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 .
Formal Matters
Applicant’s Response and Amendments filed 9 March 2026 are acknowledged and entered. Claims 2-4, 6, 16, 17, 23-25 are cancelled. Claims 1, 5, 7, 8, and 15 are currently amended. Claims 21, 22, and 26-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse during a telephone call with Bradley Edgington on 24 February 2025 and confirmed in writing the reply filed on 9 March 2026. Withdrawn claims 21 and 28 are also currently amended. Claims 1, 5, 7-15, and 18-20 are under examination.
Response to Arguments
Applicant incorporates the subject matter of prior claims 2-4 and 6 into independent claim 1 and the subject matter of prior claims 16 and 17 into independent claim 15. Applicant argues that Weldon fails to disclose each and every limitation of the amended claims, specifically the stabilizer and the positioning element, which are claimed as separate entities. Applicant’s arguments have been fully considered, but they are not persuasive. Applicant’s attention is drawn to the rejection of original claims 5 and 7, as provided of record and below, where the separate components of the stabilizer element and the positioning element were expressly separately delineated according to the recitations in the claims and where the claim mapping expressly shows the multiple separate elements of these embodiments as well as the scope of the claims, as written, showing that both the stabilizer element and the positioning element could be the same component (e.g. a balloon, a stent, a disc, or a sheath) as expressly recited in both claims 5 and 7. Given the combinatorial amendments to the claims, modified rejections are set forth below, necessitated by amendment.
Applicant’s request for an Interview is noted. However, given the amendments to the claims, an Interview would not be productive at this time given the modified rejections set forth below, based on the multiple combinatorial amendments to the claims.
Rejections Withdrawn
Rejections drawn to cancelled claims 2-4, 6, 16, 17 are withdrawn as moot. To the extent the subject matter of the withdrawn claims has been incorporated into the remaining claims, modified rejections are set forth below.
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.
Claims 1, 5, 7-13, 15,and 18-20 are rejected under 35 USC 103 as being unpatentable over Weldon et al., US 20050154401 (14 July 2005) (previously cited of record).
Regarding independent claim 1, Weldon teaches a system for radial cinching of an opening in an internal biological structure (FIGs 9A, 9C, 10), the system comprising:
a tensioning tube (delivery sheath 86) extending between a distal end and a proximal end (FIGs 9A, 9C);
a plurality of sutures (¶¶18, 20, 41; sutures 66) configured for deployment (FIGs 9A, 9C, 10) within the tensioning tube (86) from the proximal end to exit via the distal end of the tensioning tube (86), wherein the tensioning tube is configured to constrain movement of portions of the plurality of sutures disposed within the tensioning tube away from each other (¶41; tubes 94); and
a plurality of delivery tubes (94), each of the plurality of delivery tubes configured to receive a distal end of one the plurality of sutures after exiting from the distal end of the tensioning tube, wherein the plurality of delivery tubes (94) are further configured to deploy the distal ends of the plurality of sutures (66) proximate a periphery of the opening (FIG 10); and
wherein, upon deployment of the sutures proximate the periphery of the opening, tensioning of one or more of the plurality of sutures while movement of portions of the plurality of sutures is constrained by the tensioning tube causes radial cinching of the periphery to close the opening (FIG 10; ¶47; claim 46);
a delivery catheter (delivery sheath 86, ¶48), wherein the tensioning tube and the plurality of delivery tubes are deployable within a lumen of the delivery catheter (FIGs 9A, 10).
Weldon does not teach all elements of the amended claim within the same embodiment of FIGs 9A, 9C, and 10.
Weldon teaches a guidewire (guidewire 72) in embodiments shown in FIGs 5-7B and 8.
Weldon teaches a stabilizer (outer/delivery sheath 74, ¶29) deployable over the guidewire and configured to be disposed on a side of the opening that does not include the plurality of sutures such that the stabilizer can stabilize the plurality of delivery tubes with respect to the opening during deployment of the sutures in embodiments shown in FIGs 5-7B (¶29).
Weldon teaches a positioning element in embodiments shown in FIG 8 (inflatable member 90) deployable over the guidewire and configured to control positioning of the sutures during deployment (¶37, “inflatable member 90 can be inflated to drive radial expansion of end 81 of graft 18 to frictionally engage the inside of vessel wall 12. This ensures that graft 18 is expanded and held in the proper position during deployment of the tubes 32 of suturing device 30”) by causing outward bending of one or more of the plurality of delivery tubes (¶39, “inflatable member90 has an end 92 which is curved to have an outward conformation that generally corresponds to the conformation of tubes 32 in the radially expanded position. This allows inflatable member 90 to exert frictional pressure on graft 18 in the radial outward direction at a point closely proximate the tips of tubes 32, as they engage graft 18”).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the different embodiments of Weldon for particular device use-cases such as different anatomical surgical needs, given that the multiple embodiments are taught within the same reference and utilize the same base-hypotube suture delivery device.
Although the embodiments taught in FIGs 9A, 9C, and 10, disclose the base suture delivery device comprising a plurality of sutures configured to radially cinch an opening in an internal biological structure, such as a blood vessel, the embodiments taught in FIGs 9A, 9C, and 10 do not expressly teach a guidewire, a stabilizer, or a positioning element within that individual embodiment.
Weldon specifically addresses other elements of the suturing device in other embodiments within the same reference in addition to the base suture delivery device.
Weldon specifically addresses the apparatus comprising a guidewire (guidewire 72) and a stabilizer component (outer/delivery sheath 74, ¶29) deployable over the guidewire and configured to be disposed on a side of the opening that does not include the plurality of sutures such that the stabilizer can stabilize the plurality of delivery tubes with respect to the opening during deployment of the sutures in embodiments shown in FIGs 5-7B (¶29). Weldon specifically addresses the apparatus comprising a positioning element in embodiments shown in FIG 8 (inflatable member 90) deployable over the guidewire and configured to control positioning of the sutures during deployment (¶37) by causing outward bending of one or more of the plurality of delivery tubes (¶39).
Because Weldon teaches the multiple component elements of a suture apparatus system in different embodiments within the same reference, a person of ordinary skill in the art, seeking to provide an end-to-end system for radially cinching a vessel, for example, using Weldon’s base tensioning tube, plurality of sutures, and plurality of delivery tubes (hypotubes) would reasonably consult Weldon’s other system components to avoid creating a novel suture delivery system. The components of Weldon’s suture delivery system components can be readily incorporated alongside Weldon’s base tensioning tube, plurality of sutures, and plurality of delivery tubes using known assembly methods without redesigning Weldon’s core device and suture delivery path. Because the different embodiments of Weldon address the same engineering problem (an apparatus for radial cinching of a vessel) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a delivery catheter, a guidewire, a stabilizer, and a positioning element), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
The phrase “tensioning tube” is interpreted under the broadest reasonable interpretation standard. The specification recites that “the tensioning tube may be configured to constrain movement of portions of the plurality of sutures disposed within the tensioning tube away from each other” (¶¶7, 15). The specification at ¶20 recites “deploying a tensioning tube within a lumen of the delivery catheter, the tensioning tube being axially rigid; deploying a plurality of sutures through a proximal end of the tensioning tube to exit from a distal end of the tensioning tube”. The specification at ¶44 recites “a tensioning tube that prevents outwards movement of the sutures while being tensioned”. Accordingly, the tensioning tube is broadly interpreted to encompass the constraining and outward motion preventing movement of the sutures while being tensioned.
Weldon does not teach “a tensioning tube” using that specific label, as a tube having a special purpose of holding tension. Weldon teaches tube 86 at FIGs 9A, 9C, and 10, which comprises the multiple hypotubes containing sutures. It is innate in the design and structure of the plurality of hypotubes that tension is held within the structure and supported by the delivery sheath 86. Claim 46 of Weldon expressly recites “a delivery sheath slidable over the array of delivery tubes, the delivery sheath holding the delivery tubes in the contracted position and removal of the delivery sheath allowing movement of the delivery tubes into the deployment position”. The “holding the delivery tubes in the contracted position” indicates tensioning or the ability to tension.
One of ordinary skill in the art would have recognized the structural functionality of the hypotubes 32 taught by Weldon based on the express teachings in Weldon, even if the “fixation system components” of Weldon were not labeled as “a tensioning tube”. The delivery sheath is taught as capable of holding tension of the hypotubes and the hypotubes themselves are taught as being resilient within the text and Figures of Weldon’s disclosure. One of ordinary skill in the art before the effective filing date of the claimed invention, would have recognized these functional attributes and understood their predictable results in a fixation system.
Regarding claim 5, Weldon teaches the system of claim 1, as set forth above, wherein the stabilizer is selected from at least one of the following: a balloon (FIG 8; ¶17, inflatable member 90), a stent (¶25), a disc, or a sheath (¶26, outer/delivery sheath 74).
Regarding claim 7, Weldon teaches the system of claim 1, as set forth above, wherein the positioning element is selected from at least one of the following: a balloon (¶17, 90), a stent (¶25), a disc, or a sheath (¶26 delivery sheath 74).
Regarding claim 8, Weldon teaches the system of claim 1, as set forth above, wherein the plurality of sutures are configured to be either symmetrically deployed or asymmetrically deployed around the periphery of the opening (FIGs 9A-C, 10).
Regarding claim 9, Weldon teaches the system of claim 1, as set forth above, further comprising a suture lock (¶¶44, 49, graft 18) configured to lock the plurality of sutures in a tensioned state after the opening is closed (¶¶33, 44, 49).
Regarding claim 10, Weldon teaches the system of claim 1, as set forth above, wherein the distal ends of each of the plurality of sutures is associated with a suture anchor, the suture anchor being in a compressed state when the distal end of the corresponding suture is disposed within a delivery tube (FIGs 7B, 8; ¶26; fasteners 34, 50; fixation components 36, 38; tether 40).
Regarding claim 11, Weldon teaches the system of claim 10, as set forth above, wherein the suture anchor is configured to be in an expanded state upon deployment from the delivery tube and anchor the corresponding suture to the periphery (FIGs 7B, 8, 10; ¶26; fasteners 34, 50; fixation components 36, 38; tether 40; claims 44-46).
Regarding claim 12, Weldon teaches the system of claim 1, as set forth above, wherein each of the plurality of sutures is configured to be individually controlled for deployment and tensioning (FIGs 9A-9C; ¶41-45).
Regarding claim 13, teaches the system of claim 1, as set forth above, wherein the opening is located within a cardiovascular region (¶¶1-3, 22, 24, vascular graft for treating an ascending aortic aneurism (AAA)).
Regarding independent claim 15, Weldon teaches a system for radial cinching of an opening in an internal biological structure (FIGs 9A-9C, 10), the system comprising:
a delivery catheter (delivery sheath 86, ¶48), wherein the tensioning tube and the plurality of delivery tubes are deployable within a lumen of the delivery catheter (FIGs 9A, 10); and
a suturing device (FIGs 9A-C, needles 62, 64; suture 66) comprising:
an axially rigid tensioning tube deployable, via the delivery catheter, to the opening (FIGs 9A, 10, claim 46);
a plurality of sutures (¶¶18, 20, 41; sutures 66) configured for deployment (FIGs 9A, 9C, 10) within the tensioning tube (86) from the proximal end to exit via the distal end of the tensioning tube (86), wherein the tensioning tube is configured to constrain movement of portions of the plurality of sutures disposed within the tensioning tube away from each other (¶41; tubes 94); and
a plurality of delivery tubes (94) disposed within the delivery catheter (86), each of the plurality of delivery tubes configured to receive a distal end of one the plurality of sutures after exiting from the distal end of the tensioning tube (FIG 9A, ¶41),
wherein the plurality of delivery tubes are further configured to deploy the distal ends of the plurality of sutures proximate a periphery of the opening (FIG 9A-C, ¶41),
the distal ends of the plurality of sutures associated with suture anchors (¶48),
a suture lock disposed near the distal end of the tensioning tube (T-fastener 34) and
wherein, upon deployment of the sutures proximate the periphery of the opening, tensioning of one or more of the plurality of sutures while movement of portions of the plurality of sutures is constrained by the tensioning tube causes radial cinching of the periphery to close the opening (FIG 10; ¶47; claim 46).
Weldon does not teach all of the elements of the amended claim within the same embodiment of FIGs 9A-9C, and 10.
Weldon teaches a guidewire (guidewire 72) in embodiments shown in FIGs 5-7B and 8.
Weldon teaches a stabilizer (outer/delivery sheath 74, ¶29) deployable over the guidewire and configured to stabilize the suturing device with respect to the opening during the deployment of the sutures in embodiments shown in FIGs 5-7B (¶29).
Weldon teaches a positioning element in embodiments shown in FIG 8 (inflatable member 90) deployable over the guidewire and configured to control positioning of the sutures during deployment (¶37, “inflatable member 90 can be inflated to drive radial expansion of end 81 of graft 18 to frictionally engage the inside of vessel wall 12. This ensures that graft 18 is expanded and held in the proper position during deployment of the tubes 32 of suturing device 30”) by causing outward bending of one or more of the plurality of delivery tubes (¶39, “inflatable member90 has an end 92 which is curved to have an outward conformation that generally corresponds to the conformation of tubes 32 in the radially expanded position. This allows inflatable member 90 to exert frictional pressure on graft 18 in the radial outward direction at a point closely proximate the tips of tubes 32, as they engage graft 18”).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of the different embodiments of Weldon for particular device use-cases such as different anatomical surgical needs, given that the multiple embodiments are taught within the same reference and utilize the same base-hypotube suture delivery device.
Although the embodiments taught in FIGs 9A-9C, and 10, disclose the base suture delivery device comprising a plurality of sutures configured to radially cinch an opening in an internal biological structure, such as a blood vessel, the embodiments taught in FIGs 9A-9C, and 10 do not expressly teach a guidewire, a stabilizer, or a positioning element within that individual embodiment.
Weldon specifically addresses other elements of the suturing device in other embodiments within the same reference in addition to the base suture delivery device.
Weldon specifically addresses the apparatus comprising a guidewire (guidewire 72) and a stabilizer component (outer/delivery sheath 74, ¶29) deployable over the guidewire and configured to stabilize the suturing device with respect to the opening during the deployment of the sutures in embodiments shown in FIGs 5-7B (¶29). Weldon specifically addresses the apparatus comprising a positioning element in embodiments shown in FIG 8 (inflatable member 90) deployable over the guidewire and configured to control positioning of the sutures during deployment (¶37) by causing outward bending of one or more of the plurality of delivery tubes (¶39).
Because Weldon teaches the multiple component elements of a suture apparatus system in different embodiments within the same reference, a person of ordinary skill in the art, seeking to provide an end-to-end system for radially cinching a vessel, for example, using Weldon’s base tensioning tube, plurality of sutures, and plurality of delivery tubes (hypotubes) would reasonably consult Weldon’s other system components to avoid creating a novel suture delivery system. The components of Weldon’s suture delivery system components can be readily incorporated alongside Weldon’s base tensioning tube, plurality of sutures, and plurality of delivery tubes using known assembly methods without redesigning Weldon’s core device and suture delivery path. Because the different embodiments of Weldon address the same engineering problem (an apparatus for radial cinching of a vessel) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a delivery catheter, a guidewire, a stabilizer, and a positioning element), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
The phrase “tensioning tube” is interpreted under the broadest reasonable interpretation standard. The specification recites that “the tensioning tube may be configured to constrain movement of portions of the plurality of sutures disposed within the tensioning tube away from each other” (¶¶7, 15). The specification at ¶20 recites “deploying a tensioning tube within a lumen of the delivery catheter, the tensioning tube being axially rigid; deploying a plurality of sutures through a proximal end of the tensioning tube to exit from a distal end of the tensioning tube”. The specification at ¶44 recites “a tensioning tube that prevents outwards movement of the sutures while being tensioned”. Accordingly, the tensioning tube is broadly interpreted to encompass the constraining and outward motion preventing movement of the sutures while being tensioned.
Weldon does not teach “a tensioning tube” using that specific label, as a tube having a special purpose of holding tension. Weldon teaches tube 86 at FIGs 9A, 9C, and 10, which comprises the multiple hypotubes containing sutures. It is innate in the design and structure of the plurality of hypotubes that tension is held within the structure and supported by the delivery sheath 86. Claim 46 of Weldon expressly recites “a delivery sheath slidable over the array of delivery tubes, the delivery sheath holding the delivery tubes in the contracted position and removal of the delivery sheath allowing movement of the delivery tubes into the deployment position”. The “holding the delivery tubes in the contracted position” indicates tensioning or the ability to tension.
A “suture anchor” is broadly interpreted as being a structure with the function of “anchorage of the distal ends of the sutures around a periphery of the opening” (Specification ¶57). The specification discloses that FIGs 3A-3E are some embodiments suture anchors (¶27). Suture anchors 113 are taught at ¶62 of the Specification. Paragraph 66 of the Specification also recites that “other types of anchors are also possible, such as pledget-based anchors. In some examples, one or more of the anchors may have additional features to facilitate radial cinching of an opening”.
A “suture lock” is broadly interpreted as “configured to lock the plurality of sutures in a tensioned state after the opening is closed” (Specification ¶9). The specification at ¶80 also recites that “the sutures can then be locked in a tensioned state using a suture lock and/or knot for permanently closing an opening”.
One of ordinary skill in the art would have recognized the structural functionality of the hypotubes 32 taught by Weldon based on the express teachings in Weldon, even if the “fixation system components” of Weldon were not labeled as “a tensioning tube”. The delivery sheath is taught as capable of holding tension of the hypotubes and the hypotubes themselves are taught as being resilient within the text and Figures of Weldon’s disclosure. One of ordinary skill in the art before the effective filing date of the claimed invention, would have recognized these functional attributes and understood their predictable results in a fixation system.
Regarding claim 18, Weldon teaches the system of claim 15, as set forth above, wherein each of the plurality of delivery tubes comprises a slot (FIGs 9A, 9B, slots 96; ¶41) extending, from a distal end thereof, at least partially along a length of that delivery tube, the slot being configured to receive the distal end of one of the plurality of sutures after exiting from the distal end of the tensioning tube (FIGs 9A, 9B, slots 96; ¶41).
Regarding claim 19, Weldon teaches the system of claim 15, as set forth above, wherein each of the plurality of delivery tubes comprises a mechanism for deployment, by pushing, of a suture from a distal end of that delivery tube (claim 1; FIG 4B; ¶27 pusher member 44 disposed within tube 32; ¶28).
Regarding claim 20, Weldon teaches the system of claim 15, as set forth above, wherein the suture lock is configured to be advanced over the plurality of sutures and to lock the plurality of sutures in a tensioned state (FIGs 4A, 4B; ¶¶27, 28; ¶36 T-fasteners; FIG 7C).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Weldon et al., US 20050154401 (14 July 2005) in view of Houghton et al., US 20040193177 (30 September 2004) (both previously cited of record).
Regarding claim 14, Weldon teaches the system of claim 1, as set forth above.
Weldon teaches suture 66 and suture 82, but does not teach wherein the plurality of sutures are made of a material that is absorbable by a human body.
Houghton teaches medical devices for use in cardiovascular repair including absorbable sutures at ¶299.
Weldon and Houghton both teach in the field of biomedical devices used in vascular repair. The selection of suture material is old, routine, and well-known. A person of ordinary skill in the art is readily able to select any suitable suture material for the applicable use case (see Houghton ¶299). A person of ordinary skill in the art before the effective filing date of the claimed invention would have recognized that the results using a adsorbable suture in the base suture fixation system taught by Weldon would performed as a suture of any given composition is expected to perform and that the selection of a specific type of suture material would be based on parameters unique to the end-use-case for which the base system of Weldon was used. One of ordinary skill in the art, before the effective filing date of the claimed invention, would have recognized that the results of the combination were predictable based on the express teachings of Weldon and Houghton.
Conclusion
No claim is allowed.
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 CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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