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
Claims 1 and 3-12 are pending in the application. Claim 2 has been canceled. Claim 2 has been canceled. Claims 1, 3, and 12 have been amended.
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 1, 3, 6, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wahr et al. (US 2002/0165598 A1) (“Wahr”) in view of Rosetti (US 2008/0009804 A1), Zeroni et al. (US 2012/0109171 A1) (“Zeroni”), and Kameoka et al. (US 2022/0323720 A1) (“Kameoka”).
Regarding claim 1, Wahr discloses (Figures 1A-1C and 5A-5D) an extended catheter (100), comprising: a catheter body (132), provided with a delivery channel (140) for transporting a medical device, and a proximal end of the catheter body being provided with an inlet (140a) connected to the delivery channel; a pushing reinforcement wire (135), arranged on a side wall of the catheter body along an axial direction of the catheter body; a pushing rod (110, 120, 130; paragraph 0080), a distal end of the pushing rod being connected to the proximal end of the catheter body (paragraphs 0081-0084), and an interior of the distal end of the pushing rod being provided with a filling channel (142; paragraph 0084) and a positioning balloon (134), sleeved on the catheter body and located near the proximal end of the catheter body (Figure 1A), and an inner cavity of the positioning balloon being connected to the filling channel (paragraph 0069); wherein a proximal end of the pushing reinforcement wire (135) is connected to the distal end of the pushing rod (via proximal and distal welds, paragraphs 0085-0086).
However, Wahr fails to disclose that the pushing reinforcement wire not located in the filling channel of the pushing rod. Wahr also fails to disclose an outer surface of the pushing rod is provided with an anticoagulant coating. Wahr further fails to disclose the catheter body comprises an inner layer, an intermediate reinforcement layer, and an outer layer; a connector is configured at the proximal end of the catheter body, and the connector comprises a connecting piece and a plurality of connecting strips in an arc shaped structure; the connecting piece and each connecting strip are connected to the intermediate reinforcement layer, and each connecting strip wraps and is connected to the inner layer.
Rosetti teaches that it is known in the art for a pushing reinforcement wire to be either embedded in a side wall (20) of a catheter shaft (40) or disposed through an interior lumen (21) of the catheter shaft. Both options provide enhanced stiffness and pushability to the catheter (paragraph 0031).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pushing reinforcement wire to be embedded in a side wall of the catheter body (not located in the filling channel), as taught by Rosetti, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Further, Rosetti teaches both that embedding a pushing reinforcement wire in the side wall of the catheter body or disposing the pushing reinforcement wire within a lumen of the catheter body provide enhanced stiffness and pushability (Rosetti, paragraph 0031).
Zeroni teaches that it is known in the art to coat shafts with an anticoagulant or thrombolytic coating such as heparin or urokinase to prevent blood coagulation (paragraph 0045).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify an outer surface of the pushing rod to be provided with an anticoagulant coating, as taught by Zeroni. This modification would prevent blood coagulation during a procedure (Zeroni, paragraph 0045).
Kameoka teaches (Figures 2-6B) a multi-layered catheter body (33) with an inner layer (35), a reinforcing layer (36), and an outer layer (41) and a pushing rod (34). The reinforcing layer (36) of the catheter body (33) is shaped as a tubular mesh (tubular net) including metal wires (36a) made of a metal such as stainless steel and wound in first and second opposite directions. The reinforcing layer (36) is located on the outer circumferential surface of the inner layer (35). Kameoka teaches (Figure 5B) a connector (40A) is configured at the proximal end of the catheter body, wherein the connector comprises a connecting piece (39) and a plurality of connecting strips (37) in an arc shaped structure (paragraph 0095), the connecting strips are connected on opposite sides of the connecting piece (Figure 5B), the pushing rod (34) is connected to the connecting piece, and a central axis of each connecting strip is same as a central axis of the catheter body. Kameoka teaches that one connecting strip (37) of the connector (40A) is placed and welded over the four welds (WP) located at the 0° location and the other connecting strip (37) is placed and welded over the four welds (WP) located at the 180° location (paragraph 0095). Kameoka teaches that the connecting piece (39) and each connecting strip (37) are connected to the intermediate reinforcement layer, and each connecting strip wraps and is connected to the inner layer (paragraphs 0095).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter body to be a multi-layered catheter body within an inner layer, a reinforcing layer, and an outer layer, and to have a connector configured at the proximal end of the catheter body, wherein the connector comprises a connecting piece and a plurality of connecting strips in an arc shaped structure, the connecting piece and each connecting strip are connected to the intermediate reinforcement layer, and each connecting strip wraps and is connected to the inner layer, as taught by Kameoka. This modification would provide a support catheter in which one end portion of the pushing rod is resistant to detachment from the braided reinforcing layer and a connector that is fixed to the braided reinforcing layer and is resistant to detachment from the braid (Kameoka, paragraph 0044).
Regarding claim 3, Wahr as modified by Rosetti, Zeroni, and Kameoka teaches (Kameoka, Figure 5B) the connecting strips (37) are connected on opposite sides of the connecting piece (39), the pushing rod (34) is connected to the connecting piece, and a central axis of each connecting strip is same as a central axis of the catheter body.
Regarding claim 6, Wahr as modified by Rosetti, Zeroni, and Kameoka teaches (Wahr, Figures 5A-5D, 6A-61) a catheter system for removing an embolus in a small blood vessel, comprising a guiding catheter (160), a guiding wire (170), and the extended catheter according to claim 1 (100; Figure 5A, paragraph 0062; see rejection of claim 1 above), wherein the guiding catheter is provided with a guiding channel (Wahr, paragraph 0074), the extended catheter is inserted into the guiding channel, a distal end of the catheter body penetrates from a distal end of the guiding channel (Wahr, Figure 5A), the proximal end of the catheter body is located within the guiding channel (Wahr, Figure 5A), the proximal end of the pushing rod is located on an outer side of a proximal end of the guiding channel (Wahr, Figure 5A, in communication with inflation device 199, paragraph 0069), the delivery channel is connected with the guiding channel via the inlet (Wahr, paragraph 0066), the positioning balloon (134) is configured to press against an inner wall of the guiding channel after expansion (Wahr, paragraph 0076), the guiding wire (170) is configured to move through the guiding channel and the delivery channel (Wahr, Figure 6B), a distal end of the guiding wire is exposed from a distal end of the delivery channel (Wahr, Figures 6B-6D), and the distal end of the guiding wire is provided with a thrombus fragmenting device (Wahr, paragraph 0100). Figures 6E-6G of Wahr disclose that the distal end of the guiding wire is provided with a stent delivery catheter (193) that has a balloon that is expanded (Wahr, paragraphs 0097-0098). Wahr discloses that expansion of the balloon causes fragments (197) to break off the thrombus (Wahr, paragraph 0100). Wahr further discloses that while a stent delivery catheter is presented, other therapies can be administered such as balloon angioplasty, atherectomy, thrombectomy, drug delivery, radiation, and diagnostic procedures (Wahr, paragraph 0088).
Regarding claim 11, Wahr as modified by Rosetti, Zeroni, and Kameoka teaches (Wahr, Figure 5A) the distal end of the guiding catheter is provided with a Y-shaped connecting valve (184), the Y-shaped connecting valve has a first interface and a second interface respectively connected to the guiding channel (Wahr, paragraph 0092), the guiding wire and the extended catheter are both inserted into the first interface, and the proximal end of the pushing rod is located on an outer side of the Y-shaped connecting valve (Wahr, Figure 5A).
Regarding claim 12, Wahr as modified by Rosetti, Zeroni, and Kameoka teaches (Wahr, Figure 5A) an aspiration device (188) for aspirating thrombi, which is connected to the second interface and connected to the guiding channel (Wahr, paragraph 0096).
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Wahr et al. (US 2002/0165598 A1) (“Wahr”) in view of Rosetti (US 2008/0009804 A1), Zeroni et al. (US 2012/0109171 A1) (“Zeroni”), and Kameoka et al. (US 2022/0323720 A1) (“Kameoka”) as applied to claim 1 above, and further in view of Ge et al. (CN 202654186 U, previously cited) (“Ge”).
Regarding claim 4, Wahr as modified by Rosetti, Zeroni, and Kameoka teaches that the catheter body (132) has a stiffness decreasing sequentially from the proximal end of the catheter body to a distal end thereof (Wahr, paragraph 0087). However, the combined teaching fails to teach the catheter body has a hardness decreasing sequentially from the proximal end of the catheter body to a distal end thereof.
Ge teaches (Figures 1-4) a catheter body with a hardness decreasing sequentially from the proximal end of the catheter body to a distal end thereof. The decrease in hardness is due to a reinforcement wire (5) within the catheter body made of medical 304 stainless steel and has a certain taper from the proximal end to the distal end to provide a decreasing support hardness, which helps to improve the transmission of the overall pushing force of the catheter (see page 3 of English Machine Translation).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter body taught by Wahr in view of Rosetti, Zeroni, and Kameoka to have a hardness decreasing sequentially from the proximal end of the catheter body to a distal end thereof by modifying the reinforcement wire therein to be made of 304 stainless steel with a certain taper from the proximal end to the distal end to provide a decreasing support hardness, as taught by Ge. This modification would improve the transmission of the overall pushing force of the catheter body (Ge, page 3 of English Machine Translation).
Regarding claim 5, Wahr as modified by Rosetti, Zeroni, and Kameoka teaches the pushing reinforcement wire (135) has a stiffness decreasing gradually from a proximal end to a distal end thereof (Wahr, paragraph 0087). However, the combined teaching fails to teach the pushing reinforcement wire has a hardness decreasing gradually from a proximal end to a distal end thereof.
Ge teaches (Figures 1-4) a pushing reinforcement wire (5) having a hardness decreasing gradually from the proximal end to a distal end thereof. The decrease in hardness is due to the reinforcement wire (5) being made of medical 304 stainless steel and having certain taper from the proximal end to the distal end to provide a decreasing support hardness, which helps to improve the transmission of the overall pushing force of the catheter (see page 3 of English Machine Translation).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pushing reinforcement wire to have a hardness decreasing gradually from a proximal end to a distal end thereof, as taught by Ge. This modification would improve the transmission of the overall pushing force of the catheter body (Ge, page 3 of English Machine Translation).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Wahr et al. (US 2002/0165598 A1) (“Wahr”) in view of Rosetti (US 2008/0009804 A1), Zeroni et al. (US 2012/0109171 A1) (“Zeroni”), and Kameoka et al. (US 2022/0323720 A1) (“Kameoka”) as applied to claim 6 above, and further in view of Chen et al. (CN 112754600 A, previously cited) (“Chen”).
Regarding claims 7-10, Wahr as modified by Rosetti, Zeroni, and Kameoka teaches the invention substantially as claimed. However, the combined teaching fails to teach the thrombus fragmenting device includes a first thrombus fragmenting balloon and a second thrombus fragmenting balloon, a volume size of the first thrombus fragmenting balloon is larger than that of the second thrombus fragmenting balloon, and the first thrombus fragmenting balloon and the second thrombus fragmenting balloon are arranged alternately along an axial direction of the guiding wire to form an axial serrated structure, wherein the first thrombus fragmenting balloon and the second thrombus fragmenting balloon are arranged alternately along a circumferential direction of the guiding wire to form a circumferential serrated structure, wherein the guiding wire is provided with a flow channel, and the first thrombus fragmenting balloon and the second thrombus fragmenting balloon are connected to a distal end of the flow channel, and wherein the proximal end of the guiding wire is provided with a guiding wire needle holder, and the guiding wire needle holder is connected to a proximal end of the flow channel.
Chen teaches (Figures 1-3) a thrombus fragmenting device that includes a first thrombus fragmenting balloon (7) and a second thrombus fragmenting balloon (6), a volume size of the first thrombus fragmenting balloon is larger than that of the second thrombus fragmenting balloon (Figures 1 and 3), and the first thrombus fragmenting balloon and the second thrombus fragmenting balloon are arranged alternately along an axial direction of the guiding wire (4) to form an axial serrated structure (Figure 1), wherein the first thrombus fragmenting balloon and the second thrombus fragmenting balloon are arranged alternately along a circumferential direction of the guiding wire to form a circumferential serrated structure (Figure 1), wherein the guiding wire is provided with a flow channel (3), and the first thrombus fragmenting balloon (7) and the second thrombus fragmenting balloon (6) are connected to a distal end of the flow channel (Figure 1), and wherein the proximal end of the guiding wire (3) is provided with a guiding wire needle holder (connector 1, 2; Figure 1), and the guiding wire needle holder is connected to a proximal end of the flow channel (Figure 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the guiding wire/fragmenting device taught by Wahr in view of Rosetti, Zeroni, and Kameoka to include a first thrombus fragmenting balloon and a second thrombus fragmenting balloon, a volume size of the first thrombus fragmenting balloon larger than that of the second thrombus fragmenting balloon, and the first thrombus fragmenting balloon and the second thrombus fragmenting balloon arranged alternately along an axial direction of the guiding wire to form an axial serrated structure, wherein the first thrombus fragmenting balloon and the second thrombus fragmenting balloon are arranged alternately along a circumferential direction of the guiding wire to form a circumferential serrated structure, wherein the guiding wire is provided with a flow channel, and the first thrombus fragmenting balloon and the second thrombus fragmenting balloon are connected to a distal end of the flow channel, and wherein the proximal end of the guiding wire is provided with a guiding wire needle holder, and the guiding wire needle holder is connected to a proximal end of the flow channel, as taught by Chen. This modification would provide a fragmenting device that if rotated 360° along the circumference of the blood vessel, and at the same time, is pushed and retracted along the parallel direction of the blood vessel, can provide cutting and shredding thrombus treatment in two mutually perpendicular directions at the same time, which can be efficient and fast to thoroughly smash the thrombus, reduce the dose of thrombolytic drugs and improve the thrombolytic effect, reduce the number of balloon operations in the vascular cavity, and reduce the risk of balloon damage to the blood vessel wall (page 3 of English Machine Translation).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 3-12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Rosetti reference is newly cited to teach the pushing reinforcement wire not located in the filling channel of the pushing rod. The Zeroni reference is newly cited to teach an anticoagulant coating.
Applicant's arguments regarding the teachings of the Kameoka reference have been fully considered but they are not persuasive. The Applicant has argued that the cover piece 37 taught by Kameoka is connected with the outer layer 41, but not wraps the inner layer and is connected to the inner layer. The Examiner respectfully disagrees. The claim does not specify the nature of the connection between the connecting strips and the inner layer. Looking at Figure 6A of Kameoka, inner layer (35), intermediate layer (36), outer layer (41) and connecting strip (37) are all connected to one another, either directly or indirectly via the other layers to form a uniform structure. Kameoka teaches that the connecting strips 37 as viewed in the axial direction of the tubular member 39 are arc-shaped. Kameoka teaches that one connecting strip is placed and welded over the four welds WP located at the 0° location and the other connecting strip is placed and welded over the four welds WP located at the 180° location (paragraph 0095). The connecting strips are arc-shaped and disposed radially over all three of the outer layer, intermediate layer, and inner layer. Thus, the connecting strips “wrap” the inner layer as claimed.
For these reasons, the claims as amended do not distinguish over the prior art of record.
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.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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