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 Amendment
In response to the amendment filed on 07/09/2026, Claims 1-19 and 26 have been cancelled, Claims 20-25 and 27-40 and newly added Claim 41 are pending.
Response to Arguments
Applicant's arguments filed 07/09/2026 have been fully considered but they are not persuasive.
Applicant argues, on Pages 7-8, that Maisano fails to disclose “wherein one of the at least one expandable arm is affixed to the open distal end”, however the Examiner respectfully disagrees.
Maisano teaches flexible longitudinal members (14) deployed from an open distal end of catheter (32) through apertures (26a 26b; Figure 3C; Paragraph 0402) which slidably affixed the longitudinal members (14) to the catheter (32). Therefore, it is the Examiner’s position that Maisano does indeed teach “wherein one of the at least one expandable arm is affixed to the opened distal end.” as shown in Figures 3A-4C). See also the following elements (88; Figures 6B-6C)(94, Figure 8A in which the expandable arms are the filaments on the mesh)(14; Figure 8C in which the arms are the flexible longitudinal members in Paragraph 0441) (92; Figure 10).
As to Applicant’s arguments directed to the dependent claims as being patentable due to their dependency to Claim 20, the rejection of Claim 20 is being maintained in light of the teachings of Maisano. Applicant has not separately argued the patentability of the dependent claims. Thus, the dependent claims are also being rejected.
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) 20-30 and 32-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maisano (US PGPub 2014/0309675).
Regarding Claim 20, Maisano teaches a method for puncturing a wall of an anatomical vessel (Figures 1-4C; abstract), the method comprising:
advancing a flexible catheter (38; Figure 1B) having an opened distal end in the anatomical vessel (Paragraph 0405 states that the flexible catheter houses both dilator 50 and puncturing element 32; see Figures 1B-1B);
manipulating the opened distal end so that the opened distal end (of catheter 38; Figures 1B-1C) opposes a target location (18) on the wall of the anatomical vessel (Figures 1B-1C; Paragraph 0406);
bracing the opened distal end (of catheter 38) within the anatomical vessel to restrict movement of the opened distal end (as disclosed in Paragraph 0405 and see Figures 1C, 3C-3E, 4B-4C);
advancing a tissue puncturer (32) through the flexible catheter (38) to puncture the wall of the anatomical vessel at the target location (28; Figure 1C; as described in Paragraph 0406); and
positioning the tissue puncturer (32) near the target location by expanding at least one expandable arm (14/58 Figures 3A-4C)(88; Figures 6B-6C)(94, Figure 8A in which the expandable arms are the filaments on the mesh)(14; Figure 8C in which the arms are the flexible longitudinal members in Paragraph 0441) (92; Figure 10) on a distal end of a first catheter (38; Figure 3B, 4B, 6B, 8C-D), wherein one of the at least one expandable arm (14, 88, or 94) is affixed to the opened distal end (It’s the Examiner’s position that the arms are radially and slidably affixed to the open distal end of the catheter since the expandable arms are radially restricted and slidably fixed to the first catheter).
Regarding Claim 21, Maisano teaches the method of claim 20, wherein manipulating the opened distal end includes bending a flexible positioning arm (14/58) to which the distal open end (of catheter 32) is connected (via openings 26a/26b as disclosed in Paragraph 0405 which specifically states that flexible longitudinal member 14 is made to loop around the target location and thus “includes bending” as claimed; see Figures 1B-3D).
Regarding Claim 22, Maisano teaches the method of claim 20, wherein bracing includes causing a plurality of flexible braces (14/58) to expand against differing locations on the wall of the anatomical vessel (see Figures 3B-3C and see Paragraphs 0413 and 0422).
Regarding Claim 23, Maisano teaches the method of claim 20, wherein the tissue puncturer (32) includes a needle (as seen in Figure 1C and Paragraph 0413 and 0423, in which the term needle does not impart any new structure into the claims as element 32 is a puncturing element is a sharp tip).
Regarding Claim 24¸ Maisano teaches the method of claim 20, further comprising dilating an opening in the wall of the anatomical vessel caused by the tissue puncturer (32) (as disclosed in Paragraph 0421 and shown in Figure 1C)
Regarding Claim 25, Maisano teaches the method of claim 24, wherein dilating includes advancing a dilator (16/50) over the tissue puncturer (32; as seen in Figures 1C and described in Paragraph 0421).
Regarding Claim 27, Maisano teaches the method of claim 20, wherein the method further comprises sliding a sheath (12) to radially expand the at least one expandable arm such that at least one of the at least one expandable arm contacts at least a portion of the wall of the anatomical vessel (Paragraph 0440).
Regarding Claim 28, Maisano teaches the method of claim 27, wherein the method further comprises sliding the sheath (12) to radially collapse the at least one expandable arm within the sheath (Paragraph 0440).
Regarding Claim 29, Maisano teaches the method of claim 20, wherein the anatomical vessel includes a coronary sinus (Paragraph 0391).
Regarding Claim 30, Maisano teaches the method of claim 20, wherein puncturing the wall of the anatomical vessel at the target location includes forming a hole in a wall between a coronary sinus and a left atrium (Paragraph 0391 and 0406).
Regarding Claim 32, Maisano teaches the method of claim 20, wherein the tissue puncturer (32) includes a non-hollow structure (Paragraph 0464-0465; the Examiner notes that Maisano is not particular about this claim however the puncturer can either be hollow or non-hollow and Maisano doesn’t disclose any lumen for the tissue puncturer or any structure for coring tissue, and Maisano teaches that the puncturing element is removed so that a guidewire can be disposed within a dilator and if the puncturing element had a lumen then it would be used to deploy the guidewire).
Regarding Claim 33, Maisano teaches the method of claim 26, wherein the method further comprises retracting the flexible catheter (38) to move a distal end of one of the at least one expandable arm (14/58) away from the target location (Paragraph 0405-0406 state that the catheter is steerable).
Regarding Claim 34, Maisano teaches the method of claim 20, wherein manipulating includes axial or radial manipulation of the flexible catheter (38; see Figures 1B-1C in which the catheter 38 can be moved axially and radially; see Paragraphs 0405-0406).
Regarding Claim 35, Maisano teaches the method of claim 20, wherein manipulating includes adjusting an angle of the opened distal end (see Figures 1B-1C in which the catheter 38 can be moved axially and radially; see Paragraphs 0405-0406).
Regarding Claim 36, Maisano teaches the method of claim 21, wherein manipulating includes adjusting an angle of the flexible positioning arm (14/58; Figures 3D-3E; Paragraph 0415).
Regarding Claim 37, Maisano teaches the method of claim 20, wherein manipulating includes adjusting a distance of the opened distal end from the wall (Figures 3D-3E; Paragraph 0415).
Regarding Claim 38, Maisano teaches the method of claim 21, wherein manipulating includes adjusting a distance of the flexible positioning arm from the wall (Figures 3D-3E; Paragraph 0412-0415).
Regarding Claim 39, Maisano teaches the method of claim 25, further comprising exchanging the tissue puncturer (32) with a guidewire through the dilator (49; Paragraph 0465).
Regarding Claim 40, Maisano teaches the method of claim 20, wherein orientation markers are used to guide axial and rotational orientation of one or more of: a first catheter, the flexible catheter, and the tissue puncturer (Paragraph 0419, 0424, and 0447).
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.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maisano (US PGPub 2014/0309675) as applied to claim 20 above, and further in view of Gammie (US PGPub 2020/0229805).
Regarding Claim 31, Maisano teaches the method of claim 20, but fails to explicitly teach wherein the tissue puncturer includes a hollow structure.
Gammie teaches a tissue transeptal puncture device (abstract) wherein the tissue puncturer (22) has a lumen/hollow structure for housing a guidewire (24; see Figure 2A; Paragraph 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tissue puncturer of Maisano to include a hollow structure, as taught by Gammie, for the advantage of not having to withdraw the puncturer from the dilator in order to deploy a guidewire and thus having the ability of deploy a guidewire through a lumen/hollow structure of the tissue puncturer, as taught by Gammie.
Allowable Subject Matter
Claim 41 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record fails to disclose “The method of claim 20, wherein advancing the tissue puncturer through the flexible catheter to puncture the wall of the anatomical vessel at the target location comprises advancing the tissue puncturer through an orifice included in one of the at least one expandable arm”
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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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) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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