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
Applicant's election with traverse of Group I (claims 1-15) in the reply filed on 5/18/2026 is acknowledged.
The restriction requirement has been withdrawn and thus claims 1-20 are pending.
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, 4, 10, 12, 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20080172082 Holzer et al. (hereinafter Holzer).
Regarding claim 1, Holzer discloses a catheter assembly (100, Fig. 1a-d) for performing a thrombectomy (abstract, paragraph 18-19), the catheter assembly comprising:
a catheter sheath (134, Fig. 2d); and
a dilation and capture assembly (balloon 130 and retrieval basket 122) slidably positioned within the catheter sheath (as seen in Fig. 2d, paragraph 124-126), the dilation and capture assembly comprising:
a catheter (132) comprising a balloon portion (130) at a distal end of the catheter, the balloon portion being selectively inflatable and deflatable between respectively a maceration orientation and a delivery orientation (paragraph 63, 96-98, 109, 112); and
a retrieval basket (122) deployable from a delivery configuration mounted to the balloon portion and a retrieving configuration axially displaced from the distal end of the catheter (paragraph 95-97, 111-112, Fig. 1a-2d).
Regarding claim 4, Holzer discloses the limitations of claim 1, and further discloses wherein:
the retrieval basket comprises a retrieval side (proximal side (left side) of the basket 122, Fig. 1a-d) configured to receive particulate (160) removed during the thrombectomy, and a closed side (distal side (right side) of the basket 122, Fig. 1a-d) opposite the retrieval side configured to retain the particulate in the retrieval basket (paragraph 98-100, 104, 112), and
the retrieval basket is at least partially formed of a mesh configured to allow blood flow through the closed side of the retrieval basket (paragraph 100).
Regarding claim 10, Holzer discloses a catheter assembly (100, Fig. 1a-d) for performing a thrombectomy (abstract, paragraph 18-19), the catheter assembly comprising:
a catheter sheath (134, Fig. 2d); and
a dilation and capture assembly (balloon 130 and retrieval basket 122) slidably positioned within the catheter sheath (as seen in Fig. 2d, paragraph 124-126), the dilation and capture assembly comprising:
a catheter (132) comprising a proximal portion and a balloon portion (130) at a distal end of the proximal portion (as seen in Fig. 1a), the balloon portion being selectively inflatable and deflatable between respectively a maceration orientation and a delivery orientation (paragraph 63, 96-98, 109, 112);
a retrieval basket (122) deployable from a delivery configuration mounted to the balloon portion and a retrieving configuration axially displaced from the balloon portion (paragraph 95-97, 111-112, Fig. 1a-2d); and
one or more attachment wires (110/112) configured to position the retrieval basket relative to the catheter sheath (paragraph 95, 114, 117-119).
Regarding claim 12, Holzer discloses the limitations of claim 10, wherein:
the retrieval basket comprises a retrieval side (proximal side (left side) of the basket 122, Fig. 1a-d) configured to receive particulate (160) removed during the thrombectomy, and a closed side (distal side (right side) of the basket 122, Fig. 1a-d) opposite the retrieval side configured to retain the particulate in the retrieval basket (paragraph 98-100, 104, 112), and
the retrieval basket is at least partially formed of a mesh configured to allow blood flow through the closed side of the retrieval basket (paragraph 100).
Regarding claim 16, Holzer discloses a method of performing a thrombectomy (paragraph 80-84, claims 76-83), the method comprising:
inserting a catheter assembly (100, Fig. 1a-d) into a body vessel (141), the catheter assembly comprising:
a catheter sheath (134, Fig. 2d); and
a dilation and capture assembly (balloon 130 and retrieval basket 122) slidably positioned within the catheter sheath (as seen in Fig. 2d, paragraph 124-126), the dilation and capture assembly comprising:
a catheter (132) comprising a balloon portion (130) at a distal end of the catheter, the balloon portion being selectively inflatable and deflatable between respectively a maceration orientation and a delivery orientation (paragraph 63, 96-98, 109, 112); and
a retrieval basket (122) deployable from a delivery configuration mounted to the balloon portion and a retrieving configuration axially displaced from the distal end of the catheter (paragraph 95-97, 111-112, Fig. 1a-2d);
translating the balloon portion and the retrieval basket relative to the catheter sheath past a treatment site (paragraph 80, Fig. 2d, 3c); and
inflating the balloon portion, thereby dilating the retrieval basket (paragraph 80, 95-97, 111-112, Fig. 1a-2d, 3c).
Regarding claim 17, Holzer discloses the limitations of claim 16, and further discloses further comprising:
deflating the balloon portion (paragraph 63, 98, 104-105, Fig. 1a, 1c, 2a, 2c, 3a, 3c);
translating the balloon portion toward the treatment site (paragraph 80, 95-97, Fig. 1a-5e); and
repeatedly inflating and deflating the balloon portion at the treatment site (paragraph 3, 33-35, 88, 109).
Regarding claim 18, Holzer discloses the limitations of claim 17, and further discloses wherein the retrieval basket collects particulate removed during inflation and deflation of the balloon portion at the treatment site (paragraph 88, 109, 112).
Regarding claim 19, Holzer discloses the limitations of claim 18, and further discloses further comprising:
deflating the balloon portion (paragraph 98, 104-105, Fig. 1a, 1c, 2a, 2c, 3a, 3c); and
retracting the balloon portion into the catheter sheath (paragraph 80-82, 108, Fig. 2d).
Regarding claim 20, Holzer discloses the limitations of claim 19, and further discloses further comprising:
retracting the retrieval basket toward the treatment site to collect the particulate with the retrieval basket (paragraph 7, 81, 83, 112-114); and
retracting the catheter assembly out of the body vessel (paragraph 7, 80-83).
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.
Claims 2-3, 5-7, 9, 11, 13, 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 5053008 Bajaj.
Regarding claim 2, Holzer discloses the limitations of claim 1, and further discloses wherein the retrieval basket comprises one or more attachment wires (110/112) that are connected to the retrieval basket throughout movement of the retrieval basket from the delivery configuration to the retrieving configuration (paragraph 95, 114, 117-119, Fig. 1a-2d).
Holzer is silent on wherein the one or more attachment wires connect the retrieval basket to the catheter sheath.
However, Bajaj teaches a balloon expandable mesh filter (abstract, col. 5 line 62 – col. 6 line 40) having a catheter sheath (16, Fig. 1-2), a retrieval basket (18), and attachment wires (34) that connect the retrieval basket to the catheter sheath (col. 8 line 3-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holzer with the teachings of Bajaj to provide a unified connection point for even tensioning on the actuation wires to the retrieval basket.
Regarding claim 3, the combination of Holzer and Bajaj teaches the limitations of claim 2, and Bajaj teaches wherein:
the catheter sheath (16) comprises a sheath wall (as seen in Fig. 2, 6-7, cross section of catheter sheath 16 having a wall) and one or more attachment wire lumens formed within the sheath wall (col. 8 line 8-14); and
the one or more attachment wires are slidably positioned within the one or more attachment wire lumens (col. 8 line 8-14).
Regarding claim 5, Holzer discloses the limitations of claim 4, and further discloses wherein:
the retrieval basket comprises one or more attachment wires (110/112) that are connected to the retrieval side of the retrieval basket throughout movement of the retrieval basket from the delivery configuration to the retrieving configuration (paragraph 95, 114, 117-119, Fig. 1a-2d).
Holzer is silent on wherein the one or more attachment wires connect the retrieval side of the retrieval basket to the catheter sheath.
However, Bajaj teaches a balloon expandable mesh filter (abstract, col. 5 line 62 – col. 6 line 40) having a catheter sheath (16, Fig. 1-2), a retrieval basket (18), and attachment wires (34) that connect the retrieval basket to the catheter sheath (col. 8 line 3-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holzer with the teachings of Bajaj to provide a unified connection point for even tensioning on the actuation wires to the retrieval basket.
Regarding claim 6, the combination of Holzer and Bajaj teaches the limitations of claim 5, and Bajaj teaches wherein:
the catheter sheath (16) comprises a sheath wall (as seen in Fig. 2, 6-7, cross section of catheter sheath 16 having a wall) and one or more attachment wire lumens formed within the sheath wall (col. 8 line 8-14); and
the one or more attachment wires are slidably positioned within the one or more attachment wire lumens (col. 8 line 8-14).
Regarding claim 7, the combination of Holzer and Bajaj teaches the limitations of claim 5, and Holzer further discloses wherein the one or more attachment wires (110/112) are formed of nitinol (paragraph 150).
Regarding claim 9, Holzer discloses the limitations of claim 1.
While Holzer discloses the cords 110 exit lumen 138 ex vivo to allow manipulation by an operator, i.e. pulling on the cords for axial translation (paragraph 95, 114, 117-119), Holzer is silent on further comprising: an actuator operatively coupled to the retrieval basket, the actuator being configured to axially translate the retrieval basket.
However, Bajaj teaches a balloon expandable mesh filter (abstract, col. 5 line 62 – col. 6 line 40) having a retrieval basket (18), attachment wires (34) that connect to retrieval basket, and an actuator (32) to actuate the attachment wires to control the retrieval basket (col. 8 line 3-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holzer with the teachings of Bajaj in order provide an actuator to easily and effectively actuate the retrieval basket.
Regarding claim 11, Holzer discloses the limitations of claim 10, and further discloses wherein the catheter sheath comprises a sheath wall (as seen in Fig. 2d).
Holzer is silent on wherein:
the catheter sheath comprises one or more attachment wire lumens formed within the sheath wall; and
the one or more attachment wires are slidably positioned within the one or more attachment wire lumens.
However, Bajaj teaches a balloon expandable mesh filter (abstract, col. 5 line 62 – col. 6 line 40) having a catheter sheath (16, Fig. 1-2) that comprises a sheath wall (as seen in Fig. 2, 6-7, cross section of catheter sheath 16 having a wall), attachment wires (34), one or more attachment wire lumens formed within the sheath wall (col. 8 line 8-14), and the one or more attachment wires are slidably positioned within the one or more attachment wire lumens (col. 8 line 8-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holzer with the teachings of Bajaj to provide a unified connection point for even tensioning on the actuation wires to the retrieval basket.
Regarding claim 13, Holzer discloses the limitations of claim 12, and further discloses wherein:
the one or more attachment wires (110/112) are connected to the retrieval side of the retrieval basket throughout movement of the retrieval basket from the delivery configuration to the retrieving configuration (paragraph 95, 114, 117-119, Fig. 1a-2d).
Holzer is silent on wherein the one or more attachment wires connect the retrieval side of the retrieval basket to the catheter sheath.
However, Bajaj teaches a balloon expandable mesh filter (abstract, col. 5 line 62 – col. 6 line 40) having a catheter sheath (16, Fig. 1-2), a retrieval basket (18), and attachment wires (34) that connect the retrieval basket to the catheter sheath (col. 8 line 3-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holzer with the teachings of Bajaj to provide a unified connection point for even tensioning on the actuation wires to the retrieval basket.
Regarding claim 15, Holzer discloses the limitations of claim 10.
While Holzer discloses the cords 110 exit lumen 138 ex vivo to allow manipulation by an operator, i.e. pulling on the cords for axial translation (paragraph 95, 114, 117-119), Holzer is silent on further comprising an actuator operatively coupled to the retrieval basket, the actuator being configured to axially translate the retrieval basket.
However, Bajaj teaches a balloon expandable mesh filter (abstract, col. 5 line 62 – col. 6 line 40) having a retrieval basket (18), attachment wires (34) that connect to retrieval basket, and an actuator (32) to actuate the attachment wires to control the retrieval basket (col. 8 line 3-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holzer with the teachings of Bajaj in order to provide an actuator to easily and effectively actuate the retrieval basket.
Claims 8, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Holzer in view of US 20050038468 Panetta et al. (hereinafter Panetta).
Regarding claim 8, Holzer discloses the limitations of claim 4, wherein:
the catheter comprises a proximal portion coupled to a proximal end of the balloon portion (as seen in Fig. 1a) and an inflation lumen (148) for inflating and deflating the balloon portion (paragraph 97).
Holzer is silent on the catheter defining the inflation lumen and a guidewire lumen (while Holzer discloses a catheter lumen 138 and using a guidewire for delivering the balloon and retrieval basket (paragraph 115), Holzer does not specifically disclose a guidewire lumen).
However, Panetta teaches a similar catheter assembly for filtering embolic particles (abstract, paragraph 6-8) that comprises a catheter (10, Fig. 2-3) having an inflation lumen (22) and a guidewire lumen (paragraph 51-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holzer with the teachings of Panetta in order to transport liquids for inflating and deflating the balloon and to guide the catheter to a target area as disclosed by Panetta (paragraph 51).
Regarding claim 14, Holzer discloses the limitations of claim 12.
While Holzer discloses an inflation lumen (148) for inflating and deflating the balloon portion (paragraph 97), a catheter lumen 138 and using a guidewire for delivering the balloon and retrieval basket (paragraph 115), Holzer does not specifically disclose the catheter defines the inflation lumen for inflating and deflating the balloon portion and a guidewire lumen.
However, Panetta teaches a similar catheter assembly for filtering embolic particles (abstract, paragraph 6-8) that comprises a catheter (10, Fig. 2-3) having an inflation lumen (22) and a guidewire lumen (paragraph 51-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Holzer with the teachings of Panetta in order to transport liquids for inflating and deflating the balloon and to guide the catheter to a target area as disclosed by Panetta (paragraph 51).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/ Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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