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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/17/25 has been entered.
Response to Amendment
Claims 1-32 are pending in the application. Claims 1, 3, 4, 9, 16, 17, and 23-26 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/17/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 24 is 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 24 recites the limitation "the inner and outer layers" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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 1-4, 8, 23, 25-26, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Vale et al. (US 2021/0393277 A1) (“Vale”) in view of Calhoun et al. (US 10,668,258 B1).
Regarding claims 1-4, Vale discloses (Figures 2, 31A, 31B) an apparatus, comprising: a sheath (30) defining a first lumen; and an aspiration catheter (35) defining a second lumen, the aspiration catheter including: a proximal end coupleable to a vacuum source configured to apply a vacuum pressure within the aspiration catheter (paragraph 0064); an expandable tip (100) disposable within a vessel (20), the expandable tip configured to transition between a retracted configuration in which the expandable tip is constrained within the sheath and an expanded configuration in which at least a portion of the expandable tip is disposed distal to the sheath (paragraphs 0009, 0020, 0060), the expandable tip in the expanded configuration having a funnel-shaped profile that gradually increases in diameter from a proximal end of the expandable tip to a distal end of the expandable tip (paragraphs 0009, 0018, 0067), the expandable tip in the expanded configuration having a pinch strength that enables the expandable tip to withstand collapse from pressure gradients generated within the expandable tip by the vacuum source applying the vacuum pressure to draw a thrombus into the expandable tip (paragraphs 0005 and 0085); and an elongate body extending between the proximal end and the expandable tip, at least one of the aspiration catheter and the sheath configured to translate relative to the other of the aspiration catheter and the sheath to selectively extend the expandable tip of the aspiration catheter distal to the sheath to transition the expandable tip to the expanded configuration. Vale discloses the expandable tip (100) and a first portion of the aspiration catheter (35) are formed from a single metallic tube (paragraph 0067), wherein the metallic tube has a first cut pattern (Figures 1, 3A, 3B, 7A-7C, 20, 22, 31A) for forming the first portion of the aspiration catheter and a second cut pattern (Figures 1-31A) different from the first cut pattern for forming the expandable tip.
However, Vale fails to disclose the elongate body has a linear section and a memory-set curved section distal to the linear section and disposed near the expandable tip, at least one of the aspiration catheter and the sheath configured to translate relative to the other of the aspiration catheter and the sheath to selectively extend the memory-set curved section of the aspiration catheter distal to the sheath to change a degree of curvature of the memory-set curved section to direct the expandable tip toward the thrombus. Vale also fails to disclose the aspiration catheter further configured to rotate within the first lumen of the sheath to change the position of the expandable tip relative to the thrombus. Vale fails to disclose the aspiration catheter configured to be rotated when the memory-set curved section is extended distal to the sheath to sweep the expandable tip in the expanded configuration within a lumen of the vessel, thereby directing a distal end of the expandable tip toward the thrombus.
Calhoun teaches (Figures 26A, 28A-29B) a steerable catheter (660) comprising a linear section (661) and a memory-set curved section (662) distal to the linear section and disposed at the distal tip of the steerable catheter, the memory-set curved section configured to transition to a curved configuration in response to being extended from a sheath (Column 37, line 40 - Column 38, line 32). Calhoun teaches an actuator (694) is configured to translate the catheter (660) relative to the sheath (670) to selectively control a degree of extension of the memory-set curved section (662) from the sheath to change a degree of curvature of the memory-set curved section (Column 37, line 40 - Column 38, line 32). Calhoun teaches that the memory-set curved section may be imparted by pre-forming the NiTi hypotube before assembly. Calhoun teaches (Figure 26C) that the memory-set curved section is formed by laser cutting a pattern into the NiTi hypotube and then placing the cut NiTi hypotube in a forming fixture to have the desired shape. The forming fixture may be a fixture that retains that outer diameter of the hypotube, a mandrel inside the hypotube, or a combination of the two. While in the forming fixture, the cut NiTi hypotube may be annealed at 300 C for 3 minutes in heated oven or salt bath, then heat set for 6-10 minutes at 500-510 C. The NiTi hypotube is then removed from heat source and immediately quenched in room temperature water. The heat set laser cut NiTi hypotube may be electropolished or chemically etched to remove surface tarnish or discoloration due to heat exposure (Column 36, lines 32-53). Calhoun also teaches (Figures 26A, 28A-29B) the catheter further configured to rotate within the first lumen of the sheath (via actuator 692) to change the position of the expandable tip relative to the thrombus (Column 37, line 40 – Column 38, line 32).
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 elongate body disclosed by Vale to have a linear section and a memory-set curved section with a cut pattern (different from the second cut pattern for forming the expandable tip) distal to the linear section and disposed near the expandable tip, wherein translation of the aspiration catheter relative to the sheath selectively extends the memory-set curved section of the aspiration catheter distal to the sheath to change a degree of curvature of the memory-set curved section, as taught by Calhoun, to direct the expandable tip toward the thrombus. It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the aspiration catheter to be configured to rotate within the first lumen of the sheath when the memory-set curved section is extended distal to the sheath to change the position of the expandable tip and to sweep the expandable tip in the expanded configuration within a lumen of the vessel, thereby directing a distal end of the expandable tip towards the thrombus, as taught by Calhoun. These modifications would allow the operator to steer, adjust, and aim the catheter with precision (Calhoun, Column 37, line 50 – Column 38, line 32).
Regarding claim 5, Vale as modified by Calhoun teaches (Calhoun, Figures 26A, 28A-29B) that the memory-set curved section, when at least partially extended from the distal end of the sheath, is configured to have a radius of curvature (Calhoun, Column 37, line 50 – Column 38, line 32). However, the combined teaching fails to teach a radius of curvature between about 10 mm and about 40 mm.
Calhoun teaches that actuator (694) controls axial movement of the memory-set curved section relative to the sheath, which adjusts the degree of curvature of the memory-set curved section in order to steer the catheter through the tortuous anatomy of blood vessels. Thus, the radius of curvature of the memory-set curved section is a result effective variable because changing the degree that the memory-set curved section is extended from/retracted into the sheath changes the degree of curvature of the memory-set curved section. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the memory-set curved section to have a radius of curvature within the claimed range, as it involves only adjusting a dimension of a component disclose to require adjustment. 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 the memory-set curved section, when at least partially extended from the distal end of the sheath, to have a radius of curvature between about 10 mm and about 40 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, it appears that the Applicant places no criticality on the claimed range, indicating only that “curved section 318 at least partially extended from the distal end of the sleeve can be configured to have a radius of curvature between about 10 mm and about 40 mm” (paragraph 0101).
Regarding claim 8, Vale as modified by Calhoun teaches that the expandable tip in the expanded configuration is retractable into the sheath (Vale, paragraph 0081). However, the combined teaching fails to explicitly teach the pinch strength of the expandable tip in the expanded configuration is between about 0.4 lbs. and about 3 lbs., the expandable tip in the expanded configuration is retractable into the sheath in response to a retracting force of between about 0.5 lbs. and about 4.0 lbs.
Vale teaches that catheter elements must survive the severe mechanical strains imparted but also generate a sufficient radial force when expanded to prevent collapse under the suction of aspiration (paragraph 0005). Further, Vale teaches that the pattern of the frame of an expandable tip can be tuned for desired flexibility characteristics and the width of the struts can be adjusted to maintain flexibility while achieving a desired radial force (paragraph 0085). Thus, the width of the struts is a result-effective variable because adjusting the width of the struts adjusts the flexibility and radial strength of the funnel. Further, it appears that one having ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in modifying the expandable tip to have a pinch strength of between about 0.4 lbs. and about 3 lbs. in the expanded configuration and in modifying the expandable tip to be collapsed and retracted back into the sheath with a retracting force between about 0.5 lbs. and 4.0 lbs., as it involves only adjusting a dimension of the struts. Additionally, Vale discloses the importance of catheter elements having sufficient radial force when expanded to prevent collapse under the suction of aspiration.
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 the expandable tip of the aspiration catheter taught by Yang to have a pinch strength between about 0.4 Ibs. and about 3 lbs. in the expanded configuration and to be retractable into the sheath in response to a retracting force of between about 0.5 lbs. and about 4.0 lbs., as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 23, Vale as modified by Calhoun teaches (Figures 2, 31A, 31B) the expandable tip including a frame that defines a plurality of open cells (316). Vale as modified by Calhoun teaches (Vale, Figures 1, 3A, 3B) the expandable tip (100) comprises a transition section disposed between the elongate body (at 35) and the expandable tip (100), the transition section defining a plurality of openings (127). However, Figures 2, 31A, and 31B fail to disclose a first coating disposed over the frame and a second coating different from the first coating that is disposed between the proximal end of the aspiration catheter and the expandable tip.
In an alternate embodiment, Vale teaches (Figure 20) that the support frame can be enclosed or encapsulated by an elastomeric membrane cover (50; paragraph 0100). Vale teaches that the elastomeric membrane (coating) can utilize an inner layer and an outer layer so that the struts have membrane material above the outer surface and below the inner surface of the support struts. Vale teaches that the inner and outer layers can be heat welded between the inner and outer layers between the struts (paragraph 0102). Vale further teaches that the inner lumen of the aspiration catheter can be provided with a lubricious film or coating that is delivered via dipping, spray, plasma, or any other commonly used technique (paragraph 0105).
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 expandable tip disclosed by Vale to include a first coating disposed over the frame and a second coating different from the first coating that is disposed between the proximal end of the aspiration catheter and the expandable tip, as taught in Figure 20 of Vale. These modifications would provide coatings that can prevent a buildup of static or dynamic friction, mitigating the risk of the catheter binding or kinking in tortuous areas of the vasculature (paragraph 0026). Further, these modifications would allow for smooth delivery of auxiliary device through the lumen of the aspiration catheter (paragraph 0104).
Regarding claim 25, Vale as modified by Calhoun teaches the expandable tip (100) includes a frame (110) and a coating (electro-spun/other porous cover) disposed over the frame to prevent fluid from passing through the frame and into an inside of the expandable tip (reduction between 50%-99%), the expandable tip further including at least one opening (pores) disposed near a proximal end of the expandable tip that extends through the coating, the at least one opening capable of increasing fluid available to mix with the thrombus to improve flow of the thrombus proximally into the aspiration catheter (Vale, paragraph 0106).
Regarding claim 26, Vale as modified by Calhoun teaches the invention substantially as claimed. Vale as modified by Calhoun teaches that the expandable tip (100) includes a frame (110) that defines a plurality of open cells. Vale discloses that each of the plurality of open cells (316) can have either a large area the expandable tip enhanced flexibility yielding deliverability advantages (paragraph 0123) or a micro-sized area to form a mesh array which is dense enough to impede flow sufficiently (paragraph 0124). However, the combined teaching fails to explicitly teach each of the plurality of open cells has an area of at least about 0.5 mm2.
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 plurality of open cells to each have an area of at least about 0.5 mm2, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device taught by Vale in view of Calhoun would not operate differently with open cells having the claimed area because Vale discloses that the cell size can be either large to provide the expandable tip enhanced flexibility yielding deliverability advantages or small to form a mesh array that is dense enough to impede flow (paragraphs 0123-0124). Further, applicant places no criticality on the range claimed, indicating simply that each of the plurality of open cells has an area of at least about 0.5 mm2 (see paragraph 0114 of Specification).
Regarding claim 30, Vale as modified by Calhoun above teaches an expandable tip, a memory-set curved section, and a linear section of the elongate body as claimed. The combined teaching fails to explicitly teach that the expandable tip, the memory-set curved section, and the linear section of the elongate body are formed from a single metallic tube.
Vale teaches that the expandable tip and the linear section can be formed from a single metallic tube via laser cutting (Vale, paragraphs 0066-0067). Calhoun further teaches that the memory-set curved section can also be formed by laser cutting and then heat treating a metallic tube (Calhoun, Column 36, lines 32-53).
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 expandable tip, the memory-set curved section, and the linear section of the elongate body are formed from a single metallic tube. Forming the aspiration catheter from a single metallic tube results in good push and torque characteristics, small bend radii, kink resistance, and solid resistance to tensile elongation (Vale, paragraph 0066).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Vale et al. (US 2021/0393277 A1) (“Vale”) in view of Calhoun et al. (US 10,668,258 B1) as applied to claim 1 above, and further in view of Corcoran et al. (US 2006/0241564 A1) (“Corcoran”).
Regarding claims 6 and 7, Vale as modified by Calhoun teaches the invention substantially as claimed. However, the combined teaching fails to teach that the sheath has a curved section, and wherein the aspiration catheter is further configured to rotate within the first lumen of the sheath to change a relative orientation of the memory-set curved section of the aspiration catheter with respect to the curved section of the sheath such that a total radius of curvature of the apparatus can be adjusted to position the expandable tip relative to the thrombus.
Corcoran teaches (Figures 1-2) a steerable catheter assembly comprising a catheter (3) with a memory-set curved section (6) and a sheath (1) with a curved section (4), wherein catheter is further configured to rotate within the first lumen of the sheath to change a relative orientation of the memory-set curved section of the catheter with respect to the curved section of the sheath such that a total radius of curvature of the apparatus can be adjusted (Figure 2; paragraph 0057).
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 sheath taught by Vale in view of Calhoun to have a curved section, and wherein the aspiration catheter is further configured to rotate within the first lumen of the sheath to change a relative orientation of the memory-set curved section of the aspiration catheter with respect to the curved section of the sheath such that a total radius of curvature of the apparatus can be adjusted, as taught by Corcoran, to position the expandable tip relative to the thrombus. This modification provides the desirable properties of a hypotube, such as pushability, trackability, torqueability and kink resistance, while also providing the steerability normally associated with more complex pull wire systems (Corcoran, paragraph 0021).
Claims 9-12, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2019/0336149 A1) (“Yang”) in view of Noriega et al. (US 2006/0074442 A1) (“Noriega”) and Heitzmann et al. (US 7,771,445 B2) (“Heitzmann”).
Regarding claims 9, 10, 27, and 28, Yang discloses (Figures 1-29) an apparatus, comprising: a handle assembly (12, 18); an aspiration catheter (34, 38) (paragraph 0085) coupled to the handle assembly, the aspiration catheter including: an elongate body defining a lumen (Figures 4F and 4G); and an expandable tip (50) configured to transition from a retracted configuration (Figure 4F) having a first diameter that is substantially similar to an inner diameter of the elongate body (Figure 4F) to an expanded configuration (Figure 4G) having a funnel-like shape that progressively increases to a second diameter that is greater than the inner diameter of the elongate body (Figure 4G, paragraph 0105): a flexible shaft (1900) having a proximal end and a distal end (paragraphs 0167-0168, 0184), the distal end of the flexible shaft terminating within the expandable tip (paragraph 0168); and a rotational drive assembly (1906) coupled to the proximal end of the flexible shaft and configured to rotate the flexible shaft (paragraph 0168).
However, Yang fails to disclose an actuator disposed on the handle assembly, the actuator configured to be transitioned to a first configuration to generate vacuum pressure within the lumen of the elongate body to draw a thrombus disposed in a vessel into the expandable tip, the actuator, when the rotational drive assembly is coupled to the handle assembly, configured to be transitioned from the first configuration to a second configuration to activate the rotational drive assembly to cause rotation of the flexible shaft while the vacuum pressure is being generated to reshape the thrombus, such that the thrombus can be drawn further proximally into the aspiration catheter, wherein the actuator is a button, the button configured to (1) transition to the first configuration in response to being depressed a first amount and (2) transition from the first configuration to the second configuration in response to being depressed a second amount greater than the first amount. Yang further fails to disclose that the rotational drive assembly and the flexible shaft are detachably coupled to the handle assembly. Yang fails to disclose that the flexible shaft is configured to be inserted into the handle assembly and advanced along the aspiration catheter until the rotational drive assembly is positioned to couple to the handle assembly such that the rotational drive assembly can be coupled to the handle assembly. Yang fails to disclose the rotational drive assembly couples to the handle assembly along a longitudinal axis of the aspiration catheter.
Noriega teaches (Figures 1-25) an apparatus comprising a handle assembly (12) an aspiration catheter (14) coupled to the handle assembly, the aspiration catheter including: an elongate body defining a lumen (20); a flexible shaft (22) having a proximal end and a distal end (24); a rotational drive assembly (78) coupled to the proximal end of the flexible shaft (Figure 17A) and configured to rotate the flexible shaft (paragraph 0139), the rotational drive assembly and the flexible shaft being detachably couplable to the handle assembly (paragraphs 0122, 0137, 0138); and an actuator (82) disposed on the handle assembly (12). Noriega teaches that the flexible shaft (22) is configured to be inserted into the handle assembly (12; Figure 17B) and advanced along the aspiration catheter (14; Figure 1) until the rotational drive assembly (78) is positioned to couple to the handle assembly (via attachment to motor shaft 48). Noriega teaches (Figure 17B) the rotational drive assembly (26) couples to the handle assembly (12) along a longitudinal axis of the aspiration catheter (14).
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 rotational drive assembly and the flexible shaft disclosed by Yang to be detachably coupled to the handle assembly, the flexible shaft configured to be inserted into the handle assembly and advanced along the aspiration catheter until the rotational drive assembly is positioned to couple to the handle assembly, wherein the rotational drive assembly couples to the handle assembly along a longitudinal axis of the aspiration catheter, as taught by Noriega. These modifications would allow the flexible shaft to move and be manipulated freely axially of the handle assembly (paragraph 0138) and would allow a support or access system to be advanced over a free proximal end of the aspiration catheter (paragraph 0138). Further, Noriega teaches that it is conventional and known in the art for a rotatable flexible shaft to have detachable couplings, such as adhesive, welding, a snap fit assembly, or the like (paragraph 0139).
Heitzmann teaches (Figures 1-10C) an atherectomy device comprising a handle assembly (18) with an actuator (124) disposed on the handle assembly, the actuator configured to be transitioned to a first configuration (Figure 10B) to generate vacuum pressure within a lumen of an elongate body (88) to draw material disposed in a vessel into the tip (21; Column 29, lines 3-4), the actuator configured to be transitioned to a second configuration (Figure 10C) from the first configuration to activate the rotational drive assembly to cause rotation of a drive shaft (24) of a cutter (22) while the vacuum pressure is being generated to reshape the thrombus, such that the thrombus can be drawn further proximally into the aspiration catheter (Column 22, line 57 - Column 23, line 2). Heitzmann teaches that the actuator is a button (124), the button configured to (1) transition to the first configuration in response to being depressed a first amount (Figure 10B) and (2) transition from the first configuration to the second configuration in response to being depressed a second amount greater than the first amount (Figure 10C; Column 22, line 57 - Column 23, line 2).
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 handle assembly taught by Yang in view of Noriega to include an actuator configured to be transitioned to a first configuration to generate vacuum pressure within the lumen of the elongate body to draw a thrombus disposed in a vessel into the expandable tip, the actuator configured to be transitioned to a second configuration from the first configuration to activate the rotational drive assembly to cause rotation of the flexible shaft while the vacuum pressure is being generated to reshape the thrombus, such that the thrombus can be drawn further proximally into the aspiration catheter, wherein the actuator is a button, the button configured to (1) transition to the first configuration in response to being depressed a first amount and (2) transition from the first configuration to the second configuration in response to being depressed a second amount greater than the first amount, as taught by Heitzmann. This modification would provide an actuator button that would activate vacuum pressure within the aspiration catheter to pull material into the expandable tip when the actuator button is depressed a first amount (Heitzmann, Column 29, lines 3-4) and activate rotation of the flexible shaft to break up/re-size the material to remove the material from the body via the vacuum pressure (Heitzmann, Column 22, line 57 — Column 23, line 2) when the actuator button is depressed a second amount greater than the first amount. This modification would also ensure that rotation of the flexible shaft does not happen before the vacuum pressure is activated.
Regarding claim 11, Yang as modified by Noriega and Heitzmann teaches (Yang, Figures 1, 2, 4F, 4G) that the actuator is a first actuator, and the apparatus further comprises a sheath (52) disposed around the aspiration catheter (34, 38), the sheath and the aspiration catheter being movable relative to one another (Figures 4F and 4G, paragraph 0105); and a second actuator (24) disposed on the handle assembly, the second actuator configured to be actuated to cause at least one of the sheath and the aspiration catheter to translate relative to the other of the sheath and the aspiration catheter to allow the expandable tip to transition from the retracted configuration to the expanded configuration (paragraphs 0105, 0108), the first and second actuators capable of being manipulated by a single hand of a user.
Regarding claim 12, Yang as modified by Noriega and Heitzmann teaches (Yang, Figures 4F and 4G) that the aspiration catheter (Figures 34, 38) defines at least one opening (Yang discloses that the expandable tip is formed of NiTinol mesh, paragraph 0105) disposed near a proximal end of the expandable tip (50), the at least one opening capable of increasing fluid available to mix with the thrombus to improve flow of the thrombus proximally into the aspiration catheter.
Claims 13 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2019/0336149 A1) (“Yang”) in view of Noriega et al. (US 2006/0074442 A1) (“Noriega”) and Heitzmann et al. (US 7,771,445 B2) (“Heitzmann”) as applied to claim 9 above, and further in view of Vale et al. (US 2021/0275197 A1) (“Vale”).
Regarding claim 13, Yang in view of Noriega and Heitzmann teaches the invention substantially as claimed. However, the combined teaching fails to teach the expandable tip and at least a portion of the elongate body are formed from a single metallic tube.
In the same field of endeavor, Vale teaches (Figures 1-26) a suction catheter with an elongate body (124) defining a lumen and an expandable tip (112). Vale teaches that the elongate body (124) and the expandable tip (124) can be laser cut from a hypotube made of nitinol or familiar medical-grade stainless-steel alloys. When a cut hypotube is utilized, the expanding mouth support framework can be formed integral with the hypotube such that the stiffness profile of the catheter is smoother and weak transitions can be eliminated (paragraph 0094).
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 the expandable tip and at least a portion of the elongate body taught by Yang in view of Noriega and Heitzmann to be formed from a single metallic tube, as taught by Vale. This modification would result in an aspiration catheter with a stiffness profile that is smoother and weak transitions can be eliminated (Vale, paragraph 0094).
Regarding claim 31, Yang in view of Noriega and Heitzmann teaches the invention substantially as claimed. However, the combined teaching fails to teach the expandable tip and the elongate body are formed from a single metallic tube.
In the same field of endeavor, Vale teaches (Figures 1-26) a suction catheter with an elongate body (124) defining a lumen and an expandable tip (112). Vale teaches that the elongate body (124) and the expandable tip (124) can be laser cut from a hypotube made of nitinol or familiar medical-grade stainless-steel alloys. When a cut hypotube is utilized, the expanding mouth support framework can be formed integral with the hypotube such that the stiffness profile of the catheter is smoother and weak transitions can be eliminated (paragraph 0094).
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 the expandable tip and the elongate body taught by Yang in view of Noriega and Heitzmann to be formed from a single metallic tube, as taught by Vale. This modification would result in an aspiration catheter with a stiffness profile that is smoother and weak transitions can be eliminated (Vale, paragraph 0094).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2019/0336149 A1) (“Yang”) in view of Noriega et al. (US 2006/0074442 A1) (“Noriega”) and Heitzmann et al. (US 7,771,445 B2) (“Heitzmann”) as applied to claim 9 above, and further in view of Calhoun et al. (US 10,668,258 B1) (“Calhoun”).
Regarding claim 14, Yang in view of Noriega and Heitzmann teaches the invention substantially as claimed. However, the combined teaching fails to teach the elongate body includes a memory-set curved section, the handle assembly further including a second actuator configured to rotate the aspiration catheter to change a position of the expandable tip relative to the thrombus.
Calhoun teaches (Figures 26A, 28A-29B) a steerable catheter (660) with a memory-set curved section (662). Calhoun teaches (Figure 29a) a handle assembly (690) including an actuator (692) configured to rotate the catheter to aim the distal end portion of the catheter (Column 37, line 40 — Column 38, line 32).
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 elongate body taught by Yang in view of Noriega and Heitzmann to include a memory-set curved section, as taught by Calhoun, and to modify the handle assembly to include a second actuator configured to rotate the aspiration catheter, as taught by Calhoun, to change a position of the expandable tip relative to the thrombus. This modification would enable precise steering and aiming (Calhoun, Column 37, line 40 - Column 38, line 32).
Regarding claim 15, Yang in view of Noriega, Heitzmann, and Calhoun teaches (Yang, Figures 1, 2, 4F, 4G) a sheath (52) disposed around the aspiration catheter, the handle assembly further including a third actuator (24) configured to translate at least one of the aspiration catheter and the sheath relative to the other of the aspiration catheter and the sheath (Yang, paragraphs 0105, 0108).
Claims 16, 17, 20, and 29 rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2019/0336149 A1) (“Yang”) in view of Noriega et al. (US 2006/0074442 A1) (“Noriega”).
Regarding claim 16, Yang discloses (Figures 1-29) an apparatus, comprising: an aspiration catheter (34, 38; paragraph 0085) defining a lumen (Figures 4F, 4G), the aspiration catheter including: an expandable tip (50) configured to transition between a retracted configuration (Figure 4F) in which the expandable tip is constrained within a sheath and an expanded configuration (Figure 4G) in which at least a portion of the expandable tip is disposed distal to the sheath, the expandable tip in the expanded configuration having a funnel-shaped profile that gradually increases in diameter from a proximal end of the expandable tip to a distal end of the expandable tip (Figure 4G, paragraph 0098); and a proximal end coupleable to a vacuum source configured to apply a vacuum pressure within the lumen to draw a thrombus from a vessel into the expandable tip (paragraph 0107); and a flexible shaft (1900) disposable within the lumen of the aspiration catheter, the flexible shaft having a distal end with a non-linear shape (paragraph 0174), the flexible shaft configured to extend from the proximal end of the aspiration catheter to the expandable tip such that the distal end of the flexible shaft is disposed within the expandable tip (paragraph 0174); and a drive unit (motor) coupled to a proximal end of the flexible shaft (paragraphs 0168, 0220), the drive unit configured to rotate the flexible shaft such that the distal end of the flexible shaft rotates orbitally about a central longitudinal axis of the flexible shaft (Figure 19; paragraph 0174) to engage with and reshape the thrombus while remaining within the expandable tip so as to avoid damaging a wall of the vessel (paragraphs 0168, 0172, 0184).
However, Yang fails to explicitly disclose that the distal end of the flexible shaft is disposed within the expandable tip within 2 cm of the distal end of the expandable tip. Yang also fails to disclose that the flexible shaft includes first and second layers of wires that are wound in different directions. Yang also fails to disclose that the distal end of the elongate shaft rotates to diameters greater than a diameter of the proximal end of the expandable tip.
Yang discloses that the flexible shaft may be placed at, beyond, or inside the distal end of the catheter (paragraph 0166) so that the distal end of the flexible shaft is unconstrained and is able to agitate thrombus to facilitate drawing the thrombus into the distal end portion. Once the thrombus has been drawn proximally under vacuum and with activation of the agitator as needed, the risk of clogging is greatly reduced (paragraph 0167). Thus, the positioning of the distal end of the flexible shaft within the distal end portion is a result effective variable in that its positioning and activation reduces the risk of clogging. Further, it appears that one having ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in modifying the distal end of the flexible shaft disclosed by Yang to be positioned within the distal end portion at a preset distance within the claimed range, as it involves only adjusting a dimension that the flexible shaft extends. 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 the distal end of the flexible shaft disclosed by Yang to be disposed within the expandable tip within 2 cm of the of the distal end of the expandable tip as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, it appears that the Applicant places no criticality on the range claimed, indicating simply that “the shaft and optionally stylet can be advanced until it is positioned a preset distance proximal of a distal end of the aspiration catheter, at 1922, e.g., about 1 mm, about 5 mm, about 1 cm, about 2 cm, including all values and ranges in-between” (paragraph 0190).
Noriega teaches (Figure 10-15) a flexible shaft (22) that includes first (71) and second (51) layers of wires that are wound in different directions (paragraph 0126), the flexible shaft having a distal end (24) with a non-linear shape (paragraph 0122). Noriega further teaches (Figures 14A-14C) that the distal end (24) of the flexible shaft (22) rotates orbitally about a central longitudinal axis of the flexible shaft to diameters greater than a diameter of the lumen of the aspiration catheter (14) to reshape the thrombus.
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 flexible shaft disclosed by Yang to include first and second layers of wires that are wound in different directions, as taught by Noriega. This modification would provide a counter-wound drive shaft that has better flexibility, while still maintaining its torqueability, maneuverability, and columnar strength (Noriega, paragraph 0126). It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the distal end of the flexible shaft to rotate orbitally about a central longitudinal axis of the flexible shaft to diameters greater than a diameter of the proximal end of the expandable tip (attached to the aspiration catheter) to reshape the thrombus, as taught by Noriega. This modification would create a cutting path forward of the distal end of the aspiration catheter for passing through the occlusive or stenotic material in the body lumen (Noriega, paragraph 0096).
Regarding claim 17, Yang as modified by Noriega teaches (Yang, Figures 1, 2, 26-29) a handle assembly (12) coupled to the proximal end of the aspiration catheter (34, 38); and a drive assembly system (2950) including the drive unit (motor), the drive assembly being releasably coupleable to the handle assembly (Figures 26-28 show the system uncoupled).
Regarding claim 20, Yang as modified by Noriega teaches the expandable tip (50) includes a metallic frame that defines a plurality of open cells (Yang, Figure 4G, paragraph 0105), the plurality of open cells increasing in size from the proximal end to the distal end of the expandable tip (Figure 4G shows the cells at the proximal end are smaller than the cells at the distal end).
Regarding claim 29, Yang as modified by Noriega above teaches the invention substantially as claimed. However, the combined teaching fails to explicitly teach that the first layer and the second layer are each constructed of a coiled flat wire or a round wire.
In an alternate embodiment presented in Figures 24C-24G, Yang teaches a flexible drive shaft (2412) including first (2413) and second (2415) layers of wires that are wound in different directions (paragraph 0192). Yang teaches (Figure 24G) that the first layer and the second layer are each constructed of a coiled flat wire or a round wire.
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 the first layer and the second layer of the flexible shaft to each be constructed of a coiled flat wire or a round wire, as taught by the alternate embodiment of Yang. Yang teaches that a flexible drive shaft including first and second layers of wire that are wound in opposite directions and each layer constructed of a coiled flat wire or a round wire is well known in the art. One having ordinary skill in the art would recognize that a coiled flat wire or a round wire are known configurations for forming a counter-wound drive shaft.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2019/0336149 A1) (“Yang”) in view of Noriega et al. (US 2006/0074442 A1) (“Noriega”) as applied to claim 17 above, and further in view of Heitzmann et al. (US 7,771,445 B2) (“Heitzmann’).
Regarding claim 18, Yang as modified by Noriega teaches the invention substantially as claimed. However, the combined teaching fails to teach an actuator disposed on the handle assembly configured to apply the vacuum pressure and to activate the drive assembly system to rotate the flexible shaft.
Heitzmann teaches (Figures 1-10C) an atherectomy device comprising a handle assembly (18) with an actuator (124) disposed on the handle assembly. Heitzmann teaches the actuator (124) is configured to apply the vacuum pressure and to activate the drive assembly to rotate the flexible shaft. The actuator is configured to be transitioned to a first configuration (Figure 10B) to generate vacuum pressure within a lumen of an elongate body (88) to draw material disposed in a vessel into the tip (21; Column 29, lines 3-4), the actuator in the first configuration configured to be transitioned to a second configuration (Figure 10C) to activate the rotational drive assembly to cause rotation of a drive shaft (24) of a cutter (22) while the vacuum pressure is being generated to reshape the thrombus, such that the thrombus can be drawn further proximally into the aspiration catheter (Column 22, line 57 — Column 23, line 2). Heitzmann teaches that the actuator is a button (124), the button configured to (1) transition to the first configuration in response to being depressed a first amount (Figure 10B) and (2) transition from the first configuration to the second configuration in response to being depressed a second amount greater than the first amount (Figure 10C; Column 22, line 57 — Column 23, line 2).
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 handle assembly taught by Yang in view of Noriega to include an actuator configured to apply the vacuum pressure and to activate the drive assembly system to rotate the flexible shaft. This modification would provide an actuator button that would activate vacuum pressure within the aspiration catheter to pull material into the expandable tip when the actuator button is depressed a first amount (Heitzmann, Column 29, lines 3-4) and activate rotation of the flexible shaft to break up/re-size the material to remove the material from the body via the vacuum pressure (Heitzmann, Column 22, line 57 — Column 23, line 2) when the actuator button is depressed a second amount greater than the first amount. This modification would also ensure that rotation of the flexible shaft does not happen before the vacuum pressure is activated.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2019/0336149 A1) (“Yang”) in view of Noriega et al. (US 2006/0074442 A1) (“Noriega”) as applied to claim 16 above, and further in view of Vale et al. (US 2021/0393277 A1) (“Vale”).
Regarding claim 19, Yang in view of Noriega teaches the invention substantially as claimed. Yang in view of Noriega teaches that the expandable tip is capable of being retracted back into the sheath (Yang, paragraph 0081).
However, Yang in view of Noriega fails to teach the expandable tip in the expanded configuration has a pinch strength of between about 0.4 Ibs. and about 3 lbs. such that the expandable tip in the expanded configuration is configured to withstand collapse from pressure gradients being generated within the expandable tip as the vacuum pressure acts on the thrombus disposed within the expandable tip, and the expandable tip in the expanded configuration is retractable into the sheath in response to a retracting force of between about 0.5 lbs. and about 4.0 Ibs.
Vale teaches that catheter elements must survive the severe mechanical strains imparted but also generate a sufficient radial force when expanded to prevent collapse under the suction of aspiration (paragraph 0005). Further, Vale teaches that the pattern of the frame of an expandable tip can be tuned for desired flexibility characteristics and the width of the struts can be adjusted to maintain flexibility while achieving a desired radial force (paragraph 0085). Thus, the width of the struts is a result-effective variable because adjusting the width of the struts adjusts the flexibility and radial strength of the funnel. Further, it appears that one having ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in modifying the expandable tip to have a pinch strength of between about 0.4 lbs. and about 3 Ibs. in the expanded configuration and in modifying the expandable tip to be collapsed and retracted back into the sheath with a retracting force between about 0.5 lbs. and 4.0 lbs., as it involves only adjusting a dimension of the struts. Additionally, Vale discloses the importance of catheter elements having sufficient radial force when expanded to prevent collapse under the suction of aspiration.
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 the expandable tip of the aspiration catheter taught by Yang in view of Noriega to have a pinch strength between about 0.4 lbs. and about 3 Ibs. in the expanded configuration and to be retractable into the sheath in response to a retracting force of between about 0.5 lbs. and about 4.0 lbs., as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2019/0336149 A1) (“Yang”) in view of Noriega et al. (US 2006/0074442 A1) (“Noriega”) as applied to claim 20 above, and further in view of Vale et al. (US 2021/0393277 A1) (“Vale”).
Regarding claim 21, Yang as modified by Noriega teaches the invention substantially as claimed. However, Yang as modified by Noriega fails to teach the expandable tip includes a coating that is disposed over the metallic frame, the coating includes an inner layer and an outer layer that connect to one another at each cell from the plurality of rows of open cells.
Vale teaches (Figure 22) a coating (50) disposed over a metallic frame (110), the coating including an inner layer and an outer layer that are connected to one another at each cell from the plurality of rows of open cell (stitched together/reflowed over and between struts; paragraph 0102).
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 expandable tip to include a coating that is disposed over the metallic frame, wherein the coating includes an inner layer and an outer layer that connect to one another at each cell from the plurality of rows of open cells. This modification would provide an expandable tip mouth capable of local flow restriction (Vale, abstract).
Regarding claim 22, Yang as modified by Noriega and Vale teaches that the coating of the expandable tip is a first coating, the aspiration catheter further including a second coating between the proximal end and the expandable tip (Yang, paragraph 0176).
18. Claim 32 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US 2019/0336149 A1) (“Yang”) in view of Noriega et al. (US 2006/0074442 A1) (“Noriega”) as applied to claim 16 above, and further in view of Vale et al. (US 2021/0275197 A1) (“Vale”).
Regarding claim 32, Yang in view of Noriega teaches the invention substantially as claimed. However, the combined teaching fails to teach that each of the expandable tip and an elongate body of the aspiration catheter are formed from a single metallic tube.
In the same field of endeavor, Vale teaches (Figures 1-26) a suction catheter with an elongate body (124) defining a lumen and an expandable tip (112). Vale teaches that the elongate body (124) and the expandable tip (124) can be laser cut from a hypotube made of nitinol or familiar medical-grade stainless-steel alloys. When a cut hypotube is utilized, the expanding mouth support framework can be formed integral with the hypotube such that the stiffness profile of the catheter is smoother and weak transitions can be eliminated (paragraph 0094).
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 the expandable tip and an elongate body of the aspiration catheter disclosed by Yang in view of Noriega to be formed from a single metallic tube, as taught by Vale. This modification would result in an aspiration catheter with a stiffness profile that is smoother and weak transitions can be eliminated (Vale, paragraph 0094).
Allowable Subject Matter
Claim 24 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.
Claim 24 recites that the expandable tip comprises a transition section disposed between the elongate body and the expandable tip, the transition section defining a plurality of openings, the inner and outer layers of the first coating configured to be attached to the second coating within each opening of the plurality of openings. These limitations, in combination with the limitations of claim 1 and intervening claim 23, are not disclosed or suggested by the prior art of record. The Vale reference teaches first and second coatings. However, there is no teaching or suggestion of inner and outer layers of the first coating attaching to the second coating within a plurality of openings of a transition section between the elongate body and the expandable tip.
Response to Arguments
Applicant's arguments filed 10/17/25 regarding the rejection of claim 1 have been fully considered but they are not persuasive.
Regarding claim 1, the Applicant has argued that the Vale reference teaches away from an aspiration catheter having a memory-set curved portion and an expandable tip in an expanded configuration, whereby the catheter can be rotated to sweep the expandable tip in the expanded configuration within a lumen of a vessel. A person of ordinary skill in the art, upon reading Vale, would have been led to avoid having an aspiration catheter with an expandable tip in the expanded configuration that can be swept within a vessel. The Applicant cites paragraph 0064, which discloses that the mouth of the expandable tip expands to match the vessel 20 diameter and have the radial force to seal with the vessel. The Examiner respectfully disagrees. Paragraph 0064 further discloses that a partial sealing expandable tip will still out-perform many current aspiration catheters that leave more cross-sectional area open to the vessel proximal of the tip. Further, Vale discloses that the diameter of the tip can range from 1 mm to 10 mm to treat blockages in different blood vessels (paragraph 0071). Vale discloses that the tip is designed to expand to treat a wide range of vessel diameters (paragraph 0067). Thus, the combined teaching of Vale in view of Calhoun teaches an aspiration catheter that can be rotated when the memory-set curved section is extended distal to the sheath to sweep the expandable tip in the expanded configuration within a lumen of the vessel to direct a distal end of the expandable tip toward the thrombus as claimed.
Applicant’s arguments with respect to claim 9 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 Examiner provided a new interpretation of the “rotational drive assembly” in the current rejections.
Applicant's arguments filed 10/17/25 regarding the rejection of claim 16 have been fully considered but they are not persuasive.
The Applicant has argued that Yang in view of Noriega fail to teach claim 16 as amended. The Applicant argues that Yang fails to disclose or suggest that the flexible shaft is disposed within 2 cm of the distal end of the expandable tip to allow the flexible shaft to rotate orbitally to a diameter greater than a diameter of the aspiration catheter without damaging the wall of the vessel. The Examiner respectfully disagrees.
Yang discloses that the flexible shaft may be placed at, beyond, or inside the distal end of the catheter (paragraph 0166) so that the distal end of the flexible shaft is unconstrained and is able to agitate thrombus to facilitate drawing the thrombus into the distal end portion. Once the thrombus has been drawn proximally under vacuum and with activation of the agitator as needed, the risk of clogging is greatly reduced (paragraph 0167). Thus, the positioning of the distal end of the flexible shaft within the distal end portion is a result effective variable in that its positioning and activation reduces the risk of clogging. Further, it appears that one having ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in modifying the distal end of the flexible shaft disclosed by Yang to be positioned within the distal end portion at a preset distance within the claimed range, as it involves only adjusting a dimension that the flexible shaft extends. 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 the distal end of the flexible shaft disclosed by Yang to be disposed within the expandable tip within 2 cm of the of the distal end of the expandable tip as a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, it appears that the Applicant places no criticality on the range claimed, indicating simply that “the shaft and optionally stylet can be advanced until it is positioned a preset distance proximal of a distal end of the aspiration catheter, at 1922, e.g., about 1 mm, about 5 mm, about 1 cm, about 2 cm, including all values and ranges in-between” (paragraph 0190).
Additionally, in the current rejections, the flexible shaft disclosed by Yang has been modified in view of Noriega to rotate orbitally about a central longitudinal axis of the flexible shaft to diameters greater than a diameter of the proximal end of the aspiration catheter, as claimed.
For these reasons, the claims as currently written do not distinguish over the prior art of record.
Conclusion
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771