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 2/24/26 have been fully considered but they are not persuasive.
Applicant argues that Foerster fails to disclose each and every element of the one-piece suture covering including a second end of a hollow region configured to hold and retain limbs of a flexible coupler by friction; entry and termination of coupler limbs within the hollow region, and a configuration for removable attachment and detachment from a flexible coupler.
Examiner notes Foerster US 6296659 discloses a one-piece suture covering comprises the same structure including a hollow portion and a tail, and would be configured to be perform the function as claimed, including receiving the limbs within the hollow portion from the second end and terminating within the hollow portion even if not the intended use. Although figure 3 of Foerster shows the tail being inserted back through the hollow portion, this is intended use of the assembly. The structure of Foerster is the same claimed structure, including a hollow region terminating in a single tail (see annotated figure 3 below). Examiner notes the covering is only configured to hold and retain limbs of a flexible coupler, the limbs of the flexible coupler are not being positively claimed as an assembly. The hollow region is configured to receive and hold limbs of a flexible coupler by friction by being inserted in either direction through the hollow portion first end (see annotated figure 3 below). The hollow region configured to hold or retain the limbs of a flexible coupler is functional language. Any limbs of sufficient size that are placed or inserted within the hollow region allows for the covering to retain the limbs by friction, as friction will be present between the contact of two structures. Examiner notes, the claim does not require a structure configured to collapse around and engage to frictionally engage the limbs, a suture placed within the hollow region will have at least a degree of frictional engagement between contact of two structures, and if large enough to fill the space within the hollow region, the limbs would be held and retained therein. Examiner further notes the device is not being modified to perform the function, but the device provides a structure configured to perform the function as claimed – by placing limbs of the flexible coupler within the covering hollow portion. The prior art discloses a structure arranged, shaped and set up to perform that function without any reconstruction of the suture covering. Examiner notes that the limbs are not positively claimed in claim 1, and must only be configured to be received by the hollow region (see annotated figure 3 below, limbs configured to be inserted through end of hollow region and terminate within the hollow region in this direction; the assembly does not require to have the intended use of the prior art, but only the claimed structure). Figure 3 shows the one-piece sure covering being detached from the flexible coupler. The flexible coupler may be attached or detached by inserting or removing the limbs of the flexible coupler into the hollow portion.
The rejections of claims 1, 2 and 4 by Foerster et al. are maintained.
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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.
Claim(s) 1, 2 and 4-7 is/are rejected under 35 U.S.C. 102(b) as being anticipated by Foerster US 6296659.
Regarding claim 1, Foerster discloses a one-piece suture covering comprising a hollow region 13 or 113 (figures 3 or 37) terminating in a single tail (figure 3, tail of 111; figure 37, tail 11), wherein the single tail is a smaller diameter suture (figure 3, portion 111 is smaller diameter than 113, tail 11 is smaller diameter than 13) wherein the hollow region is configured to hold and retain limbs of a flexible coupler by friction (configured to engage and be held by friction when limbs of a particular size are inserted within the portion 13 or 113, additionally or alternatively, the limbs may compressed to decrease in diameter to engage a suture creating a binding interface, for example, column 10, lines 15-24), the limbs of the flexible coupler entering the second end and terminating inside the hollow region (limbs are configured to be inserted through either end as it is a hollow passage therethrough, the limbs configured to terminate if not pulled all the way through; Examiner notes the one-piece suture covering comprises the same structure and would be configured to be perform the function as claimed, including receiving the limbs within the hollow portion) and wherein the hollow region is configured to be removably attached to and detached from the flexible coupler (a flexible coupler is configured to be inserted into the hollow portion 13 or 113, as they are separate from the suture covering, they are thereby configured to be disengaged or detached).
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Regarding claim 2, Foerster discloses the one-piece suture covering consisting essentially of suture (11 or 111 is a braided suture with a compressed suture portion 13 or 113, column 7, lines 1-6; column 9, lines 55-58).
Regarding claim 4, Foerster discloses wherein the single tail is configured to be passed with the limbs of the flexible coupler through soft tissue in a single step and without shuttling instrumentation (device comprises the same structure as the claimed device, therefore, although not disclosed, the claim limitations are functional language and the single tail must only be shaped and configured to pass through soft tissue in a single step and without shutting instrumentation).
Regarding claims 5-7, Foerster discloses wherein the limbs of the flexible coupler are slidingly attached to a fixation device being a suture anchor (Examiner notes the limbs are not positively claimed, and may be configured to be attached to a fixation device such as a surgical pledget or surgical anchor threaded onto the limbs, and to be placed adjacent the tissue being engaged), the suture is a high strength suture (Examiner notes the limbs are not positively claimed, and the one-piece suture covering is configured to hold and retain limbs of a flexible coupler being a suture or suture tape, the suture being a high strength suture).
Allowable Subject Matter
Claims 8-10 and 12-16 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Foerster US 6296659 discloses a suture covering comprising a hollow portion tapering down to a single tail (figure 3), but fails to disclose an assembly comprising a flexible coupler attached to a fixation device in combination with the suture covering.
Fucci et al. US 5697950 discloses a suture covering (70, figure 7B) attached to a flexible coupler attached to a fixation device, but does not disclose wherein the hollow region tapers down in combination with the hollow region being configured to be removably attached to and detached from the flexible coupler. Examiner notes the covering, or shrink tube, would only have a tapered portion once shrunk around the limbs of the flexible coupler, however, once shrunk it would not be configured to be attached and detached from the limbs.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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