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, see pages 2-3, filed 05/28/2025, with respect to the rejection(s) of claim(s) 1-14 under 35 U.S.C. 103 under Re (US Pub No.: 2006/0052787) in view of Anderson (US Patent No.: 6,214,007), Jarvinen (US Pub No.: 2002/0040241) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Rubio (US Pub No.: 2017/0143470).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9, 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubio (US Pub No.: 2017/0143470).
Regarding claim 1, Rubio (US Pub No.: 2017/0143470) discloses a medical fastening device for the fastening of a graft (in the abstract, grafts in [0003]-[0004]), wherein the medical fastening device is configured to be inserted in a bone tunnel of a bone (in [0006]), and wherein said medical fastening device comprises: a first fastening element (figure 2 part 100), a second fastening element (figure 2 part 200), comprising: a first through conduit with a first end and a second end (part 202 that is in part 200), wherein said first through conduit extends along a first longitudinal axis (shown in figure 2. While part 202 is not labeled in figure 6, part 202 extends along a longitudinal axis in figure 6), a second fastening conduit with a first end and a second end (being the opening in part 100 along axis 101 shown in figure 4), wherein said second fastening conduit extends along a second longitudinal axis (the second longitudinal axis 101), wherein the first through conduit intersects the second fastening conduit inside the second fastening element (shown visually in figure 6 where parts 100 and 200 are attached to each other) with the first longitudinal axis and the second longitudinal axis defining an angle (a) with one another other than 0 (being the angle depicted in figure 4), and wherein the second end of the first through conduit and the second end of the second fastening conduit are joined defining an annular proximal surface (shown in figure 6 where the first and second through conduits are joined), such that when the graft is received in the second fastening element and the first fastening element is fastened in the second fastening conduit (in [0001]-[0002], where a soft material is passing through a bone tunnel defined in the abstract, where said soft material is defined as a graft in [0003]-[0004]), the graft extends through the first through conduit and out the second fastening conduit and is retained in an annular fastening passage defined between the first fastening element and the annular proximal surface (as openings are depicted in parts 100 and 200, and as a soft material is passing through the device as per the abstract with a graft disclosed in [0003]-[0004], a graft passes through the openings of the first and second conduits. Cone-shaped clamp in figures 2 and 6 to provide retaining force in [0007]).
Regarding claim 2, Rubio discloses the device according to claim 1, characterized in that the annular proximal surface is prolonged along the entire annular perimeter, defining a proximal cavity (shown in figures 2 and 5).
Regarding claim 3, Rubio discloses the device according to claim 1, wherein the second fastening element comprises a distal appendage with a first end and a second end (being the rim element in figure 4 with edges 130 and 140).
Regarding claim 4, Rubio discloses the device according to claim 3, wherein the second end of the distal appendage is connected to the first end of the first through conduit, the distal appendage projecting from the first end of the first through conduit (shown in figure 4).
Regarding claim 5, Rubio discloses the device according to claim 3, wherein the second end of the distal appendage is additionally housed in the first through conduit dividing said first through conduit into two sections, and the first end of the distal appendage projects from the first end of the first through conduit (as the soft material passes through the entirety of the device in the abstract, the soft material passes through a first through conduit and will project out of the first through conduit. Placement in the device shown in [0018]).
Regarding claim 6, Rubio discloses the device according to claim 4, wherein the first end of the distal appendage additionally comprises a hole (being the opening between both parts of the distal appendage), said hole being configured intended for the suspension of a bent end of the graft (bending of a graft via part 500 in [0018], where part 500 enters the device in figure 8, where it stands to reason that part 500 interfaces with the distal appendage as per what is depicted in figure 8), such that when the first fastening element is housed and fastened in the second fastening conduit of the second fastening element (shown in figure 6), the medical fastening device allows fastening at least one free end of the graft (as one end of a soft material is trapped in [0001]-[0002] and [0018], it is implied that the second end of the soft material projects out of the device) while simultaneously at the same time the hole allows maintaining the suspension of the at least one bent end of the graft (adjusting of part 500 in [0018] with griping elements 505, bent end of a soft material disclosed in [0018] with the end of the soft material at an acute angle).
Regarding claim 7, Rubio discloses the device according to claim 3, wherein: the distal appendage is a strip, cord, or band (being a graft in [0003]-[0004]), the first end of the distal appendage is connected to the second fastening element (trapping of a soft material in [0018]), and wherein the second end of the distal appendage is a free end (as one end of a soft material is trapped in [0001]-[0002] and [0018], it is implied that the second end of the soft material projects out of the device), such that when the fastening element is housed and fastened in the fastening conduit (in [0018]), the second end of the distal appendage is housed in the fastening passage (being one of the ends of the soft material in the abstract), configuring an adjustable loop (as the wedge element 500 defined as used for trapping a soft material in [0018] is depicted as being circular (as it passes through a circular part in figure 8), with the adjustable loop being configured for the suspension of a bent end of the graft (adjusting of part 500 in [0018] with griping elements 505, bent end of a soft material disclosed in [0018] with the end of the soft material at an acute angle).
Regarding claim 8, Rubio discloses the device according to claim 3, wherein: the distal appendage is a strip, cord, or band, and the first end (being a graft in [0003]-[0004], where said graft would be a band) and the second end of the distal appendage are connected to the second fastening element configuring a hole (as per the abstract, where a soft material is the graft that is entering the fastening elements through holes), the hole being configured for the suspension of a bent end of the graft (trapping of a soft material in [0018]), such that when the first fastening element is housed and fastened in the second fastening conduit of the second fastening element, the medical fastening device allows fastening at least one free end of the graft while simultaneously at the same time the hole maintains the suspension of the at least one bent end of the graft (in [0018], a trapping of one end of a soft material is disclosed, a suspension is shown in [0003]-[0004], with figure 8 taken to show a soft material along part 10 being suspended by the device).
Regarding claim 9, Rubio discloses the device according to The device according to wherein the first fastening element is a screw with a screw shaft and a head (shown in figure 4 where part 100 has an inner thread 152 and the rightmost end creates a head portion)), and a washer (part 300 in figure 2), and wherein the head of the screw comprises a circular step concentric to the shaft of the screw (part 170 in figure 4), and the washer comprises an inner circular step with a reciprocal shape with respect to the circular step concentric to the shaft of the screw (in figure 3, where part 300 interfaces with part 100), wherein said inner circular step is located in the area of the washer for receiving the head of the screw (shown in figure 3).
Regarding claim 11, Rubio discloses the device according to claim 1, wherein the angle (a) is comprised between 30˚ and 60˚ (the angle depicted in figure 4 is measured to be 45 degrees).
Regarding claim 12, Rubio discloses the device according to claim 1, wherein the second end of the second fastening element additionally comprises at least one flange located on an axis perpendicular to the second longitudinal axis (being the flanges part 320 in figure 5 that extend perpendicular with respect to the longitudinal of the screw of figure 5).
Regarding claim 13, Rubio discloses the device according to claim 12, wherein the second end of the second fastening element comprises two flanges located on the axis perpendicular to the second longitudinal axis (two flanges part 320 are shown in the bottommost image of figure 5 about part 301).
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(s) 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubio (US Pub No.: 2017/0143470) in view of Re (US Pub No.: 2006/0052787).
Regarding claim 10, Rubio discloses the the device according to claim 1, wherein the second fastening element comprises a movable junction area movable between the first through conduit and the second fastening conduit (being the outer thread 201 that is configured to move through the first through conduit and second fastening conduit, threads part 201 interface part 200 with part 100 such that the second fastening conduit within part 200 can move with respect to the first through conduit),
However, Rubio does not teach wherein said movable junction area is configured for: moving to a first position inside the second fastening conduit, and moving to a second position inside the first through conduit.
Instead, Re teaches wherein said movable junction area is configured for: moving to a first position inside the second fastening conduit, and moving to a second position inside the first through conduit (as the first through conduit is taken to extend within the second fastening conduit, when a screw element like 210 in figure 41 extends through the second fastening conduit, it would also extend within the first through conduit. As the screw would have to move to pass through the conduit, a movable element is present in said conduit).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the fastening means of Re into Rubio for the purpose of providing a component with a movable junction as presented in part 210 of Re into Rubi in order to provide a locking pin (defined in [0120]) that provides an additional means to fix a ligament as per [0114]. Fixing a retainer in place within a bone tunnel with a locking pin is also in [0027].
Regarding claim 14, Rubio teaches system for inserting a medical fastening device, comprising a medical fastening device according to claim 1. However, Rubio does not teach an inserter comprising a first end with a reciprocal shape with respect to a shape of the second fastening element and configured for engaging the second end of the second fastening element, a handle located at a second end of the inserter, and a coupling screw.
Instead, Re US Pub No.: 2006/0052787) teaches a system for inserting a medical fastening device, with Re disclosing a comprising a medical fastening device according to claim 1, an inserter (in [0036]), comprising a first end with a reciprocal shape with respect to a shape of the second fastening element and configured for engaging the second end of the second fastening element (in [0038]-[0039]), a handle located at a second end of the inserter (part 350 in figures 42-43 as per [0140]), and a coupling screw (while not called a screw, part 335 in figure 42 has grooves 345 that match the grooves within the retainer 205, as per [0140]. As such, part 335 is a coupling device with screw grooves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the inserter means of Re into Rubio in order to provide a system that can be used to implant the bone screw device of Rubio into a patient body via inserter part 225, while [0153] also details that the inserter interfaces with a graft ligament during insertion to allow for insertion of both the device and the graft.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hart (US Pub No.: 2013/0304099) discloses a fixation device with a bone tunnel in the abstract and graft details in [0025].
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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