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 .
Election/Restrictions
Claims 6-7 and 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II and Species A-D and F-I, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on 07 October 2025 of Invention I, Species E, directed to Claims 1-5, 8, and 9.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 8-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang et al. (US Publication No. 2022/0110679).
Regarding Claim 1, Wang et al. discloses a medical device (atrial septostomy device, Abstract) comprising:
an expansion body (device body 20, see Figs. 1 and 5 annotated below) configured to expand and contract in a radial direction (expanding/compressing, Paragraph 0036, 0038);
an elongated shaft portion (delivery mechanism 50, see Fig. 1 annotated below) including a distal portion (portion in the distal direction, see Fig. 1 annotated below), the distal portion including a proximal end fixing portion to which a proximal end of the expansion body is fixed (proximal end 278 of device body 20 fixed to delivery mechanism shaft 50, see Fig. 1 annotated below; Paragraph 0036-0037);
an electrode portion (electrodes 60 in recessed expansion portion 23, see Figs. 3-6) provided along the expansion body (device body 20, see Figs. 1 and 5 annotated below), the expansion body including a recessed portion (recessed expansion portion 23, see Fig. 5 annotated below, see also Figs. 3-4 and 6) recessed radially inward when the expansion body expands and defining a receiving space configured to receive a biological tissue (receives tissue to expand a puncture hole in an atrial septum during atrial septostomy procedure, Abstract, Paragraph 0036-0037, 0010-0011);
the recessed portion includes a bottom portion positioned on a radial innermost side (“bottom portion” of recessed portion, see Fig. 5 annotated below), a proximal side upright portion (sections 26, 260, 233, “proximal side upright portion “, see Fig. 5 annotated below) extending radially outward from a proximal end of the bottom portion, and a distal side upright portion (sections 24, 240, 231, “distal side upright portion“, see Fig. 5 annotated below) extending radially outward from a distal end of the bottom portion;
the proximal side upright portion (sections 26, 260, 233, “proximal side upright portion “, see Fig. 5 annotated below, sections include opposite facing surfaces) includes a first surface facing the receiving space and a second surface opposite to the first surface;
the distal side upright portion (sections 24, 240, 231, “distal side upright portion“, see Fig. 5 annotated below, sections include opposite facing surfaces) includes a third surface facing the receiving space and a fourth surface opposite to the third surface;
one of the proximal side upright portion and the distal side upright portion is an electrode arrangement portion (electrodes 60 on surface of recessed expansion portion 23, see Figs. 3-6; as shown in Fig. 5 annotated below, electrodes 60/electrode portion is on the surface of the proximal side upright portion; but electrodes may be located in other portions as shown in Figs. 3-6; “electrodes 60 can be provided at a position on the expansion portion 23, the first positioning portion 24, or the second positioning portion 26 that contacts tissue surrounding the puncture hole”, Paragraph 0058) in which the electrode portion is arranged to face the receiving space (Paragraph 0036-0037, 0040-0042), and an other of the proximal side upright portion and the distal side upright portion is an opposing surface portion opposing the electrode portion (electrodes 60 on surface of recessed expansion portion 23, see Figs. 3-6; including surfaces opposing the electrodes);
and the expansion body includes a heat insulation layer (insulation layer or insulation sleeve, Paragraph 0058-0060, 0074, 0091; Claim 14) at least on one or more of the first surface, the second surface, the third surface, and the fourth surface so as to oppose the electrode portion across the receiving space (insulation layer or insulation sleeve is on all other surfaces besides the electrodes themselves, Paragraph 0057-0060, 0091; Claim 14; “insulation treatment is needed on the outer surface at portions of the support frame 21 other than the parts used as the ablation electrode 60,” Paragraph 0058; “an insulating coating can be applied to the outer surface at other portions of the support frame 21 that is in pressure contact with the atrial septal tissue”, Paragraph 0058).
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Regarding Claim 2, Wang et al. discloses the medical device further wherein the expansion body (device body 20, Figs. 1-6) includes a frame (support frame 21, Fig. 1) defining a shape of the expansion body (Paragraph 0036-0038), and the heat insulation layer is disposed on a surface of the frame (insulation layer or insulation sleeve, Paragraph 0058-0060).
Regarding Claim 3, Wang et al. discloses the medical device further wherein the heat insulation layer (insulation layer or insulation sleeve, Paragraph 0058-0060, 0074, 0091; Claim 14) is disposed over substantially entire surfaces of an inner surface of the frame in an expansion direction and an outer surface of the frame in the expansion direction (insulation layer or insulation sleeve is on all other surfaces besides the electrodes themselves, Paragraph 0057-0060, 0091; Claim 14; “insulation treatment is needed on the outer surface at portions of the support frame 21 other than the parts used as the ablation electrode 60,” Paragraph 0058; “an insulating coating can be applied to the outer surface at other portions of the support frame 21 that is in pressure contact with the atrial septal tissue”, Paragraph 0058).
Regarding Claim 4, Wang et al. discloses the medical device further wherein the heat insulation layer (insulation layer or insulation sleeve, Paragraph 0058-0060, 0074, 0091; Claim 14) is disposed on two or more of the first surface, the second surface, the third surface, and the fourth surface to sandwich the receiving space (insulation layer or insulation sleeve is on all other surfaces besides the electrodes themselves, Paragraph 0057-0060, 0091; Claim 14; “insulation treatment is needed on the outer surface at portions of the support frame 21 other than the parts used as the ablation electrode 60,” Paragraph 0058; “an insulating coating can be applied to the outer surface at other portions of the support frame 21 that is in pressure contact with the atrial septal tissue”, Paragraph 0058).
Regarding Claim 5, Wang et al. discloses the medical device further wherein the heat insulation layer (insulation layer or insulation sleeve, Paragraph 0058-0060, 0074, 0091; Claim 14) is disposed at the bottom portion on an inner surface of the frame in an expansion direction or an outer surface of the frame in the expansion direction (insulation layer or insulation sleeve is on all other surfaces besides the electrodes themselves, Paragraph 0057-0060, 0091; Claim 14; “insulation treatment is needed on the outer surface at portions of the support frame 21 other than the parts used as the ablation electrode 60,” Paragraph 0058; “an insulating coating can be applied to the outer surface at other portions of the support frame 21 that is in pressure contact with the atrial septal tissue”, Paragraph 0058).
Regarding Claim 8, Wang et al. discloses a medical device (atrial septostomy device, Abstract) comprising:
an expansion body (device body 20, see Figs. 1 and 5 annotated below) configured to expand and contract in a radial direction (expanding/compressing, Paragraph 0036, 0038);
an elongated shaft portion (delivery mechanism 50, see Fig. 1 annotated below) including a distal portion (portion in the distal direction, see Fig. 1 annotated below), the distal portion including a proximal end fixing portion to which a proximal end of the expansion body is fixed (proximal end 278 of device body 20 fixed to delivery mechanism shaft 50, see Fig. 1 annotated below; Paragraph 0036-0037);
an electrode portion (electrodes 60 in recessed expansion portion 23, see Figs. 3-6) provided along the expansion body (device body 20, see Figs. 1 and 5 annotated below);
a heat insulation cover portion (insulation layer or insulation sleeve, Paragraph 0058-0060, 0074, 0091; Claim 14) covering at least a part of the expansion body;
the expansion body (device body 20, see Figs. 1 and 5 annotated below) including a recessed portion (recessed expansion portion 23, see Fig. 5 annotated below, see also Figs. 3-4 and 6) recessed radially inward when the expansion body expands and defining a receiving space configured to receive a biological tissue (receives tissue to expand a puncture hole in an atrial septum during atrial septostomy procedure, Abstract, Paragraph 0036-0037, 0010-0011);
the recessed portion including a bottom portion positioned on a radial innermost side (“bottom portion” of recessed portion, see Fig. 5 annotated below), a proximal side upright portion (sections 26, 260, 233, “proximal side upright portion “, see Fig. 5 annotated below) extending radially outward from a proximal end of the bottom portion, and a distal side upright portion (sections 24, 240, 231, “distal side upright portion“, see Fig. 5 annotated below) extending radially outward from a distal end of the bottom portion;
the electrode portion is arranged in the recessed portion to face the receiving space (electrodes 60 on surface of recessed expansion portion 23, see Figs. 3-6; as shown in Fig. 5 annotated below, electrodes 60/electrode portion is on the surface of the proximal side upright portion; but electrodes may be located in other portions as shown in Figs. 3-6; “electrodes 60 can be provided at a position on the expansion portion 23, the first positioning portion 24, or the second positioning portion 26 that contacts tissue surrounding the puncture hole”, Paragraph 0058);
and the heat insulation cover portion (insulation layer or insulation sleeve, Paragraph 0058-0060, 0074, 0091; Claim 14) is configured to cover at least a part of the recessed portion on a surface opposite to a surface facing the receiving space in a vicinity of the electrode portion (insulation layer or insulation sleeve is on all other surfaces besides the electrodes themselves, Paragraph 0057-0060, 0091; Claim 14; “insulation treatment is needed on the outer surface at portions of the support frame 21 other than the parts used as the ablation electrode 60,” Paragraph 0058; “an insulating coating can be applied to the outer surface at other portions of the support frame 21 that is in pressure contact with the atrial septal tissue”, Paragraph 0058).
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Regarding Claim 9, Wang et al. discloses the medical device further wherein one of the proximal side upright portion and the distal side upright portion is an electrode arrangement portion in which the electrode portion is arranged to face the receiving space (electrodes 60 on surface of recessed expansion portion 23, see Figs. 3-6; as shown in Fig. 5 annotated above, electrodes 60/electrode portion is on the surface of the proximal side upright portion; but electrodes may be located in other portions as shown in Figs. 3-6; “electrodes 60 can be provided at a position on the expansion portion 23, the first positioning portion 24, or the second positioning portion 26 that contacts tissue surrounding the puncture hole”, Paragraph 0058),
and an other of the proximal side upright portion and the distal side upright portion is an opposing surface portion opposing the electrode portion (electrodes 60 on surface of recessed expansion portion 23, see Figs. 3-6; including surfaces opposing the electrodes);
and the heat insulation cover portion is disposed on the opposing surface portion on a surface opposite to a surface facing the receiving space (insulation layer or insulation sleeve is on all other surfaces besides the electrodes themselves, Paragraph 0057-0060, 0091; Claim 14; “insulation treatment is needed on the outer surface at portions of the support frame 21 other than the parts used as the ablation electrode 60,” Paragraph 0058; “an insulating coating can be applied to the outer surface at other portions of the support frame 21 that is in pressure contact with the atrial septal tissue”, Paragraph 0058).
Conclusion
The prior art made of record and not relied upon is considered pertinent to the Applicant's disclosure:
He et al. (US Publication No. 2004/0187875) discloses a medical device (10, Fig. 14, Abstract) comprising an expansion body (10, Fig. 14; Paragraph 0086), including electrodes (Paragraph 0030, 0037, 0046) and recessed portions (see Fig. 14; Paragraph 0086) configured to contact tissue.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796