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 argues in the response filed 12/17/2025 that prior art McIntosh does not seem disclose the suture with the three portions including the pre-tied suture knot. The rejection has been withdrawn and a new rejection with respect to McIntosh, Chanduszko/Chambers, Belef, and Modesitt has been made below. Modesitt does disclose the suture with the three portions, where the pre-tied knot can be formed on a structure which can be the needles of McIntosh. Further, using the suture of McIntosh with the needles of Modesitt, the first portion of the suture will be bonded to the distal needle tip of the second needle where the first suture needle will carry the pre-tied suture knot. The examiner maintains the rejection below.
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 1-3, 9, 10, 25-27, 29, 30 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2005/0070923 to McIntosh in view of U.S. Patent Publication 2007/0049970 to Belef, U.S. Patent Publication 2007/0167959 to Modesitt, U.S. Patent Publication 2004/0073242 to Chanduszko and in view of or as evidenced by U.S. Patent Publication 2006/0095052 to Chambers.
As to claim 1, McIntosh discloses a method of closing a patent foramen ovale (PFO) (paragraph 46) including a septum primum and a septum secundum separated by a PFU tunnel (figure 12), the method implemented using a suture device (10) including: an operational shaft (50/60/70) housing an anchor assembly (60), a needle assembly (45), and a suture (34), the needle assembly including a first needle (41) and a second needle (42), the method comprising: advancing an end of the operational shaft to a proximal side of the PFO (paragraph 88); advancing a distal portion of the end of the operational shaft including the anchor assembly to a distal side of the PFO (figure 11, 12), after advancing the distal portion, actuating the anchor assembly to deploy the anchor assembly on the distal side of the PFO (figure 11, 12, paragraph 90); after actuating the anchor assembly, actuating the needle assembly on the proximal side of the PFO to deploy the needle assembly through tissue of PFO, the actuating of the needle assembly comprising deploying at least one of the first needle and the second needle through the tissue of the PFO, (figure 12, the suture seems to go through the PFO tissue), and deploying at least one of the first needle and second needle through the anchor assembly (figure 12, paragraph 90), thereby deploying the suture through tissue of the PFO (paragraph 90); retracting the anchor assembly into the operational shaft (paragraph 92 ); and withdrawing the distal portion of the operational shaft from the PFO, leaving the deployed suture (paragraph 90-92), prior to actuating the needle assembly, the suture includes (i) a first suture portion coupled to a distal needle tip of one of the first needle or the second needle (paragraph 91, 93), (ii) a second suture portion terminating in a suture guide (either the feature 137, or features in paragraph 93, or the coating, shrink wrap tubing, bead, coating, or dye in paragraph 78-80 can read on the suture guide), and (iii) a third suture portion intermediate the first suture portion and the second suture portion, the third suture portion forming a pre-tied suture knot being a clinch knot with a plurality of wraps (136, 101, paragraph 78) but is silent about puncturing, using a puncture component separate from the needle assembly, a portion of the PFO including at least one of the septum primum or the septum secundum to form a puncture in the PFO tissue, after the puncturing advancing the distal portion of the operational shaft through the formed puncture, and advancing the first or second needle through the tissue of the PFO including where the septum primum and septum secundum overlap across the PFO tunnel, and third suture portion forming the pre-tied suture knot is on a needle shank of the other of the first needle or the second needle with the plurality of wraps around the needle shank.
Chanduszko teaches a similar method (PFO closure, abstract) having a step of puncturing, using a separate puncturing component (151), a portion of tissue of the PFO including at least one of the septum primum or the septum secundum (figure 15a-e, paragraph 69) and then advancing a distal portion of an end of an operational shaft (150) through the punctured PFO tissue to a distal side of the PFO (figure 15a-e, paragraph 69) for the purpose of providing a more straightforward delivery approach to a distal side of the PFO. Chambers teaches a similar method (occlusion repair) including puncturing, using a puncture component (234) separate from a needle assembly (22), a portion of the PFO including at least one of the septum primum or the septum secundum to form a puncture in the PFO tissue, after the puncturing, advancing the distal portion of the operational shaft through the formed puncture (figure 4-6, paragraph 74-76). Chanduszko teaches that the channel of the PFO can be extremely oblique and creating a passageway can be easier. Instead of going through the passageway of the PFO as disclosed by McIntosh, the method can include puncturing a portion of the tissue of the PFO to simplify the approach to the distal side of the PFO. The puncturing component 151 of Chanduszko is separate from the catheter 150 which is then advanced through the formed puncture to the distal side of the PFO. Chambers can teach or provide evidence of using a separate puncturing component of a needle assembly to form a puncture in the PFO, and then after the puncture is formed, advancing the needle assembly through the puncture to the distal side of the PFO. This can help to allow a straightforward approach to position the distal portion of the operational shaft of McIntosh at the distal side of the PFO. It would have been obvious to one of ordinary skill in the art before the effective filing date to puncture, using a puncture component separate from the needle, a portion of the tissue of the PFO including at least one of the septum primum or septum secundum to form a puncture in the PFO tissue, and after the puncturing, advancing the distal portion of the end of the operational shaft including the anchor assembly through the formed puncture to a distal side of the PFO in order for providing a more straightforward delivery approach to a distal side of the PFO.
Belef teaches a similar method (treating septal defects, abstract) including advancing first or second needle through the tissue of the PFO including where the septum primum and septum secundum overlap across the PFO tunnel (paragraph 139, 140) for the purpose to accommodate variable thickness, shape, and orientation of the PFO tissue. Belef does teach that the needle can be inserted through the septum primum and/or septum secundum as well as embodiments showing a needle inserted through both of the septum to deliver a closure device on the distal side (figure 4b). Deploying the needle and thus the sutures through both the septums where they overall can securely attach both of the septums which will make sure the PFO can be closed. The needles of McIntosh can be deployed through where the first and second septums overlap which will yield the predictable results of approximating tissue to close the PFO. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method include advancing first or second needle through the tissue of the PFO including where the septum primum and septum secundum overlap across the PFO tunnel in order to accommodate variable thickness, shape, and orientation of the PFO tissue.
Modesitt teaches a similar method (suturing device and method, abstract) comprising prior to actuating a needle assembly, a suture includes (i) a first suture portion coupled to a distal needle tip of one of the first needle or the second needle (figure 15a-f), (ii) a second suture portion terminating in a suture guide (the ends of the suture can have distinguishing features such as dye, shrink wrap, bead, or a knot, all of which can be the suture guide termination the second portion, paragraph 121), and (iii) a third suture portion intermediate the first suture portion and the second suture portion, the third suture portion forming a pre-tied suture knot (104) on a needle shank of the other of the first needle or the second needle (figure 15a, paragraph 114), the pre-tied suture not being a clinch knot with a plurality of wraps around the needle shank (figure 15a) for the purpose of storing the suture before delivery and carrying the suture with the pre-tied knot to the tissue to be sutured (paragraph 114, 116, 120, 124). McIntosh does disclose a suture with a first portion attached to a distal needle tip, a second portion with a suture guide and a third suture portion with a clinch knot. Modesitt teaches how a similar suture with three sections can be stored specifically having the pre-tied knot formed around a needle like structure. The suture portions of Modesitt can be positioned around the needle shanks of McIntosh which can help deploy the suture and pre-tied knot. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the needles of McIntosh carry the suture with the first, second, and third portions with the pre-tied knot formed on the needle shank of the needle having the plurality of wraps of the knots being around the needle shank in order for storing the suture before delivery and carrying the suture with the pre-tied knot to the tissue to be sutured.
As to claim 2, with the method of McIntosh, Chanduszko/Chambers, Belef, and Modesitt above, McIntosh discloses tightening the suture to engage the septum primum tightly against the septum secundum, to secure the PFO in a closed configuration (paragraph 91, 93).
As to claim 3, with the method of McIntosh, Chanduszko/Chambers, Belef, and Modesitt above, McIntosh discloses cutting a proximal end of the suture (paragraph 93).
As to claim 9, with the method of McIntosh, Chanduszko/Chambers, Belef, and Modesitt above, McIntosh discloses actuating the anchor assembly comprises actuating a first locator (65a) and a second locator (65b) of the anchor assembly to engage against a distal side of the septum primum (figure 12). The anchor can be interpreted to have two lateral sections which are the first and second locators. They are disposed distal to the septum primum and therefore will engage the distal side of the septum primum.
As to claim 10, with the method of McIntosh, Chanduszko/Chambers, Belef, and Modesitt above, McIntosh discloses withdrawing the distal portion from the PFO comprises withdrawing the distal portion proximally through the formed puncture (paragraph 92, figure 10-12). The device will be withdrawn proximally through the formed puncture since that is where the device was introduced and is then withdrawn.
As to claim 25, with the method of McIntosh, Chanduszko/Chambers, Belef, and Modesitt above, Chanduszko further teaches puncturing comprises puncturing the tissue of the PFO using the puncture component including a puncture needle (151). Chambers also teaches and/or provides evidence of a puncture needle (234).
As to claim 26, with the method of McIntosh, Chanduszko/Chambers, Belef, and Modesitt above, McIntosh discloses actuating the anchor assembly comprises actuating a lever (30, paragraph 49) of the suture device.
As to claim 27, with the method of McIntosh, Chanduszko/Chambers, Belef, and Modesitt above, McIntosh discloses actuating the needle assembly comprises actuating a plunger (40, paragraph 90) of the suture device.
As to claim 29, with the method of McIntosh, Chanduszko/Chambers, Belef, and Modesitt above, Modesitt further teaches the first needle carries the pretied knot (figure 15a paragraph 67, 78, 93) and the distal needle tip is part of the second needle, the distal needle tip being bonded with the first needle suture portion (figure 15a, paragraph 114,117, 130), and wherein actuating the needle assembly on the proximal side of the proximal side of the PFO comprises engaging the second needle with the first needle (figure 15b) and retracting the first needle to draw at least a portion of the second needle and the suture through the anchor assembly and through the pre-tied suture knot (figure 15b-F). McIntosh does disclose bonding a needle to a first suture portion, engaging the second needle with the first needle, and retracting the first needle to draw at least a portion of the second needle and the suture through the anchor assembly and through the pre-tied suture knot (of Modesitt) (paragraph 67, 86, 78, 93). McIntosh does disclose a needle can be bonded to an end of the suture, the needles can be detachable and be retracted, and a pre-tied knot can be used. Therefore, using the suture of Modesitt with the pre-tied suture knot on the first needle and the first suture portion attached to the distal needle tip of the second needle, McIntosh as modified by Modesitt will be able to read on the claim limitations.
As to claim 30, with the method of with the method of McIntosh, Chanduszko/Chambers, Belef, and Modesitt above, Modesitt further teaches the plurality of wraps includes an anchor loop, the pre-tied suture knot including a first underpass at the anchor loop, and a second underpass of a non-rail section of the pre-tied suture knot (figure 15f, 16a). The knot of Modesitt has two parts of the suture passing under a portion of the knot which can read on the “anchor loop”. The knot as seen in figure 15f, 16a of Modesitt can read on the claim limitations.
Claims 7, 11, 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2005/0070923 to McIntosh in view of U.S. Patent Publication 2007/0049970 to Belef, U.S. Patent Publication 2007/0167959 to Modesitt, U.S. Patent Publication 2004/0073242 to Chanduszko and in view of or as evidenced by U.S. Patent Publication 2006/0095052 to Chambers as applied to claims 1-3, 9, 10, 25-27, 29, 30 above, and further in view of U.S. Patent Publication 2008/0015636 to Olsen as evidenced by U.S. Patent 2014/0350565 to Yacoby.
As to claim 11, McIntosh as modified by Chanduszko/Chambers, Belef, and Modesitt discloses the method above but is silent about advancing the distal portion through the formed punctured comprises: advancing a guide wire through the formed punctured; and advancing the distal portion along the guide wire through the formed punctured. McIntosh does disclose that the device can be used with a guidewire (paragraph 90)
Olsen teaches a similar method (closing a PFO, abstract) having a method of advancing a guide wire through the punctured PFO tissue; and advancing the distal portion along the guide wire through the punctured PFO tissue (paragraph 69, 79) for the purpose of providing additional guidance for the device. Yacoby teaches a similar method (delivery in the heart, abstract) including inserting a guidewire through a formed puncture in order to advance a device therethrough (paragraph 95). Olsen teaches that the a guidewire can be pushed through a septum primum and/or secundum and that the delivery device can be advanced over the guide wire through the puncture. Yacoby can provide evidence that the guidewire can be known to be placed through a formed puncture in order to provide the guidance. McIntosh does disclose the device can be used with a guide wire. Therefore a guide wire can be placed through the formed punctured where the distal portion of the device can be advanced over the guide wire to the distal side of the PFO. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the method of advancing a guide wire through the formed puncture and advancing the distal portion along the guide wire through the formed puncture in order for providing additional guidance for the device.
As to claim 7, with the method of McIntosh, Chanduszko/Chambers, Belef, Modesitt, and Olsen/Yacoby above, McIntosh discloses advancing a guide wire separate from the suture device through the formed punctured (paragraph 89, figure 1, through the formed puncture). The guide wire can be separate from the device 10. The guidewire will extend through the distal section 70 of the suture device but can be separate from the device.
As to claim 13, with the method of McIntosh, Chanduszko/Chambers, Belef, Modesitt, and Olsen/Yacoby above, Belef further teaches puncturing a portion of the PFO tissue comprises puncturing the septum primum in a location where the septum primum does not overlap the septum secundum across the PFO tunnel (paragraph 140). Belef teaches puncturing at least a portion of septal wall adjacent the tunnel and the septum primum and/or septum secundum. Therefore Belef does disclose that one puncturing can be adjacent the tunnel which can be not where the septums overlap. If it would not be known that Belef would be able to read on the limitation, it would have been obvious in order to provide the desired orientation of the puncture and obtain the desired configuration of the sutured tissue.
As to claim 14, with the method of McIntosh, Chanduszko/Chambers, Belef, Modesitt, and Olsen/Yacoby above, McIntosh discloses actuating the anchor assembly comprises actuating the anchor assembly to engage against a distal side of the septum primum (figure 12). Belef further teaches actuating the needle assembly comprises: deploying the first needle distally through the tissue of the PFO where the septum primum and the septum secundum overlap across the PFO (figure 31c); and deploying the second needle distally through the tissue of the PFO where the septum primum does not overlap the secundum across the PFO tunnel (paragraph 140, 146-147, 136). Belef does disclose that two needles can be used, and that a needle can be passed through tissue adjacent the tunnel, or the septum primum and/or the septum secundum. One needle can be punctured through both of the septums which can be where they overlap, and through the septum primum where it does not overlap the tunnel since it can be deployed adjacent the tunnel. If it would not have been known that a first needle can be deployed through the septum primum and septum secundum where they overlap and a second needle can be deployed through the septum primum where it does not overlap the septum secundum, it would have been obvious in order to provide the desired orientation of the puncture and obtain the desired configuration of the sutured tissue.
As to claim 15, with the method of McIntosh, Chanduszko/Chambers, Belef, Modesitt, and Olsen/Yacoby above, Belef further teaches puncturing a portion of the PFO tissue comprises puncturing the portion of the tissue of the PFO where the septum primum and the septum secundum overlap across the PFO tunnel (paragraph 140). If both of the septums are punctured, the tunnel can ultimately pass through the space and therefore the septums are overlapped across the PFO tunnel.
As to claim 16, with the method of McIntosh, Chanduszko/Chambers, Belef, Modesitt, and Olsen/Yacoby above, McIntosh discloses actuating the anchor assembly comprises actuating the anchor assembly to engage against a distal side of the septum primum (figure 12). Belef further teaches actuating the needle assembly comprises: deploying the first needle distally through the tissue of the PFO where the septum primum and the septum secundum overlap across the PFO tunnel; and deploying the second needle distally through the tissue of the PFO where the septum primum and the septum secundum overlap the PFO tunnel (figure 4f-h, figure 31a-c, paragraph 140, 315-316, 318, 140, 146-148-). Belef can teach that both needles are advanced through both of the septums which can untimely be where they overlap the PFO tunnel. If it would not be known it would have been obvious to one of ordinary skill in the art before the effective filing date to advance both the first and the second needles distally through the tissue of the PFO where the septum primum and the septum secundum overlap across the PFO tunnel it would have been obvious in order to provide the desired orientation of the puncture and obtain the desired configuration of the sutured tissue
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2005/0070923 to McIntosh in view of U.S. Patent Publication 2007/0049970 to Belef, U.S. Patent Publication 2007/0167959 to Modesitt, U.S. Patent Publication 2004/0073242 to Chanduszko, and in view of or as evidenced by U.S. Patent Publication 2006/0095052 to Chambers, and in view of U.S. Patent Publication 2008/0015636 to Olsen as evidenced by U.S. Patent 2014/0350565 to Yacoby as applied to claims 7, 11, 13-16 above, and further in view of U.S. Patent Publication 2008/0269876 to Nobles
As to claim 12, McIntosh as modified by Chanduszko/Chambers, Belef, Modesitt, and Olsen/Yacoby discloses advancing the guide wire comprising advancing the guide wire distally from the end of the operational shaft and through the formed puncture. McIntosh does disclose that the device is used with a guidewire. Olson does disclose that a device has a delivery wire lumen which would advance over the guidewire. Therefore the guidewire would be extending, and advanced out of the distal end of the operational shaft. Nobles teaches a similar device having a guide wire (10) extending and advanced from an distal end of an operational shaft (paragraph 126) in order to help advance and position the device in place as desired. It would have been obvious to one of ordinary skill in the art before the effective filing date for advancing the guide wire comprising advancing the guide wire distally from the end of the operational shaft and through the formed puncture in order to help advance and position the device in place as desired.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2005/0070923 to McIntosh in view of U.S. Patent Publication 2007/0049970 to Belef, U.S. Patent Publication 2007/0167959 to Modesitt, U.S. Patent Publication 2004/0073242 to Chanduszko, and in view of or as evidenced by U.S. Patent Publication 2006/0095052 to Chambers as applied to claims 1-3, 9, 10, 25-27, 29, 30 above, and further in view of U.S. Patent Publication 2007/0118151 to Davidson or U.S. Patent Publication 2021/0186515 to Sorajja.
As to claim 24, McIntosh as modified by Chanduszko/Chambers, Belef, and Modesitt disclose the method above but is silent about loading a suture trimmer into the suture device, advancing the suture trimmer distally to the PFO, and trimming the suture. However, McIntosh does disclose cutting the tails of the suture (paragraph 46, 93).
Davidson including loading a suture trimmer into the suture device, advancing the suture trimmer distally to the PFO, and trimming the suture (paragraph 126, 127) for the purpose of using known mechanisms that can be advanced into a catheter and used to cut a suture to a desired length. Sorajja also teaches a similar method (repairing septal defects, abstract) including loading a suture trimmer into the suture device, advancing the suture trimmer distally to the PFO, and trimming the suture (paragraph 49) for the purpose of allowing the suture to be trimmed. It would have been obvious to one of ordinary skill in the art before the effective filing date to include the steps of loading a suture trimmer into the suture device, advancing the suture trimmer distally to the PFO, and trimming the suture in order for cutting the suture to the desired length.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2005/0070923 to McIntosh in view of U.S. Patent Publication 2007/0049970 to Belef, U.S. Patent Publication 2007/0167959 to Modesitt , U.S. Patent Publication 2004/0073242 to Chanduszko, and in view of or as evidenced by U.S. Patent Publication 2006/0095052 to Chambers as applied to claims 1-3, 9, 10, 25-27, 29, 30 above, and further in view of and/or as evidenced by U.S. Patent 6,245,079 to Nobles.
As to claim 28, McIntosh as modified by Chanduszko/Chambers, Belef, and Modesitt disclose the method above but is silent about actuating the anchor assembly to deploy the anchor assembly on the distal side of the PFO comprises pivoting a first and second locator in opposite directions about a shared pivot point from respective enclosed positions to respective transversely deployed positions. McIntosh does disclose first and second locators in transversely deployed positions in figure 12 but not how the locators got there.
Modesitt further teaches including actuating the anchor assembly to deploy the anchor assembly on the distal side of the PFO comprises pivoting a first and second locator in opposite directions about a shared pivot point from respective enclosed positions to respective transversely deployed positions (figure 35, paragraph 171-172). Modesitt teaches that the embodiment of figure 35 incorporates by reference U.S. patent 6,245,079 to Nobles in its entirety. Nobles teaches pivoting a first and second locator in opposite directions about a shared pivot point from respective enclosed positions to respective transversely deployed positions (figure 41-47 col. 24 ll. 2-31) for the purpose of providing a stable base for securely holding sutures for which the needles to engage. It would have been obvious to one of ordinary skill in the art before the effective filing date for the actuating the anchor assembly to deploy the anchor assembly on the distal side of the PFO step comprise pivoting a first and second locator in opposite directions about a shared pivot point from respective enclosed positions to respective transversely deployed positions in order for providing a stable base for securely holding sutures for which the needles to engage.
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.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771