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 07/16/2026 that prior art Sauer, Nobles, and Voss do not disclose the claims as amended specifically the actuator slidably disposed within the shaft, comprising a groove to receive the suture extending through the side aperture, and distally advances the suture lock from the shaft. The rejections have been withdrawn. New rejections with respect to Roorda and Nobles in view of Dana have been made below.
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 11, 13, 22, 23, 25, 27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2013/0053884 to Roorda.
As to claim 11, Roorda discloses a knot replacement device (paragraph 8) for use with a suture used to close an opening in tissue, the knot replacement device comprising: a handle (proximal portions of shafts 402,404) with a shaft (distal portion of 402) extending from the handle, the shaft comprising a side aperture (418, figure 4) configured to receive the suture (304) that is captured by the knot replacement device; a cutting member (420) configured to shear the suture extending through the aperture (paragraph 55); a suture lock (100, figure 4) disposed in a distal end of the shaft, the suture lock comprising a suture receiving opening (402); and an actuator (distal portion of 404) extending from the handle and slidably disposed within the shaft (paragraph 50), the actuator comprising a groove 416) configured to receive the suture extending through the side aperture, where the actuator is configured to slidably engage with the suture lock and distally advance the suture lock from the shaft (paragraph 50, 51).
As to claim 13, Roorda discloses wherein the suture lock comprises a distal portion (the distal end of 100, figure 3) and a proximal portion (side surface and portion extending from the end of 100, figure4), the distal portion comprising a front face (figure 4) and the proximal portion comprising first structures (“complimentary structure”, paragraph 62) to resist twisting or rotating of the suture lock in relation to a distal end of the shaft.
As to claim 22, Roorda discloses the cutting member comprises a distal cutting edge (figure the cutting edge 420 is distal to the aperture, so can be considered a “distal cutting edge”).
As to claim 23, Roorda discloses the distal cutting edge is configured to cooperate with the distal end of the side aperture to define a shearing interface (paragraph 55).
As to claim 25, Roorda discloses the suture lock is releasably retained within the distal end of the shaft prior to distal advancement by the actuator (paragraph 50, 51).
As to claim 27, Roorda discloses the actuator comprising the groove is aligned with the side aperture (figure 4).
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.
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.
Claims 11, 12, 16-29 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2007/0010829 to Nobles in view of U.S. Patent Publication 2003/0181926 to Dana.
As to claim 11, Nobles discloses a knot replacement device (100, paragraph 46) for use with a suture used to close an opening in tissue, the knot replacement device comprising: a handle (102, figure 2) with a shaft (114) extending from the handle, the shaft comprising a side aperture (120) configured to receive the suture (34, figure 20) that is captured by the knot replacement device; a cutting member (distal end 123 of the intermediate tube 116, paragraph 48) configured to slidably cooperate with a distal end of the aperture of the shaft to shear the suture extending through the aperture (figure 21-22, paragraph 58); a suture lock (124) disposed in a distal end of the shaft, the suture lock comprising a suture receiving opening (136 including the lumen of the plug 124, alternatively any of the other knot body embodiments with a suture receiving opening as seen in figure 12, 15, 16a,b, 18a-c, 24); and an actuator (118) extending from the handle and slidably disposed within the shaft, where the actuator is configured to slidably engage with the suture lock and advance the suture lock from the shaft (paragraph 48, 58, 60, figure 19-23) but is silent about the actuator comprising a groove configured to receive the suture extending from the side aperture.
Dana teaches a similar device (suture device, abstract) having an actuator (28, figure 4) with a groove (26, paragraph 65) configured to receive a suture extending through a side aperture of a shaft (figure 5-7, 20b) in order to protect the suture from unintentional cutting of the suture (paragraph 65, 69). It would have been obvious to one of one ordinary skill in the art before the effective filing date to have the actuator of Nobles comprise a groove configured to receive the suture extending through the side aperture in order to protect the suture from unintentional cutting of the suture.
As to claim 12, with the device of Nobles and Dana above, Nobles discloses wherein the cutting member and the actuator are coaxially disposed within the shaft (figure 20).
As to claim 16, with the device of Nobles and Dana above, Nobles discloses the suture receiving opening comprises a second structure (either 134 that defines the narrowing of the lumen in the embodiment of figure 5, or 198 in figure 16a,b, or 210 on figure 18a-c) to retain the suture within the suture receiving opening.
As to claim 17, with the device of Nobles and Dana above, Nobles discloses wherein the second structure comprises one or more grooves (figure 5; figure 16a,b; 18a-c). The structure of each embodiment will define at least one or more grooves
As to claim 18, with the device of Nobles and Dana above, Nobles discloses the one or more grooves are formed axially, non-axially, spirally, helical, or combinations thereof (figure 5; figure 16a,b; 18a-c).
As to claim 19, 21, with the device of Nobles and Dana above, Nobles discloses the one or more grooves have a uniform or non-uniform depth along a length of the one or more grooves (figure 5; figure 16a,b; 18a-c). The grooves will either have a uniform and non-uniform depth as seen in the figures.
As to claim 20, with the device of Nobles and Dana above, Dana further teaches a first lever (45, paragraph 62) configured to control movement of the cutting member and a second lever (40, paragraph 62) configured to control movement of the actuator for the purpose of controlling movement of portions of the device. It would have been obvious to one of ordinary skill in the art before the effective filing date to have Nobles use a first lever configured to control movement of the cutting member and a second lever configured to control movement of the actuator in order to control movement of the actuator and the cutting member
As to claim 22, with the device of Nobles and Dana above, Nobles discloses the cutting member comprises a distal cutting edge (figure 7).
As to claim 23, with the device of Nobles and Dana above, Nobles discloses the distal cutting edge is configured to cooperate with the distal end of the side aperture to define a shearing interface (paragraph 55).
As to claim 24, with the device of Nobles and Dana above, Dana teaches the groove extends longitudinally along an outer surface of the actuator (figure 4-7).
As to claim 25, with the device of Nobles and Dana above, Nobles discloses the suture lock is releasably retained within the distal end of the shaft prior to distal advancement by the actuator (paragraph 53).
As to claim 26, with the device of Nobles and Dana above, Nobles discloses the actuator is biased in a distal direction (paragraph 49, the actuator can be biased in the distal direction based on the engagement of 108 with the proximal end of 116).
As to claims 27-29, with the device of Nobles and Dana above, Dana teaches the actuator comprising the groove is aligned with the side aperture (at least figure 5-7) and Nobles discloses the actuator extends into a proximal portion of the suture receiving opening (figure 21).
Claim 14 is rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2013/0053884 to Roorda in view of U.S. Patent P6,126,677 to Ganaja
As to claim 14, Roorda discloses the device above including the shaft comprising detents (“complimentary structure”, paragraph 62) as the first structures, but is silent about the shaft is crimped to the suture lock.
Ganaja teaches a similar device (suture fastener) where a suture lock is crimped onto the shaft in order to attach an anchor to ta delivery device (col. 7 ll. 41-47). It would have been obvious to one of ordinary skill in the art before the effective filing date for the shaft of Roorda to be crimped to the suture lock in order to help attach the suture lock to the device.
Claim 15 is rejected under 35 U.S.C. 103 as obvious over U.S. Patent Publication 2013/0053884 to Roorda.
As to claim 15, Roorda discloses the device above but is silent about an engagement force between the suture lock and the shaft is about 0.5 lbf to about 1.25 lbf. Roorda discloses in paragraph 62 that the suture lock is held by a friction fit within the shaft, so there will be an engagement force. The engagement force will be controlled in order for how much the actuator needs to be pushed to expel the suture lock. As such, an engagement force is disclosed to be a result effective variable in that the amount of force applied to the suture lock can control when the suture lock is deployed. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Roorda to have an engagement before within the claimed range as it involves only adjusting the characteristics of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Roorda by making the engagement force be between 0.5 lbf to about 1.25 lbf as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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