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 Amendment
The preliminary amendment filed May 12, 2025 has been entered. Claims 16-35 are currently pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-35 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 16, there is insufficient support in the disclosure for “a method of syndesmosis repair” comprising the steps of “securing one of the two fixation devices on a cortex of the first bone and securing the other of the two fixation devices within the second bone”. As shown in Figs 20-21 and para [0071-0073], the method of syndesmosis repair is described as comprising securing one of the two fixation devices on a cortex of the first bone and securing the other of the two fixation devices on a cortex of the second bone. For the purpose of examination, the claim is interpreted more broadly to include the construct (100d), including the flexible coupler, being secured within the within the second bone as the specification recites “Construct 100d is secured within the fibula 61 and tibia 62 of an ankle joint.” (para [0071]). Claims 17-29 are additionally rejected due to their dependency on claim 16.
Regarding claim 18, there is insufficient support in the disclosure for the step of “wherein the first fixation device exits on a medial side of the tibia and rests against a medial cortex of the tibia, and wherein the second fixation device is positioned within the fibula.” As shown in Figs 20-21, the method of syndesmosis repair is described as comprising: “the steps of drilling a hole 64 through fibula 61 and tibia 62; pulling a first button 70a through the hole 64 using a pull-through suture 35 and/or being pushed through on an inserter until the first button 70a exits on a medial side of the tibia 62; flipping the first button 70a so it rests against a medial cortex of the tibia 62; and positioning a second button 70b together with the weave pleat accordion-style region 55 at a lateral side of the fibula 61.” (para [0071]). The second fixation device (70b) is not inserted through the fibula, but rather is pulled against the lateral side of the fibula (Figs 20-21) and thus there is insufficient support for the step of second fixation device being positioned within the fibula.
Regarding claim 27, there is insufficient support in the disclosure for the step of “wherein passing the self-locking tensionable construct through the first bone tunnel and the second bone tunnel includes: passing one of the two fixation devices through the first bone tunnel in the first bone until the one of the two fixation devices exits on a medial side of the first bone; flipping the one of the two fixation devices so it rests against a medial cortex of the first bone; and anchoring the other of the two fixation devices within the second bone tunnel in the second bone. As shown in Figs 20-21, the method of syndesmosis repair is described as comprising: “the steps of drilling a hole 64 through fibula 61 and tibia 62; pulling a first button 70a through the hole 64 using a pull-through suture 35 and/or being pushed through on an inserter until the first button 70a exits on a medial side of the tibia 62; flipping the first button 70a so it rests against a medial cortex of the tibia 62; and positioning a second button 70b together with the weave pleat accordion-style region 55 at a lateral side of the fibula 61.” (para [0071]). The second fixation device or other of the two fixation devices (70b) is not secured within the second bone tunnel of the fibula, but rather is pulled against the lateral side of the fibula (Figs 20-21) and thus there is insufficient support for the step of anchoring the other of the two fixation devices within the second bone tunnel in the second bone. For the purpose of examination, the claim is interpreted more broadly to include the construct (100d), including the flexible coupler, being secured within the within the second bone as the specification recites “Construct 100d is secured within the fibula 61 and tibia 62 of an ankle joint.” (para [0071]). Thus, the step of “anchoring the other of the two fixation devices within the second bone tunnel of the second bone” is interpreted broadly as including anchoring the other of the two fixation devices within the second bone tunnel of the second bone through the flexible coupler positioned within the first and second bones.
Regarding claim 30, there is insufficient support in the disclosure for a method of “fracture stabilization” or passing a self-locking tensionable construct through first and second “bone fragments”. For the purpose of examination, the claimed method of “fracture stabilization” and terms “bone fragments” are interpreted broadly to include the method of ankle syndesmosis repair and passing a self-locking tensionable construct through the fibula (61) and tibia (62) as shown in Figs 20-21 and para [0071-0073], for example. Claims 31-35 are additionally rejected due to their dependency on claim 30.
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.
Claim(s) 16-17, 19, 23-32 and 35 is/are rejected under 35 U.S.C. 102(a)(1) as being ancitipated by Zajac et al. (US 2012/0123474, hereinafter “Zajac”).
Regarding claim 16, Zajak discloses a method of syndesmosis repair (para [0002]), comprising:
passing a self-locking tensionable construct (100) through a first bone tunnel (drill hole 88 through first bone 80) formed through a first bone of a joint and through a second bone tunnel (drill hole 88 through second bone 90) of a second bone of the joint (Figs 17-20; para [0076]), wherein the self-locking tensionable construct comprises:
a flexible coupler (30) attached to two fixation devices (10, 20), the flexible coupler having a first end and a second end, wherein the first end and the second end are run in opposition to one another to form a first closed, adjustable, continuous, knotless loop with an adjustable perimeter and a second closed, adjustable, continuous, knotless loop with an adjustable perimeter (Figs 15-16; para [0067]), respectively, wherein the first end is passed through the flexible coupler at least once (splice 44a) to form the first closed, adjustable, continuous, knotless loop with an adjustable perimeter and the second end is passed through the flexible coupler at least once (splice 44b) to form the second closed, adjustable, continuous, knotless loop with an adjustable perimeter (para [0068]); and
securing one of the two fixation devices (20) on a cortex of the first bone (tibia 90) and securing the other of the two fixation devices (10) within the second bone (fibula 80) (Fig 20; para [0076-0077]; the second fixation device 10 is interpreted as being secured within the second bone via the flexible coupler 30).
Regarding claim 17, further comprising pulling on the first end and the second end to adjust tension of the first closed, adjustable, continuous, knotless loop and the second closed, adjustable, continuous, knotless loop, and to bring the first bone closer to the second bone (para [0077]).
Regarding claim 19, wherein the first fixation device and the second fixation device are knotlessly secured relative to the first bone and the second bone without tying knots (para [0068, 0075]).
Regarding claim 23, wherein the first closed, adjustable, continuous,knotless loop includes at least one splice (44a) formed by splicing the first end through the flexible coupler (30).
Regarding claim 24, wherein the second closed, adjustable,continuous, knotless loop includes at least one splice (44b) formed by splicing the second end through the flexible coupler (30).
Regarding claim 25, wherein each of the two fixation devices (10, 20) is an implantable button (para [0038, 0043]) and wherein the flexible coupler (30) is suture or suture tape (para [0041]).
Regarding claim 26, wherein one of the two fixation devices is a round button (10) and the other of the two fixation devices is an oblong button (20) (para [0043]).
Regarding claim 27, wherein passing the self-locking tensionable (100) construct through the first bone tunnel (drill hole 88 through first bone 90) and the second bone tunnel (drill hole 88 through second bone 80) includes: passing one of the two fixation devices (20) through the first bone tunnel in the first bone until the one of the two fixation devices exits on a medial side of the first bone (90); flipping the one of the two fixation devices so it rests against a medial cortex of the first bone (90); and anchoring the other of the two fixation devices (10) within the second bone tunnel in the second bone (80) (Fig 20; para [0076-0077]; the second fixation device 10 is interpreted as being anchored within the second bone tunnel via the flexible coupler 30).
Regarding claim 28, wherein passing the one of the two fixation devices includes: connecting the one of the two fixation devices (20) to a suture passing instrument (85); and inserting the suture passing instrument through the first bone tunnel (90) and the second bone tunnel (80) to advance the one of the two fixation devices horizontally through the bone tunnel (para [0076]; Figs 17-20).
Regarding claim 29, wherein the syndesmosis repair is radioulnar syndesmosis or tibiofibular syndesmosis (Figs 17-20; para [0075-0077]; abstract).
Regarding claim 30, Zajak discloses method of fracture stabilization, comprising: passing a self-locking tensionable construct (100) through a first bone fragment (80) to be attached or reattached to a second bone fragment (90), wherein the self-locking tensionable construct comprises:
a flexible coupler (30) attached to a first fixation device (10) and a second fixation device (20), the flexible coupler having a first end and a second end; wherein the first end and the second end are run in opposition to one another to form a first closed, adjustable, continuous, knotless loop with an adjustable perimeter and a second closed, adjustable, continuous, knotless loop with an adjustable perimeter (Figs 15-16; para [0067]), respectively, wherein the first end is passed through the flexible coupler at least once (splice 44a) to form the first closed, adjustable, continuous, knotless loop with an adjustable perimeter and the second end is passed through the flexible coupler at least once (splice 44b) to form the second closed, adjustable, continuous, knotless loop with an adjustable perimeter (para [0068]);
securing the first fixation device (10) on a cortex of the first bone fragment (80) and securing the second fixation device (20) on a cortex of the second bone fragment (90); and pulling on the first end and the second end to adjust tension of the first closed, adjustable, continuous, knotless loop and the second closed, adjustable, continuous, knotless loop, and to reduce a distance between the first bone fragment and the second bone fragment (Fig 20; para [0076-0077]).
Regarding claim 31, wherein the self-locking tensionable construct consists essentially of the flexible coupler (30) and the two fixation devices (10, 20) (Figs 15-16).
Regarding claim 32, wherein each of the first and second fixation devices is a cortical button (Fig 20; para [0076-0077]).
Regarding claim 35, wherein each of the first and second ends is configured to be pulled to lock the self-locking tensionable construct (para [0038, 0068, 0077]).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 20-22 and 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zajac (US 2012/0123474), as applied to claims 16 and 30 above, further in view of Stone (US 2014/0046367, hereinafter “Stone”).
Regarding claims 20 and 33, Zajac discloses the invention substantially as claimed including the flexible coupler (30) having a first end and a second end, wherein the first end and the second end are run in opposition to one another to form a first closed, adjustable, continuous, knotless loop with an adjustable perimeter and a second closed, adjustable, continuous, knotless loop with an adjustable perimeter (Figs 15-16; para [0067]), respectively, wherein the first end is passed through the flexible coupler at least once (splice 44a) using a passing device to form the first closed, adjustable, continuous, knotless loop with an adjustable perimeter and the second end is passed through the flexible coupler at least once (splice 44b) using a passing device to form the second closed, adjustable, continuous, knotless loop with an adjustable perimeter (para [0068]). However, Zajac fails to disclose the first and second ends passed through the flexible coupler multiple times to form the continuous loops with first and second accordion-type weave regions, respectively, each having a plurality of locking points as claimed. Stone discloses a self-locking adjustable loop in a flexible coupler comprising an end (26) passed multiple times through the coupler (14) to form an accordion- type weave region (34) and a plurality of locking points (Figs 2A, 2; para [0039]). Stone teaches "the legs 38, by way of their non-parallel orientation to the second portion 30, can cause a transverse force to be applied to second portion 30 once tension is applied from the loop 46 and the second portion 30" (para [0042]). Additionally, "Such reduction in diameter can cause the legs 38 to squeeze or constrict around the portions of second portion 30 passing therethrough, which creates a mechanical interface between the interior portions or apertures of the legs 38 that are constricting around the portions of the second portion 30 passing therethrough. As a result, under tension, the mechanical interface along with the transverse force applied by each leg 38 can efficiently lock the second portion 30 to the accordion configuration 34 at a de sired size of loop 46" (para [0043]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zajac such that the splices (44a, 44b) with a single locking point instead comprised a plurality of locking points formed by each end being passed multiple times the through flexible coupler to form an accordion-type weave region, as claimed, wherein the accordion-type weave region and the plurality of locking points of each terminal end lock the two flexible, continuous, closed, knotless loops. Thus, Zajac would have the advantage of the transverse force and additional locking points improving the locking effect, as taught by Stone. Furthermore, substitution of one known element for another element providing the same function (i.e. a splicing method with a single locking point or a splicing method with multiple locking points) to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention.
Regarding claim 21, the combination teaches wherein the first accordion-type weave region (modified splice region 44a) and the second accordion-type weave region (modified splice region 44b) are located at a lateral side of one of the two bones (Figs 16-20).
Regarding claim 22, the combination teaches wherein the first accordion-type weave region (modified splice region 44a) and the second accordion-type weave region (modified splice region 44b) are located within one of the first bone tunnel and the second bone tunnel (Figs 16-20).
Regarding claim 34, wherein at least one of the first and second passing devices is a needle (40/41) (Fig 11; para [0061]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Albertorio (US 2010/0268273) additionally discloses a method comprising inserting a self-locking tensionable construct comprising first and second fixation devices (20, 30) attached to a flexible coupler (1) forming first and second closed, adjustable, continuous, knotless loops with an adjustable perimeter formed by an end passed through the flexible coupler at least once (eyesplices 2) (Fig 5).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M RODJOM/ Primary Examiner, Art Unit 3771
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