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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/10/23 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the proximal end of the pushing rod is located on an outer side of the Y-shaped connecting valve” (claim 11) and “an aspiration device for aspirating thrombi, which is connected to the first interface and connected to the guiding channel” (claim 12) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 2, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wahr et al. (US 2002/0165598 A1) (“Wahr”).
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 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).
Regarding claim 2, Wahr discloses that 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).
Regarding claim 6, Wahr discloses (Figures 5A-5D, 6A-6I) 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), wherein the guiding catheter is provided with a guiding channel (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 (Figure 5A), the proximal end of the catheter body is located within the guiding channel (Figure 5A), the proximal end of the pushing rod is located on an outer side of a proximal end of the guiding channel (Figure 5A, in communication with inflation device 199, paragraph 0069), the delivery channel is connected with the guiding channel via the inlet (paragraph 0066), the positioning balloon (134) is configured to press against an inner wall of the guiding channel after expansion (paragraph 0076), the guiding wire (170) is configured to move through the guiding channel and the delivery channel (Figure 6B), a distal end of the guiding wire is exposed from a distal end of the delivery channel (Figures 6B-6D), and the distal end of the guiding wire is provided with a thrombus fragmenting device (paragraph 0100). Figures 6E-6G disclose that the distal end of the guiding wire is provided with a stent delivery catheter (193) that has a balloon that is expanded (paragraphs 0097-0098). Wahr discloses that expansion of the balloon causes fragments (197) to break off the thrombus (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 (paragraph 0088).
Regarding claim 11, Wahr discloses (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 (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 (Figure 5A).
Regarding claim 12, Wahr discloses (Figure 5A) an aspiration device (188) for aspirating thrombi, which is connected to the first interface (first interface and second interface are connected) and connected to the guiding channel (paragraph 0096).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wahr et al. (US 2002/0165598 A1) (“Wahr”) in view of Kameoka et al. (US 2022/0323720 A1) (“Kameoka”).
Regarding claim 3, Wahr discloses the invention substantially as claimed. However, Wahr fails to disclose 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 strips are connected on opposite sides of the connecting piece, the pushing rod 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 (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) 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).
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 disclosed by Wahr 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 strips are connected on opposite sides of the connecting piece, the pushing rod is connected to the connecting piece, and a central axis of each connecting strip is same as a central axis of the catheter body, 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).
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 Ge et al. (CN 202654186 U, English Machine Translation attached) (“Ge”).
Regarding claim 4, Wahr discloses that the catheter body (132) has a stiffness decreasing sequentially from the proximal end of the catheter body to a distal end thereof (paragraph 0087). However, Wahr fails to disclose 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 disclosed by Wahr 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 discloses the pushing reinforcement wire (135) has a stiffness decreasing gradually from a proximal end to a distal end thereof (paragraph 0087). However, Wahr fails to disclose 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 Chen et al. (CN 112754600 A, English Machine Translation attached) (“Chen”).
Regarding claims 7-10, Wahr discloses the invention substantially as claimed. However, Wahr fails to disclose 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 disclosed by Wahr 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771