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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is unclear with the recitation of “a supporting unit” (line 4) and then the subsequent recitation of “a plurality of supporting units” (line 5). It is not clear if recitation intends to recite two different types of supporting units, or is further reciting that there are a plurality of the first mention supporting unit. Similarly, the claim also recites “a wall attachment unit” (line 4) and “a plurality of wall attachment units (line 7) and is unclear for the same reasoning. Claims 2-20 are rejected based on their dependency from claim 1.
Claim Rejections - 35 USC § 102
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.
Claims 1-9 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson et al (10,058,380).
Regarding claim 1, Anderson et al provide an ablation apparatus comprising a catheter (110 – Figure 14a) and an ablation portion (104) connected to a distal end of the catheter. The ablation portion has an expansible property (Figures 14a and 14b, for example) and comprises a plurality of ablation members. Each ablation member comprises a supporting unit (106), a wall attachment unit (104) and an energy release unit (i.e. wire 104 is an electrode) on the wall attachment unit. See, for example, Figures 15c and 15d. A plurality of supporting units are deployed radially and outwardly and extend toward a distal end of the ablation portion as seen in Figure 15d. Each of the wall attachment portions (104) is independently deformed relative to the adjacent wall attachment units when deployed as shown in Figure 15d.
Regarding claim 2, see Figure 15d which shows the supporting units forming a cavity with an opening at a distal end and the plurality of wall attachment units (104) are provided around the opening at spaced intervals. Regarding claim 3, the wall attachment unit comprises first and second connecting ends connected to a wall supporting unit (106), and there is a deformable section (104 in Figure 15d) extending between the first and second connecting ends. The deformable section has an elastic deformation property that is bent and protruded toward an outer side of the ablation portion when deployed as seen in Figure 15d. Regarding claim 4, see again Figures 15c and 15d which show the claimed relationship. Regarding claim 5, the deformable sections comprises a first wall attachment section and a second wall attachment section (108, 108s) with each attachment section connected to one end of wall attachment section (106) and the connecting ends are configured to be close to each other under action of an external force (Figure 15c) and move away from each other when the external force is removed (Figure 15d). Regarding claim 6, see Figure 15d which shows the relationship for the attachment sections as claimed. Regarding claim 7, see again Figure 15d which shows a vertex for the connecting section (104) and first and second connecting arms jointly connecting the vertex (Figure 15d). Regarding claim 8, the connecting section protrudes towards the distal end of the ablation apparatus (Figure 15d). Regarding claim 9, the supporting unit comprises two first supporting rods (106) provided at spaced intervals with a first connecting end and a second connecting attached to the supporting rods (Figure 15d, for example). Regarding claim 11, the supporting units (106) comprise a straight section connected to the wall attachment unit through a straight section with an included angle being less closer to the catheter (Figure 15f, proximal to 110) that a remaining region closer to the wall attachment unit in the expanded state). Regarding claim 12, the ablation apparatus has multiple regions (i.e. each curved section may be deemed a “region”) and each region is independently deformed and in the same plane (Figure 15d). Regarding claim 13, see Figure 15c which shows the wall units compressed into an abutting relationship when a force toward an inside of the ablation probe (i.e. withdrawal of the ablation unit) is provided.
Claims 1, 3-9 and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kunis et al (7,429,261).
Regarding claim 1, Kunis et al provide an ablation apparatus comprising a catheter (22) and an ablation portion (23) at the distal end of the catheter. The ablation portion has an extensible property (Figures 2-7, for example) and comprises a plurality of ablation members. Each ablation member comprises a supporting unit (42), a wall attachment unit (41) and an energy release unit (40) on the wall attachment unit. See Figures 6 and 7, for example. There are a plurality of supporting units (Figures 6 and 7) that are deployed radially outward and extend toward the distal end of the ablation portion, each supporting unit connected to a wall attachment unit. When the ablation portion is in a naturally expanded state, at least one wall attachment unit is independently deformed relative to adjacent wall attachment units (Figures 6 and 7).
Regarding claim 3, the wall attachment unit comprises a first connecting end (connected to the support unit) and a second connecting end (connected to center support 44) and a deformable section (41) extending between the first and second ends. The deformable section has an elastic deformation property and is bent and protruded toward an outer side of the ablation portion when deployed (Figure 13, for example). Regarding claim 4, the deformable section is elastically deformed to increase a distance between the first and second ends when expanded/retracted (see Figures). Regarding claim 5, the deformable section has a first wall attachment section and a second wall attachment section connected to the first connecting end and second connecting end, respectively. The ends are configured to be close to each other under the action of an external force (i.e. withdrawn into the catheter as in Figure 10) and configured to be away from each other when the force is removed (i.e. the ablation device is extended from the catheter. Regarding claim 6, the first and second wall attachment sections each comprise an arcuate structure (i.e. the bend where 41 and 42 connect) protruding toward the outer side of the ablation portion. Regarding claim 7, the deformable section comprises a connecting section, the connecting section comprises a distal vertex (i.e. where 44 connects to 41 in Figure 9)and a first connecting arm (i.e. one of arms 41) and a second connecting arm (i.e. another one of arms 41) are jointly connected at the vertex. There is a gap (46 – Figure 7) between the first and second connecting arms with the wall attachment second connected to the first connecting end and the other end of the first wall attachment section is connected to the first connecting arm as seen in the Figures. Regarding claim 8, the connecting section protrudes toward a distal end of the ablation apparatus (Figure 9, for example). Regarding claim 9, the supporting unit comprises multiple supporting rods (42) provided at spaced intervals with the first and second connecting ends fixedly connected to the supporting rods (Figures 5-7, for example). Regarding claim 11, the supporting unit comprises a straight section (Figure 6, for example) and is connected to the wall attachment unit through the straight section. The angle between the straight section and an axis of the ablation portion is less than an angle between a remaining region of the supporting unit (i.e. at the bend where 41 and 42 meet) in a naturally expanded state. Regarding claim 12, the ablation apparatus has a first region and a second region. That is, any two adjacent arms of Figure 7 may be deemed a first section, and the remaining arms may be the second section. Each wall attachment unit is independently deformed, and all the wall attachment units are in the same plane (Figures 7 and 8, for example). Regarding claim 13, the all units in the first region are located between the wall units in the second region (i.e. when considering the circumference of the device in Figure 7), and when the ablation portion is withdrawn into the catheter the wall units abut against each other within the catheter body (Figures 2 and 10, for example). Regarding claim 14, the energy release unit in the first region comprises strip electrodes (i.e. two electrodes 40 on each arm) with the electrodes provided at spaced intervals on the attachment units (Figure 7). The electrodes may be bipolar (col. 5, lines 49-60, for example).
Claims 1 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edwards et al (6,355,031).
Edwards et al provide an ablation apparatus comprising a catheter (30) and an ablation portion (36) connected to a distal end of the catheter (Figure 3). The ablation portion has an expansible property (Figures 3 and 4) and comprises a plurality of ablation members (58). Each ablation member comprises a supporting unit (i.e. proximal and distal ends of the spline) and a wall attachment unit (i.e. middle section that contacts tissue) and an energy release unit (i.e. electrode 66 – Figure 5) provided on the wall attachment unit. There are a plurality of supporting units (i.e. splines) that are deployed radially outward and are connected to a plurality of wall attachment units (i.e. middle of each spline). Each of the splines are independently deformed relative to adjacent wall attachment units.
Regarding claim 16, the catheter and the ablation portion have delivery channels (e.g. channels 222 in each spline which connect to a channel in the catheter connected to port 40 to provide cooling fluid to tissue). Cooling holes (98) are provided on the splines (i.e. on the wall attachment unit as seen in Figure 7) to provide a fluid to the outside of the ablation portion. Regarding claim 17, the ablation apparatus further comprises a cooling balloon (72 – Figure 3, for example) defining a balloon chamber. There is a delivery channel (204) that delivers a cooling fluid to the balloon, and the outer surface of the balloon is attached to the wall attachment units when expanded (Figures 4 and 5, for example). One or more cooling holes (PH – Figure 58B) are arranged on the surface of the balloon to discharge the cooling medium from the chamber of the balloon to the outside. Regarding claim 18, there is inherently a recovery channel within the balloon, as well as an aspiration channel.
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kunis et al (7,429,261) in view of the teaching of Oral et al (7,857,808).
Kunis et al provide electrodes (40) on the wall attachment unit, but fails to disclose the wall attachment comprises a mesh structure having conductive wires to expose an electrode.
Oral et al disclose an analogous device having a plurality of splines that are expanded to treat tissue, each of the splines having a wall attachment unit that contacts tissue and supports an electrode. In particular, Oral et al teach that the electrodes may be formed with a mesh-like structure (col. 9, lines 50-53, for example).
To have provided the Kunis et al device with electrodes having a mesh-like structure to provide energy to tissue would have been an obvious design consideration for one of ordinary skill in the art at the time of the invention since Oral et al fairly teach it is known to use mesh-like electrodes on a wall attachment unit of a similarly constructed ablation device.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards et al (6,355,031) in view of the teaching of Bencini et al (8,128,617).
Edwards et al disclose a single balloon used to expand the splines and provide cooling, and fail to disclose the use of first and second balloons as claimed.
Bencini et al disclose another device that uses a balloon to expand a plurality of splines having electrodes thereon (Figure 3, for example). In particular, Bencini et al teach that it is known to provide a dual balloon structure with an inner balloon chamber located within an outer balloon chamber as claimed. See, for example, Figures 2A and 2B and column 13, lines 1-15.
To have provided the Edwards et al device with a dual-balloon structure having a balloon chamber within an outer balloon chamber to provide a cooling fluid to the treatment area and expand the splines would have been an obvious design modification for one of ordinary skill in the art at the time of the invention since Bencini et al fairly teach such a structure is known to be used in an analogous treatment device.
Allowable Subject Matter
Claims 10 and 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fang (9,314,299), Oral et al (7,468,062), de la Rama et al (8,224,416) and Ibrahim et al (10,548,611) disclose other catheters having deployable arms with electrodes for ablating tissue.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/April 16, 2026
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