DETAILED ACTION
Claims 14-20 are withdrawn. A complete action on the merits of pending claims 1-13 appears below.
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 without traverse of claims 1-13 in the reply filed on 05/11/2026 is acknowledged. Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 07/17/2024, 01/29/2025, & 05/11/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc.
The abstract of the disclosure is objected to because:
It recites the phrase, “Systems and methods are provided for…” which is an implied phrase and an abstract should avoid implicit phrases that merely state what the document concerns or describes.
The following sentence in the abstract should be amended, “Systems and methods are provided for applying a lubricious coating to a catheter such as a catheter for distal access and/or removing an obstruction or clot from a blood vessel, e.g., in the neurovasculature.” To avoid a grammatical/repetitive error.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
Paragraph [0020] should be amended to the following, “U.S. Patent App. Pub. No. 2017/0143938 to Ogle describes a suction catheter system with a suction nozzle that can extend from a guide catheter of the like. The suction nozzle can be positioned by tracking the suction nozzle through a vessel while moving a proximal portion of the suction extension within the lumen of the guide catheter. A suction lumen extends from the proximal end of the guide catheter through at least part of the guide catheter central lumen and through the suction tip.”
Paragraph [0022] should be amended to the following, “WO 2017/097616 A1 discloses a plurality of devices and methods for removing blockages from blood vessels. A stent retriever is first deployed via a microcatheter and, to improve the clot removal process, an aspiration catheter is then advanced to the position of the clot. A clot receptor device is deployed, which circumferentially seals against a distal section of the aspiration catheter, such that the stent retriever and the clot may be aspirated through the tapered opening of the receptor device during the removal process. The stent retriever may also be deployed using the microcatheter and an aspiration catheter is then forwarded to the position of the clot to aspirate the stent retriever and the clot.”
Paragraph [0028] should be amended to the following, “Provided herein are systems and methods for applying a lubricious coating to a catheter such as a distal access catheter and/or a catheter for removing an obstruction or clot from a blood vessel, including in the neurovasculature. For example, an improved catheter is provided that is sufficiently small and flexible to permit navigation through small and/or tortuous vessels (e.g., the neurovasculature) while being sufficiently robust to perform an intervention at the target location in the blood vessel, such as removing an obstruction such as a clot/thrombus (e.g., via aspiration through the catheter). The catheter is designed to be easily expandable for obstruction removal and collapsible for delivery and removal within the vasculature. Further, the lubricious nature of the catheter facilitates advancement and slidability of catheter shafts that are embedded and movable relative to one another at the target location.”
Paragraph [0029] should be amended to the following, “The catheter may include at least an elongated tube having a proximal section and a distal section which may be a braided section at a distal end for expansion in the vasculature, for example, to retrieve a clot or obstruction. The distal section may form a tube and the catheter may cause the distal section to transition from a neutral position to an extended or expanded state with a diameter larger than a collapsed state. The elongated tube and the distal section may include an inner and outer surface made of silicone or polyurethane. A lubricious coating may be applied to the inner and outer surface of the elongated tube, including the distal section. The elongated tube may first be prepared by exposing the elongated tube to an initial solution such as a methyl acetate solution and/or a primer coating which may include (3-Aminopropyl)triethoxysilane (APTES). A reactive primer solution may also optionally be applied. For example, a reactive primer solution including polyethylenimie (PEI) and perfluorophenylazide (PFPA) may be used. The catheter tube may then be exposed to a lubricious coating solution which may include a methyl ethyl ketone (MEK) solution include poly(methyl vinyl ether-maleic acid).”
Paragraph [0033] should be amended to the following, “Yet another method is provided herein for applying a lubricious coating to a catheter. The method may include selecting a catheter including an elongated tube having a proximal section and a braided section at a distal end, the elongated tube having an inner surface and an outer surface each including silicone or polyurethane, the catheter designed to remove an obstruction from a blood vessel, exposing a distal portion of the catheter having the braided section and at least part of the proximal section to a first solution including methyl acetate for a first duration, exposing, after exposing the distal portion of the catheter to the first solution, the distal portion of the catheter to a second solution including (3-Aminopropyl) triethoxysilane (APTES) for a second duration, selecting a reactive primer solution including Polyethylenimie (PEI) reacted with an N-Hydroxysuccinimide (NHS) grafted Perfluorophenylazide (PFPA) in ethanol, exposing, after exposing the distal portion of the catheter to the second solution, the distal portion of catheter to the reactive primer solution, and, exposing, after exposing the distal portion of the catheter to the primer coating, the distal portion of catheter to a lubricious coating solution including a poly(methyl vinyl ether-maleic acid) copolymer to apply a lubricous coating to the distal end of the catheter. A catheter is also provided herein, made according to the foregoing method.”
The use of the terms “Tecoflex” and “Lubrizol” in paragraph [0048], which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Paragraph [0051] should be amended to the following, “While the lubricious coating applied to an outer surface of the elongated tube of the catheter may facilitate efficient navigation of the catheter through a patient’s neurovasculature, the lubricious coating applied to an internal surface of the elongated tube of the catheter may facilitate movement of an internal catheter or tube within the inner surface. For example, the lubricious coating may facilitate smooth advancement and retraction of the intermediate coiled reinforcement shaft.”
Paragraph [0055] includes the following unclear sentence which should be clarified, “Shaft 218 may be made from another may be coated in polyurethane and/or silicone.” Further, the following sentence of paragraph [0055] should be amended to the following, “Similarly, distal region 204 may be coated in polyurethane and/or silicone such that a continuous and flexible inner and outer surface is formed at distal region 204.”
Paragraph [0058] should be amended to the following, “Actuator tube 300 may function as a microcatheter. Shaft 308 at proximal region 302 may be relatively stiff, e.g., a hypotube. The diameter of actuator tube 300 may be fixed such that actuator tube 300 is not expandable. Distal region 304 may be more flexible than proximal region to permit bending and navigation through tortuous vessels. Actuator tube 300 may include guidewire lumen 310 to receive a guidewire therethrough. As illustrated, actuator tube 300 may be a dual lumen microcatheter having both guidewire lumen 310 and lumen 306 for receiving actuation wire 208 therethrough. Guidewire lumen 310 may extend more distally in the shaft than actuation lumen 306 for actuation wire 208 in actuator tube 300.”
Paragraph [0063] should be amended to the following, “Referring now to FIGS. 1B and 1C, catheter 100 is shown, respectively, in a collapsed state and an expanded state. Actuator tube 300 is actuated to cause catheter 100 to transition from the collapsed state to the expanded state, and then may be further actuated to cause catheter 100 to transition from the expanded state to the collapsed state. Actuator tube 300 may be moved in one direction (e.g., proximally) relative to actuation wire 208 to actuate the transition from collapsed to expanded and may be moved in another direction (e.g., distally) relative to actuation wire 208 to actuate the transition from expanded to collapsed. For example, actuator tube 300 may be unlocked by the clinician and moved proximally while elongated shaft 200 and intermediate tube 400 remain in place to cause distal region 204 (e.g., braid 216) of elongated shaft to expand. As such, elongated tube 200 is collapsible via longitudinal force at the distal end of elongated tube 200. As shown, elongated tube 200 is longer in the collapsed state than in the expanded state.”
Paragraph [0085] should be amended to the following, “At block 506, a portion (e.g., distal portion) of the elongated tube may be exposed to methyl acetate at room temperature. For example the portion may be dipped into the solution such that an inner surface and an outer surface of the elongated tube are exposed simultaneously. The elongated tube may be exposed for a duration of 24 hours or anywhere within the range of 22-26 hours. The methyl acetate solution may remove mobile low molecular weight silicone molecules, for example,” It is also noted that the last sentence of the paragraph is an incomplete sentence and should be addressed by Applicant.
Paragraph [0087] should be amended to the following (Extra/Additional parenthesis that should be removed), “At block 510, the portion of the elongated tube may be exposed to (e.g., dipped into) a primer coating. The primer coating may be an aqueous solution of (3-Aminopropyl)triethoxysilane (APTES). For example, the primer coating may include 1% APTES weight-by-volume. The portion of the elongated tube may be positioned in the primer coating 30 minutes or any period of time between 20 and 40 minutes. The primer coating may be room temperature for the duration of exposure.”
Paragraph [0096] should be amended to the following, “Block 624 may be initiated after block 622. Blocks 624-632 may be the same as or similar to blocks 516-524 of FIG. 5. It is understood that one or more blocks of FIG. 6 may be optional. For example, blocks 604, 612, 614, 620, 628, 630 and/or 632 may be optional. It is further understood that different ranges of temperatures and/or time periods than those provided with respect to FIG. 6 may be used to achieve similar results.”
Appropriate correction is required.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Claim 1 uses redundant language in the preamble. The phrase, “for advancement in a vasculature to a target site in a blood vessel” is redundant, as “vasculature” already refers to blood vessels.
Claim 11 depends from claim 1, but it refers to “the layers of polyurethane of the outer coating” and “the layers of polyurethane of the inner coating.” These features are introduced in claim 10. Therefore, claim 11 should properly depend from claim 10. Further, for consistency with claim 10, which recites “multiple layers of polyurethane,” the phrase “the layers of polyurethane” should be amended to recite “the multiple layers of polyurethane.”
Appropriate correction is required.
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.
Claim(s) 1-3, 6-9, and 12-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang (US 2017/0238953 A1).
Regarding claim 1, Yang discloses, a catheter system (Figure 1, catheter (10); Paragraph [0063]) for advancement in a vasculature to a target site in a blood vessel (Figure 5; Paragraphs [0094]-[0096]), the catheter system comprising:
an elongated tube (Figures 1-2, elongate tubular body (16); Paragraph [0065]) comprising a proximal section (Figures 1-2, fixed proximal section (33); Paragraph [0066]) and an expandable distal section (Figures 2-3B & 4F-4K, axially extendable and retractable distal section (34)/distal end (38)/mesh (50); Paragraph [0066]-[0067] & [0079]-[0087]), the expandable distal section comprising an inner coating forming an inner lubricious surface (Paragraph [0157], discloses “Any of the ID or OD of any of the catheter shafts… may be provided with a lubricious coating or may be made from a lubricious material. For example, a hydrophilic polymer… The lubricious coating or the lubricious material contributes to at least ease of navigation, lower ID skin friction…” Further, with regards to Figures 30-31C, an inner liner (3014) (PTFE dip-coated) & a tie layer (3012) (polyurethane) for low friction ID are disclosed (Paragraphs [0180]-[0181])) and an outer coating (Figures 30-31C, outer jacket (3020); Paragraphs [0183]-[0185], shrink-wrap polymer layers, polyurethane/PEBAX/etc., surrounding the braid/coil), the expandable distal section with the inner coating and the outer coating configured to transition from a contracted state to an expanded state at the target site in the blood vessel for performing an intervention (Figures 4F-4G; Paragraphs [0079]-[0085] and [0098]-[0101]; distal section (34) which includes distal tip (38) has “self-expandable (e.g., Nitinol) mesh (50)” constrained by outer restraint (52), proximal retraction of restraint (or distal advance) releases it to “self expand to a funnel shape”. Thus, there is indeed transition between a contracted state (for navigation) and an expanded state (funnel for clot engagement/aspiration) at the target site); and
an inner elongated tube (Figures 32A-32C, intraluminal catheter (3200); Paragraphs [0191]-[0192]) configured to be advanced into the expandable distal section in the expanded state via the inner lubricious surface (Paragraphs [0075], [0098], & [0157]).
Regarding claim 2, Yang further discloses, further comprising an actuation tube configured to be disposed within a lumen of the inner elongated tube, the actuation tube configured to cause the expandable distal section to transition from the contracted state to the expanded state (Figures 3A-3B, pull wire/control wire (42) & actuator mechanisms for expansion/transition); Paragraphs [0072] and [0089]-[0090]; Where pull wire/control wire (42) which possesses central lumen (45) (Paragraph [0076]), is capable of being disposed in intraluminal catheter (3200)).
Regarding claim 3, Yang further discloses, wherein the inner coating comprises an innermost lubricious layer that forms the inner lubricious surface (Yang explicitly describes a “tubular inner liner” (e.g., PTFE formed by dip coating a mandrel) that provides the low-friction inner surface (“lower ID skin friction”). This is the innermost layer in contact with the lumen. Paragraph [0157], “Any of the ID… may be provided with a lubricious coating or may be made from a lubricious material. For example, a hydrophilic polymer… The lubricious coating or the lubricious material contributes to… lower ID skin friction…” and Paragraph [0180], “tubular inner liner 3014” formed by dip coating) and a supporting layer having a higher hardness than the innermost lubricious layer (Directly after the inner liner is a “soft tie layer” (e.g., polyurethane/Tecoflex) applied over it. This tie layer bonds the inner liner to the reinforcing braid/coil and provides mechanical support. It is positioned as a supporting layer between the soft/lubricious inner liner and the outer structural elements. The overall design uses graduated hardness (softer distally, with inner layers optimized for lubricity and support). Paragraphs [0180]-[0181], “…soft tie layer 3012 such as polyurethane (e.g., Tecoflex™), to produce a layer having a thickness of no more than about 0.005 inches…”).
Regarding claim 6, Yang further discloses, wherein the expandable distal section (distal section (34)) comprises a nitinol braid (Figures 4F-4I, mesh (50); Paragraph [0086]).
Regarding claim 7, Yang further discloses, wherein the outer coating is softer than the inner coating (Yang describes a graduated durometer construction where the outer jacket (outer coating/layers) uses softer materials in the distal regions, while the inner layers (inner liner + tie layer) are harder/stiffer for support and lubricity. This’s reinforced by the outer jacket being formed from multiple tubular segments with decreasing durometer in the distal direction – distal outer segments as low as 25D or 35D (very soft) (See Figure 34 and Paragraphs [0185] & [0194]). Inner construction: Inner liner (PTFE, hard/low friction) & polyurethane tie layer (Tecoflex, structurally supportive). The overall inner structure is designed for mechanical support and low ID friction, while the outer jacket is deliberately made softer distally for flexibility/trackability (See Paragraphs [0180]-[0181] & [0185]). The design explicitly trades off hardness: proximal outer segments higher durometer (60D-75D+), distal outer segments much softer (≤35D). The inner layers maintain higher structural integrity. As such, an outer coating/jacket that is softer (lower durometer) than the inner coating/layers, particularly in the expandable distal section).
Regarding claim 8, Yang further discloses, wherein the expandable distal section (axially extendable and retractable distal section (34)) comprises a proximal region and a distal region (distal section (34) as seen in Figures 2, 3A-3B, & 4F-4I, has a proximal region and a distal region) and wherein the outer coating is thicker near the proximal region than the distal region (Outer jacket construction: Paragraph [085], “The distal 1 or 2 or 4 or more segments 3036, 3038, may have a smaller OD following shrinking than the more proximal segments 3022-3034 to produce a step down in OD for the finished catheter body 3000.” (Proximal outer segments are thicker (larger OD/wall); Distal outer segment are thinner (smaller OD, lower wall thickness)). This creates a thicker outer coating near the proximal region of the expandable distal section and thinner toward the distal tip – exactly as claimed. Achieved by using different wall thicknesses in the outer jacket segments and by the shrinking process (See also Figure 30 and Paragraphs [0184]-[0186])).
Regarding claim 9, Yang further discloses, wherein the outer coating (outer jacket (3020)) comprises polyurethane (Paragraph [0183]).
Regarding claim 12, Yang further discloses, wherein the inner coating is applied to a mandrel, the expandable distal section is applied on the inner coating on the mandrel, and the outer coating is applied on the expandable distal section while on the mandrel (Paragraphs [0180]-[0184], provide the manufacturing description whereas explicitly disclosed, “…an inner liner 3014 may be formed by dip coating a mandrel…” (see Paragraph [0180]), followed by braid/coil (expandable section) being applied over the inner coating, followed by the outer jacket being applied over the assembly while on the mandrel, then heat shrunk).
Regarding claim 13, Yang further discloses, further comprising a plurality of struts positioned distal to the expandable distal section and coupled to the expandable distal section to cause the expandable distal section to transition from the contracted state to the expanded state (Paragraph [0086], discloses, the distal tip (38) of distal section (34) as, “The tubular body is provided with a distal tip 38 in the form of a self expandable (e.g., NiTinol) mesh 50…”, where a “self expandable (e.g., NiTinol) mesh” possesses a plurality of struts distal to the distal section (34) as seen in Figures 4F-4I (the struts of mesh (50) that are at the most distal end/side of the mesh) and are coupled to distal section (34) to cause the transition from the contracted state to the expanded state as the mesh is a self expandable (e.g., NiTinol) mesh), wherein the plurality of struts are coated with the inner coating, the outer coating, or both (Paragraph [0157], explicitly discloses, “Any of the ID or OD of any of the catheter shafts or other catheter components disclosed herein may be provided with a lubricious coating or may be made from a lubricious material.” This covers all catheter components including mesh (50) which includes the plurality of struts seen in Figures 4F-4I).
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang.
Regarding claim 4, Yang further discloses, wherein the supporting layer (tie layer (3012)) is formed of polyurethane (Paragraph [0180]).
Further, Yang discloses the claimed invention except for, “wherein the innermost lubricious layer is also formed of polyurethane.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the innermost lubricious layer of polyurethane, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. This’s further supported by the disclosure of Yang’s Paragraph [0057], which states, “Any of the ID… may be provided with a lubricious coating or may be made from a lubricious material. For example, a hydrophilic polymer such as Polyacrylamide, PEO, thermoplastic starch, PVP, copolymers of hydrophilic polymer can be extruded with hydrophobic polymers such as PEO soft segmented polyurethane blended with Tecoflex…” and Paragraph [0180], “Referring to FIG. 30, an inner liner 3014 may be formed by dip coating a mandrel (not shown) to provide a thin walled tubular inside layer of the catheter body 3000. The dip coating may be produced by coating a wire such as a silver coated copper wire in PTFE.” In re Leshin.
Regarding claim 10, Yang further discloses, wherein the inner coating comprises multiple layers of polyurethane (an inner liner (3014) (PTFE dip-coated) & a tie layer (3012) (polyurethane); Paragraph [0180]) and the outer coating (outer jacket (3020)) comprises multiple layers of polyurethane (Paragraphs [0183]-[0184]).
Yang’s inner liner (3014) was not explicitly disclosed as being polyurethane. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the innermost lubricious layer of polyurethane, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. This’s further supported by the disclosure of Yang’s Paragraph [0057], which states, “Any of the ID… may be provided with a lubricious coating or may be made from a lubricious material. For example, a hydrophilic polymer such as Polyacrylamide, PEO, thermoplastic starch, PVP, copolymers of hydrophilic polymer can be extruded with hydrophobic polymers such as PEO soft segmented polyurethane blended with Tecoflex…” and Paragraph [0180], “Referring to FIG. 30, an inner liner 3014 may be formed by dip coating a mandrel (not shown) to provide a thin walled tubular inside layer of the catheter body 3000. The dip coating may be produced by coating a wire such as a silver coated copper wire in PTFE.” In re Leshin.
Regarding claim 11, Yang further teaches, wherein the multiple layers of polyurethane of the outer coating are softer than the layers of polyurethane of the inner coating (The outer jacket uses progressively softer durometer polymers distally (down to ~25-35D). The inner tie layer (polyurethane) is described as a supportive layer. The overall design explicitly makes outer layers softer than inner structural layers for flexibility vs. support (See Paragraphs [0180]-[0185])).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang, in view of Samson (US 6,824,553 B1).
Regarding claim 5, Yang teaches, the inner coating comprises multiple layers (an inner liner (3014) (PTFE dip-coated) & a tie layer (3012) (polyurethane)).
Yang fails to explicitly teach, wherein the inner coating comprises four layers.
Samson discloses, a catheter assembly used in accessing a tissue target within the body, typically a target which is accessible through the vascular system. Samson teaches, a braided neurovascular catheter having an inner coating/liner construction comprising four layers (Figure 10, innermost TFE (PTFE) layer (281), inner polyurethane layer (277), a braid (275), and an upper/outer polyurethane layer (279); Col. 15, line 24-39; with additional variations using multiple polymeric layers for the inner construction).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the inner coating of Yang to comprise four layers, as taught by Samson, as both references and the claimed invention are directed to catheter assemblies used in accessing a target through the vascular system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner coating of Yang to comprise four layers, as taught by Samson, as such a modification would have been predictable, namely, optimize lubricity (innermost layer), bonding/adhesion to the braid (intermediate layers), and structural integrity while maintaining a thin profile – a routine optimization well-known in the braided vascular catheter art. In re Aller; MPEP 2144.05.
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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