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 amended independent claim 21 have been fully 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.
Regarding independent claim 33, applicant asserts that Voss fails to disclose a first handle section and second handle section as claimed. The examiner respectfully disagrees. Voss discloses an eyelet (110B) fixed to a second handle section (110C) and extending through a first handle section (102/104/106/114/118/122; fig. 1B, 2A-2C). Snare control tab (110C) can be considered the claimed second handle section as it is clearly capable of being grasped to manipulate the eyelet (110B). Applicant asserts that eyelet (110B) of Voss is not fixed to the snare control tab (110C), which is considered the claimed second handle section. This is not found persuasive as eyelet (110B) is clearly securely fastened to the snare control tab (110C) by the wire structure extending between the two elements. It is further noted that the claimed eyelet can be considered portion (110B) as well as the wire that connects portion (110B) to handle (110C). Movement of the second handle section (snare control tab 110C) results in movement of the eyelet (110B) as clearly illustrated in figs. 2a-2c of Voss and thus it is understood that these elements are fixed together.
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.
Claim 45 is 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.
The term “substantial” in the phrase “substantial portion” in claim 45 is a relative term which renders the claim indefinite. The term “substantial” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See MPEP 2173.05(b),I and Ex parte Oetiker, 23 USPQ 2d 1641 (Bd. Pat. App. & Inter 1992). For purposes of claim interpretation, the claim is being treated as though it reads “…extends along a .
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) 33-35 and 41 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Voss et al. (US 2013/0231701). Regarding claim 33, Voss discloses a suture locking system, comprising a suture loader (everything in fig. 1b but ferrule 116) including a first handle section (102/104/106/114/118/122; fig. 1B), a second handle section (110C) that is movable relative to the first handle section, and an eyelet (110B and unnumbered wire attaching 110B to 110C) that extends through the first handle section and is fixed to the second handle section (110C); and a locking ferrule (116) preassembled to the eyelet such that the eyelet is arranged through the locking ferrule (see figs. 2a-2b), wherein the second handle section (110C) is movable in a direction away from the first handle section (102/104116/114/118/122) to translate the eyelet through a cannulation of the locking ferrule (as understood in view of figs. 2A, 2B).
Regarding claim 34, the locking ferrule is received within a recess of the first handle section (102/106).
Regarding claim 35, the eyelet is received within the cannulation of the locking ferrule (noting eyelet is pulled through cannulation to pass suture therethrough; figs. 1b, 2a,b).
Regarding claim 41, the second handle section (110C) is movable between a first position in which the first handle section (102/104/106/114/118/122) and the second handle section (110C) are in abutting contact with one another and a second position in which the first handle section and the second handle section are spaced apart from one another. Noting this is a recitation of intended use, the second handle section (110C) of Voss can be advanced distally until it abuts the proximal face of portion 122 of the second handle section and thereafter be moved to a second position (e.g., position shown in fig. 1B) in which the first and second handle sections are spaced apart from one another.
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(s) 21-23, 26-32, 39, 42-43, 45, and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al. (US 2013/0231701) in view of Fleischman et al. (US 2019/0117210). Regarding claim 21, Voss discloses a suture locking system, comprising a locking ferrule (116; figs. 1b, 2a-d) including a cannulation surrounded by an inner diameter wall and a suture loader (110) arranged through the cannulation of the locking ferrule (figs. 2a-2c), but fails to expressly disclose a plurality of locking barbs protruding inwardly into the cannulation as claimed.
Regarding claim 39, as discussed above with respect to claim 33, Voss discloses a suture locking system as discussed above with respect to claim 33, including a locking ferrule (116) preassembled to the eyelet such that the eyelet is arranged through the locking ferrule (figs. 1b, 2a,2b), and a suture connectable to the eyelet of the suture loader, but fails to expressly disclose a plurality of locking barbs as claimed.
Regarding claim 46, Voss discloses a suture locking system comprising a suture loader (everything in fig. 1b but ferrule 116) including a first handle section (102/104/106/114/118/122; fig. 1B), a second handle section (110C) that is movable relative to the first handle section (figs. 2A-C), and an eyelet (110B and wire extending proximally from 110B) that extends through the first handle section and is fixed to the second handle section; a suture (112) connectable to the eyelet of the suture loader (fig. 2A), and a locking ferrule (116) including an outer diameter wall, an inner diameter wall, and a cannulation, the eyelet of the suture loader received within a recess of the first handle section (fig. 2a,2b), the second handle section (110C) is movable between a first position in which the first handle section and the second handle section are in abutting contact with one another and a second position in which the first handle section and the second handle section are spaced apart from one another. Noting this is a recitation of intended use, the second handle section (110C) of Voss can be advanced distally until it abuts the proximal face of portion 122 of the second handle section and thereafter be moved to a second position (e.g., position shown in fig. 1B) in which the first and second handle sections are spaced apart from one another. Movement of the second handle section from the first position to the second position causes the eyelet to translate through the cannulation of the locking ferrule to shuttle the suture through the cannulation while the locking ferrule remains seated in the recess (figs. 2a-2c). However, Voss fails to disclose a plurality of locking barbs protruding inwardly into the cannulation as claimed.
Fleischman discloses another ferrule (75) including a cannulation (103) surrounded by an inner diameter wall and a plurality of locking barbs (100) protruding inwardly from the inner diameter wall into the cannulation (figs. 9-11; figs. 56-58). The plurality of locking barbs are arranged in at least a 1st longitudinal row and a 2nd longitudinal row (see examiner-annotated fig. 57 below, noting circumferential offset of barbs in 1st longitudinal row from barbs in 2nd longitudinal row) that are spaced from one another along a length of the cannulation, wherein the locking barbs of the 1st longitudinal row are staggered circumferentially relative to the locking barbs of the 2nd longitudinal row such that the locking barbs of one row are positioned at circumferentially offset locations from the locking barbs of the other row.
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It would have been obvious to one of ordinary skill in the art to have modified the prior art of Voss to include a plurality of locking barbs protruding from the inner diameter wall and extending into the cannulation and having locking barbs of the first longitudinal row staggered circumferentially from locking barbs of the second longitudinal row as taught by Fleischman in order to further prevent movement of the suture within the ferrule in the loosening direction, thus facilitating better locking ([0121] of Fleischman).
Regarding claim 22, the locking ferrule (116) of Voss includes a body including an outer diameter wall, the inner diameter wall, and the cannulation is circumscribed by the inner diameter wall (see figs. 1b,2a,2b), and further wherein the plurality of locking barbs (100 of Fleischmann) are configured to lock the suture relative to the body of the locking ferrule as taught by Liu.
Regarding claim 23, wherein the body (116 of Voss) extends along a longitudinal axis between a proximal end and a distal end, and further wherein each of the plurality of locking barbs is angled in a direction toward the proximal end as taught by Fleischmann (best shown in figs. 10 and 11) .
Regarding claim 26, it is noted that the suture is not positively recited as part of the suture locking system. Since the prior art of Voss as modified by Fleischmann is capable of being used with a suture having a tapered region wherein the suture transitions between a thickened section and a thinned section, it meets this functional limitation.
Regarding claim 27, the suture loader includes a handle (110C of Voss) and an eyelet (110B).
Regarding claim 28, the eyelet is received through the cannulation of the locking ferrule to configure the suture loader for shuttling the suture through the cannulation (figs. 1B, 2A, 2B of Voss).
Regarding claim 29, the handle includes first handle section (102/104/106/114/118/122) and a second handle section (110C) that is movable relative to first handle section (the suture loader can be considered everything in fig. 1b other than the ferrule 116; note that 110 can be moved relative to 102/104/106/114/118/122).
Regarding claim 30, the eyelet extends through the first handle section of Voss (figs. 2a-3c) and is connected to the second handle section (110C).
Regarding claim 31, the second handle section is movable in a direction away from the first handle section to move the eyelet relative to the locking ferrule (figs. 1b,2a,2b of Voss).
Regarding claim 32, the locking ferrule is received within a recess of the handle (within recess at distal end of portion 102 of the handle; fig. 1b of Voss).
Regarding claims 42 and 43, the second handle section (110C) is movable between a first position in which the first handle section (102/104/106/114/118/122) and the second handle section are in abutting contact with one another and a second position in which the first handle section and the second handle section are spaced apart from one another. Noting this is a recitation of intended use, the second handle section (110C) of Voss can be advanced distally until it abuts the proximal face of portion 122 of the second handle section and thereafter be moved to a second position (e.g., where 110C has been retracted proximally away from 122) in which the first and second handle sections are spaced apart from one another. Movement of the second handle section (110C) from the first position to the second position causes the eyelet to translate through the cannulation of the locking ferrule to shuttle the suture through the cannulation while the locking ferrule remains seated in a recess of the first handle section (figs. 2A-2B of Voss).
Regarding claim 45, noting the 35 USC 112b rejection above, the plurality of locking barbs extends along a portion of the length of the cannulation as taught by Fleischman (figs. 10,11).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voss in view of Fleischman as applied to claim 21 above and further in view of Liu (US 2019/0076141) and To et al. (US 2008/0294177). Voss in view of Fleischman discloses the invention substantially as stated above including that the barbs integrally formed with the inner diameter wall, but is silent on the material of the barbs.
Liu discloses another locking ferrule having a plurality of barbs (210) extending inward from the inner diameter wall (fig. 2A). Liu discloses that the barbs may be rigid ([0031]), and discloses such a property as a known alternative to flexible barbs. To discloses another locking ferrule (930) fig. 25) having a plurality of barbs (as result of cuts 932; [0140]) extending inward of the inner diameter wall (similar to fig. 24A), the barbs made of metal ([0140]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Voss in view of Fleischmann to construct the barbs to be rigid and metallic in view of Liu and To’s teaching that such a material is known as suitable for the construction of locking barbs, and it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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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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KSH 4/24/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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