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 .
Claim Interpretation
Independent claims 1 and 12 each recite “the support tube including a straight elongated body” and “a preformed non-linear dilator including an elongated body”. These claims, as well as further dependent claims continue to recite “the elongated body” (see second to last line of claim 1, claim 6, second to last line of claim 12, claim 13, claim 21, and claims 24-25). Since these instances do not specifically recite “the straight elongated body”, examination is continuing under the assumption that these claims refer to the elongated body of the preformed non-linear dilator, not the elongated body of the support tube.
Claim Objections
Claims 6 and 21 are objected to because of the following informalities:
Claim 6, line 2: “the elongate body” should be amended to recite “the elongated body” instead to match the antecedent basis established in claim 1.
Claim 21, line 2: “the elongate body” should be amended to recite “the elongated body” instead to match the antecedent basis established in claim 12.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-19, and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison et al. (US PGPub 2018/0064452 A1) in view of Haarer (US PGPub 2016/0001045 A1).
With respect to claim 1, Garrison et al. discloses an aspiration system (100 in Fig. 1) for removing emboli positioned a distance along a vessel from an access site (PP [0003]: “the present disclosure relates to methods and systems for navigating complex anatomy to perform rapid and safe aspiration and removal of cerebral occlusions”), the aspiration system (100) comprising:
a support tube (220) configured to provide access to an inner lumen of the vessel, the support tube (220) including a straight elongated body (222) and an inner tube passageway (PP [0046]: “the access sheath 220 can have a sheath body 222 and an inner lumen 223 extending between a proximal end and a distal end region of the sheath body 222”); and
a dilator (250) including an elongated body (252 in Fig. 1) extending between a proximal end and a distal end (elongated body 252 extends between proximal end 254 and distal end 256), to thereby guide the distal end of the elongated body (252) to emboli positioned the distance from the access site (PP [0062]: “The sheath dilator 250 allows for smooth insertion of the access sheath 220 through a puncture site in the arterial wall”).
However, Garrison et al. fails to disclose a preformed non-linear dilator including a preformed non-linear distal portion positioned adjacent the distal end, the preformed nonlinear distal portion including a preformed non-linear shape that deforms to an approximately linear shape when extending along the inner tube passageway of the support tube, the preformed non-linear distal portion reforming into preformed non-linear shape when extending out from the inner tube passageway into the vessel to thereby guide the distal end of the elongated body to emboli positioned the distance from the access site.
In the same field of dilator-sheath methods and assemblies for insertion into a vasculature of a patient (see Fig. 7A, PP [0005]: “Embodiments relate to a catheter introducer system for accessing a blood vessel”), Haarer teaches an assembly (see Fig. 1) including a preformed non-linear dilator (103 including core 102 in Fig. 4A, PP [0051]: “The dilator lumen 106 defines a diameter that is operable to slidingly receive the core 102 therein”, PP [0060]: “FIGS. 2A-5E are side views of five cores 102a-e each having a core distal end 109a-e defining a different core curve 118a-e”) and a support tube (113 in Fig. 7A), and further teaches wherein the preformed non-linear dilator (103 including core 102 in Fig. 4A) includes a preformed non-linear shape (see curves 118 in Figs. 2B-E) that deforms to an approximately linear shape when extending along the inner tube passageway of the support tube (113 in Fig. 7A, PP [0077]: “The core distal end 109 is provided with a predetermined core curve 118 that is operable to impart a curve to the dilator distal end 104 and to provide support thereto”, PP [0079]: “The core curve 118 of the core distal end 109 is as least partially suppressed, that is, the core distal end 109 is at least partially straightened, while moving through the sheath 113”), the preformed non-linear distal portion reforming into preformed non-linear shape when extending out from the inner tube passageway into the vessel (PP [0079]: “The core curve 118 of the core distal end 109 is substantially expressed once the core distal end 109 is outside of the confines of the sheath 113”) to thereby guide the distal end of the elongated body to emboli positioned the distance from the access site (PP [0075]: “The sheath 113 further includes a sheath lumen 116 extending from the sheath proximal end 110 to the sheath distal end 107, therethrough. The sheath lumen 116 defines a diameter that is operable to slidingly receive the dilator 103 therein and to allow the sheath 113 to advance over the dilator 103”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Garrison et al. method to include the preformed non-linear dilator as taught by Haarer. One of ordinary skill in the art would have been motivated to perform this modification in order to improve the Garrison et al. dilator’s ability to “[traverse] torturous blood vessels” (PP [0003] of Haarer), and furthermore because such a modification would constitute the application of a known technique (the use of a pre-curved dilator and core combination as taught by Haarer) to improve a similar method (the method of Garrison et al.) in the same way. One of ordinary skill in the art could have applied the improvement as taught by Haarer to the method of Garrison et al. and the results would have been predictable because the Haarer and Garrison et al. disclosures are both concerned with the advancement of a dilator through the vasculature of a patient (Garrison et al. PP [0043]: “the access systems described herein may be used to deliver working devices to a target vessel of a coronary anatomy, or other vasculature anatomy”, Haarer PP [0001]: “the disclosure relates to dilator and catheter introducer systems and methods for traversing tortuous blood vessels”), and additionally Garrison et al. contemplates the use of “one or more dilators 250” (see PP [0055] of Garrison et al.). The incorporation of the preformed non-linear as taught by Haarer would have resulted in an improved system and method more efficient at traversing torturous vasculature without damage to the surrounding vessels (Haarer PP [0003]: “the tip of the sheath may abut and damage the blood vessel. What is needed in the art is a dilator system capable of traversing tortuous blood vessels, and a catheter introducer system including the dilator system that is capable of traversing tortuous blood vessels”).
Regarding claim 2, Garrison et al. as modified by Haarer further discloses wherein the support tube (220 in Fig. 1 of Garrison et al.) is formed of a first material that is more rigid (PP [0058]: “the remaining portion of the sheath body 222 has a flexural stiffness in the range 500 to 1500 N-mm2”) than a second material forming at least the preformed non-linear distal portion of the dilator (PP [0064]: “the distal section of the first dilator has a bending stiffness in the range of 50 to 100 N-mm2”, Haarer PP [0028]: “A dilator is relatively less stiff than a sheath in accordance with constructs presented therein”).
Regarding claim 3, Garrison et al. as modified by Haarer further discloses wherein the preformed non-linear distal portion (104 in Fig. 5 of dilator including 103 and 102 in Fig. 4A of Haarer) is formed out of a shape memory material or a nitinol material (PP [0032]: “Stainless steel and nitinol are examples of metals that may be used to form a core”, 102 comprises nitinol which is a shape memory material).
Regarding claim 4, Garrison et al. as modified by Haarer further discloses wherein the shape of the preformed non-linear distal portion (104 in Fig. 5 of Haarer, see dilator 103 and 102 in Fig. 4A) includes an L-shape and/or an approximately 90 degree bend (see annotated Fig. 2B below with embodiment bend, the distal end of the core wire bends approximately 90 degrees to form an L-shape).
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Regarding claim 6, Garrison et al. as modified by Haarer further discloses wherein the shape of the preformed non-linear distal portion (104 in Fig. 5 of Haarer) includes a distal length of the elongate body (252 in Fig. 1 of Garrison et al., see body of 103 in Fig. 5) extending at an angle relative to the support tube (see bend 104 in Fig. 5 and core 102 bends in Figs. 2B-E, a distal length of the elongate body extends at an angle relative to the support tube 113, see also Fig. 7A).
Regarding claim 7, Garrison et al. as modified by Haarer further discloses wherein the distal length (252 in Fig. 1 of Garrison et al., see body of 103 in Fig. 7A of Haarer extending beyond the support tube 113) extends a length that is approximately the same as the distance (see Fig. 7A, the distal length of the dilator 103 and 102 extending beyond the support tube 113 extends through the vasculature to a target area, which is a distance away from an access site, and therefore the distal length extends a length through the vasculature that is approximately the same as the distance).
Regarding claim 8, Garrison et al. as modified by Haarer further discloses wherein the preformed non-linear distal portion (104 in Fig. 5 of Haarer, see dilator 103 and 102 in Fig. 4A, see also dilator 250 in Fig. 1 of Garrison et al.) is steerable such that a position of the distal end is controllable within the vessel (Haarer PP [0063]: “the core 102 may be of the type that is steerable, such as by utilizing active steering mechanisms that are known in the art for steering catheters”, by steering the core 102 within the dilator 103, the preformed non-linear distal portion of the dilator is steerable).
Regarding claim 9, Garrison et al. as modified by Haarer further discloses wherein an inner diameter of the elongated body (252 in Fig. 1 of Garrison et al., see dilator 103 and 102 in Fig. 1 of Haarer with lumens 106 and 111) is sized to allow passage of emboli therealong (106 and 111 are sized to allow the passage of emboli, see MPEP 2112.01).
Regarding claim 10, Garrison et al. as presently modified by Haarer fails to disclose wherein an inner diameter of the elongated body is approximately 10 French to approximately 14 French, since the Garrison et al. device is intended for use within the neurovasculature (see abstract of Garrison et al.) and instead utilizes a support tube comprising an outer diameter between 5 and 7 Fr (PP [0013]).
In the same field of dilator-sheath methods and assemblies for insertion into a vasculature of a patient (see Fig. 7A, PP [0005]: “Embodiments relate to a catheter introducer system for accessing a blood vessel”), Haarer further teaches wherein “the dilator 103 includes a dilator lumen 106 with a diameter of about 0.5 mm to about 4 mm, about 2 mm to about 3 mm or about 2.5 mm to about 2.90 mm” (PP [0052], 10 Fr is equivalent to about 3.33 mm, which is within the range of 0.5-4 mm as taught by Haarer).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the Garrison et al. and Haarer combination according to Haarer to incorporate the inner diameter of the elongated body as claimed. One of ordinary skill in the art would have been motivated to perform this modification since it has been held that variations in shape are a matter of choice and only involves routine skill in the art (see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966), see MPEP 2144.04). Modifying the elongated body of Garrison et al. to further incorporate the inner diameter as taught by Haarer would not have changed the intended operation of the Garrison et al. system because Garrison et al. contemplates that “one or more components of the access systems described herein may be used to deliver working devices to a target vessel of a coronary anatomy, or other vasculature anatomy” (PP [0043]), rendering the device of Garrison et al. suitable for upscaling and use in larger vascular anatomy.
Regarding claim 11, Garrison et al. as modified by Haarer further discloses wherein the distal end of the preformed non-linear dilator (250 in Fig. 1 of Garrison et al., see 103 and 102 in Fig. 4A of Haarer) includes a smooth and/or rounded end (256 in Fig. 1 of Garrison et al. is smooth and tapered, 103 in Fig. 1 of Haarer also has a smooth tapered distal end).
With respect to claim 12, Garrison et al. discloses a method of an aspiration system (100 in Fig. 1) for removing emboli positioned at a distance along a vessel from an access site (PP [0003]: “the present disclosure relates to methods and systems for navigating complex anatomy to perform rapid and safe aspiration and removal of cerebral occlusions”), the method comprising:
advancing a support tube (220) into an inner lumen of the vessel (see Fig. 2A, PP [0045]: “The access sheath 220 can be inserted through a femoral artery insertion site positioned with the distal tip of the access sheath 220 at or near the petrous portion of the internal carotid artery ICA”), the support tube (220) including a straight elongated body (222 in Fig. 1) and an inner tube passageway (PP [0046]: “As seen more clearly in detailed FIG. 2B, the access sheath 220 can have a sheath body 222 and an inner lumen 223 extending between a proximal end and a distal end region of the sheath body 222”); and
advancing a dilator (250 in Fig. 1) along the inner tube passageway (223 in Fig. 2B) of the support tube (220, PP [0062]: “The dilator 250 can be inserted into the access sheath 220 and then the two components can be inserted together over the sheath guidewire 270 into the artery”), wherein the dilator comprises:
an elongated body (252 in Fig. 1) extending between a proximal end and a distal end (elongated body 252 extends between proximal end 254 and distal end 256), to thereby guide the distal end of the elongated body (252) to emboli positioned the distance from the access site (PP [0062]: “The sheath dilator 250 allows for smooth insertion of the access sheath 220 through a puncture site in the arterial wall”).
However, Garrison et al. is silent on a preformed non-linear dilator which advances along the inner tube passageway to thereby cause a preformed non-linear distal portion of the preformed non-linear dilator to extend out from the support tube and reform into a preformed non-linear shape in the vessel, wherein the preformed non-linear dilator comprises:
an elongated body, wherein the elongated body including the preformed non-linear distal portion positioned adjacent the distal end, the preformed non-linear distal portion including the preformed non-linear shape that deforms to an approximately linear shape when extending along the inner tube passageway of the support tube, the preformed non-linear distal portion reforming into the preformed non-linear shape when extending out from the inner tube passageway into the vessel.
In the same field of dilator-sheath methods and assemblies for insertion into a vasculature of a patient (see Fig. 7A, PP [0005]: “Embodiments relate to a catheter introducer system for accessing a blood vessel”), Haarer teaches an assembly (see Fig. 1) including a preformed non-linear dilator (103 including core 102 in Fig. 4A, PP [0051]: “The dilator lumen 106 defines a diameter that is operable to slidingly receive the core 102 therein”, PP [0060]: “FIGS. 2A-5E are side views of five cores 102a-e each having a core distal end 109a-e defining a different core curve 118a-e”) and a support tube (113 in Fig. 7A), and further teaches wherein the preformed non-linear dilator (103 including core 102 in Fig. 4A) advances along an inner tube passageway of the support tube (see Fig. 7A, PP [0075]: “The sheath 113 further includes a sheath lumen 116 extending from the sheath proximal end 110 to the sheath distal end 107, therethrough. The sheath lumen 116 defines a diameter that is operable to slidingly receive the dilator 103 therein and to allow the sheath 113 to advance over the dilator 103”) to thereby cause a preformed non-linear distal portion (104 in Fig. 5, PP [0077]: “The core distal end 109 is provided with a predetermined core curve 118 that is operable to impart a curve to the dilator distal end 104 and to provide support thereto”) of the preformed non-linear dilator (103 including core 102 in Fig. 4A) to extend out from the support tube (113 in Fig. 7A) and reform into a preformed non-linear shape in the vessel (PP [0079]: “The core curve 118 of the core distal end 109 is as least partially suppressed, that is, the core distal end 109 is at least partially straightened, while moving through the sheath 113. The core curve 118 of the core distal end 109 is substantially expressed once the core distal end 109 is outside of the confines of the sheath 113”), wherein the preformed non-linear dilator (103 including core 102 in Fig. 4A) comprises:
an elongated body (see body of dilator 103 in Fig. 5) including the preformed non-linear distal portion positioned adjacent the distal end (104), the preformed non-linear distal portion (104) including the preformed non-linear shape that deforms to an approximately linear shape when extending along the inner tube passageway of the support tube (113 in Fig. 7A, PP [0077]: “The core distal end 109 is provided with a predetermined core curve 118 that is operable to impart a curve to the dilator distal end 104 and to provide support thereto”, PP [0079]: “The core curve 118 of the core distal end 109 is as least partially suppressed, that is, the core distal end 109 is at least partially straightened, while moving through the sheath 113”), the preformed non-linear distal portion (104) reforming into the preformed non-linear shape when extending out from the inner tube passageway into the vessel (PP [0079]: “The core curve 118 of the core distal end 109 is substantially expressed once the core distal end 109 is outside of the confines of the sheath 113”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Garrison et al. method to include the preformed non-linear dilator as taught by Haarer. One of ordinary skill in the art would have been motivated to perform this modification in order to improve the Garrison et al. dilator’s ability to “[traverse] torturous blood vessels” (PP [0003] of Haarer), and furthermore because such a modification would constitute the application of a known technique (the use of a pre-curved dilator and core combination as taught by Haarer) to improve a similar method (the method of Garrison et al.) in the same way. One of ordinary skill in the art could have applied the improvement as taught by Haarer to the method of Garrison et al. and the results would have been predictable because the Haarer and Garrison et al. disclosures are both concerned with the advancement of a dilator through the vasculature of a patient (Garrison et al. PP [0043]: “the access systems described herein may be used to deliver working devices to a target vessel of a coronary anatomy, or other vasculature anatomy”, Haarer PP [0001]: “the disclosure relates to dilator and catheter introducer systems and methods for traversing tortuous blood vessels”), and additionally Garrison et al. contemplates the use of “one or more dilators 250” (see PP [0055] of Garrison et al.). The incorporation of the preformed non-linear as taught by Haarer would have resulted in an improved system and method more efficient at traversing torturous vasculature without damage to the surrounding vessels (Haarer PP [0003]: “the tip of the sheath may abut and damage the blood vessel. What is needed in the art is a dilator system capable of traversing tortuous blood vessels, and a catheter introducer system including the dilator system that is capable of traversing tortuous blood vessels”).
Regarding claim 13, Garrison et al. as modified by Haarer further discloses positioning the distal end of the elongated body (252 in Fig. 1 of Garrison et al., see also body of dilator 103 in Fig. 5 of Haarer) at or adjacent the distance along the vessel (Garrison et al. PP [0062]: “The sheath dilator 250 allows for smooth insertion of the access sheath 220 through a puncture site in the arterial wall. The dilator 250 can be inserted into the access sheath 220 and then the two components can be inserted together over the sheath guidewire 270 into the artery The distal end 256 of the dilator 250 can be generally tapered to allow the dilator 250 to dilate the needle puncture site as it is being inserted through the arterial wall into the artery”).
Regarding claim 14, Garrison et al. as modified by Haarer further discloses aspirating, along the preformed non-linear distal portion (103 with core 102 in Fig. 4A of Haarer, see bend 104 in Fig. 5), at least one emboli (Garrison et al. PP [0061]: “The flush line 236 can also be used as a second point of aspiration during portions of the procedure”, PP [0112]: “a low level of aspiration to be used during steps in the procedure that are high risk of causing distal emboli, for example crossing the lesion or when flow is restored to the vessel when a retrievable stent device is expanded”).
Regarding claim 15, Garrison et al. as modified by Haarer further discloses delivering, from the preformed non-linear distal portion or the support tube (220 in Fig. 1 of Garrison et al.), a fluid into the vessel (PP [0061]: “The hemostasis valve 234 can include a flush line 236 or a connection to a flush line 236 so that the sheath 220 can be flushed with saline or radiopaque contrast during the procedure as desired”).
Regarding claim 16, Garrison et al. as modified by Haarer further discloses retracting the preformed non-linear distal portion of the preformed non-linear dilator (104 in Fig. 5 of Haarer, see dilator 103 and 102 in Fig. 4A) into the inner tube passageway (PP [0074]: “After the sheath 113 is properly placed within the blood vessel, the dilator system 100 is withdrawn from the sheath 113, with the sheath 113 remaining to provide a conduit for introducing a catheter into the blood vessel”) to thereby cause the preformed non-linear distal portion (104 in Fig. 5) to form an approximately linear shape (PP [0079]: “The core curve 118 of the core distal end 109 is as least partially suppressed, that is, the core distal end 109 is at least partially straightened, while moving through the sheath 113”).
Regarding claim 17, Garrison et al. as modified by Haarer further discloses wherein the support tube (220 in Fig. 1 of Garrison et al.) is formed of a first material that is more rigid (PP [0058]: “the remaining portion of the sheath body 222 has a flexural stiffness in the range 500 to 1500 N-mm2”) than a second material forming at least the preformed non-linear distal portion of the dilator (PP [0064]: “the distal section of the first dilator has a bending stiffness in the range of 50 to 100 N-mm2”, Haarer PP [0028]: “A dilator is relatively less stiff than a sheath in accordance with constructs presented therein”).
Regarding claim 18, Garrison et al. as modified by Haarer further discloses wherein the preformed non-linear distal portion (104 in Fig. 5 of dilator including 103 and 102 in Fig. 4A of Haarer) is formed out of a shape memory material or a nitinol material (PP [0032]: “Stainless steel and nitinol are examples of metals that may be used to form a core”, 102 comprises nitinol which is a shape memory material).
Regarding claim 19, Garrison et al. as modified by Haarer further discloses wherein the shape of the preformed non-linear distal portion (104 in Fig. 5 of Haarer, see dilator 103 and 102 in Fig. 4A) includes an L-shape and/or an approximately 90 degree bend (see annotated Fig. 2B below with embodiment bend, the distal end of the core wire bends approximately 90 degrees to form an L-shape).
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Regarding claim 21, Garrison et al. as modified by Haarer further discloses wherein the shape of the preformed non-linear distal portion (104 in Fig. 5 of Haarer) includes a distal length of the elongate body (252 in Fig. 1 of Garrison et al., see body of 103 in Fig. 5) extending at an angle relative to the support tube (see bend 104 in Fig. 5 and core 102 bends in Figs. 2B-E, a distal length of the elongate body extends at an angle relative to the support tube 113, see also Fig. 7A).
Regarding claim 22, Garrison et al. as modified by Haarer further discloses wherein the distal length (252 in Fig. 1 of Garrison et al., see body of 103 in Fig. 7A of Haarer extending beyond the support tube 113) extends a length that is approximately the same as the distance (see Fig. 7A, the distal length of the dilator 103 and 102 extending beyond the support tube 113 extends through the vasculature to a target area, which is a distance away from an access site, and therefore the distal length extends a length through the vasculature that is approximately the same as the distance).
Regarding claim 23, Garrison et al. as modified by Haarer further discloses wherein the preformed non-linear distal portion (104 in Fig. 5 of Haarer, see dilator 103 and 102 in Fig. 4A, see also dilator 250 in Fig. 1 of Garrison et al.) is steerable such that a position of the distal end is controllable within the vessel (Haarer PP [0063]: “the core 102 may be of the type that is steerable, such as by utilizing active steering mechanisms that are known in the art for steering catheters”, by steering the core 102 within the dilator 103, the preformed non-linear distal portion of the dilator is steerable).
Regarding claim 24, Garrison et al. as modified by Haarer further discloses wherein an inner diameter of the elongated body (252 in Fig. 1 of Garrison et al., see dilator 103 and 102 in Fig. 1 of Haarer with lumens 106 and 111) is sized to allow passage of emboli therealong (106 and 111 are sized to allow the passage of emboli, see MPEP 2112.01).
Regarding claim 25, Garrison et al. as presently modified by Haarer fails to disclose wherein an inner diameter of the elongated body is approximately 10 French to approximately 14 French, since the Garrison et al. device is intended for use within the neurovasculature (see abstract of Garrison et al.) and instead utilizes a support tube comprising an outer diameter between 5 and 7 Fr (PP [0013]).
In the same field of dilator-sheath methods and assemblies for insertion into a vasculature of a patient (see Fig. 7A, PP [0005]: “Embodiments relate to a catheter introducer system for accessing a blood vessel”), Haarer further teaches wherein “the dilator 103 includes a dilator lumen 106 with a diameter of about 0.5 mm to about 4 mm, about 2 mm to about 3 mm or about 2.5 mm to about 2.90 mm” (PP [0052], 10 Fr is equivalent to about 3.33 mm, which is within the range of 0.5-4 mm as taught by Haarer).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have further modified the Garrison et al. and Haarer combination according to Haarer to incorporate the inner diameter of the elongated body as claimed. One of ordinary skill in the art would have been motivated to perform this modification since it has been held that variations in shape are a matter of choice and only involves routine skill in the art (see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966), see MPEP 2144.04). Modifying the elongated body of Garrison et al. to further incorporate the inner diameter as taught by Haarer would not have changed the intended operation of the Garrison et al. system because Garrison et al. contemplates that “one or more components of the access systems described herein may be used to deliver working devices to a target vessel of a coronary anatomy, or other vasculature anatomy” (PP [0043]), rendering the device of Garrison et al. suitable for upscaling and use in larger vascular anatomy.
Regarding claim 26, Garrison et al. as modified by Haarer further discloses wherein the distal end of the preformed non-linear dilator (250 in Fig. 1 of Garrison et al., see 103 and 102 in Fig. 4A of Haarer) includes a smooth and/or rounded end (256 in Fig. 1 of Garrison et al. is smooth and tapered, 103 in Fig. 1 of Haarer also has a smooth tapered distal end).
Claims 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Garrison et al. (US PGPub 2018/0064452 A1) in view of Haarer (US PGPub 2016/0001045 A1), as applied to claims 1 and 12 above, respectively, and further in view of Mathena ().
Regarding claim 5, Garrison et al. as modified by Haarer fails to disclose wherein the shape of the preformed non-linear distal portion includes an S-shape.
In the related field of curved accessory sheaths (abstract), related in that accessory sheaths are also intended for use within torturous vasculature (PP [0002]: “the disclosure relates to dilator and catheter introducer systems and methods for traversing blood vessels and organs”) in order to facilitate navigation to a target area (PP [0022]: “At least some of the present embodiments utilize an accessory sheath that is an elongated tubular member defining a default shape with one or more curves, the curvature of which may: (i) be altered (e.g., reduced) to facilitate insertion and/or removal of the accessory sheath into and along a patient's blood vessel to a desired location”), Mathena et al. teaches a preformed non-linear sheath (400 in Fig. 4, PP [0047]: “the accessory sheath 400 (e.g., at least the curved section 440) is shaped with or otherwise configured to adopt its default shape by a shape memory material (SMM) included in the accessory sheath body portion 404”) comprising a preformed non-linear distal portion (440), wherein the shape of the preformed non-linear distal portion includes an S-shape (see Fig. 6, PP [0041]: “In the embodiment shown, the default shape of the curved section 440 includes, from a proximal portion of the curved section 440 and extending toward a distal portion of the curved section 440 (e.g., toward accessory sheath distal end 412): a first curved segment 444 having a first radius of curvature 448; a second curved segment 452 with a second radius of curvature 456; and a third curved segment 460 with a third radius of curvature 464”, the three radii of curvature denote an S-shape when observed from a plane behind the Fig. 6 perspective, i.e. looking “out” of the page).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Garrison et al. and Haarer combination to further include the teachings of Mathena and incorporate wherein the shape of the preformed non-linear distal portion includes an S-shape. One of ordinary skill in the art would have been motivated to perform this modification because it is a simple substitution of curvatures that would have yielded predictable results. Although the Mathena disclosure applies the curvature of Fig. 6 to an accessory sheath, and not a dilator, one of ordinary skill in the art would have recognized that the motivations to apply the claimed curvature would be the same, as Mathena is also concerned with creating a device that is “shaped with or otherwise configured to adopt a default shape in the absence of a shape-altering force or structure such that the default shape may correspond to a desired location for a medical intervention within the patient's circulatory system” (PP [0004], see Garrison et al. PP [0003]: “the present disclosure relates to methods and systems for navigating complex anatomy to perform rapid and safe aspiration and removal of cerebral occlusions”, see Haarer PP [0061]: “the core curves 118 may define any shape suitable for the particular purpose of supporting a dilator 103 to track a bend in a blood vessel”). Modifying the combination as proposed to incorporate the S-shape bend of Mathena would have simply been a routine variation in shape involving only routine skill in the art (see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966), see MPEP 2144.04), particularly since Haarer contemplates that “[t]he curve of a component may be formed in one or more planes or in three-dimensional configurations and each component (e.g., dilator or core) can include none (straight), one, or more than one curve” (PP [0034]).
Regarding claim 20, Garrison et al. as modified by Haarer fails to disclose wherein the shape of the preformed non-linear distal portion includes an S-shape.
In the related field of curved accessory sheaths (abstract), related in that accessory sheaths are also intended for use within torturous vasculature (PP [0002]: “the disclosure relates to dilator and catheter introducer systems and methods for traversing blood vessels and organs”) in order to facilitate navigation to a target area (PP [0022]: “At least some of the present embodiments utilize an accessory sheath that is an elongated tubular member defining a default shape with one or more curves, the curvature of which may: (i) be altered (e.g., reduced) to facilitate insertion and/or removal of the accessory sheath into and along a patient's blood vessel to a desired location”), Mathena et al. teaches a preformed non-linear sheath (400 in Fig. 4, PP [0047]: “the accessory sheath 400 (e.g., at least the curved section 440) is shaped with or otherwise configured to adopt its default shape by a shape memory material (SMM) included in the accessory sheath body portion 404”) comprising a preformed non-linear distal portion (440), wherein the shape of the preformed non-linear distal portion includes an S-shape (see Fig. 6, PP [0041]: “In the embodiment shown, the default shape of the curved section 440 includes, from a proximal portion of the curved section 440 and extending toward a distal portion of the curved section 440 (e.g., toward accessory sheath distal end 412): a first curved segment 444 having a first radius of curvature 448; a second curved segment 452 with a second radius of curvature 456; and a third curved segment 460 with a third radius of curvature 464”, the three radii of curvature denote an S-shape when observed from a plane behind the Fig. 6 perspective, i.e. looking “out” of the page).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Garrison et al. and Haarer combination to further include the teachings of Mathena and incorporate wherein the shape of the preformed non-linear distal portion includes an S-shape. One of ordinary skill in the art would have been motivated to perform this modification because it is a simple substitution of curvatures that would have yielded predictable results. Although the Mathena disclosure applies the curvature of Fig. 6 to an accessory sheath, and not a dilator, one of ordinary skill in the art would have recognized that the motivations to apply the claimed curvature would be the same, as Mathena is also concerned with creating a device that is “shaped with or otherwise configured to adopt a default shape in the absence of a shape-altering force or structure such that the default shape may correspond to a desired location for a medical intervention within the patient's circulatory system” (PP [0004], see Garrison et al. PP [0003]: “the present disclosure relates to methods and systems for navigating complex anatomy to perform rapid and safe aspiration and removal of cerebral occlusions”, see Haarer PP [0061]: “the core curves 118 may define any shape suitable for the particular purpose of supporting a dilator 103 to track a bend in a blood vessel”). Modifying the combination as proposed to incorporate the S-shape bend of Mathena would have simply been a routine variation in shape involving only routine skill in the art (see In re Dailey, 357 F.2d 669, 149 USPQ (CCPA 1966), see MPEP 2144.04), particularly since Haarer contemplates that “[t]he curve of a component may be formed in one or more planes or in three-dimensional configurations and each component (e.g., dilator or core) can include none (straight), one, or more than one curve” (PP [0034]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Moriyama et al. (US PGPub 2021/0393324 A1) teaches a dilator and sheath system for use within the vasculature (abstract), wherein the dilator (104 in Fig. 1) comprises a steerable curve (PP [0035]: “The dilator 104 can optionally have a fixed curve, or can be steerable (i.e. the curve can be changed, optionally in more than one plane). The dilator 104 can optionally be flexible, to allow it to be compatible with a steerable sheath”).
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771