from the first end to the second end, in particular wherein the at least one opening includes a further slit in the wall, the further slit extending from the second end of the hollow cylinder in the direction from the second end to the first end as taught by Bonutti ’06 as the slits allow for a multiple of positions/variations in location of the passing suture.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (US 2019/0133655) in view of Feigl (US 2003/0158562).
Regarding claim 8, Bonutti ’19 discloses the claimed invention except for the at least one opening includes a groove formed in an inner circumferential surface of the hollow cylinder and extending in a direction from the first end to the second end, in particular from the first end to the second end.
Feigl discloses the use of a groove (12, figure 1) formed in an inner circumference of the hollow cylinder (10, figure 1) and extending in a direction from the first end to the second end, in particular from the first end to the second end (figure 1) and is positioned in a manner which maximizes the performance of a suture passing through the hollow cylinder (¶42).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the at least one opening includes a groove formed in an inner circumferential surface of the hollow cylinder and extending in a direction from the first end to the second end as taught by Feigl as it is a known configuration which maximizes the performance of a suture passing through the hollow cylinder.
Regarding claim 9, Bonutti ’19 discloses the claimed invention except for the at least one opening includes a pocket formed on an inner circumferential surface of the hollow cylinder and/or wherein the at least one opening includes a channel that extends through the wall of the hollow cylinder and starts from and ends at the outer circumferential surface of the hollow cylinder.
Feigl discloses at least one opening includes a pocket (12, figure 2 or alternatively 40, figures 4A-4C) formed on an inner circumferential surface of the hollow cylinder and/or wherein the at least one opening includes a channel that extends through the wall of the hollow cylinder and starts from and ends at the outer circumferential surface of the hollow cylinder (figures 1, and 4A-4C ¶42-43) as it is a known configuration which maximizes the performance of a suture passing through the hollow cylinder (¶42-43).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the at least one opening includes a pocket formed on an inner circumferential surface of the hollow cylinder and/or wherein the at least one opening includes a channel that extends through the wall of the hollow cylinder and starts from and ends at the outer circumferential surface of the hollow cylinder as taught by Feigl as it is a known configuration which maximizes the performance of a suture passing through the hollow cylinder.
Conclusion
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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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619