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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14, 16, 23, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saadat et al. (US 20120004577), hereinafter Saadat ‘577, cited in IDS.
Regarding claim 1, Saadat ‘577 discloses a tissue piercing assembly configured to pierce a septal wall between a right atrium and a left atrium (fig. 47C, 49A-B, section 0215, 0219) comprising: a cone-shaped member 630 having inflatable walls and a closed inner chamber (Fig. 53A-D, section 0194), wherein a closed distal region of the inner chamber 642 includes a membrane 650 (Fig. 53C-D, 54A-B, section 0194, the surrounding theater is comprised of the compliant material of balloon, section 0246); a visualization member 530 adapted to be positioned to have a field of view that includes at least a portion of the closed distal region (Fig. 53C-D, section 0188, 0194); and one or more of a piercing member guide 638 (Fig. 53A-C, section 0194) and a piercing member 84, 656 disposed within the closed inner chamber 642 (Fig. 53C, section 0194, the distal portion of balloon, is partially everted to create a working theater within which imaging catheter and/or various instruments may be introduced for treating the underlying tissue), wherein the piercing member 84, 656 has a distal end that is configured to pierce the membrane 650 at the closed distal region of the inner chamber (Fig. 54a, section 0195, such as a piercing needle, may be advanced into the balloon interior and pierced through the balloon membrane and into the underlying tissue).
Regarding claim 2, Saadat ‘577 discloses the inflatable wall 630 comprises one or more second inflatable chambers 642 disposed radially outward relative to a proximal region of the inflatable chamber, at least one of the one or more second inflatable chambers not in direct fluid communication with the closed inner chamber (Figs 53A-C, section 0194).
Regarding claim 3, Saadat ‘577 discloses the membrane 384 has a lesser thickness than the inflatable walls (Fig. 32B, section 0166, Fig, 53C-D, section 0188, 0194).
Regarding claim 4, Saadat ‘577 discloses the closed distal region is adapted to have a planar or flattened configuration when the cone-shaped member is at least partially inflated (Figs. 53C-D).
Regarding claim 5, Saadat ‘577 discloses the closed distal region 514 is less stiff than a proximal region 516 of the cone-shaped member when the cone- shaped member is at least partially inflated (Fig. 47B-C, section 0186).
Regarding claim 6, Saadat ‘577 discloses the proximal region includes at least one second inflatable chamber 482 (Fig. 43B).
Regarding claim 7, Saadat ‘577 discloses one or more controllers 600 configured to control a first fluid pressure within the closed inner chamber and a second fluid pressure within the inflatable walls, wherein the first fluid pressure is different than the second fluid pressure (Section 0192).
Regarding claim 8, Saadat ‘577 discloses the closed distal region has a flattened configuration when the cone-shaped member is in an at least partially inflated configuration (Figs. 47A-B, section 0186).
Regarding claim 9, Saadat ‘577 discloses the assembly includes the piercing member guide 82, 680, 682, 684 and the piercing member 84, 692, 694, 696 the piercing member guide including a piercing member lumen sized and configured to receive the piercing member therethrough (Fig. 7A-B, 56, section 0121-0122, 0197).
Regarding claim 10, Saadat ‘577 discloses the one or more of the piercing member guide 82, 680, 682, 684 and the piercing member 84, 692, 694, 696 is axially movable relative to the cone-shaped member (Figs. 7A-B, 56, section 0121-0122, 0197).
Regarding claim 11, Saadat ‘577 discloses the assembly includes the piercing member guide, the piercing member guide having a sharpened distal end 692 (Fig. 56, section 0197).
Regarding claim 12, Saadat ‘577 discloses the assembly includes the piercing member guide 82, the piercing member guide 82 not having a sharpened distal end that it is not configured to pierce tissue (Fig. 7A).
Regarding claim 13, Saadat ‘577 discloses the visualization member 530 includes an optical element 532 (section 0188) secured relative to the one or more of the piercing member guide 16 and the piercing member 84 that is disposed within the cone-shaped chamber (Fig. 53C, section 0194) .
Regarding claim 14, Saadat ‘577 discloses the optical element 532 is secured relative to the one or more of the piercing member guide 16 and the piercing member 84 such that the optical element is adapted to self-deploy to a deployed configuration (Fig. 53C, section 0194).
Regarding claim 16, Saadat ‘577 discloses assembly includes the piercing member guide 16, wherein the visualization member 530 is disposed within a visualization member receiving area of the piercing member guide when in a delivery state (Fig. 53C, section 0194).
Regarding claim 23, Saadat ‘577 discloses the visualization member 530 is secured within any of the one or more second inflatable chambers (Fig. 52C, section 0194).
Claim(s) 33-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saadat et al. (US 20190046013) hereinafter Saadat ‘013, cited previously.
Regarding claim 33, Saadat ‘013 discloses piercing a fossa ovalis (section 0020, 0023), comprising: delivering a cone-shaped member 12 having a closed distal region into a right atrium while the cone-shaped member is in a contracted configuration (Fig. 20A, Fig. 53A-D, section 0194), the closed distal region 642 comprising a membrane 640 (Fig. 53C-D, section 0194, 0246); at least partially inflating an inflatable wall 232 of the cone-shaped member to transition the cone-shaped member to an expanded configuration in the right atrium (Figs. 16a-b, section 0172); at least partially inflating a closed inner chamber of the cone-shaped member in the right atrium (Figs. 48A-C); providing a field of view that includes the membrane and the fossa ovalis with a visualization member disposed within the closed inner chamber of the cone-shaped member (section 0216); and piercing 520, 602 the membrane of the cone-shaped member and the fossa ovalis with a piercing member 520 to create an opening in the fossa ovalis (Fig.64B, 67A-B, section 0021, With the hood positioned over the fossa ovalis and directly visualizing the pale white tissue surface of the fossa, a piercing needle within a needle sheath or a separate beveled sheath may be advanced through the catheter and into the imaging hood where the needle may be pierced into and through the fossa ovalis while under direct visualization, section 0225, imaging hood 12 may be omitted entirely and balloon 540 having a working channel could be positioned against the tissue wall directly, e.g., at the fossa ovalis. The balloon itself is used to displace the blood and provide a clear image of the tissue when positioned against the wall where a tissue engager and/or needle may be passed directly though the balloon interior and pierced through the balloon membrane to cross the atrial septum).
Regarding claim 34, Saadat ‘013 discloses piercing the membrane and the fossa ovalis comprises advancing a piercing member through the membrane and the fossa ovalis (Fig.64B, 67A-B, section 0216, 0240, 0243-0244).
Regarding claim 35, Saadat ‘013 discloses piercing the membrane comprises activating a RF electrode 718 (Fig. 80A, Section 0260).
Regarding claim 36, Saadat ‘013 discloses advancing a piercing member guide 616 distally and into contact with an inner surface of the membrane (Fig. 67A-B, section 0243-0244).
Response to Arguments
Applicant's arguments filed 11/4/2025 have been fully considered but they are not persuasive. Examiner finds that Saadat ‘577 discloses one or more of a piercing member guide 638 (Fig. 53A-C, section 0194) and a piercing member 84, 656 disposed within the closed inner chamber 642 (Fig. 53C, section 0194, the distal portion of balloon 630 is partially everted to create a working theater 642 within which imaging catheter 530 and/or various instruments may be introduced for treating the underlying tissue), wherein the piercing member 84, 656 has a distal end that is configured to pierce the membrane 650 at the closed distal region of the inner chamber (Fig. 54a, section 0195, such as a piercing needle, may be advanced into the balloon interior and pierced through the balloon membrane and into the underlying tissue).
Saadat ‘013 does disclose delivering a cone-shaped member 12 having a closed distal region into a right atrium while the cone-shaped member is in a contracted configuration (Fig. 20A, Fig. 53A-D, section 0194). piercing 520, 602 the membrane of the cone-shaped member and the fossa ovalis with a piercing member 520 to create an opening in the fossa ovalis (Fig.64B, 67A-B, section 0021, With the hood positioned over the fossa ovalis and directly visualizing the pale white tissue surface of the fossa, a piercing needle within a needle sheath or a separate beveled sheath may be advanced through the catheter and into the imaging hood where the needle may be pierced into and through the fossa ovalis while under direct visualization, section 0225, imaging hood 12 may be omitted entirely and balloon 540 having a working channel could be positioned against the tissue wall directly, e.g., at the fossa ovalis. The balloon itself is used to displace the blood and provide a clear image of the tissue when positioned against the wall where a tissue engager and/or needle may be passed directly though the balloon interior and pierced through the balloon membrane to cross the atrial septum).
Conclusion
THIS ACTION IS MADE FINAL. 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 JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796