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 09/17/2025 that prior art rejection Dharan in view of Osypka does not disclose the new amendments with respect to the “advancing a rigid elongate shaft into an atrium of a heart of a patient through a chest wall and an outer atrial wall...and forming a straight working lumen from outside the chest wall directly to the atrium septum”. The rejection(s) have been withdrawn. New rejections with respect to Osypka in view of Lau and Agnihotri in view of Lau have been made 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, 2, 5, 8-11, 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2009/0012557 to Osypka and U.S. Patent Publication 2021/0369266 to Lau.
As to claim 1, Osypka discloses a method of repairing a septal defect (paragraph 81) the method comprising deploying a plurality of tissue anchors (12, 12) from an elongate shaft in tissue of the atrial septum; and cinching suture tails (8) associated with the plurality of tissue anchors to at least partially close a defect in the atrial septum (figure 14-17, paragraph 91, 107-109), but is silent about advancing a rigid elongate shaft into an atrium of a heart of a patient through a chest wall and an outer atrial wall of the heart and contacting an atrial septum of the heart with a distal end of the rigid elongate shaft, thereby forming a straight working lumen from outside the chest wall directly to the atrial septum.
Lau teaches a similar method (deploying devices within the heart, paragraph 4) comprising advancing a rigid elongate shaft (the needle, paragraph 47, 48, similar to the rigid guide 300, paragraph 300) into an atrium of a heart of a patient through a chest wall and an outer atrial wall of the heart and contacting an atrial septum of the heart with a distal end of the rigid elongate shaft, thereby forming a straight working lumen from outside the chest wall directly to the atrial septum (paragraph 40, 45, 47, 48) for the purpose of providing direct access to the desired organ or tissue in the least amount of invasive manner possible. Lau teaches providing access to into the heart in a straight line, with an elongate shaft which can be rigid, for the purpose of providing direct, minimally invasive access. Osypka can gain access to the atrium by the method of Lau which help to provide direct, straight access into the heart in an limited invasive manner. The tissue anchors can then be deployed as disclosed by Osypka. Using the access of Lau would yield the predicable result of providing a direct access to the atrium of the heart. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the access method steps of advancing a rigid elongate shaft into an atrium of a heart of a patient through the chest wall and an outer wall of the heart, contacting an atrium septum of the heart with a distal end of the rigid elongate shaft, thereby forming a straight working channel lumen from outside the chest wall directly to the atrium septum in the method of Osypka in order for providing direct, minimally invasive access.
As to claim 2, with the method of Osypka and Lau above, Osypka discloses locking the suture tails in a cinched configuration (paragraph 84, 91, 107,107, via the knots or the connection means).
As to claim 5, with the method of Osypka and Lau above, Osypka discloses the plurality of tissue anchors comprise three or more tissue anchors (figure 15, paragraph 109).
As to claim 8, with the method of Osypka and Lau above, Lau further teaches said advancing the rigid elongate shaft into the atrium is via a minimally-invasive access between adjacent ribs (paragraph 47).
As to claim 9, with the method of Osypka and Lau above, Lau further teaches puncturing the outer atrial wall with a lumen of an introducer (220), wherein said advancing the elongate shaft into the atrium is through the lumen of the introducer.
As to claim 10, with the method of Osypka and Lau above, Lau further teaches the introducer comprises one or more hemostasis valves (paragraph 6, 39, 75, 82, 93). Lau teaches hemostasis valves can be used which can be used as associated with the introducer.
As to claim 11, with the method of Osypka and Lau above, Osypka discloses deploying the plurality of tissue anchors involves: puncturing the atrial septum with one or more needles (6) deployed from the elongate shaft; and pushing the plurality of tissue anchors off the one or more needles (paragraph 102).
As to claim 20, with the method of Osypka and Lau above, Lau further teaches withdrawing the rigid elongate shaft away from the atrial septum, thereby exposing the suture tails in the atrium (figure 9-1). Lau teaches withdrawing an elongate shaft which will expose and the suture tails. Withdrawing the elongate shaft, as taught by Lau can expose the suture tails in the atrium.
Claims 1-3, 5, 8-10, 18, 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2023/0149005 to Agnihotri and U.S. Patent Publication 2021/0369266 to Lau.
As to claim 1, Agnihotri discloses a method of repairing a septal defect (paragraph 80, 92), the method comprising advancing an elongate shaft (620) into an atrium of heart of a patient (paragraph 92,93), deploying a plurality of tissue anchors (613, figure 6a-f) from an elongate shaft in tissue of the atrial septum; and cinching suture tails (paragraph 93) associated with the plurality of tissue anchors to at least partially close a defect in the atrial septum (figure 6a-f, paragraph 93), but is silent that about the elongate shaft is rigid and about advancing the rigid elongate shaft into an atrium of a heart of a patient through a chest wall and an outer atrial wall of the heart and contacting an atrial septum of the heart with a distal end of the rigid elongate shaft, thereby forming a straight working lumen from outside the chest wall directly to the atrial septum.
Lau teaches a similar method (deploying devices within the heart, paragraph 4) comprising advancing a rigid elongate shaft (the needle, paragraph 47, 48, similar to the rigid guide 300, paragraph 300) into an atrium of a heart of a patient through a chest wall and an outer atrial wall of the heart and contacting an atrial septum of the heart with a distal end of the rigid elongate shaft, thereby forming a straight working lumen from outside the chest wall directly to the atrial septum (paragraph 40, 45, 47, 48) for the purpose of providing direct access to the desired organ or tissue in the least amount of invasive manner possible. Lau teaches providing access to into the heart in a straight line, with an elongate shaft which can be rigid, for the purpose of providing direct, minimally invasive access. Agnihotri does disclose different access mechanisms into the atrium (paragraph 92). Agnihotri can gain access to the atrium by the method of Lau which help to provide direct, straight access into the heart in an limited invasive manner. The tissue anchors can then be deployed as disclosed by Agnihotri. Using the access of Lau would yield the predicable result of providing a direct access to the atrium of the heart. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the access method steps of advancing a rigid elongate shaft into an atrium of a heart of a patient through the chest wall and an outer wall of the heart, contacting an atrium septum of the heart with a distal end of the rigid elongate shaft, thereby forming a straight working channel lumen from outside the chest wall directly to the atrium septum in the method of Agnihotri in order for providing direct, minimally invasive access.
As to claim 2, with the method of Agnihotri and Lau above, Agnihotri discloses locking the suture tails in a cinched configuration (paragraph 93, via 616).
As to claim 3 with the method of Agnihotri and Lau above, Agnihotri discloses advancing a suture fastener (616) distally over the suture tails, wherein said locking the suture tails involves locking the suture fastener (paragraph 93).
As to claim 5, Agnihotri as modified by Lau discloses the method above but is silent about the plurality of tissue anchors comprise three or more tissue anchors in the embodiment of figure 6a-h, paragraph 93). However Agnihotri does disclose another method where the system deploys comprise three or more tissue anchors (paragraph 100) for the purpose of disposing suture anchors around the opening in any desired location. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the method of figure 6a-h deploy three or more suture anchors in order for disposing suture anchors around the opening in any desired location.
As to claim 8, with the method of Agnihotri and Lau above, Lau further teaches said advancing the rigid elongate shaft into the atrium is via a minimally-invasive access between adjacent ribs (paragraph 47).
As to claim 9, with the method of Agnihotri and Lau above, Lau further teaches puncturing the outer atrial wall with a lumen of an introducer (220), wherein said advancing the elongate shaft into the atrium is through the lumen of the introducer.
As to claim 10, with the method of Agnihotri and Lau above, Lau further teaches the introducer comprises one or more hemostasis valves (paragraph 6, 39, 75, 82, 93). Lau teaches hemostasis valves can be used which can be used as associated with the introducer.
As to claim 18, with the method of Agnihotri and Lau above, Agnihotri discloses deploying the plurality of tissue anchors involves deploying a tissue anchor within a thickness of the atrial septum (figure 6d, paragraph 93).
As to claim 20, with the method of Agnihotri and Lau above, Agnihotri discloses withdrawing the rigid elongate shaft away from the atrial septum, thereby exposing the suture tails in the atrium (paragraph 93).
Claims 3, 4, are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2009/0012557 to Osypka and U.S. Patent Publication 2021/0369266 to Lau as applied to claims 1, 2, 5, 8-11, 20 above, and further in view of U.S. Patent Publication 2007/0005079 to Zarbatany.
As to claim 3, Osypka as modified by Lau discloses the method above but is silent about advancing suture fastener distally over the suture tails, wherein the locking the suture tails involve locking the suture fastener.
Zarbatany discloses a similar method (repairing septal defects, abstract) comprising advancing suture fastener (164) distally over the suture tails (paragraph 64), wherein the locking the suture tails involve locking the suture fastener (paragraph 62) for the purpose of restricting movement of the suture leads over the suture has been cinched as desired (paragraph 62). The suture fastener of Zarbatany can be used on the connection member or replacing the knot to easily securing the suture tails of Osypka. It would have been obvious to one of ordinary skill in the art before the effective filing date to using the suture faster of Zarbatany in the method of Osypka and Lau including the steps of advancing suture fastener (164) distally over the suture tails (paragraph 64), wherein the locking the suture tails involve locking the suture fastener in order for restricting movement of the suture leads over the suture has been cinched as desired.
As to claim 4, Osypka as modified by Lau discloses the method above but is silent about cutting-off proximal portions of the suture tails.
Zarbatany teaches a similar method (repairing septal defects, abstract) comprising cutting-off proximal portions of the suture tails (paragraph 64, 67) for the purpose of trimming extraneous suture material. It would have been obvious to one of ordinary skill in the art before the effective filing date to cut off proximal portions of the suture tail in the method of Osypka as modified by Lau in order for trimming extraneous suture material.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2023/0149005 to Agnihotri and U.S. Patent Publication 2021/0369266 to Lau as applied to claims 1-3, 5, 8-10, 18, 20 above, and further in view of U.S. Patent Publication 2007/0005079 to Zarbatany.
As to claim 4, Agnihotri as modified by Lau discloses the method above but is silent about cutting-off proximal portions of the suture tails.
Zarbatany teaches a similar method (repairing septal defects, abstract) comprising cutting-off proximal portions of the suture tails (paragraph 64, 67) for the purpose of trimming extraneous suture material. It would have been obvious to one of ordinary skill in the art before the effective filing date to cut off proximal portions of the suture tail in the method of Agnihotri as modified by Lau in order for trimming extraneous suture material.
Claims 6, 7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2009/0012557 to Osypka and U.S. Patent Publication 2021/0369266 to Lau as applied to claims 1, 2, 5, 8-11, 20 above, and further in view of U.S. Patent Publication 2019/0000624 to Wilson.
As to claim 6, Osypka as modified by Lau disclose the method above but is silent about the plurality of tissue anchors comprise a suture-form knot anchors. Of note, Osypka does disclose different embodiments of the suture anchor (paragraph 102, figure 4, 11-13) as well as using a flexible folding anchor, (paragraph 25).
Wilson teaches a similar method (deploying soft anchors in the heart, paragraph 13) comprising using a tissue anchor which comprises suture-form knot anchors (240, paragraph 86-88) for the purpose of using an anchor that can attain a significantly size to help anchor the device in place by simply tensioning sutures. Wilson teaches different types of anchors can be used which can be deployed within the heart that can help approximate tissue. Using the suture form knots anchors of Wilson in the method of Osypka as modified by Lau will simplify and optimize the securing of the anchoring and yield the predictable results of aiding in approximating tissue in the self defect. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the suture-form knot anchors of Wilson as the anchors in the method of Osypka and Lau in order for using an anchor that can attain a significantly size to help anchor the device in place by simply tensioning sutures.
As to claim 7, with the method of Osypka, Lau, and Wilson above, Wilson further teaches each of the suture tails is integrated with respective one of the suture-form knot anchors (242, figure 6, 7, 8a-c paragraph 86). The suture stands 242 can be the suture tails extending from the anchors of Osypka.
Claims 6, 7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2023/0149005 to Agnihotri and U.S. Patent Publication 2021/0369266 to Lau as applied to claims 1-3, 5, 8-10, 18, 20 above, and further in view of U.S. Patent Publication 2019/0000624 to Wilson.
As to claim 6, Agnihotri as modified by Lau disclose the method above but is silent about the plurality of tissue anchors comprise a suture-form knot anchors. Of note, Agnihotri does disclose different embodiments of the suture anchor (figure 3a-f).
Wilson teaches a similar method (deploying soft anchors in the heart, paragraph 13) comprising using a tissue anchor which comprises suture-form knot anchors (240, paragraph 86-88) for the purpose of using an anchor that can attain a significantly size to help anchor the device in place by simply tensioning sutures. Wilson teaches different types of anchors can be used which can be deployed within the heart that can help approximate tissue. Using the suture form knots anchors of Wilson in the method of Agnihotri as modified by Lau will simplify and optimize the securing of the anchoring and yield the predictable results of aiding in approximating tissue in the self defect. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the suture-form knot anchors of Wilson as the anchors in the method of Agnihotri and Lau in order for using an anchor that can attain a significantly size to help anchor the device in place by simply tensioning sutures.
As to claim 7, with the method of Agnihotri, Lau, and Wilson above, Wilson further teaches each of the suture tails is integrated with respective one of the suture-form knot anchors (242, figure 6, 7, 8a-c paragraph 86). The suture stands 242 can be the suture tails extending from the anchors of Agnihotri.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2009/0012557 to Osypka and U.S. Patent Publication 2021/0369266 to Lau as applied to claims 1, 2, 5, 8-11, 20 above, and further in view of U.S. Patent Publication 2019/0000624 to Wilson and U.S. Patent Publication 2007/0005079 to Zarbatany.
As to claim 12, with the method of Osypka as modified by Lau above, Osypka discloses the one or more needles comprises a first needle and a second needle (6, 6, figure 6), but is silent about each of the first and second needles, prior to said pushing, has winds of suture of one of the plurality of tissue anchors disposed about a distal portion thereof; and said puncturing the atrial septum involves simultaneously deploying at the first and second needles from the elongate shaft.
Wilson teaches a similar method (deploying soft anchors in the heart, paragraph 13) comprising using winds of suture of one of the plurality of tissue anchors disposed about a distal portion of a needle (figure 10a-e, paragraph 86-88, 90-93) for the purpose of using an anchor that can attain a significantly size to help anchor the device in place by simply tensioning sutures. Wilson teaches different types of anchors can be used which can be deployed within the heart that can help approximate tissue. Using the suture form knots anchors of Wilson in the method of Osypka as modified by Lau will simplify and optimize the securing of the anchoring and yield the predictable results of aiding in approximating tissue in the self defect. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the winds of the suture of the anchor wound around the needle of Wilson in order for using an anchor that can attain a significantly size to help anchor the device in place by simply tensioning sutures.
Zarbatany teaches a similar method (repairing septal defects, abstract) comprising puncturing the atrial septum involves simultaneously deploying at the first and second needles from the elongate shaft (paragraph 68). Osypka does disclose puncturing the atrial septum by deploying the first and second needles however is silent if it is simultaneous. Deploying the needles of Osypka would either has to be simultaneous or sequential. Zarbatany teaches that first and second needles can be puncture simultaneously or sequentially as desired by the user. Either the simultaneous deployment or the sequential deployment of the needles would both result in deploying the anchors. It would have been obvious to one of ordinary skill in the art before the effective filing date to simultaneously deploying at the first and second needles from the elongate shaft since it would have been obvious to try to deploy the needles sequentially as taught by Zarbatany.
Claims 18, 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2009/0012557 to Osypka and U.S. Patent Publication 2021/0369266 to Lau as applied to claims 1, 2, 5, 8-11, 20 above, and further in view of U.S. Patent Publication 2017/0325794 to Willard.
As to claim 18, Osypka as modified by Lau discloses the method above but is silent about deploying the plurality of tissue anchors involves deploying a tissue anchor within a thickness of the atrial septum.
Willard teaches a similar method (tissue defect closure, abstract) comprising deploying the plurality of tissue anchors (102) involves deploying a tissue anchor within a thickness of the atrial septum (figure 3) for the purpose of helping to hold the anchor’s position within the tissue (paragraph 33). Willard teaches a similar anchor which can be used as the anchor of Osypka, where the proximal portion of the anchor is within the thickness of the atrial septum. This can help secure the anchor within the tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date to deploy a tissue anchor within a thickness of the atrial septum in the deploying the plurality of tissue anchor step of the method of Osypka in order for helping to hold the anchor’s position within the tissue.
As to claim 19, with the method of Osypka, Lau, and Willard above, Osypka discloses performing a short-throw needle puncture in the atrial septum prior to deploying the tissue anchor (figure 8). The puncturing of the atrial septum as seen in figure 8, which is before the anchor deployment, can read on the “short throw needle puncture”.
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