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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/08/25 has been entered.
Response to Amendment
Applicant has amended claims 1, 15, 24-26, and added claim 28. Claims 1-7, 15-19, and 24-28 are currently pending, with claims 1-7 being withdrawn from consideration.
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.
Claims 15-18 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-David et al. (WO 2019/142152 A1) in view of McNamara et al. (US 2012/0053686 A1) and in further view of Eigler et al. (US 2018/0243071 A1).
Regarding claim 15, Ben-David discloses a method of implanting a shunting element (¶0024; Figs. 1A-2D; ¶0049-0055 – shunting element 10) in a septal wall (AS) between a left atrium (LA) and a right atrium (RA) in a patient, the method comprising: positioning the shunting element (Figs. 12A-14B, feat. 10; ¶0067-0069) around a balloon member (Figs. 12A-14B, feats. 30 and 30’) while the shunting element is in a contracted configuration having a first diameter (Figs. 12A and 13A, feats. 10 and 30; ¶0067-0068: deflated balloon catheter 30 with an initial diameter D1 is introduced within passage 20 of passage device 10 when the device is in a contracted configuration); expanding the shunting element to an expanded configuration having a second diameter by inflating the balloon member (Figs. 2A-D, feat. 16; Figs. 12B and 13B, feat. 16; ¶0067-0068: balloon catheter 30 is expanded so that the middle section 16 of the shunting element 10 has diameter D2, which may be larger than diameter D1), thereby defining a lumen having a central axis extending therethrough (Figs. 2A-D, feat. 20; ¶0051); securing the shunting element to the septal wall using one or more anchoring elements (Figs. 2A-D, feats. 12 and 14; Figs. 12B and 13B, feats. 12, 14, 32, and 34; ¶0051-0052 and 0067-0068: anchoring elements 12 and 14 are moved into position by the expansion of first and second portions 32 and 34 of the balloon catheter); and after securing the shunting element to the septal wall, adjusting the shunting element to a third diameter that is different than the second diameter (Figs. 9A-11C, 16A-C, feat. 70, and 17A-B, feat. 80; ¶0064-0066 and 0071-0072: after placement and anchoring in septal wall AS, a balloon catheter 70 and/or snare 80 may be used to adjust the diameter of the passage 20 of the middle portion 16).
Ben-David discloses that the balloon member (Figs. 13A-C, feat. 30) is introduced into the passage of the shunting element (10) after the element is positioned in the heart wall (¶0068). Therefore, Ben-David does not disclose a method comprising positioning the shunting element around the balloon member before introducing the shunting element into or near an aperture in the septal wall as claimed. Ben-David is also silent with respect to the one or more anchoring elements being configured to at least partially penetrate the septal wall, wherein the one or more anchoring elements extend substantially parallel to the central axis of the lumen when at least partially penetrating the septal wall.
McNamara teaches an interatrial shunting or venting device (Fig. 1, feat. 100; ¶0165) and methods for implanting it (¶0040-0041). McNamara teaches that implanting an interatrial shunting device involves a plurality of steps including, among other things, advancing an introducer catheter to an atrium of the heart (¶0040), preforming and dilating opening in the interatrial septum with the introducer catheter (¶0045-0046), and advancing a placement catheter with the interatrial shunting device mounted on it through the opening so that the shunting device can be secured to the septum (¶0040). McNamara further teaches that the implantation procedure may be simplified by integrating a balloon on the placement catheter so that the placement catheter may form and dilate the opening in the septum at the same time as placing the shunting device (¶0047). Forming and dilating the opening in the septum at the same time as placing the shunting device using a balloon integrates the functions of the introducer catheter in the design of the placement catheter, which simplifies the procedure by eliminating the need for catheter exchanges (¶0044-0047). By modifying the method of Ben-David so that the shunting element is positioned around the balloon member before being introduced into or near the septal wall, the implantation procedures would be simplified by eliminating the additional steps and introducer catheter, and resulting catheter exchanges, needed to place the shunting element in the septal wall before placing the balloon member inside the shunting element. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Ben-David so that the shunting element is introduced into or near an aperture in the septal wall after positioning the shunting element around the balloon member while the shunting element is in a contracted configuration in order to simplify the implantation procedure as taught by McNamara.
Eigler teaches interatrial shunts (Figs. 1A-C, feat. 10; ¶0096; Figs. 10-15, feats. 80, 90, 95, 100, 110, 120; ¶0134-0140) which may comprise collapsible tab-like retention anchors on the right atrium side of the shunt (Fig. 13, feat. 101; Fig. 14, feat. 111; ¶0138-0139) which may become buried in, or penetrate, the interatrial septum in the fossa ovalis region in order to prevent migration of the shunt into the left atrium or beyond (¶0138). The collapsible tab-like retention anchors extend substantially parallel to the central axis of the shunt (Fig. 13, feat. 101; Fig. 14, feat. 111). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the shunting element of the method disclosed by Ben-David in view of McNamara so that the one or more anchoring elements are configured to at least partially penetrate the septal wall wherein the one or more anchoring elements extend substantially parallel to the central axis of the lumen when at least partially penetrating the septal wall in order to prevent migration of the shunt into the left atrium or beyond as taught by Eigler.
Regarding claim 16, Ben-David in view of McNamara and in further view of Eigler discloses the method of claim 15, and Ben-David further discloses that adjusting the shunting element comprising expanding the shunting element to the third diameter wherein the third diameter is greater than the second diameter (Figs. 16A-C; ¶0071: a balloon catheter may be used to increase the diameter of the passage 20 of the middle portion 16 while it is positioned in the septal wall AS).
Regarding claim 17, Ben-David in view of McNamara and in further view of Eigler discloses the method of claim 16, and Ben-David further discloses that the shunting element is expanded to the third diameter using a balloon member inserted within the lumen of the shunting element (Figs. 16A-C, feats. 70 and 72; ¶0071).
Regarding claim 18, Ben-David in view of McNamara and in further view of Eigler discloses the method of claim 15, and Ben-David further discloses that adjusting the shunting element comprises compressing the shunting element to the third diameter, wherein the third diameter is smaller than the second diameter (Figs. 17A-B, feat. 82; ¶0072: a snare loop 82 may be used to decrease the diameter of the passage 20 of the middle portion 16 while it is positioned in the septal wall AS).
Regarding claim 26, Ben-David in view of McNamara and in further view of Eigler discloses the method of claim 15. Eigler further teaches an embodiment of the shunt (Fig. 14, feat. 110; ¶0139) in which the penetrating collapsible tab-like anchoring retention elements are on the right atrium side of the shunt (Fig. 13, feat. 101; Fig. 14, feat. 111; ¶0138-0139) and the structure on the left atrium side of the shunt is minimized in order to reduce the amount of structure occupying the free space in the left atrium (¶0139). Because the shunt includes minimal structure on the left atrium side of the shunt, it would be positioned substantially on the right atrium side of the septal wall while being introduced and secured to the septal wall. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method and shunting element disclosed by Ben-David in view of McNamara and in further view of Eigler so that introducing the shunting element comprises positioning the shunting element substantially on one side of the septal wall and so that securing the shunting element comprises embedding, while the shunting element is positioned substantially on the one side of the septal wall, the one or more anchoring elements on the one side of the septal wall in order to reduce the amount of structure of the shunt occupying the free space on the other side of the septal wall as taught by Eigler.
Regarding claim 27, Ben-David in view of McNamara and in further view of Eigler discloses the method of claim 15, and Ben-David further discloses that expanding the shunting element comprises transforming each of the one or more anchoring elements from a retracted and/or low-profile configuration (Figs. 12A, 13A, and 14A, feats. 12 and 14; ¶0067-0069) to an operating configuration (Figs. 12B-C, 13B-C, and 14B, feats. 12 and 14; ¶0067-0069).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-David et al. (WO 2019/142152 A1) in view of McNamara et al. (US 2012/0053686 A1), in further view of Eigler et al. (US 2018/0243071 A1), and in further view of Ben Muvhar et al. (US 2005/0055082 A1).
Regarding claim 19, Ben-David in view of McNamara and in further view of Eigler discloses the method of claim 18, but do not disclose that the shunting element is compressed to the third diameter using a balloon member positioned around an external surface of the shunting element.
Ben Muvhar teaches adjustable diameter implants for controlling blood flow in a blood vessel (Figs. 1-2, feat. 100; ¶0090 and 0125-0132) comprising a narrowed central section (Fig. 2, feat. 204; ¶0132) and a pair of flared sections on either side of the central section (Fig. 2, feats. 200, 202). Ben Muvhar teaches that the diameter of narrowed central section may be adjustable in order to control the flow of blood through the implant while it is implanted in the blood vessel (¶0090). Ben Muvhar teaches an embodiment (Figs. 10A-B, feat. 1500; ¶0209-0218) in which the external surface of the narrowed central section (1528) is constrained by one or more frangible bands with different diameters (Fig. 10A, feats. 1522 and 1524; ¶0212-0214) or a single band with an adjustable diameter (Fig. 10B, feat. 1540; ¶0216) and a balloon member is inserted into the lumen of the implant and expanded to adjust the diameter of the narrowed central section to the desired size, with the constraining bands (1522, 1524, and 1540) providing a constraining force on the external surface of the implant and therefore acting in conjunction with the balloon member to achieve the desired size (¶0213 and 0216). This is similar to the embodiment of Ben-David in which the diameter of the implant is adjusted by using a snare to radially compress the implant in conjunction with a balloon inside the lumen of the implant to achieve the desired diameter (Ben-David: ¶0072, especially lines 15-21). In both this embodiment taught by Ben Muvhar (Figs. 10A-B) and the corresponding embodiment of Ben-David (¶0072), a balloon member in the lumen constrains the radial compression of the implant, while one or more bands, in the case of Ben Muvhar, or a snare, in the case of Ben-David, constrains the radial expansion of the implant. Ben Muvhar further teaches an alternate embodiment in which the implant (Fig. 13, feat. 2400; ¶0223-0229) includes a ring shaped tube, or balloon member, (2420; ¶0034-0035 and 0223-0228) on the exterior surface of the implant (2430) such that the ring shaped tube may be inflated or deflated to adjust the diameter of the implant (2114). Because the ring shaped tube, or balloon member, may both be inflated to decrease the diameter of the implant and deflated to increase the diameter of the implant (¶0224), the ring shaped tube on the exterior surface of the implant advantageously allows the diameter of the implant to be adjusted to a desired size without needing an additional constraining balloon member on the inside of the implant, as in the embodiment of Figs. 10A-B of Ben Muvhar and of ¶0072 of Ben-David. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Ben-David in view of McNamara and in further view of Eigler so that the shunting element has a ring shaped balloon member on its external surface as taught by Ben Muvhar, and so that the shunting element is compressed to the third diameter using a balloon member positioned around an external surface of the shunting element in order to adjust the diameter of the shunting element without needing an additional constraining balloon member on the inside of the shunting element as taught by Ben Muvhar.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-David et al. (WO 2019/142152 A1) in view of McNamara et al. (US 2012/0053686 A1), in further view of Eigler et al. (US 2018/0243071 A1), and in further view of Nayak et al. (US 2005/0256532 A1).
Regarding claim 24, Ben-David in view of McNamara and in further view of Eigler discloses the method of claim 15. Ben-David further discloses that inflating the balloon member comprises inflating a widened segment of the balloon member (Figs. 12A-14B, feats. 32 and 32’; ¶0067-0069) positioned proximal or distal to the shunting element (10), and wherein the method further comprises aligning the shunting element with the septal wall using the widened segment of the balloon member (¶0068-0069: widened portion 32/32’ of the balloon expand to position an anchoring element 12 within the left atrium, thereby aligning the left atrial side of the shunting element 10 with the left atrial side of the septal wall). Ben-David in view of McNamara and in further view of Eigler does not disclose that the widened segment of the balloon directly contacts the septal wall when aligning the shunting element.
Nayak teaches a patent foramen ovale (PFO) (Fig. 1, feat. 109; ¶0038) closure device (Figs. 2A-C and 3A-B, feat. 30; ¶0039) for implanting in the atrial septal wall (Fig. 1, feats. 107 and 109; ¶0038) comprising a central hub (Fig. 3A, feat. 34; ¶0040) and penetrating anchors (Fig. 3A, feats. 35 and 36; ¶0041). Nayak teaches that the device may be delivered using a balloon catheter (Fig. 13, feat. 84’; ¶0055) inserted through the PFO (Fig. 13, feat. 109) and comprising a balloon (Fig. 13, feat. 88’) which is inflated to expand directly against the side of the septum opposite to where the device is to be implanted. Nayak teaches that this advantageously stabilizes the device during delivery and ensures that the device is centered over the implantation site at the PFO (¶0055). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Ben-David in view of McNamara and in further view of Eigler so that the widened segment of the balloon directly contacts the septal wall when aligning the shunting element in order to stabilize the shunting device and ensure that it is centered over the implantation site as taught by Nayak.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-David et al. (WO 2019/142152 A1) in view of McNamara et al. (US 2012/0053686 A1), in further view of Eigler et al. (US 2018/0243071 A1), and in further view of Costello et al. (US 2018/0055633 A1).
Regarding claim 25, Ben-David in view of McNamara and in further view of Eigler discloses the method of claim 15, but does not disclose that the one or more anchoring elements are coupled to the shunting element via one or more flanges extending radially outward from the shunting element.
Costello teaches a heart valve prosthesis (Figs. 1, 6A-C, and 10 feat. 101; ¶0034) comprising a tubular frame (102) and a support flange (Figs. 4-6C, feat. 120; ¶0043-0049; Figs. 9-10, feat. 920; ¶0053-0055) carrying tissue penetrating anchors (124). When in position, the support flange may extend radially outward from the frame (Fig. 10, feat. 920). Costello teaches that the support flange carrying the anchors advantageously serves a sealing function preventing leakage past the outer circumference of the tubular frame by providing a continuous circumferential seal (¶0050). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Ben-David in view of McNamara and in further view of Eigler so that the one or more anchoring elements are coupled to the shunting element via one or more flanges extending radially outward from the shunting element in order to seal the shunting element against leakage past the outer circumference of the shunting element as taught by Costello.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-David et al. (WO 2019/142152 A1) in view of McNamara et al. (US 2012/0053686 A1) and in further view of Nayak et al. (US 2005/0256532 A1).
Regarding claim 28, Ben-David discloses a method of implanting a shunting element (¶0024; Figs. 1A-2D; ¶0049-0055 – shunting element 10) in a septal wall (AS) between a left atrium (LA) and a right atrium (RA) in a patient, the method comprising: positioning the shunting element (Figs. 12A-14B, feat. 10; ¶0067-0069) around a balloon member (Figs. 12A-14B, feats. 30 and 30’) while the shunting element is in a contracted configuration having a first diameter (Figs. 12A and 13A, feats. 10 and 30; ¶0067-0068: deflated balloon catheter 30 with an initial diameter D1 is introduced within passage 20 of passage device 10 when the device is in a contracted configuration); expanding the shunting element to an expanded configuration having a second diameter by inflating the balloon member (Figs. 2A-D, feat. 16; Figs. 12B and 13B, feat. 16; ¶0067-0068: balloon catheter 30 is expanded so that the middle section 16 of the shunting element 10 has diameter D2, which may be larger than diameter D1), thereby defining a lumen having a central axis extending therethrough (Figs. 2A-D, feat. 20; ¶0051); securing the shunting element to the septal wall using one or more anchoring elements (Figs. 2A-D, feats. 12 and 14; Figs. 12B and 13B, feats. 12, 14, 32, and 34; ¶0051-0052 and 0067-0068: anchoring elements 12 and 14 are moved into position by the expansion of first and second portions 32 and 34 of the balloon catheter); and after securing the shunting element to the septal wall, adjusting the shunting element to a third diameter that is different than the second diameter (Figs. 9A-11C, 16A-C, feat. 70, and 17A-B, feat. 80; ¶0064-0066 and 0071-0072: after placement and anchoring in septal wall AS, a balloon catheter 70 and/or snare 80 may be used to adjust the diameter of the passage 20 of the middle portion 16).
Ben-David discloses that the balloon member (Figs. 13A-C, feat. 30) is introduced into the passage of the shunting element (10) after the element is positioned in the heart wall (¶0068). Therefore, Ben-David does not disclose a method comprising positioning the shunting element around the balloon member before introducing the shunting element into or near an aperture in the septal wall as claimed.
McNamara teaches an interatrial shunting or venting device (Fig. 1, feat. 100; ¶0165) and methods for implanting it (¶0040-0041). McNamara teaches that implanting an interatrial shunting device involves a plurality of steps including, among other things, advancing an introducer catheter to an atrium of the heart (¶0040), preforming and dilating opening in the interatrial septum with the introducer catheter (¶0045-0046), and advancing a placement catheter with the interatrial shunting device mounted on it through the opening so that the shunting device can be secured to the septum (¶0040). McNamara further teaches that the implantation procedure may be simplified by integrating a balloon on the placement catheter so that the placement catheter may form and dilate the opening in the septum at the same time as placing the shunting device (¶0047). Forming and dilating the opening in the septum at the same time as placing the shunting device using a balloon integrates the functions of the introducer catheter in the design of the placement catheter, which simplifies the procedure by eliminating the need for catheter exchanges (¶0044-0047). By modifying the method of Ben-David so that the shunting element is positioned around the balloon member before being introduced into or near the septal wall, the implantation procedures would be simplified by eliminating the additional steps and introducer catheter, and resulting catheter exchanges, needed to place the shunting element in the septal wall before placing the balloon member inside the shunting element. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Ben-David so that the shunting element is introduced into or near an aperture in the septal wall after positioning the shunting element around the balloon member while the shunting element is in a contracted configuration in order to simplify the implantation procedure as taught by McNamara.
Nayak teaches a patent foramen ovale (PFO) (Fig. 1, feat. 109; ¶0038) closure device (Figs. 2A-C and 3A-B, feat. 30; ¶0039) for implanting in the atrial septal wall (Fig. 1, feats. 107 and 109; ¶0038) comprising a central hub (Fig. 3A, feat. 34; ¶0040) and penetrating anchors (Fig. 3A, feats. 35 and 36; ¶0041). Nayak teaches that the device may be delivered using a balloon catheter (Fig. 13, feat. 84’; ¶0055) inserted through the PFO (Fig. 13, feat. 109) and comprising a balloon (Fig. 13, feat. 88’) which is inflated to expand directly against the side of the septum opposite to where the device is to be implanted. Nayak teaches that this advantageously stabilizes the device during delivery and ensures that the device is centered over the implantation site at the PFO (¶0055). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method disclosed by Ben-David in view of McNamara so that the widened segment of the balloon directly contacts the septal wall when aligning the shunting element in order to stabilize the shunting device and ensure that it is centered over the implantation site as taught by Nayak.
Response to Arguments
Applicant’s arguments, see pages 6-8 with respect to the rejections of claims 15-18, 24, 25, and 27 under 35 U.S.C. 103 as being unpatentable over Ben-David in view of McNamara in further view of Berg, of claim 19 in further view of Ben Muvhar, and of claim 26 in further view of Abbot have been fully considered and are persuasive in light of the amendments to the claims. Accordingly, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781