DETAILED ACTION
This Office Action is a Response to Applicant’s Arguments and Amendment submitted 01/08/2026.
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 .
Claim Rejections - 35 USC § 112
The rejection of claim(s) 1-5 in the previous Office Action under this section, 2nd paragraph (pre-AIA ) or subsection (b) (AIA ), for being indefinite is hereby withdrawn in view of Applicant’s Amendment.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0052270 A1 to Fortson (hereinafter “Fortson”) in view of US 2019/0261964 A1 to Zung et al. (hereinafter “Zung”) (both references previously made of record by the Examiner).
Regarding claim 1, Fortson discloses (see abstract; Figs. 1-14E; [0003] & [0023]-[0061]) a method for minimizing a suture-based infection risk associated with tissue closure (see at least [0050]), comprising: advancing a suture delivery catheter (110) into and through an opening ("P") along a wall of a vessel ("VW") such that a distal catheter segment (122) rotates about a deployment segment (116) and the distal catheter segment is angled relative to a proximal catheter segment (112) (see Figs. 7A and 13A-B and [0050]); deploying a receiver member (124) from a low-profile configuration (Fig. 8A/13B) to a deployed configuration (Fig. 8B/13C) within the vessel such that a first receiver portion (left 152) and a second receiver portion (right 152) are each located at opposite ends of the receiver member and are each extended away from the suture delivery catheter and contacted against the wall adjacent to the opening (see Figs. 13B-C and [0038]/[0039]/[0051]); distally extending a forward needle member (left 138, Figs. 10/13B) from a first side of the proximal catheter segment and a rear needle member (right 138, Figs. 10/13B) from a second side of the proximal catheter segment opposite to the first side such that each of the needle members are pierced through the wall adjacent to the opening (see Figs. 10/13B and [0052]); and receiving the forward needle member into an opening (152) along the first receiver portion and the rear needle member into an opening (152) along the second receiver portion such that the forward needle member is received into a corresponding coupling member (left 140, see Figs. 9A-10) retained within the opening along the first receiver portion and the rear needle member is received into a corresponding coupling member (right 140, see Figs. 9A-10) retained within the opening along the second receiver portion (see [0042]-[0046]); retracting the forward needle member from the first receiver portion and the rear needle member from the second receiver portion such that a first suture length is retracted proximally through the wall adjacent to the opening (see Figs. 13E-H and [0053]-[0054]); and securing the first suture length with a tissue securement anchor which prevents movement of each of the suture lengths without a knot (see [0036]/[0054], operator has option to manually tie a knot but this is disclosed as a known equivalent to using a tissue securement anchor (aka, a clamp or locking tab) instead of tying a knot as per [0003], therefore, the operator has the option to secure the suture length with a clamp or locking tab which prevents movement of each of the suture lengths without a knot).
Fortson fails to specifically disclose wherein the at least one forward and rear needle members comprises two or more forward needle members and two or more rear needle members which are received into two or more openings along each of the first and second receiver portions in corresponding coupling members such that the suture lengths retracting proximally include a first and a second suture length. Essentially, Fortson fails to specifically disclose the "doubling" of the needle/suture structures in the device such that two lengths of suture are ultimately passed through the vessel wall and extend proximally. Zung discloses, in the same field of endeavor, a similar method for suturing a puncture in a blood vessel (in fact, compare Fortson's Figs. 7A-12 & 13A-G which correspond to Figs. 2A-7 & 13A-G of Zung), wherein Zung further discloses that the needle/suture structures can be "doubled" such that two lengths of suture are passed through the vessel wall and extend proximally (see [0115]) by providing more than two needles and associated receptacles, fittings, sutures, and the like (see [0115]) for the purpose of providing multiple suture loops which are useful for closing large punctures which allows a wide variety of stitching patterns to be provided (see [0115]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Fortson's device with the multiple needles, receptacles, fittings, sutures, and the like as taught by Zung in order to provide multiple suture loops which are useful for closing large punctures which allows a wide variety of stitching patterns to be provided.
The combination of Fortson and Zung would further disclose (claim 2) wherein the first suture length and the second suture length are inhibited from contacting tissue during advancement into and through the wall (see Figs. 10/13D of Fortson, suture lengths do not contact tissue); and (claim 6) wherein deploying the receiver member from the low-profile configuration comprises deploying the receiver member such that the first receiver portion and the second receiver portion are rotated in directions opposite to one another and into contact against the wall adjacent to the opening (see Figs. 8A/8B and 13B/13C of Fortson).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fortson and Zung, as applied to claim 1 above, and further in view of US 2002/0045908 A1 to Nobles et al. (hereinafter “Nobles”) (previously of record).
The combination of Fortson and Zung discloses the invention substantially as claimed as discussed above, however, with respect to claims 3-5, the combination fails to specifically disclose wherein advancing the distal catheter segment comprises retaining the first suture length and the second suture length within a sheath member slidably positioned over the deployment segment; sliding the sheath member proximally along the proximal catheter segment while advancing the distal catheter segment such that the deployment segment is exposed by proximal retraction of the sheath member; and wherein sliding the sheath member proximally comprises contacting tissue surrounding the opening via a proximal interface member while the distal catheter segment is advanced into and through the opening. Nobles discloses a method for suturing a tissue puncture (see at least [0011]), comprising a suture delivery catheter (800) inserted into and through a vessel wall, with the delivery catheter carrying suture portions (40), wherein advancing the distal catheter segment comprises retaining the suture portions within a sheath member (872) slidably positioned over the deployment segment (see Fig. 70 and [0310]-[0313]); sliding the sheath member proximally along a proximal catheter segment while advancing a distal catheter segment such that the deployment segment is exposed by proximal retraction of the sheath member (see Figs. 70-71 and [0310]-[0313]); and wherein sliding the sheath member proximally comprises contacting tissue surrounding the opening via a proximal interface member (proximal portion of sheath) while the distal catheter segment is advanced into and through the opening (see Figs. 70-71 and [0310]-[0313]) in the same field of endeavor for the purpose of protecting the exposed portions of the sutures as the device is inserted into the vessel (see [0311]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination's method with the step of protecting the suture with a sheath, as taught by Nobles, in order to protect the exposed portions of the sutures as the device is inserted into the vessel.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6 have been 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.
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 SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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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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/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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